WorldWideScience

Sample records for regulatory perspectives based

  1. Risk-based regulation: A regulatory perspective

    International Nuclear Information System (INIS)

    Scarborough, J.C.

    1993-01-01

    In the early development of regulations for nuclear power plants, risk was implicitly considered through qualitative assessments and engineering reliability principles and practices. Examples included worst case analysis, defense in depth, and the single failure criterion. However, the contributions of various systems, structures, components and operator actions to plant safety were not explicitly assessed since a methodology for this purpose had not been developed. As a consequence of the TMI accident, the use of more quantitative risk methodology and information in regulation such as probabilistic risk analysis (PRA) increased. The use of both qualitative and quantitative consideration of risk in regulation has been a set of regulations and regulatory guides and practices that ensure adequate protection of public health and safety. Presently, the development of PRA techniques has developed to the point that safety goals, expressed in terms of risk, have been established to help guide further regulatory decision making. This paper presents the personal opinions of the author as regards the use of risk today in nuclear power plant regulation, areas of further information needs, and necessary plans for moving toward a more systematic use of risk-based information in regulatory initiatives in the future

  2. Performance-Based (Risk-Informed) Regulation: A Regulatory Perspective

    International Nuclear Information System (INIS)

    Kadambi, N. Prasad

    2005-01-01

    Performance-based regulation (PBR) has been mandated at the national level in the United States and at the agency level, where appropriate, at the U.S. Nuclear Regulatory Commission (USNRC). Guidance has been developed that implements the USNRC's definitions of PBR and other such conceptual regulatory improvements. This paper describes why PBR is important, what constitutes PBR in the context of direction provided at the USNRC, and how PBR can be implemented using a five-step process. The process steps articulate questions to be posed by the analyst regarding various aspects of a regulatory issue so that a suitably performance-based resolution can be developed. A regulatory alternative thus developed can be included among other options to be considered as part of the regulatory decision-making process

  3. BIOSENSORS FOR ENVIRONMENTAL MONITORING: A REGULATORY PERSPECTIVE

    Science.gov (United States)

    Biosensors show the potential to complement laboratory-based analytical methods for environmental applications. Although biosensors for potential environmental-monitoring applications have been reported for a wide range of environmental pollutants, from a regulatory perspective, ...

  4. Regulatory perspectives of concept assessment

    International Nuclear Information System (INIS)

    Flavelle, Peter A.

    1987-09-01

    The Atomic Energy Control Board is the head agency for the regulatory review of the Assessment of the Canadian Concept for Nuclear Fuel Waste Disposal being done by Atomic Energy of Canada Limited and Ontario Hydro. This paper describes the regulatory perspective of how the Concept Assessment could demonstrate the feasibility of a disposal conforming to regulatory requirements. The long-term aspects of Concept Assessment encourage the use of various predictive techniques for different time scales. Each technique will have a different potential for establishing confidence in the predictions. The predicted performance of a facility during operation should have a very high confidence, as it can be based on standard engineering calculations and the predictions can be validated later by monitoring during operation. The predictions of the transient period following closure of the facility should achieve a medium level of confidence, since they can be based on extrapolations of predictions of operational performance, using models that can be calibrated with monitoring data and with averaged input data derived from natural analog studies. Predictions based on fundamental processes will have a medium level of confidence when made to intermediate times after closure. Long-term predictions using generic or typical input data or Monte Carlo calculations of simplified models will have the least confidence and yet they can still contribute to the confidence that the disposal concept will conform to regulatory requirements

  5. Probabilistic safety assessment - regulatory perspective

    International Nuclear Information System (INIS)

    Solanki, R.B.; Paul, U.K.; Hajra, P.; Agarwal, S.K.

    2002-01-01

    Full text: Nuclear power plants (NPPs) have been designed, constructed and operated mainly based on deterministic safety analysis philosophy. In this approach, a substantial amount of safety margin is incorporated in the design and operational requirements. Additional margin is incorporated by applying the highest quality engineering codes, standards and practices, and the concept of defence-in-depth in design and operating procedures, by including conservative assumptions and acceptance criteria in plant response analysis of postulated initiating events (PIEs). However, as the probabilistic approach has been improved and refined over the years, it is possible for the designer, operator and regulator to get a more detailed and realistic picture of the safety importance of plant design features, operating procedures and operational practices by using probabilistic safety assessment (PSA) along with the deterministic methodology. At present, many countries including USA, UK and France are using PSA insights in their decision making along with deterministic basis. India has also made substantial progress in the development of methods for carrying out PSA. However, consensus on the use of PSA in regulatory decision-making has not been achieved yet. This paper emphasises on the requirements (e.g.,level of details, key modelling assumptions, data, modelling aspects, success criteria, sensitivity and uncertainty analysis) for improving the quality and consistency in performance and use of PSA that can facilitate meaningful use of the PSA insights in the regulatory decision-making in India. This paper also provides relevant information on international scenario and various application areas of PSA along with progress made in India. The PSA perspective presented in this paper may help in achieving consensus on the use of PSA for regulatory / utility decision-making in design and operation of NPPs

  6. A Process Perspective on Regulation: A Grounded Theory Study into Regulatory Practice in Newly Liberalized Network-Based Markets

    NARCIS (Netherlands)

    Ubacht, J.

    The transition from a former monopolistic towards a more competitive market in
    newly liberalized network-based markets raises regulatory issues. National Regulatory Authorities (NRA) face the challenge to deal with these issues in order to guide the transition process. Although this transition

  7. Prioritization of chemicals in the aquatic environment based on risk assessment: analytical, modeling and regulatory perspective.

    Science.gov (United States)

    Guillén, D; Ginebreda, A; Farré, M; Darbra, R M; Petrovic, M; Gros, M; Barceló, D

    2012-12-01

    The extensive and intensive use of chemicals in our developed, highly technological society includes more than 100,000 chemical substances. Significant scientific evidence has lead to the recognition that their improper use and release may result in undesirable and harmful side-effects on both the human and ecosystem health. To cope with them, appropriate risk assessment processes and related prioritization schemes have been developed in order to provide the necessary scientific support for regulatory procedures. In the present paper, two of the elements that constitute the core of risk assessment, namely occurrence and hazard effects, have been discussed. Recent advances in analytical chemistry (sample pre-treatment and instrumental equipment, etc.) have allowed for more comprehensive monitoring of environmental pollution reaching limits of detection up to sub ng L(-1). Alternative to analytical measurements, occurrence models can provide risk managers with a very interesting approach for estimating environmental concentrations from real or hypothetical scenarios. The most representative prioritization schemes used for issuing lists of concerning chemicals have also been examined and put in the context of existing environmental policies for protection strategies and regulations. Finally, new challenges in the field of risk-assessment have been outlined, including those posed by new materials (i.e., nanomaterials), transformation products, multi-chemical exposure, or extension of the risk assessment process to the whole ecosystem. Copyright © 2012 Elsevier B.V. All rights reserved.

  8. Root cause - A regulatory perspective

    International Nuclear Information System (INIS)

    Huey, F.R.

    1990-01-01

    During the past 3 yr, US Nuclear Regulatory Commission (NRC) region V has been pursuing an initiative with region V power reactor licensees to provide improved and more consistent performance in event evaluation. The objectives of the initiative have been to encourage licensees to (a) develop improved skills within the plant organization for events evaluation, with particular emphasis on formal root-cause analysis, and (b) to increase the number of events subjected to root-cause analysis. The NRC's continuing effort now focuses on the need for more consistent quality of event evaluation by licensees. As current licensee programs continue to develop, the NRC will be paying additional attention to how well licensees maintain these programs as an effective and useful tool. Now that licensees have taken the initial steps to establish these programs, licensee management will need to provide continuing attention to ensure that the process does not become overly cumbersome. It is important that the final format for the root-cause programs be easy to use and recognized as being a valuable tool by all licensee personnel involved in the event evaluation process. This will become increasingly important as licensees expand the population of events requiring root-cause analysis and place additional responsibility on the line organization for the implementation of these programs

  9. Isotope production technologies from a regulatory perspective

    Energy Technology Data Exchange (ETDEWEB)

    Murthy, K. [Canadian Nuclear Safety Committee, Ottawa, Ontario (Canada)

    2012-07-01

    This paper discusses isotope production technologies from a regulatory perspective. The regulator is the CNSC which has the mandate to protect the health, safety and security of persons and the environment and to implement Canada's international commitments on the peaceful use of nuclear energy. Nuclear facilities regulated by CNSC include linear accelerator (medical), pool irradiator (industrial) and Pelletron (research) as well as cyclotrons.

  10. Perspectives on Regulatory T Cell Therapies.

    Science.gov (United States)

    Probst-Kepper, Michael; Kröger, Andrea; Garritsen, Henk S P; Buer, Jan

    2009-01-01

    Adoptive transfer in animal models clearly indicate an essential role of CD4+ CD25+ FOXP3+ regulatory T (T(reg)) cells in prevention and treatment of autoimmune and graft-versus-host disease. Thus, T(reg) cell therapies and development of drugs that specifically enhance T(reg) cell function and development represent promising tools to establish dominant tolerance. So far, lack of specific markers to differentiate human T(reg) cells from activated CD4+ CD25+ effector T cells, which also express FOXP3 at different levels, hampered such an approach. Recent identification of the orphan receptor glycoprotein-A repetitions predominant (GARP or LRRC32) as T(reg) cell-specific key molecule that dominantly controls FOXP3 via a positive feedback loop opens up new perspectives for molecular and cellular therapies. This brief review focuses on the role of GARP as a safeguard of a complex regulatory network of human T(reg) cells and its implications for regulatory T cell therapies in autoimmunity and graft-versus-host disease.

  11. Steering healthcare service delivery: a regulatory perspective.

    Science.gov (United States)

    Prakash, Gyan

    2015-01-01

    The purpose of this paper is to explore regulation in India's healthcare sector and makes recommendations needed for enhancing the healthcare service. The literature was reviewed to understand healthcare's regulatory context. To understand the current healthcare system, qualitative data were collected from state-level officials, public and private hospital staff. A patient survey was performed to assess service quality (QoS). Regulation plays a central role in driving healthcare QoS. India needs to strengthen market and institutional co-production based approaches for steering its healthcare in which delivery processes are complex and pose different challenges. This study assesses current healthcare regulation in an Indian state and presents a framework for studying and strengthening regulation. Agile regulation should be based on service delivery issues (pull approach) rather than monitoring and sanctions based regulatory environment (push approach). Healthcare pitfalls across the world seem to follow similar follies. India's complexity and experience is useful for emerging and developed economies. The author reviewed around 70 publications and synthesised them in healthcare regulatory contexts. Patient's perception of private providers could be a key input towards steering regulation. Identifying gaps across QoS dimensions would be useful in taking corrective measures.

  12. Safety culture from a regulatory perspective

    International Nuclear Information System (INIS)

    Dahlgren, K.

    1996-01-01

    The Swedish Nuclear Power Inspectorate, SKI, has in its regulatory approach to the area of management and organization focussed on the process of continuous improvement and have in collaboration with Battelle Human Affairs Research Center, Seattle, developed a conceptual model of the important characteristics of a continuous improvement organization and how to assess it. In this work SKI has also recognized the importance of the regulatory goals and strategies adopted by SKI for promoting an improvement process on the part of the utilities, which will be further discussed below. 15 refs

  13. Safety culture from a regulatory perspective

    Energy Technology Data Exchange (ETDEWEB)

    Dahlgren, K [Swedish Nuclear Power Inspectorate, Stockholm (Sweden)

    1997-12-31

    The Swedish Nuclear Power Inspectorate, SKI, has in its regulatory approach to the area of management and organization focussed on the process of continuous improvement and have in collaboration with Battelle Human Affairs Research Center, Seattle, developed a conceptual model of the important characteristics of a continuous improvement organization and how to assess it. In this work SKI has also recognized the importance of the regulatory goals and strategies adopted by SKI for promoting an improvement process on the part of the utilities, which will be further discussed below. 15 refs.

  14. Design reviews from a regulatory perspective

    International Nuclear Information System (INIS)

    Foster, B.D.

    1991-01-01

    This paper presents views on the role of the licensing engineer in the design process with specific emphasis on design reviews and the automated information management tools that support design reviews. The licensing engineer is seen as an important member of a design review team. The initial focus of the licensing engineer during design reviews is shown to be on ensuring that applicable regulatory requirements are addressed by the design. The utility of an automated tool, such as a commitments management system, to support regulatory requirements identification is discussed. The next responsibility of the licensing engineer is seen as verifying that regulatory requirements are transformed into measurable performance requirements. Performance requirements are shown to provide the basis for developing detailed design review criteria. Licensing engineer input during design reviews is discussed. This input is shown to be especially critical in cases where review findings may impact application of regulatory requirements. The use of automated tools in supporting design reviews is discussed. An information structure is proposed to support design reviews in a regulated environment. This information structure is shown to be useful to activities beyond design reviews. Incorporation of the proposed information structure into the Licensing Support System is proposed

  15. Perspectives on Regulatory T Cell Therapies

    OpenAIRE

    Probst-Kepper, Michael; Kröger, Andrea; Garritsen, Henk S.P.; Buer, Jan

    2009-01-01

    Adoptive transfer in animal models clearly indicate an essential role of CD4+ CD25+ FOXP3+ regulatory T (Treg) cells in prevention and treatment of autoimmune and graft-versus-host disease. Thus, Treg cell therapies and development of drugs that specifically enhance Treg cell function and development represent promising tools to establish dominant tolerance. So far, lack of specific markers to differentiate human Treg cells from activated CD4+ CD25+ effector T cells, which also express FOXP3 ...

  16. Regulatory perspective on NAS recommendations for Yucca Mountain standards

    International Nuclear Information System (INIS)

    Brocoum, S.J.; Nesbit, S.P.; Duguid, J.A.; Lugo, M.A.; Krishna, P.M.

    1996-01-01

    This paper provides a regulatory perspective from the viewpoint of the potential licensee, the US Department of Energy (DOE), on the National Academy of Sciences (NAS) report on Yucca Mountain standards published in August 1995. The DOE agrees with some aspects of the NAS report; however, the DOE has serious concerns with the ability to implement some of the recommendations in a reasonable manner

  17. Hydrogen mitigation systems - a Canadian regulatory perspective

    International Nuclear Information System (INIS)

    Khosla, J.K.; Rizk, M.

    1997-01-01

    This is a discussion paper to examine the regulatory requirements that may be necessary for the design, operation and maintenance of the hydrogen mitigation systems. These systems (if deemed necessary to maintain the containment function), may be considered to be a part of the containment systems. Therefore, these requirements are derived mostly from the AECB Regulatory Document R-7, which specifies the requirements for containment systems for CANDU nuclear power plants. Some additional requirements, which are specific to these systems have also been included. These requirements relate to a systematic examination of the hazards of hydrogen, the design basis for the mitigation systems, their functional and design requirements, analytical support to justify their selection, and operating and testing requirements. The requirements for severe accident have not yet been developed. It is, however, anticipated that the design of the hydrogen mitigation system would be such that future requirement can be accommodated. These requirements are intended for application to the new reactors in Canada. For the existing reactors, their application will be subjected to practicability. (author)

  18. Biosimilars: a regulatory perspective from America.

    Science.gov (United States)

    Kay, Jonathan

    2011-05-12

    Biosimilars are protein products that are sufficiently similar to a biopharmaceutical already approved by a regulatory agency. Several biotechnology companies and generic drug manufacturers in Asia and Europe are developing biosimilars of tumor necrosis factor inhibitors and rituximab. A biosimilar etanercept is already being marketed in Colombia and China. In the US, several natural source products and recombinant proteins have been approved as generic drugs under Section 505(b)(2) of the Food, Drug, and Cosmetic Act. However, because the complexity of large biopharmaceuticals makes it difficult to demonstrate that a biosimilar is structurally identical to an already approved biopharmaceutical, this Act does not apply to biosimilars of large biopharmaceuticals. Section 7002 of the Patient Protection and Affordable Care Act of 2010, which is referred to as the Biologics Price Competition and Innovation Act of 2009, amends Section 351 of the Public Health Service Act to create an abbreviated pathway that permits a biosimilar to be evaluated by comparing it with only a single reference biological product. This paper reviews the processes for approval of biosimilars in the US and the European Union and highlights recent changes in federal regulations governing the approval of biosimilars in the US.

  19. TRUPACT-II, a regulatory perspective

    International Nuclear Information System (INIS)

    Gregory, P.C.; Spooner, O.R.

    1995-01-01

    The Transuranic Package Transporter II (TRUPACT-II) is a US Nuclear Regulatory Commission (NRC) certified Type B packaging for the shipment of contact-handled transuranic (CH-TRU) material by the US Department of Energy (DOE). The NRC approved the TRUPACT-II design as meeting the requirements of Title 10, Code of Federal Regulations, Part 71 (10 CFR 71) and issued Certificate of Compliance (CofC) Number 9218 to the DOE. There are currently 15 certified TRUPACT-IIs. Additional TRUPACT-IIs will be required to make more than 15,000 shipments of CH-TRU waste to the Waste Isolation Pilot Plant (WIPP) site near Carlsbad, New Mexico. The TRUPACT-II may also be used for the DOE inter-site and intra-site shipments of CH-TRU waste. The Land Withdrawal Act (Public Law 102-579), enacted by the US Congress, October 30, 1992, and an agreement between the DOE and the State of New Mexico, signed August 4, 1987, both stipulate that only NRC approved packaging may be used for shipments of TRU waste to the WIPP. Early in the TRUPACT-II development phase it was decided that the transportation system (tractor, trailer, and TRUPACT-II) should be highway legal on all routes without the need for oversize and/or overweight permits. In large measure, public acceptance of the DOE's efforts to safely transport CH-TRU waste depends on the public's perception that the TRUPACT-II is in compliance with all applicable regulations, standards, and quality assurance requirements. This paper addresses some of the numerous regulations applicable to Type B packaging, and it describes how the TRUPACT-II complies with these regulations

  20. Regulatory perspective on incomplete control rod insertions

    International Nuclear Information System (INIS)

    Chatterton, M.

    1997-01-01

    The incomplete control rod insertions experienced at South Texas Unit 1 and Wolf Creek are of safety concern to the NRC staff because they represent potential precursors to loss of shutdown margin. Even before it was determined if these events were caused by the control rods or by the fuel there was an apparent correlation of the problem with high burnup fuel. It was determined that there was also a correlation between high burnup and high drag forces as well as with rod drop time histories and lack of rod recoil. The NRC staff initial actions were aimed at getting a perspective on the magnitude of the problem as far as the number of plants and the amount of fuel that could be involved, as well as the safety significance in terms of shutdown margin. As tests have been performed and data has been analyzed the focus has shifted more toward understanding the problem and the ways to eliminate it. At this time the staff's understanding of the phenomena is that it was a combination of factors including burnup, power history and temperature. The problem appears to be very sensitive to these factors, the interaction of which is not clearly understood. The model developed by Westinghouse provides a possible explanation but there is not sufficient data to establish confidence levels and sensitivity studies involving the key parameters have not been done. While several fixes to the problem have been discussed, no definitive fixes have been proposed. Without complete understanding of the phenomena, or fixes that clearly eliminate the problem the safety concern remains. The safety significance depends on the amount of shutdown margin lost due to incomplete insertion of the control rods. Were the control rods to stick high in the core, the reactor could not be shutdown by the control rods and other means such as emergency boration would be required

  1. Risk-based Regulatory Evaluation Program methodology

    International Nuclear Information System (INIS)

    DuCharme, A.R.; Sanders, G.A.; Carlson, D.D.; Asselin, S.V.

    1987-01-01

    The objectives of this DOE-supported Regulatory Evaluation Progrwam are to analyze and evaluate the safety importance and economic significance of existing regulatory guidance in order to assist in the improvement of the regulatory process for current generation and future design reactors. A risk-based cost-benefit methodology was developed to evaluate the safety benefit and cost of specific regulations or Standard Review Plan sections. Risk-based methods can be used in lieu of or in combination with deterministic methods in developing regulatory requirements and reaching regulatory decisions

  2. Development Perspective of Regulatory Audit Code System for SFR Nuclear Safety Evaluation

    Energy Technology Data Exchange (ETDEWEB)

    Bae, Moo Hoon; Lee, Gil Soo; Shin, An Dong; Suh, Nam Duk [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

    2012-05-15

    A sodium-cooled fast reactor (SFR) in Korea is based on the KALIMER-600 concept developed by KAERI. Based on 'Long-term R and D Plan for Future Reactor Systems' which was approved by the Korea Atomic Energy Commission in 2008, the KAERI designer is scheduled to apply the design certification of the prototype SFR in 2017. In order to establish regulatory infrastructure for the licensing of a prototype SFR, KINS has develop the regulatory requirements for the demonstration SFR since 2010, and are scheduled to develop the regulatory audit code systems in regard to core, fuel, and system, etc. since 2012. In this study, the domestic code systems used for core design and safety evaluation of PWRs and the nuclear physics and code system for SFRs were briefly reviewed, and the development perspective of regulatory audit code system for SFR nuclear safety evaluation were derived

  3. Patient Preferences in Regulatory Benefit-Risk Assessments: A US Perspective.

    Science.gov (United States)

    Johnson, F Reed; Zhou, Mo

    Demands for greater transparency in US regulatory assessments of benefits and risks, together with growing interest in engaging patients in Food and Drug Administration regulatory decision making, have resulted in several recent regulatory developments. Although Food and Drug Administration's Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) have established patient-engagement initiatives, CDRH has proposed guidelines for considering quantitative data on patients' benefit-risk perspectives, while CDER has focused on a more qualitative approach. We summarize two significant studies that were developed in collaboration and consultation with CDER and CDRH. CDER encouraged a patient advocacy group to propose draft guidance on engaging patient and caregiver stakeholders in regulatory decision making for Duchenne muscular dystrophy. CDRH sponsored a discrete-choice experiment case study to quantify obese respondents' perspectives on "meaningful benefits." CDRH and CDER issued draft guidance in May and June 2015, respectively, on including patient-preference data in regulatory submissions. Both organizations face challenges. CDER is working on integrating qualitative data into existing evidence-based review processes and is exploring options for therapeutic areas not included on a priority list. CDRH has adopted an approach that requires patient-preference data to satisfy standards of valid scientific evidence. Although that strategy could facilitate integrating patient perspectives directly with clinical data on benefits and harms, generating such data requires building capacity. Copyright © 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  4. Status of nuclear regulatory research and its future perspectives

    International Nuclear Information System (INIS)

    Lee, J. I.; Kim, W. S.; Kim, M. W.

    1999-01-01

    A comprehensive investigation of the regulatory research comprising an examination of the research system, its areas and contents, and the goals and financial resources is undertaken. As a result of this study, the future direction of regulatory research and its implementation strategies are suggested to resolve the current issues emerging from this examination. The major issues identified in the study are; (a) an insufficient investment in nuclear regulatory and safety research, (b) an interfacial discrepancy between similar research areas, and (c) a limitation of utilizing research results. To resolve these issues, several measures are proposed : (1) developing a lead project to establish a comprehensive infrastructure for enhancing research cooperation between nuclear organizations including institutes, industry, and universities, with an aim to improve cooperation between projects and to strengthen overall coordination functions among research projects, (2) introducing a certification system on research outcome to promote the proliferation of both research results themselves and their application with a view to enhancing the research quality, (3) strengthening the cooperative system to promote the international cooperative research, and (4) digitalizing all documents and materials relevant to safety and regulatory research to establish KIMS (knowledge and information based management system). It is expected that the aforementioned measures suggested in this study will enhance the efficiency and effectiveness of both nuclear regulatory and safety research, if they are implemented after deliberating with the government and related nuclear industries in the near future

  5. Safety system upgrades to a research reactor: A regulatory perspective

    International Nuclear Information System (INIS)

    Lamarre, G.B.; Martin, W.G.

    2003-01-01

    The NRU (National Research Universal) reactor, located at the Chalk River Laboratories of Atomic Energy of Canada Limited (AECL), first achieved criticality November 3, 1957. AECL continues to operate NRU for research to support safety and reliability studies for CANDU reactors and as a major supplier of medical radioisotopes. Following a detailed systematic review and assessment of NRU's design and the condition of its primary systems, AECL formally notified the Canadian Nuclear Safety Commission's (CNSC) predecessor - the Atomic Energy Control Board - in 1992 of its intention to upgrade NRU's safety systems. AECL proposed seven major upgrades to provide improvements in shutdown capability, heat removal, confinement, and reactor monitoring, particularly during and after a seismic event. From a CNSC perspective, these upgrades were necessary to meet modern safety standards. From the start of the upgrades project, the CNSC provided regulatory oversight aimed at ensuring that AECL maintained a structured approach to the upgrades. The elements of the approach include, but are not limited to, the determination of project milestones and target dates; the formalization of the design process and project quality assurance requirements; the requirements for updated documentation, including safety reports, safety notes and commissioning reports; and the approval and authorization process. This paper details, from a regulatory perspective, the structured approach used in approving the design, construction, commissioning and subsequent operation of safety system upgrades for an existing and operating research reactor, including the many challenges faced when attempting to balance the requirements of the upgrades project with AECL's need to keep NRU operating to meet its important research and production objectives. (author)

  6. Regulatory systems-based licensing guidance documentation

    International Nuclear Information System (INIS)

    Delligatti, M.S.

    1991-01-01

    The US Nuclear Regulatory Commission (NRC) has developed a series of licensing guidance documents based on the regulatory requirements in Part 60 of Title 10 of the Code of Federal Regulations (10 CFR Part 60). This regulatory systems-based approach to licensing guidance documentation relies on the definition of the high-level waste repository in 10 CFR Part 60. A document which is important for the frame-work it gives to other programmatic licensing guidance is the Draft Regulatory Guide open-quotes Format and Content for the License Application for the High-Level Waste Repositoryclose quotes (FCRG). The FCRG describes a format and content acceptable to NRC for a high-level waste repository license application pursuant to the requirements of 10 CFR Part 60. Other licensing guidance documents will be compatible with the FCRG

  7. The European Regulatory Environment of RNA-Based Vaccines.

    Science.gov (United States)

    Hinz, Thomas; Kallen, Kajo; Britten, Cedrik M; Flamion, Bruno; Granzer, Ulrich; Hoos, Axel; Huber, Christoph; Khleif, Samir; Kreiter, Sebastian; Rammensee, Hans-Georg; Sahin, Ugur; Singh-Jasuja, Harpreet; Türeci, Özlem; Kalinke, Ulrich

    2017-01-01

    A variety of different mRNA-based drugs are currently in development. This became possible, since major breakthroughs in RNA research during the last decades allowed impressive improvements of translation, stability and delivery of mRNA. This article focuses on antigen-encoding RNA-based vaccines that are either directed against tumors or pathogens. mRNA-encoded vaccines are developed both for preventive or therapeutic purposes. Most mRNA-based vaccines are directly administered to patients. Alternatively, primary autologous cells from cancer patients are modified ex vivo by the use of mRNA and then are adoptively transferred to patients. In the EU no regulatory guidelines presently exist that specifically address mRNA-based vaccines. The existing regulatory framework, however, clearly defines that mRNA-based vaccines in most cases have to be centrally approved. Interestingly, depending on whether RNA-based vaccines are directed against tumors or infectious disease, they are formally considered gene therapy products or not, respectively. Besides an overview on the current clinical use of mRNA vaccines in various therapeutic areas a detailed discussion of the current regulatory situation is provided and regulatory perspectives are discussed.

  8. Upgrading Atucha 1 nuclear power plant. Regulatory perspective

    International Nuclear Information System (INIS)

    Caruso, G.

    1998-01-01

    Atucha 1 nuclear power plant has unique design and its commercial operation started in 1974. The upgrading decisions, the basis for an upgrading program and its status of implementation are presented. Regulatory decisions derived from the performance-based approach have the advantage that they enable balancing of the overall plant risk and identifying at different plant levels the areas where improvements are necessary. (author)

  9. Phylogeny based discovery of regulatory elements

    Directory of Open Access Journals (Sweden)

    Cohen Barak A

    2006-05-01

    Full Text Available Abstract Background Algorithms that locate evolutionarily conserved sequences have become powerful tools for finding functional DNA elements, including transcription factor binding sites; however, most methods do not take advantage of an explicit model for the constrained evolution of functional DNA sequences. Results We developed a probabilistic framework that combines an HKY85 model, which assigns probabilities to different base substitutions between species, and weight matrix models of transcription factor binding sites, which describe the probabilities of observing particular nucleotides at specific positions in the binding site. The method incorporates the phylogenies of the species under consideration and takes into account the position specific variation of transcription factor binding sites. Using our framework we assessed the suitability of alignments of genomic sequences from commonly used species as substrates for comparative genomic approaches to regulatory motif finding. We then applied this technique to Saccharomyces cerevisiae and related species by examining all possible six base pair DNA sequences (hexamers and identifying sequences that are conserved in a significant number of promoters. By combining similar conserved hexamers we reconstructed known cis-regulatory motifs and made predictions of previously unidentified motifs. We tested one prediction experimentally, finding it to be a regulatory element involved in the transcriptional response to glucose. Conclusion The experimental validation of a regulatory element prediction missed by other large-scale motif finding studies demonstrates that our approach is a useful addition to the current suite of tools for finding regulatory motifs.

  10. Some areas of concern in Indian PHWRs from regulatory perspective

    International Nuclear Information System (INIS)

    Gupta, V.K.

    1991-01-01

    The basic concern from regulatory perspective in the operation of Indian PHWRs is for radiation exposure to the occupational workers and to the members of public during normal operation as well as abnormal conditions. The radiation exposure to the occupational workers is the result of radiation conditions in the plant and the practices followed for operation and maintenance. Both technical and administrative actions are responsible in controlling the radiation exposures. As far as exposure to the members of public is concerned, integrity of heat transport and moderator systems, performance of the ventilation system and integrity of fuel cladding are important elements during normal operation and some of the anticipated operational occurrences. Containment systems play an important role in controlling the impact in public domain during accident conditions. Elaborate emergency preparedness plans ready in advance perfected and optimised through drills and exercises give an assurance that should a mishap occur requiring emergency action in the public domain, adequate and necessary actions to reduce the radiological consequences will be taken. In this context, four areas of interest are: Radiation Exposure of Occupational Workers, Fuel Performance, Containment Systems and Emergency Preparedness in Public Domain. (author)

  11. Some areas of concern in Indian PHWRs from regulatory perspective

    Energy Technology Data Exchange (ETDEWEB)

    Gupta, V K [Operating Plants Safety Division, Atomic Energy Regulatory Board, Bhabha Atomic Research Centre (BARC), Bombay (India)

    1991-04-01

    The basic concern from regulatory perspective in the operation of Indian PHWRs is for radiation exposure to the occupational workers and to the members of public during normal operation as well as abnormal conditions. The radiation exposure to the occupational workers is the result of radiation conditions in the plant and the practices followed for operation and maintenance. Both technical and administrative actions are responsible in controlling the radiation exposures. As far as exposure to the members of public is concerned, integrity of heat transport and moderator systems, performance of the ventilation system and integrity of fuel cladding are important elements during normal operation and some of the anticipated operational occurrences. Containment systems play an important role in controlling the impact in public domain during accident conditions. Elaborate emergency preparedness plans ready in advance perfected and optimised through drills and exercises give an assurance that should a mishap occur requiring emergency action in the public domain, adequate and necessary actions to reduce the radiological consequences will be taken. In this context, four areas of interest are: Radiation Exposure of Occupational Workers, Fuel Performance, Containment Systems and Emergency Preparedness in Public Domain. (author)

  12. Future time perspective, regulatory focus, and selection, optimization, and compensation: Testing a longitudinal model

    NARCIS (Netherlands)

    Baltes, B.B.; Wynne, K.; Sirabian, M.; Krenn, D.; Lange, A.H. de

    2014-01-01

    This study examines the behavioral processes through which future time perspective (FTP) and regulatory focus may influence coping behaviors in older workers. A three-wave longitudinal study was conducted to test a novel model, positing that FTP affects regulatory focus, which then influences the

  13. Generic antibiotic industries: Challenges and implied strategies with regulatory perspectives

    Directory of Open Access Journals (Sweden)

    M Venkatesh

    2011-01-01

    Full Text Available Ever since the discovery of antibiotics, the quality of human life greatly improved in the 20 th century. The discovery of penicillin transformed the medicine industry and initiated a search for a better antibiotic every time resulting in several synthetic and semi-synthetic antibiotics. Beginning with the 1937 sulfa drug tragedy, the drug regulations had a parallel growth along with the antibiotics and the antibiotic-based generic Pharma industries. This review article is focused on the scenario depicting current global Pharma industries based on generic antibiotics. Several regulatory aspects involved with these industries have been discussed along with the complexity of the market, issues that could affect their growth, their struggle for quality, and their compliance with the tightened regulations. With the skyrocketing commercialization of antibiotics through generics and the leveraging technologic renaissance, generic industries are involved in providing maximum safer benefits for the welfare of the people, highlighting its need today.

  14. Generic antibiotic industries: Challenges and implied strategies with regulatory perspectives

    Science.gov (United States)

    Venkatesh, M.; Bairavi, V. G.; Sasikumar, K. C.

    2011-01-01

    Ever since the discovery of antibiotics, the quality of human life greatly improved in the 20th century. The discovery of penicillin transformed the medicine industry and initiated a search for a better antibiotic every time resulting in several synthetic and semi-synthetic antibiotics. Beginning with the 1937 sulfa drug tragedy, the drug regulations had a parallel growth along with the antibiotics and the antibiotic-based generic Pharma industries. This review article is focused on the scenario depicting current global Pharma industries based on generic antibiotics. Several regulatory aspects involved with these industries have been discussed along with the complexity of the market, issues that could affect their growth, their struggle for quality, and their compliance with the tightened regulations. With the skyrocketing commercialization of antibiotics through generics and the leveraging technologic renaissance, generic industries are involved in providing maximum safer benefits for the welfare of the people, highlighting its need today.. PMID:21430959

  15. Systemic Approach to Safety from a Regulatory Perspective

    International Nuclear Information System (INIS)

    Edland, A.

    2016-01-01

    In Sweden and especially in the Swedish oversight of nuclear power plants there has been a strong commitment to the interactions between Man-Technology-Organization (MTO) for many years. Safety issues and the importance of working with these issues have often been highlighted in specific oversight actions. Since 30 years there has been a tradition and a development of experience in Sweden taking a systemic MTO approach to safety. Inspection teams have been created with both psychologists and technical expertise in order to cover the whole MTO perspective during oversight inspections at the nuclear power plants. Safety is based on preventive actions where both technology and human behaviour are taken into account. To do this, it is important to have knowledge about the different factors that influence the performance of individuals, groups and organizations. However, it is also important to remember to not only discuss humans, management and organizations in terms of their limitations, errors and shortcomings but also in terms of their strengths in stopping a chain of events, in learning, inventing and improving. Having an integrated view of safety, focussing on the relations between human, technology and organization (MTO) refers to a systemic perspective on how radiation safety are affected by the relationship between: Human’s abilities and limitations; Technical equipment and the surrounding environment; The organization and the opportunities this provides. The Section of Man-Technology-Organization in the Swedish authority consist today of 12 Human factors specialists with behaviour science education. The section is responsible for the oversight at nuclear power plants in many areas; safety management, leadership and organization, safety culture, competence assurance, fitness for duty, suitability, education and staffing, knowledge management, working conditions, MTO perspective/ergonomics of control room work and plant modification, incident analysis and risk

  16. Determinants to dose reduction in EMCCR - in regulatory perspective

    International Nuclear Information System (INIS)

    Mohan, V.; Venkataraman, S.; Venkataraman, R.; Sajeev, B.S.

    2006-01-01

    Indian PHWRs had experienced three en masse coolant channel replacement campaigns, (EMCCR) first in RAPS-2, next in MAPS-2 and the last in MAPS-1. The campaign is already in full swing at NAPS-1. At MAPS, two EMCCR campaigns were done in a span of four years. The collective dose consumption in the MAPS-1 campaign was only about 25 % that of MAPS-2, a commendable achievement. Based on the experience of RAPS-2 and MAPS-2 campaigns, AERB - through several regulatory means- had given directives for reduction in collective dose in MAPS-1 campaign which was successfully implemented. This paper analyses and quantifies the key factors that contributed to collective dose reduction in MAPS-1 EMCCR. These factors could be put to use in the on going NAPS and forthcoming KAPS campaigns. (author)

  17. Information resources in state regulatory agencies-a California perspective

    Energy Technology Data Exchange (ETDEWEB)

    DiZio, S.M. [California Environmental Protection Agency, Sacramento (United States)

    1990-12-31

    Various state regulatory agencies have expressed a need for networking with information gatherers/researchers to produce a concise compilation of primary information so that the basis for regulatory standards can be scientifically referenced. California has instituted several programs to retrieve primary information, generate primary information through research, and generate unique regulatory standards by integrating the primary literature and the products of research. This paper describes these programs.

  18. Regulatory compliance for a Yucca Mountain Repository: A performance assessment perspective

    International Nuclear Information System (INIS)

    Dyer, J.R.; Van Luik, A.E.; Gil, A.V.; Brocoum, S.J.

    1997-01-01

    The U.S. Department of Energy's Yucca Mountain Site Characterization Project is scheduled to submit a License Application in the year 2002. The License Application is to show compliance with the regulations promulgated by the U.S. Nuclear Regulatory Commission which implement standards promulgated by the U.S. Environmental Protection Agency. These standards are being revised, and it is not certain what their exact nature will be in term of either the performance measure(s) or the time frames that are to be addressed. This paper provides some insights pertaining to this regulatory history, an update on Yucca Mountain performance assessments, and a Yucca Mountain Site Characterization Project perspective on proper standards based on Project experience in performance assessment for its proposed Yucca Mountain Repository system. The Project's performance assessment based perspective on a proper standard applicable to Yucca Mountain may be summarized as follows: a proper standard should be straight forward and understandable; should be consistent with other standards and regulations; and should require a degree of proof that is scientifically supportable in a licensing setting. A proper standard should have several attributes: (1) propose a reasonable risk level as its basis, whatever the quantitative performance measure is chosen to be, (2) state a definite regulatory time frame for showing compliance with quantitative requirements, (3) explicitly recognize that the compliance calculations are not predictions of actual future risks, (4) define the biosphere to which risk needs to be calculated in such a way as to constrain potentially endless speculation about future societies and future human actions, and (5) have as its only quantitative requirement the risk limit (or surrogate performance measure keyed to risk) for the total system

  19. Time perspective and social preference in older and younger adults: Effects of self-regulatory fatigue.

    Science.gov (United States)

    Segerstrom, Suzanne C; Geiger, Paul J; Combs, Hannah L; Boggero, Ian A

    2016-09-01

    Socioemotional selectivity theory predicts that when perceived time in life is limited, people will prefer emotionally close social partners over less emotionally rewarding partners. Regulating social choices with regard to time perspective can make the best use of time with regard to well-being. However, doing so may depend on the self-regulatory capacity of the individual. Two studies, 1 with younger adults (N = 101) and 1 with younger (N = 42) and older (N = 39) adults, experimentally tested the effects of time perspective and self-regulatory fatigue on preferences for emotionally close partners and knowledgeable partners. In both studies and across younger and older adults, when self-regulatory fatigue was low, the perception of limited time resulted in a greater preference for close social partners relative to knowledgeable social partners. However, this shift was eliminated by self-regulatory fatigue. In Study 2, when fatigued, younger adults preferred close social partners to knowledgeable partners across time perspectives; older adults preferred close and knowledgeable partners more equally across time perspectives. These findings have implications for social decision-making and satisfaction among people who experience chronic self-regulatory fatigue. They also contradict previous suggestions that only younger adults are susceptible to self-regulatory fatigue. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

  20. Steam Generator tube integrity -- US Nuclear Regulatory Commission perspective

    International Nuclear Information System (INIS)

    Murphy, E.L.; Sullivan, E.J.

    1997-01-01

    In the US, the current regulatory framework was developed in the 1970s when general wall thinning was the dominant degradation mechanism; and, as a result of changes in the forms of degradation being observed and improvements in inspection and tube repair technology, the regulatory framework needs to be updated. Operating experience indicates that the current U.S. requirements should be more stringent in some areas, while in other areas they are overly conservative. To date, this situation has been dealt with on a plant-specific basis in the US. However, the NRC staff is now developing a proposed steam generator rule as a generic framework for ensuring that the steam generator tubes are capable of performing their intended safety functions. This paper discusses the current U.S. regulatory framework for assuring steam generator (SG) tube integrity, the need to update this regulatory framework, the objectives of the new proposed rule, the US Nuclear Regulatory Commission (NRC) regulatory guide (RG) that will accompany the rule, how risk considerations affect the development of the new rule, and some outstanding issues relating to the rule that the NRC is still dealing with

  1. Patient-Focused Benefit-Risk Analysis to Inform Regulatory Decisions: The European Union Perspective.

    Science.gov (United States)

    Mühlbacher, Axel C; Juhnke, Christin; Beyer, Andrea R; Garner, Sarah

    Regulatory decisions are often based on multiple clinical end points, but the perspectives used to judge the relative importance of those end points are predominantly those of expert decision makers rather than of the patient. However, there is a growing awareness that active patient and public participation can improve decision making, increase acceptance of decisions, and improve adherence to treatments. The assessment of risk versus benefit requires not only information on clinical outcomes but also value judgments about which outcomes are important and whether the potential benefits outweigh the harms. There are a number of mechanisms for capturing the input of patients, and regulatory bodies within the European Union are participating in several initiatives. These can include patients directly participating in the regulatory decision-making process or using information derived from patients in empirical studies as part of the evidence considered. One promising method that is being explored is the elicitation of "patient preferences." Preferences, in this context, refer to the individual's evaluation of health outcomes and can be understood as statements regarding the relative desirability of a range of treatment options, treatment characteristics, and health states. Several methods for preference measurement have been proposed, and pilot studies have been undertaken to use patient preference information in regulatory decision making. This article describes how preferences are currently being considered in the benefit-risk assessment context, and shows how different methods of preference elicitation are used to support decision making within the European context. Copyright © 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  2. Licensing of Generic Medicines: Are There Any Challenges Left? A Pharmaceutical Regulatory Perspective.

    Science.gov (United States)

    Borg, John Joseph; Tomasi, Paolo; Pani, Luca; Aislaitner, George; Pirozynski, Michal; Leufkens, Hubert; Melchiorri, Daniela

    2014-01-01

    When an innovative product (innovator) is not covered anymore by intellectual property rights, cheaper equivalent medicinal products (generic products) may be marketed and used in clinical practice. The regulation of generic products is well-established, and is primarily based on standard rules for quality, therapeutic equivalence requirements (the latter in most instances proven through a bioequivalence study), and safety data for the innovator. The extensive experience from bringing generic products to the market over the last decades allows the conclusion that they are well-accepted and provide a useful alternative option for cost-effective pharmacotherapy. While supporting this conclusion, there are a number of issues to be considered during the assessment of a generic product application. Six scenarios are described in total, from an efficacy and a safety perspective, where potential concerns with the current regulatory standards could arise in the approval of generic products. We also propose solutions to these scenarios in order to foster debate on these issues.

  3. The Dutch drug policy from a regulatory perspective

    NARCIS (Netherlands)

    Spapens, A.C.M.; Müller, T.; Van de Bunt, H.G.

    2015-01-01

    Starting in the 1970s, the Netherlands developed a regulatory regime for narcotic drugs by distinguishing between hashish and marihuana (“soft drugs”) and other drugs (“hard drugs”). The authorities decided to cease prosecuting the possession of consumer quantities of the former type and to allow

  4. Regulatory toxicology in the twenty-first century: challenges, perspectives and possible solutions.

    Science.gov (United States)

    Tralau, Tewes; Oelgeschläger, Michael; Gürtler, Rainer; Heinemeyer, Gerhard; Herzler, Matthias; Höfer, Thomas; Itter, Heike; Kuhl, Thomas; Lange, Nikola; Lorenz, Nicole; Müller-Graf, Christine; Pabel, Ulrike; Pirow, Ralph; Ritz, Vera; Schafft, Helmut; Schneider, Heiko; Schulz, Thomas; Schumacher, David; Zellmer, Sebastian; Fleur-Böl, Gaby; Greiner, Matthias; Lahrssen-Wiederholt, Monika; Lampen, Alfonso; Luch, Andreas; Schönfelder, Gilbert; Solecki, Roland; Wittkowski, Reiner; Hensel, Andreas

    2015-06-01

    The advent of new testing systems and "omics"-technologies has left regulatory toxicology facing one of the biggest challenges for decades. That is the question whether and how these methods can be used for regulatory purposes. The new methods undoubtedly enable regulators to address important open questions of toxicology such as species-specific toxicity, mixture toxicity, low-dose effects, endocrine effects or nanotoxicology, while promising faster and more efficient toxicity testing with the use of less animals. Consequently, the respective assays, methods and testing strategies are subject of several research programs worldwide. On the other hand, the practical application of such tests for regulatory purposes is a matter of ongoing debate. This document summarizes key aspects of this debate in the light of the European "regulatory status quo", while elucidating new perspectives for regulatory toxicity testing.

  5. Performance-based quality assurance: the regulatory viewpoint

    International Nuclear Information System (INIS)

    Sajaroff, Pedro M.

    2000-01-01

    This paper complements and upgrades a previous one recently presented, the aim is a further contribution to a wide dissemination of this new methodology and way of thinking. Modern quality management techniques emphasizes errors prevention instead of finding and correcting them, in line with the new generation of ISO-9000 documents. Performance-based QA is coherent with this 'right-first-time' attitude, resting on the managerial role (establishing and applying policies and instructions allowing to integrate quality objectives to everyday work) and on the responsibility of every single involved person (the attainment of such objectives). The contents of the final draft of the revised IAEA NUSS Code on QA -namely 'Quality Assurance for Safety in Nuclear Power Plants and other Nuclear Facilities', is based on that approach, so it is not perspective. The text only contains ten basic requirements, where the objective is improving nuclear safety through an improvement in the methods applied for attaining quality during design, construction, commissioning, operation and decommissioning of nuclear installations. These requirements are assigned to: 'Management' (QA programme; training and qualification; non-conformance control and corrective actions; document control and records); 'Performance' (work; design; procurement; inspection and testing for acceptance) and 'Assessment' (management self-assessment; independent assessment). The management is responsible for planning, organization, direction, control and support; the line groups are responsible for attaining quality; and the assessment group is responsible for analyzing the management's and the line groups' effectiveness. From the regulatory point of view in the performance context, operating organizations will have to demonstrate the effective fulfillment of QA requirements to the satisfaction of regulatory authorities. This is not a novel mechanism, it is usual within the regulatory performance approach. The Code is

  6. Future water table rise at Yucca Mountain: A regulatory perspective

    International Nuclear Information System (INIS)

    Coleman, N.M.

    1995-01-01

    The U.S. Nuclear Regulatory Commission staff has developed a program of Systematic Regulatory Analysis (SRA). The purpose of this program is to ensure that important technical issues related to compliance with 10 CFR Part 60 will be identified before receipt of a license application. A plan is being developed to review the U.S. Department of Energy's (DOE's) demonstration of compliance in the license application for each part of the regulation. Under the siting criteria of NRC's Part 60, one of the potentially adverse conditions is the possibility that the water table may rise high enough to saturate a repository in the unsaturated zone. DOE must evaluate this and other conditions in a license application for a geologic repository site. DOE's evaluation must show compliance with the requirements of Part 60 with reasonable assurance. This paper describes the NRC staff's preliminary plans to review DOE's demonstration of compliance, including assumptions about a future rise of the water table

  7. Transport of radioactive material in Bangladesh: a regulatory perspective

    International Nuclear Information System (INIS)

    Mollah, A.S.

    2004-01-01

    Radioactive material is transported in Bangladesh in various types of packages and by different modes of transport. The transport of radioactive materials involves a risk both for the workers and members of the public. The safe transport of radioactive material is ensured in Bangladesh by compliance with Nuclear Safety and Radiation Control (NSRC) Act-93 and NSRC Rules-97. The Bangladesh Atomic Energy Commission (BAEC) is the competent authority for the enforcement of the NSRC act and rules. The competent authority has established regulatory control at each stage to ensure radiation safety to transport workers, members of general public and the environment. An overview is presented of the activities related to the transport of radioactive material in Bangladesh. In particular, the applicable legislation, the scope of authority and the regulatory functions of the competent authority are discussed. The categories of radioactive materials transported and the packaging requirements for the safe transport of these radioactive materials are also described. (author)

  8. Enhancement of Nuclear Safety in Korea: A Regulatory Perspective

    International Nuclear Information System (INIS)

    Chung, K.Y.

    2016-01-01

    In the aftermath of Fukushima Daiichi accident in 2011 Korean regulatory body immediately performed special inspections on nuclear power plants (NPPs) and a research reactor in Korea, and issued an enforcement order for the licensees to implement fifty Fukushima action items to address the safety issues identified by the inspections. Subsequently, the licensees have established the implementation plans for resolution of the action items. By the implementation of the action items, the possibility of severe accident due to the extreme hazards has been greatly reduced and the capabilities to mitigate the severe accident, should it occur, have been upgraded. To improve the consistency and predictability of the regulation on severe accidents, Nuclear Safety and Security Commission (NSSC) the regulatory body in Korea, is revising the regulatory framework for severe accidents. The new framework will require the licensee to enhance the capabilities for prevention and mitigation of severe accidents in view of the defence in depth principle, to assess the radiological effects from the severe accidents, and to improve current accident management procedures and guidelines necessary for the prevention and mitigation of severe accidents. This rulemaking also considers the safety principles provided by the IAEA Vienna Declaration in 2015, which require new NPPs to prevent large radioactive releases. (author)

  9. The future regulatory environment - a South African perspective

    International Nuclear Information System (INIS)

    Van der Woude, S.; Leaver, J.; Metcalf, P.E.

    2000-01-01

    The South African nuclear regulatory authority, the National Nuclear Regulator, regulates nuclear fuel cycle facilities as well as a large variety of mining and minerals processing activities. The future political, social, economical and technological environment, within which these facilities operate, will present numerous challenges to those who will be regulating them. In our presentation the challenges to be fulfilled in discharging the regulatory function are discussed, particularly in the context of a country with a small nuclear programme and a substantial developing component. Amongst the challenges discussed are: As part of the growing internationalization, the need to harmonize standards applied in different countries and the need to balance standards and practice applied in developed countries with resources available in developing countries; The need to consider the impact on the environment and not only on human beings; The impact of rapid advances in information technology on regulation; The maintenance and development of the appropriate expertise in the face of uncertainties regarding the future of the nuclear industry; Public involvement; The demands by society for greater standards of safety but at the same time for more effective and cost-effective regulation; The need for regulators to match customer demands on operators in terms of quality, speed, flexibility and costs; The privatization of nuclear fuel cycle facilities; The increased trend for larger facilities to outsource work to smaller companies; and, The need to balance good practice considerations with quantitatively determined risks in regulatory decision-making. (author)

  10. The future regulatory environment - a South African perspective

    Energy Technology Data Exchange (ETDEWEB)

    Van der Woude, S.; Leaver, J.; Metcalf, P.E. [National Nuclear Regulator, Centurion (South Africa)

    2000-07-01

    The South African nuclear regulatory authority, the National Nuclear Regulator, regulates nuclear fuel cycle facilities as well as a large variety of mining and minerals processing activities. The future political, social, economical and technological environment, within which these facilities operate, will present numerous challenges to those who will be regulating them. In our presentation the challenges to be fulfilled in discharging the regulatory function are discussed, particularly in the context of a country with a small nuclear programme and a substantial developing component. Amongst the challenges discussed are: As part of the growing internationalization, the need to harmonize standards applied in different countries and the need to balance standards and practice applied in developed countries with resources available in developing countries; The need to consider the impact on the environment and not only on human beings; The impact of rapid advances in information technology on regulation; The maintenance and development of the appropriate expertise in the face of uncertainties regarding the future of the nuclear industry; Public involvement; The demands by society for greater standards of safety but at the same time for more effective and cost-effective regulation; The need for regulators to match customer demands on operators in terms of quality, speed, flexibility and costs; The privatization of nuclear fuel cycle facilities; The increased trend for larger facilities to outsource work to smaller companies; and, The need to balance good practice considerations with quantitatively determined risks in regulatory decision-making. (author)

  11. Adolescents’ and Parents’ Regulatory Focus as Determinants of Future Time Perspective on School and Professional Career

    NARCIS (Netherlands)

    Andre, L.; van Vianen, A.E.M.; Peetsma, T.T.D.

    2017-01-01

    Future time perspective (FTP) - individuals' orientation towards future goals and consideration of future consequences - is a successful motivator in education and work. This study is the first that integrates Regulatory focus (RF) theory with FTP theory to explore relationships between adolescents'

  12. A Glance on the Safety Culture in Industrial Gamma Radiography in the Philippines: Regulatory Body Perspective

    International Nuclear Information System (INIS)

    Borras, A.M.

    2016-01-01

    The current version of the Code of PNRI Regulations (CPR) Part 11 was published in the Official Gazette on 2010. It is just a year ahead of the publication of the IAEA Specific Safety Guide No. 11. In view of these, radiation safety culture in the practice of industrial gamma radiography was not yet fully introduced in the said national regulations in the country. However, it should not be a reflection that the radiation workers in the country specifically in the said field of practice do not exercise positive safety culture. The Nuclear Regulatory Division (NRD)—regulatory arm, although not yet separated from the Philippine Nuclear Research Institute (PNRI0) as mandated by law — the promotional organization, has a well established and systemic regulatory infrastructure. It is attested by several studies and reports, among others. This study aims to assess the status of the existing safety culture in the conduct of industrial gamma radiography in the country through personnel perception survey of the radiation workers, i.e., managers, radiation safety officers, radiographers and radiographer’s assistants, based on the IAEA five characteristics of safety culture stipulated in the IAEA Safety Guide No. GS-G-3.5, “The Management System for Nuclear Installations”. It is assessed by the NRD of the PNRI. Also, the study determines the existence of safety culture as to the perspective of NRD through observations on the conduct of radiographic operations and walk-through of the facility while using the three-level Schein Model, i.e., “artefacts”, “espoused values” and “basic assumptions” and document reviews, among others

  13. Maintenance of ageing CANDU reactors. A regulatory perspective

    International Nuclear Information System (INIS)

    Dunstan, T.

    1996-01-01

    The subject of this paper is, 'requirements for maintenance of ageing reactors from the perspective of a regulator', with a focus on the particular theme of; 'continuing safety assurance'. A major role of maintenance is to ensure the continuing reliability and effectiveness of safety related systems and equipment. Continuing safety assurance is an issue the Atomic Energy Control Board has been wrestling with for some time. From my perspective, much remains to be done before the AECB can be confident that Canadian nuclear plants have the necessary programs in place to achieve continuing safety assurance. To introduce the topic, it would be appropriate to say a few words about the AECB's position with respect to the situation at the Pickering NGS. Why did we blow the whistle last August and, what are we doing about it? (author)

  14. The "shoulds" and "should nots" of moral emotions: a self-regulatory perspective on shame and guilt.

    Science.gov (United States)

    Sheikh, Sana; Janoff-Bulman, Ronnie

    2010-02-01

    A self-regulatory framework for distinguishing between shame and guilt was tested in three studies. Recently, two forms of moral regulation based on approach versus avoidance motivation have been proposed in the literature. Proscriptive regulation is sensitive to negative outcomes, inhibition based, and focused on what we should not do. Prescriptive regulation is sensitive to positive outcomes, activation based, and focused on what we should do. In the current research, consistent support was found for shame's proscriptive and guilt's prescriptive moral underpinnings. Study 1 found a positive association between avoidance orientation and shame proneness and between approach orientation and guilt proneness. In Study 2, priming a proscriptive orientation increased shame and priming a prescriptive orientation increased guilt. In Study 3, transgressions most apt to represent proscriptive and prescriptive violations predicted subsequent judgments of shame and guilt, respectively. This self-regulatory perspective provides a broad interpretive framework for understanding and extending past research findings.

  15. Decommissioning of Australian nuclear facilities - a regulatory perspective

    International Nuclear Information System (INIS)

    Diamond, T.V.; Mabbott, P.E.; Lawrence, B.R.

    2000-01-01

    Decommissioning has been a key political, economic and technical issue for the nuclear industry in recent years as older nuclear facilities have been retired. The management of decommissioning is an important part of nuclear safety as the potential exists for occupational exposures that are several times those expected during normal operation. It involves pre-planning and preparatory measures, procedures and instructions, technical and safety assessments, technology for handling large volumes of radioactive material, cost analyses, and a complex decision process. A challenge for the Commonwealth Government regulatory body, the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA), is to allow the Commonwealth entities that operate nuclear facilities ample freedom to address the above, at the same time ensuring that international best practice is invoked to ensure safety. Accordingly, ARPANSA has prepared a regulatory guideline, first drafted by the Nuclear Safety Bureau in March 1997, that documents the process and the criteria that it uses when assessing an application from an operating organisation for a decommissioning licence. Copyright (2000) Australasian Radiation Protection Society Inc

  16. Confidential data in a competitive utility environment: A regulatory perspective

    Energy Technology Data Exchange (ETDEWEB)

    Vine, E.

    1996-08-01

    Historically, the electric utility industry has been regarded as one of the most open industries in the United States in sharing information but their reputation is being challenged by competitive energy providers, the general public, regulators, and other stakeholders. As the prospect of competition among electricity power providers has increased in recent years, many utilities have been requesting that the data they submit to their utility regulatory commissions remain confidential. Withholding utility information from the public is likely to have serious and significant policy implications with respect to: (1) consumer education, the pursuit of truth, mutual respect among parties, and social cooperation; (2) the creation of a fair market for competitive energy services; (3) the regulatory balance; (4) regional and national assessments of energy-savings opportunities; (5) research and development; and (6) evaluations of utility programs, plans, and policies. In a telephone survey of all public utility commissions (PUCs) that regulate electric and gas utilities in the U.S., we found that almost all PUCs have received requests from utility companies for data to be filed as confidential, and confidential data filings appear to have increased (both in scope and in frequency) in those states where utility restructuring is being actively discussed. The most common types of data submitted as confidential by utilities dealt with specific customer data, market data, avoided costs, and utility costs.

  17. Stability Testing of Herbal Drugs: Challenges, Regulatory Compliance and Perspectives.

    Science.gov (United States)

    Bansal, Gulshan; Suthar, Nancy; Kaur, Jasmeen; Jain, Astha

    2016-07-01

    Stability testing is an important component of herbal drugs and products (HDPs) development process. Drugs regulatory agencies across the globe have recommended guidelines for the conduct of stability studies on HDPs, which require that stability data should be included in the product registration dossier. From the scientific viewpoint, numerous chemical constituents in an herbal drug are liable to varied chemical reactions under the influence of different conditions during its shelf life. These reactions can lead to altered chemical composition of HDP and consequently altered therapeutic profile. Many reports on stability testing of HDPs have appeared in literature since the last 10 years. A review of these reports reveals that there is wide variability in temperature (-80 to 100 °C), humidity (0-100%) and duration (a few hours-36 months) for stability assessment of HDPs. Of these, only 1% studies are conducted in compliance with the regulatory guidelines for stability testing. The present review is aimed at compiling all stability testing reports, understanding key challenges in stability testing of HDPs and suggesting possible solutions for these. The key challenges are classified as chemical complexity and biochemical composition variability in raw material, selection of marker(s) and influences of enzymes. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  18. Novel excipients - Regulatory challenges and perspectives - The EU insight.

    Science.gov (United States)

    Kozarewicz, Piotr; Loftsson, Thorsteinn

    2018-05-21

    Novel excipients are indispensable in development of modern, advanced drug delivery systems and biotechnology-derived drugs. Although numerous novel excipients are developed for pharmaceutical use, they are not frequently seen in medicinal products due to the strict regulatory requirements and perception that their use makes new product evaluation more complex with risk of delays in the approval process. Regulators regard novel excipients as new substances and whenever new excipient is used in a formulation it must be subjected to full evaluation, similarly to the one required for new active substance. Consequently, the amount of information required in support of the regulatory approval (i.e. marketing authorization) is much more complex and comprehensive than for established excipients. This short review provides an insight into the use of novel excipients in medicinal products approved in the European Union. In addition, barriers and challenges in development of novel excipients are being discussed as well as means to overcome those barriers. Copyright © 2018 Elsevier B.V. All rights reserved.

  19. Regulatory perspective on future climates at Yucca Mountain

    International Nuclear Information System (INIS)

    Coleman, N.M.; Eisenberg, N.A.; Brooks, D.J.

    1996-01-01

    Current regulations of the U.S. Nuclear Regulatory Commission (NRC) require that any performance assessment supporting the license application for a high-level waste (HLW) repository must consider the potential for changes in hydrologic conditions caused by reasonably foreseeable climatic conditions. The requirement is important because the earth's climate will almost certainly change significantly during the thousands of years that disposed nuclear wastes will remain hazardous. More importantly, climate controls the range of precipitation, which in turn controls the rates of infiltration, deep percolation, and groundwater flux through a geologic repository located in an unsaturated environment. Therefore, future changes in climate could significantly influence waste isolation in a repository at Yucca Mountain

  20. Yersinia pestis and Yersinia pseudotuberculosis infection: a regulatory RNA perspective

    Science.gov (United States)

    Martínez-Chavarría, Luary C.; Vadyvaloo, Viveka

    2015-01-01

    Yersinia pestis, responsible for causing fulminant plague, has evolved clonally from the enteric pathogen, Y. pseudotuberculosis, which in contrast, causes a relatively benign enteric illness. An ~97% nucleotide identity over 75% of their shared protein coding genes is maintained between these two pathogens, leaving much conjecture regarding the molecular determinants responsible for producing these vastly different disease etiologies, host preferences and transmission routes. One idea is that coordinated production of distinct factors required for host adaptation and virulence in response to specific environmental cues could contribute to the distinct pathogenicity distinguishing these two species. Small non-coding RNAs that direct posttranscriptional regulation have recently been identified as key molecules that may provide such timeous expression of appropriate disease enabling factors. Here the burgeoning field of small non-coding regulatory RNAs in Yersinia pathogenesis is reviewed from the viewpoint of adaptive colonization, virulence and divergent evolution of these pathogens. PMID:26441890

  1. Colloid-facilitated radionuclide transport: a regulatory perspective

    Science.gov (United States)

    Dam, W. L.; Pickett, D. A.; Codell, R. B.; Nicholson, T. J.

    2001-12-01

    What hydrogeologic-geochemical-microbial conditions and processes affect migration of radionuclides sorbed onto microparticles or native colloid-sized radionuclide particles? The U.S. Nuclear Regulatory Commission (NRC) is responsible for protecting public health, safety, and the environment at numerous nuclear facilities including a potential high-level nuclear waste disposal site. To fulfill these obligations, NRC needs to understand the mechanisms controlling radionuclide release and transport and their importance to performance. The current focus of NRC staff reviews and technical interactions dealing with colloid-facilitated transport relates to the potential nuclear-waste repository at Yucca Mountain, Nevada. NRC staff performed bounding calculations to quantify radionuclide releases available for ground-water transport to potential receptors from a Yucca Mountain repository. Preliminary analyses suggest insignificant doses of plutonium and americium colloids could be derived from spent nuclear fuel. Using surface complexation models, NRC staff found that colloids can potentially lower actinide retardation factors by up to several orders of magnitude. Performance assessment calculations, in which colloidal transport of plutonium and americium was simulated by assuming no sorption or matrix diffusion, indicated no effect of colloids on human dose within the 10,000 year compliance period due largely to long waste-package lifetimes. NRC staff have identified information gaps and developed technical agreements with the U.S. Department of Energy (DOE) to ensure sufficient information will be presented in any potential future Yucca Mountain license application. DOE has agreed to identify which radionuclides could be transported via colloids, incorporate uncertainties in colloid formation, release and transport parameters, and conceptual models, and address the applicability of field data using synthetic microspheres as colloid analogs. NRC is currently

  2. Global Regulatory Differences for Gene- and Cell-Based Therapies

    DEFF Research Database (Denmark)

    Coppens, Delphi G M; De Bruin, Marie L; Leufkens, Hubert G M

    2017-01-01

    Gene- and cell-based therapies (GCTs) offer potential new treatment options for unmet medical needs. However, the use of conventional regulatory requirements for medicinal products to approve GCTs may impede patient access and therapeutic innovation. Furthermore, requirements differ between...... jurisdictions, complicating the global regulatory landscape. We provide a comparative overview of regulatory requirements for GCT approval in five jurisdictions and hypothesize on the consequences of the observed global differences on patient access and therapeutic innovation....

  3. NRC review of passive reactor design certification testing programs: Overview and regulatory perspective

    International Nuclear Information System (INIS)

    Levin, A.E.

    1993-01-01

    Reactor vendors are developing new designs for future deployment, including open-quotes passiveclose quotes light water reactors (LWRs), such as General Electric's (G.E.'s) simplified boiling water reactor (SBWR) and Westinghouse's AP600, which depend primarily on inherent processes, such as national convection and gravity feed, for safety injection and emergency core cooling. The U.S. Nuclear Regulatory Commission (NRC) has implemented a new process, certification of standardized reactor designs, for licensing these Plants. Part 52 of Title 10 of the Code of Federal Regulations (10CFR52) contains the requirements that vendors must meet for design certification. One important section, 10CFR52.47, reads open-quotes Certification of a standard design which . . . utilizes simplified, inherent, passive, or other innovative means to accomplish its safety functions will be granted only if: (1) The performance of each safety feature of the design has been demonstrated through either analysis, appropriate test programs, experience, or a combination thereof; (2) Interdependent effects among the safety features have been found acceptable by analysis, appropriate test programs, experience, or a combination thereof; and (3) Sufficient data exist on the safety features of the design to assess the analytical tools used for safety analyses. . . . The vendors have initiated programs to test innovative features of their designs and to develop data bases needed to validate their analytical codes, as required by the design certification rule. Accordingly, the NRC is reviewing and evaluating the vendors programs to ensure that they address adequately key issues concerning safety system performance. This paper provides an overview of the NRC's review process and regulatory perspective

  4. Regulatory challenges in the review of data from global clinical trials: the PMDA perspective.

    Science.gov (United States)

    Asano, K; Tanaka, A; Sato, T; Uyama, Y

    2013-08-01

    Regulatory agencies face challenges in reviewing data from global clinical trials (GCTs) in the era of globalization of drug development. One major challenge is consideration of ethnic factors in evaluating GCT data so as to extrapolate foreign population data to one's own national population. Here, we present the Pharmaceuticals and Medical Devices Agency (PMDA) perspective in reviewing GCT data in new drug applications (NDAs) and discuss future challenges for new drug approval.

  5. Drug shortages in Israel: regulatory perspectives, challenges and solutions.

    Science.gov (United States)

    Schwartzberg, Eyal; Ainbinder, Denize; Vishkauzan, Alla; Gamzu, Ronni

    2017-01-01

    and temporary drug shortages are being implemented in Israel, such as suspending any further reductions in drug prices below 17 new Israeli shekels, instructing all MAHs to maintain no less than 1 month supply of all registered and non-registered drugs in Israel and allowing an expedited registration pathway for well-established use/grandfather drugs. Drug shortages pose significant public health hazards worldwide. Early notification to the MoH and open dialog with MAHs are essential for managing DSs and mitigating their impact. Despite the efforts carried out by health regulatory authorities worldwide, DSs still pose a significant threat to public health.

  6. Regulatory perspective on remaining challenges for utilization of pharmacogenomics-guided drug developments.

    Science.gov (United States)

    Otsubo, Yasuto; Ishiguro, Akihiro; Uyama, Yoshiaki

    2013-01-01

    Pharmacogenomics-guided drug development has been implemented in practice in the last decade, resulting in increased labeling of drugs with pharmacogenomic information. However, there are still many challenges remaining in utilizing this process. Here, we describe such remaining challenges from the regulatory perspective, specifically focusing on sample collection, biomarker qualification, ethnic factors, codevelopment of companion diagnostics and means to provide drugs for off-target patients. To improve the situation, it is important to strengthen international harmonization and collaboration among academia, industries and regulatory agencies, followed by the establishment of an international guideline on this topic. Communication with a regulatory agency from an early stage of drug development is also a key to success.

  7. Tracing the self-regulatory bases of moral emotions

    OpenAIRE

    Sheikh, Sana; Janoff-Bulman, Ronnie

    2010-01-01

    In this article we explore a self-regulatory perspective on the self-evaluative moral emotions, shame and guilt. Broadly conceived, self-regulation distinguishes between two types of motivation: approach/activation and avoidance/inhibition. We use this distinction to conceptually understand the socialization dimensions (parental restrictiveness versus nurturance), associated emotions (anxiety versus empathy), and forms of morality (proscriptive versus prescriptive) that serve as precursors to...

  8. Architecture-based regulatory compliance argumentation

    DEFF Research Database (Denmark)

    Mihaylov, Boyan; Onea, Lucian; Hansen, Klaus Marius

    2016-01-01

    Standards and regulations are difficult to understand and map to software, which makes compliance with them challenging to argue for software products and development process. This is problematic since lack of compliance may lead to issues with security, safety, and even to economic sanctions....... An increasing number of applications (for example in healthcare) are expected to have to live up to regulatory requirements in the future, which will lead to more software development projects having to deal with such requirements. We present an approach that models regulations such that compliance arguments...... the approach on the migration of the telemedicine platform Net4Care to the cloud, where certain regulations (for example privacy) should be concerned. The approach has the potential to support simpler compliance argumentation with the eventual promise of safer and more secure applications....

  9. Nanoparticulate materials and regulatory policy in Europe: An analysis of stakeholder perspectives

    International Nuclear Information System (INIS)

    Helland, Aasgeir; Kastenholz, Hans; Thidell, Aake; Arnfalk, Peter; Deppert, Knut

    2006-01-01

    The novel properties of nanoparticulate materials (NPM) and the rapid development of NPM based products have raised many unanswered questions and concerns by different stakeholders over its consequences for the environment and human health. These concerns have led to an increasing discussion in both the US and Europe about possible regulatory policies for NPM. In this article a comparative study of stakeholders' perceptions on regulatory policy issues with NPM in Europe is presented. It was found that industry wants to regulate this area if the scientific evidence demonstrates that NPM are harmful, but also that the regulatory bodies do not find it necessary at this point of time to regulate until scientific evidence demonstrates that NPM are harmful. This research therefore shows that there will most likely not be any regulatory interventions until there is an established and convincing scientific knowledge base demonstrating that NPM can be hazardous. It is furthermore discussed in this article the different roles and responsibilities of the stakeholders in financing the research required to establish the necessary level of fundamental scientific evidence. It was also found that the activity of the regulatory bodies on this issue differ between the European countries

  10. Backtesting for Risk-Based Regulatory Capital

    NARCIS (Netherlands)

    Kerkhof, F.L.J.; Melenberg, B.

    2002-01-01

    In this paper we present a framework for backtesting all currently popular risk measurement methods (including value-at-risk and expected shortfall) using the functional delta method.Estimation risk can be taken explicitly into account.Based on a simulation study we provide evidence that tests for

  11. Task-based dermal exposure models for regulatory risk assessment

    NARCIS (Netherlands)

    Warren, N.D.; Marquart, H.; Christopher, Y.; Laitinen, J.; Hemmen, J.J. van

    2006-01-01

    The regulatory risk assessment of chemicals requires the estimation of occupational dermal exposure. Until recently, the models used were either based on limited data or were specific to a particular class of chemical or application. The EU project RISKOFDERM has gathered a considerable number of

  12. Sequence-based model of gap gene regulatory network.

    Science.gov (United States)

    Kozlov, Konstantin; Gursky, Vitaly; Kulakovskiy, Ivan; Samsonova, Maria

    2014-01-01

    The detailed analysis of transcriptional regulation is crucially important for understanding biological processes. The gap gene network in Drosophila attracts large interest among researches studying mechanisms of transcriptional regulation. It implements the most upstream regulatory layer of the segmentation gene network. The knowledge of molecular mechanisms involved in gap gene regulation is far less complete than that of genetics of the system. Mathematical modeling goes beyond insights gained by genetics and molecular approaches. It allows us to reconstruct wild-type gene expression patterns in silico, infer underlying regulatory mechanism and prove its sufficiency. We developed a new model that provides a dynamical description of gap gene regulatory systems, using detailed DNA-based information, as well as spatial transcription factor concentration data at varying time points. We showed that this model correctly reproduces gap gene expression patterns in wild type embryos and is able to predict gap expression patterns in Kr mutants and four reporter constructs. We used four-fold cross validation test and fitting to random dataset to validate the model and proof its sufficiency in data description. The identifiability analysis showed that most model parameters are well identifiable. We reconstructed the gap gene network topology and studied the impact of individual transcription factor binding sites on the model output. We measured this impact by calculating the site regulatory weight as a normalized difference between the residual sum of squares error for the set of all annotated sites and for the set with the site of interest excluded. The reconstructed topology of the gap gene network is in agreement with previous modeling results and data from literature. We showed that 1) the regulatory weights of transcription factor binding sites show very weak correlation with their PWM score; 2) sites with low regulatory weight are important for the model output; 3

  13. Future time perspective and health behaviors: temporal framing of self-regulatory processes in physical exercise and dietary behaviors.

    Science.gov (United States)

    Gellert, Paul; Ziegelmann, Jochen P; Lippke, Sonia; Schwarzer, Ralf

    2012-04-01

    Limitations in perceived lifetime can undermine long-term goal striving. Planning is supposed to translate intentions into health behaviors and to operate as a compensatory strategy to overcome goal striving deficits associated with a limited time perspective. Two longitudinal studies were conducted examining the compensatory role of planning: an online survey on fruit and vegetable consumption (N = 909; 16-78 years; follow-up at 4 months) and a questionnaire study on physical exercise in older adults (N = 289; 60-95 years, over a half-year period). Intentions, planning, and behavior were measured in a behavior-specific, future time perspective in a generic manner. Planning mediated between intentions and both health behaviors. Time perspective operated as a moderator, indicating that in individuals with a more limited time perspective, a stronger effect of planning on health behaviors emerged. Planning as a self-regulatory strategy may compensate for a limited time perspective.

  14. Regulatory changes to renewable energy support schemes: An international investment law perspective

    OpenAIRE

    Paleckaite, Gintare

    2014-01-01

    Thesist analyzes how regulatory changes related to renewable energy investment support schemes can be perceived under international investment law standards and how possible decisions of international investment law tribunals could impact investment in this sector. This research is based on case studies of two states: Spain and the Czech Republic and claims against them. These cases will assist in analyzing the effects of the amendment/revocation of renewable energy support schemes. Answers t...

  15. Historical perspectives on evidence-based nursing.

    Science.gov (United States)

    Beyea, Suzanne C; Slattery, Mary Jo

    2013-04-01

    The authors of this article offer a review and historical perspective on research utilization and evidence-based practice in nursing. They present the evolution of research utilization to the more contemporary framework of evidence-based nursing practice. The authors address the role of qualitative research in the context of evidence-based practice. Finally, some approaches and resources for learning more about the fundamentals of evidence-based healthcare are provided.

  16. Scientific and Regulatory Perspectives in Herbal and Dietary Supplement Associated Hepatotoxicity in the United States

    Directory of Open Access Journals (Sweden)

    Mark I. Avigan

    2016-03-01

    Full Text Available In the United States (US, the risk of hepatotoxicity linked to the widespread use of certain herbal products has gained increased attention among regulatory scientists. Based on current US law, all dietary supplements sold domestically, including botanical supplements, are regulated by the Food and Drug Administration (FDA as a special category of foods. Under this designation, regulatory scientists do not routinely evaluate the efficacy of these products prior to their marketing, despite the content variability and phytochemical complexity that often characterizes them. Nonetheless, there has been notable progress in the development of advanced scientific methods to qualitatively and quantitatively measure ingredients and screen for contaminants and adulterants in botanical products when hepatotoxicity is recognized.

  17. Manufacturing, regulatory and commercial challenges of biopharmaceuticals production: a Finnish perspective.

    Science.gov (United States)

    Närhi, Marko; Nordström, Katrina

    2005-04-01

    Biopharmaceuticals product development is a broad and multidisciplinary field. Science and technology are combined with new manufacturing, regulatory and commercial challenges. However, although there is ample literature on the molecular biology and biochemistry of products, the implementation of processes from test tube to commercial scale has not received similar attention. Consequently, the present study aims to highlight, from practical point of view, some of the key issues involved with manufacturing technologies of biopharmaceuticals at a commercial scale. Regulatory requirements and investments are also addressed based on the practical experiences of start-up and small companies. Finland is used as a case-example of such companies as this is a EU-member state with strong technological growth and rapidly increasing number of biotech companies.

  18. Different perspectives on economic base.

    Science.gov (United States)

    Lisa K. Crone; Richard W. Haynes; Nicholas E. Reyna

    1999-01-01

    Two general approaches for measuring the economic base are discussed. Each method is used to define the economic base for each of the counties included in the Interior Columbia Basin Ecosystem Management Project area. A more detailed look at four selected counties results in similar findings from different approaches. Limitations of economic base analysis also are...

  19. Decisions by regulatory agencies: are they evidence-based?

    Directory of Open Access Journals (Sweden)

    Furberg Curt D

    2007-04-01

    Full Text Available Abstract Contradictory statements about the non-steroidal anti-inflammatory drugs from the European Medicines Agency and the United States Food and Drug Administration have raised questions about whether regulatory decisions are evidence-based. For the selective COX-2 inhibitors, there are clear contraindications and warnings in Europe, but only a vaguely worded Black Box warning in the United States. All the non-selective agents are given an almost "clean bill of health" in Europe, while all of them are judged to have a similar risk-benefit ratio as celecoxib in the United States. The regulatory agencies have failed to recognize the clinical trial evidence that the risk of cardiovascular events varies substantially among the non-selective agents, with diclofenac carrying the highest risk of harm.

  20. A regulatory perspective on appropriate seismic loading stress criteria for advanced light water reactor piping systems

    International Nuclear Information System (INIS)

    Terao, D.

    1995-01-01

    In the foregoing sections, the author has discussed the NRC staff's perspective on the evolving seismic design criteria for piping systems. He also addressed the need for developing seismic loading stress criteria and provided several recommendations and considerations for ensuring piping functional capability, pressure integrity, and structural integrity. Overall, the general consensus in the NRC staff is that in the past several years, many initiatives have been developed and implemented by the industry and the NRC staff to reduce the excessive conservatisms that might have existed in nuclear piping system design criteria. The regulations, regulatory guides, and Standard Review Plan have been (or are currently in the process of being) revised to reflect these initiatives in an effort to produce requirements and guidelines that will continue to result in a safe and practical design of piping systems. However, further proposals to reduce margins are continually being submitted to the ASME Boiler and Pressure Vessel Code and the NRC for review and approval. Improvements to the piping seismic design criteria are always encouraged, but there is a point at which the benefits might be outweighed by drawbacks. Because of this rapidly evolving situation the need exists for the industry and the NRC staff to develop a course of action to ensure that piping seismic design criteria for future ALWR plants will result in piping system designs that provide adequate safety margins and practical designs at a reasonable cost

  1. The Regulatory Roles of MicroRNAs in Bone Remodeling and Perspectives as Biomarkers in Osteoporosis

    Directory of Open Access Journals (Sweden)

    Mengge Sun

    2016-01-01

    Full Text Available MicroRNAs are involved in many cellular and molecular activities and played important roles in many biological and pathological processes, such as tissue formation, cancer development, diabetes, neurodegenerative diseases, and cardiovascular diseases. Recently, it has been reported that microRNAs can modulate the differentiation and activities of osteoblasts and osteoclasts, the key cells that are involved in bone remodeling process. Meanwhile, the results from our and other research groups showed that the expression profiles of microRNAs in the serum and bone tissues are significantly different in postmenopausal women with or without fractures compared to the control. Therefore, it can be postulated that microRNAs might play important roles in bone remodeling and that they are very likely to be involved in the pathological process of postmenopausal osteoporosis. In this review, we will present the updated research on the regulatory roles of microRNAs in osteoblasts and osteoclasts and the expression profiles of microRNAs in osteoporosis and osteoporotic fracture patients. The perspective of serum microRNAs as novel biomarkers in bone loss disorders such as osteoporosis has also been discussed.

  2. A regulatory perspective of the role of construction in revitalizing the United States nuclear industry

    International Nuclear Information System (INIS)

    Stello, V. Jr.

    1983-01-01

    Technical and managerial experience in nuclear power plant construction is presented from the perspective of the United States Nuclear Regulatory Commission (NRC). In the context of actions that would contribute to revitalizing the nuclear industry in the United States of America, greater effectiveness of utility management during construction is proposed. The reasons why management effectiveness is so important are developed beginning with summaries of defects that were built into several US plants under construction. The root causes of these significant defects were management failures. In terms of benefits, effective management is important because of its effects on nuclear safety, project construction costs, and future reliability of the plant after commissioning. Actions that would enhance good management include emphasizing the inseparable nature of production and quality, that quality cannot be inspected into a plant, and that a strong construction management staff and exchanges of experience and information are essential. Techniques that have been used successfully in construction management are discussed. NRC and industry initiatives are in progress to improve management responsibility and learning from experience. Projects include Owner's Certification, assessments of licensee performance, fostering good practices across the industry, and improving the NRC inspection programme. Revitalization will not be easy, but it is achievable. (author)

  3. Waste management strategy for nuclear fusion power systems from a regulatory perspective

    Energy Technology Data Exchange (ETDEWEB)

    Heckman, R.A.

    1977-12-06

    A waste management strategy for future nuclear fusion power systems is developed using existing regulatory methodology. The first step is the development of a reference fuel cycle. Next, the waste streams from such a facility are identified. Then a waste management system is defined to safely handle and dispose of these wastes. The future regulator must identify the decisions necessary to establish waste management performance criteria. The data base and methodologies necessary to make these decisions must then be developed. Safe management of nuclear fusion wastes is not only a technological challenge, but encompasses significant social, political, and ethical questions as well.

  4. Waste management strategy for nuclear fusion power systems from a regulatory perspective

    International Nuclear Information System (INIS)

    Heckman, R.A.

    1977-01-01

    A waste management strategy for future nuclear fusion power systems is developed using existing regulatory methodology. The first step is the development of a reference fuel cycle. Next, the waste streams from such a facility are identified. Then a waste management system is defined to safely handle and dispose of these wastes. The future regulator must identify the decisions necessary to establish waste management performance criteria. The data base and methodologies necessary to make these decisions must then be developed. Safe management of nuclear fusion wastes is not only a technological challenge, but encompasses significant social, political, and ethical questions as well

  5. Finding gene regulatory network candidates using the gene expression knowledge base.

    Science.gov (United States)

    Venkatesan, Aravind; Tripathi, Sushil; Sanz de Galdeano, Alejandro; Blondé, Ward; Lægreid, Astrid; Mironov, Vladimir; Kuiper, Martin

    2014-12-10

    Network-based approaches for the analysis of large-scale genomics data have become well established. Biological networks provide a knowledge scaffold against which the patterns and dynamics of 'omics' data can be interpreted. The background information required for the construction of such networks is often dispersed across a multitude of knowledge bases in a variety of formats. The seamless integration of this information is one of the main challenges in bioinformatics. The Semantic Web offers powerful technologies for the assembly of integrated knowledge bases that are computationally comprehensible, thereby providing a potentially powerful resource for constructing biological networks and network-based analysis. We have developed the Gene eXpression Knowledge Base (GeXKB), a semantic web technology based resource that contains integrated knowledge about gene expression regulation. To affirm the utility of GeXKB we demonstrate how this resource can be exploited for the identification of candidate regulatory network proteins. We present four use cases that were designed from a biological perspective in order to find candidate members relevant for the gastrin hormone signaling network model. We show how a combination of specific query definitions and additional selection criteria derived from gene expression data and prior knowledge concerning candidate proteins can be used to retrieve a set of proteins that constitute valid candidates for regulatory network extensions. Semantic web technologies provide the means for processing and integrating various heterogeneous information sources. The GeXKB offers biologists such an integrated knowledge resource, allowing them to address complex biological questions pertaining to gene expression. This work illustrates how GeXKB can be used in combination with gene expression results and literature information to identify new potential candidates that may be considered for extending a gene regulatory network.

  6. Analytical perspectives on performance-based management

    DEFF Research Database (Denmark)

    Wadmann, Sarah; Johansen, Sarah; Lind, Ane

    2013-01-01

    Performance-based management (PBM) has become a dominant form of governance in health care and there is a need for careful assessment of its function and effects. This article contains a cross-disciplinary literature synthesis of current studies of PBM. Literature was retrieved by database search...... perspectives allows appreciation of otherwise implicit assumptions and potential implications of PBM. Reflections on such differences are important to ensure vigilant appropriation of shifting management tools in health quality governance.......Performance-based management (PBM) has become a dominant form of governance in health care and there is a need for careful assessment of its function and effects. This article contains a cross-disciplinary literature synthesis of current studies of PBM. Literature was retrieved by database searches....... In the functionalist perspective, PBM is perceived as a management tool aimed at improving health care services by means of market-based mechanisms. In the interpretive perspective, the adoption of PBM is understood as consequence of institutional and individual agents striving for public legitimacy. In the post...

  7. Heart Rate Variability: New Perspectives on Physiological Mechanisms, Assessment of Self-regulatory Capacity, and Health risk.

    Science.gov (United States)

    McCraty, Rollin; Shaffer, Fred

    2015-01-01

    Heart rate variability, the change in the time intervals between adjacent heartbeats, is an emergent property of interdependent regulatory systems that operates on different time scales to adapt to environmental and psychological challenges. This article briefly reviews neural regulation of the heart and offers some new perspectives on mechanisms underlying the very low frequency rhythm of heart rate variability. Interpretation of heart rate variability rhythms in the context of health risk and physiological and psychological self-regulatory capacity assessment is discussed. The cardiovascular regulatory centers in the spinal cord and medulla integrate inputs from higher brain centers with afferent cardiovascular system inputs to adjust heart rate and blood pressure via sympathetic and parasympathetic efferent pathways. We also discuss the intrinsic cardiac nervous system and the heart-brain connection pathways, through which afferent information can influence activity in the subcortical, frontocortical, and motor cortex areas. In addition, the use of real-time HRV feedback to increase self-regulatory capacity is reviewed. We conclude that the heart's rhythms are characterized by both complexity and stability over longer time scales that reflect both physiological and psychological functional status of these internal self-regulatory systems.

  8. Role of In Vitro Release Methods in Liposomal Formulation Development: Challenges and Regulatory Perspective.

    Science.gov (United States)

    Solomon, Deepak; Gupta, Nilesh; Mulla, Nihal S; Shukla, Snehal; Guerrero, Yadir A; Gupta, Vivek

    2017-11-01

    In the past few years, measurement of drug release from pharmaceutical dosage forms has been a focus of extensive research because the release profile obtained in vitro can give an indication of the drug's performance in vivo. Currently, there are no compendial in vitro release methods designed for liposomes owing to a range of experimental challenges, which has created a major hurdle for both development and regulatory acceptance of liposome-based drug products. In this paper, we review the current techniques that are most often used to assess in vitro drug release from liposomal products; these include the membrane diffusion techniques (dialysis, reverse dialysis, fractional dialysis, and microdialysis), the sample-and-separate approach, the in situ method, the continuous flow, and the modified United States Pharmacopeia methods (USP I and USP IV). We discuss the principles behind each of the methods and the criteria that assist in choosing the most appropriate method for studying drug release from a liposomal formulation. Also, we have included information concerning the current regulatory requirements for liposomal drug products in the United States and in Europe. In light of increasing costs of preclinical and clinical trials, applying a reliable in vitro release method could serve as a proxy to expensive in vivo bioavailability studies. Graphical Abstract Appropriate in-vitro drug release test from liposomal products is important to predict the in-vivo performance.

  9. RNA regulatory networks in animals and plants: a long noncoding RNA perspective.

    Science.gov (United States)

    Bai, Youhuang; Dai, Xiaozhuan; Harrison, Andrew P; Chen, Ming

    2015-03-01

    A recent highlight of genomics research has been the discovery of many families of transcripts which have function but do not code for proteins. An important group is long noncoding RNAs (lncRNAs), which are typically longer than 200 nt, and whose members originate from thousands of loci across genomes. We review progress in understanding the biogenesis and regulatory mechanisms of lncRNAs. We describe diverse computational and high throughput technologies for identifying and studying lncRNAs. We discuss the current knowledge of functional elements embedded in lncRNAs as well as insights into the lncRNA-based regulatory network in animals. We also describe genome-wide studies of large amount of lncRNAs in plants, as well as knowledge of selected plant lncRNAs with a focus on biotic/abiotic stress-responsive lncRNAs. © The Author 2014. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  10. OECD/NEA WGFCS Workshop: Safety Assessment of Fuel Cycle Facilities - Regulatory Approaches and Industry Perspectives

    International Nuclear Information System (INIS)

    2013-01-01

    Nuclear fuel is produced, processed, and stored mainly in industrial-scale facilities. Uranium ores are processed and refined to produce a pure uranium salt stream, Uranium is converted and enriched, nuclear fuel is fabricated (U fuel and U/Pu fuel for the closed cycle option); and spent fuel is stored and reprocessed in some countries (close cycle option). Facilities dedicated to the research and development of new fuel or new processes are also considered as Fuel Cycle Facilities. The safety assessment of nuclear facilities has often been led by the methodology and techniques initially developed for Nuclear Power Plants. As FCFs cover a wide diversity of installations the various approaches of national regulators, and their technical support organizations, for the Safety Assessment of Fuel Cycle Facilities are also diverse, as are the approaches by their industries in providing safety justifications for their facilities. The objective of the Working Group on Fuel Cycle Safety is to advance the understanding for both regulators and operators of relevant aspects of nuclear fuel cycle safety in member countries. A large amount of experience is available in safety assessment of FCFs, which should be shared to develop ideas in this field. To contribute to this task, the Workshop on 'Safety Assessment of Fuel Cycle Facilities - Regulatory Approaches and Industry Perspectives' was held in Toronto, on 27 - 29 September 2011. The workshop was hosted by Canadian Nuclear Safety Commission. The current proceedings provide summary of the results of the workshop with the text of the papers given and presentations made

  11. GIS Based Measurement and Regulatory Zoning of Urban Ecological Vulnerability

    Directory of Open Access Journals (Sweden)

    Xiaorui Zhang

    2015-07-01

    Full Text Available Urban ecological vulnerability is measured on the basis of ecological sensitivity and resilience based on the concept analysis of vulnerability. GIS-based multicriteria decision analysis (GIS-MCDA methods are used, supported by the spatial analysis tools of GIS, to define different levels of vulnerability for areas of the urban ecology. These areas are further classified into different types of regulatory zones. Taking the city of Hefei in China as the empirical research site, this study uses GIS-MCDA, including the index system, index weights and overlay rules, to measure the degree of its ecological vulnerability on the GIS platform. There are eight indices in the system. Raking and analytical hierarchy process (AHP methods are used to calculate index weights according to the characteristics of the index system. The integrated overlay rule, including selection of the maximum value, and weighted linear combination (WLC are applied as the overlay rules. In this way, five types of vulnerability areas have been classified as follows: very low vulnerability, low vulnerability, medium vulnerability, high vulnerability and very high vulnerability. They can be further grouped into three types of regulatory zone of ecological green line, ecological grey line and ecological red line. The study demonstrates that ecological green line areas are the largest (53.61% of the total study area and can be intensively developed; ecological grey line areas (19.59% of the total area can serve as the ecological buffer zone, and ecological red line areas (26.80% cannot be developed and must be protected. The results indicate that ecological green line areas may provide sufficient room for future urban development in Hefei city. Finally, the respective regulatory countermeasures are put forward. This research provides a scientific basis for decision-making around urban ecological protection, construction and sustainable development. It also provides theoretical method

  12. Event-based cluster synchronization of coupled genetic regulatory networks

    Science.gov (United States)

    Yue, Dandan; Guan, Zhi-Hong; Li, Tao; Liao, Rui-Quan; Liu, Feng; Lai, Qiang

    2017-09-01

    In this paper, the cluster synchronization of coupled genetic regulatory networks with a directed topology is studied by using the event-based strategy and pinning control. An event-triggered condition with a threshold consisting of the neighbors' discrete states at their own event time instants and a state-independent exponential decay function is proposed. The intra-cluster states information and extra-cluster states information are involved in the threshold in different ways. By using the Lyapunov function approach and the theories of matrices and inequalities, we establish the cluster synchronization criterion. It is shown that both the avoidance of continuous transmission of information and the exclusion of the Zeno behavior are ensured under the presented triggering condition. Explicit conditions on the parameters in the threshold are obtained for synchronization. The stability criterion of a single GRN is also given under the reduced triggering condition. Numerical examples are provided to validate the theoretical results.

  13. A model surveillance program based on regulatory experience

    International Nuclear Information System (INIS)

    Conte, R.J.

    1980-01-01

    A model surveillance program is presented based on regulatory experience. The program consists of three phases: Program Delineation, Data Acquistion and Data Analysis. Each phase is described in terms of key quality assurance elements and some current philosophies is the United States Licensing Program. Other topics include the application of these ideas to test equipment used in the surveillance progam and audits of the established program. Program Delineation discusses the establishment of administrative controls for organization and the description of responsibilities using the 'Program Coordinator' concept, with assistance from Data Acquisition and Analysis Teams. Ideas regarding frequency of surveillance testing are also presented. The Data Acquisition Phase discusses various methods for acquiring data including operator observations, test procedures, operator logs, and computer output, for trending equipment performance. The Data Analysis Phase discusses the process for drawing conclusions regarding component/equipment service life, proper application, and generic problems through the use of trend analysis and failure rate data. (orig.)

  14. Marketing Regulatory Oversight of Advanced Therapy Medicinal Products (ATMPs) in Europe: The EMA/CAT Perspective.

    Science.gov (United States)

    Salmikangas, Paula; Schuessler-Lenz, Martina; Ruiz, Sol; Celis, Patrick; Reischl, Ilona; Menezes-Ferreira, Margarida; Flory, Egbert; Renner, Matthias; Ferry, Nicolas

    2015-01-01

    With the release of Regulation 1394/2007, a new framework for gene and cell therapy medicinal products and tissue-engineered products was established in the European Union. For all three product classes, called advanced therapy medicinal products, a centralised marketing authorisation became mandatory. The European Medicines Agency (EMA) together with its Committee for Advanced Therapies, Committee for Human Medicinal Products and the network of national agencies is responsible for scientific evaluation of the marketing authorisation applications. For a new application, data and information relating to manufacturing processes and quality control of the active substance and the final product have to be submitted for evaluation together with data from non-clinical and clinical safety and efficacy studies. Technical requirements for ATMPs are defined in the legislation, and guidance for different products is available through several EMA/CAT guidelines. Due to the diversity of ATMPs, a tailored approach for regulating these products is considered necessary. Thus, a risk-based approach has been introduced for ATMPs allowing flexibility for the regulatory requirements. Since the regulatory framework for ATMPs was established, five products have been licenced in the European Union. However, the pipeline of new ATMPs is much bigger, as seen from the significant numbers of different products discussed by the CAT in scientific advice and classification procedures. In 2013, a public consultation on the ATMP Regulation was conducted by the European Commission, and the results were published in 2014. The report proposes several improvements for the current framework and established procedures for the regulation of ATMPs.

  15. Task-based dermal exposure models for regulatory risk assessment.

    Science.gov (United States)

    Warren, Nicholas D; Marquart, Hans; Christopher, Yvette; Laitinen, Juha; VAN Hemmen, Joop J

    2006-07-01

    The regulatory risk assessment of chemicals requires the estimation of occupational dermal exposure. Until recently, the models used were either based on limited data or were specific to a particular class of chemical or application. The EU project RISKOFDERM has gathered a considerable number of new measurements of dermal exposure together with detailed contextual information. This article describes the development of a set of generic task-based models capable of predicting potential dermal exposure to both solids and liquids in a wide range of situations. To facilitate modelling of the wide variety of dermal exposure situations six separate models were made for groupings of exposure scenarios called Dermal Exposure Operation units (DEO units). These task-based groupings cluster exposure scenarios with regard to the expected routes of dermal exposure and the expected influence of exposure determinants. Within these groupings linear mixed effect models were used to estimate the influence of various exposure determinants and to estimate components of variance. The models predict median potential dermal exposure rates for the hands and the rest of the body from the values of relevant exposure determinants. These rates are expressed as mg or microl product per minute. Using these median potential dermal exposure rates and an accompanying geometric standard deviation allows a range of exposure percentiles to be calculated.

  16. Safety Management in Non-Nuclear Contexts. Examples from Swedish Railway Regulatory and Company Perspectives

    International Nuclear Information System (INIS)

    Salo, Ilkka; Svensson, Ola

    2005-06-01

    studied organizations respectively. These three chapters give a detailed account of safety management from a system perspective and applications in the organizations studied, and could be read independently of each other. In the fourth chapter the report concludes with summarizing safety management in SRA and SJ by mapping the results on important concepts from the system theoretical framework, and general themes for safety management applicable across contexts are suggested. The qualitative descriptions of the organizations generated a detailed account on how safety is managed in Swedish railway operations. Examples of safety management in practice are given both from the regulatory point of view and from an organizational position close to the actual operations. The Swedish railway operations are strictly regulated and the safety goals are identifiable along the legislative documentation from the government's goals for safe operations expressed in the railway legislation, through SRA's regulations, to SJ's internal regulations. There is a high degree of coherence between SJ's and SRA's formulations of safety management and safe operations in general. Both organizations have their origin in the former national railway company, which may is partly reflected in the high degree of correspondence between the approaches towards safety. Both organizations make use of a system approach to their operations, which are clearly reflected in the highly structured organizations, with core objectives, operational responsibilities, procedures, and information feedback prerequisites sufficiently mapped on the organizational units. The report gives both detailed accounts and summaries of a number of central themes for safety management derived from the system theoretical framework, and also themes relevant for safety management in general. For example: the organizations definitions of safety management, descriptions of the organizational structures, recent processes of organizational

  17. Safety Management in Non-Nuclear Contexts. Examples from Swedish Railway Regulatory and Company Perspectives

    Energy Technology Data Exchange (ETDEWEB)

    Salo, Ilkka; Svensson, Ola (Risk Analysis, Social and Decision Research Unit, Dept. of Psychology, Stockholm Univ., Stockholm (Sweden))

    2005-06-15

    studied organizations respectively. These three chapters give a detailed account of safety management from a system perspective and applications in the organizations studied, and could be read independently of each other. In the fourth chapter the report concludes with summarizing safety management in SRA and SJ by mapping the results on important concepts from the system theoretical framework, and general themes for safety management applicable across contexts are suggested. The qualitative descriptions of the organizations generated a detailed account on how safety is managed in Swedish railway operations. Examples of safety management in practice are given both from the regulatory point of view and from an organizational position close to the actual operations. The Swedish railway operations are strictly regulated and the safety goals are identifiable along the legislative documentation from the government's goals for safe operations expressed in the railway legislation, through SRA's regulations, to SJ's internal regulations. There is a high degree of coherence between SJ's and SRA's formulations of safety management and safe operations in general. Both organizations have their origin in the former national railway company, which may is partly reflected in the high degree of correspondence between the approaches towards safety. Both organizations make use of a system approach to their operations, which are clearly reflected in the highly structured organizations, with core objectives, operational responsibilities, procedures, and information feedback prerequisites sufficiently mapped on the organizational units. The report gives both detailed accounts and summaries of a number of central themes for safety management derived from the system theoretical framework, and also themes relevant for safety management in general. For example: the organizations definitions of safety management, descriptions of the organizational structures, recent

  18. Regulatory agencies and regulatory risk

    OpenAIRE

    Knieps, Günter; Weiß, Hans-Jörg

    2008-01-01

    The aim of this paper is to show that regulatory risk is due to the discretionary behaviour of regulatory agencies, caused by a too extensive regulatory mandate provided by the legislator. The normative point of reference and a behavioural model of regulatory agencies based on the positive theory of regulation are presented. Regulatory risk with regard to the future behaviour of regulatory agencies is modelled as the consequence of the ex ante uncertainty about the relative influence of inter...

  19. NRC review of passive reactor design certification testing programs: Overview, progress, and regulatory perspective

    Energy Technology Data Exchange (ETDEWEB)

    Levin, A.E.

    1995-09-01

    New reactor designs, employing passive safety systems, are currently under development by reactor vendors for certification under the U.S. Nuclear Regulatory Commission`s (NRC`s) design certification rule. The vendors have established testing programs to support the certification of the passive designs, to meet regulatory requirements for demonstration of passive safety system performance. The NRC has, therefore, developed a process for the review of the vendors` testing programs and for incorporation of the results of those reviews into the safety evaluations for the passive plants. This paper discusses progress in the test program reviews, and also addresses unique regulatory aspects of those reviews.

  20. A regulatory perspective on design and performance requirements for engineered systems in high-level waste

    International Nuclear Information System (INIS)

    Bernero, R.M.

    1992-01-01

    For engineered systems, this paper gives an overview of some of the current activities at the U.S. Nuclear Regulatory Commission (NRC), with the intent of elucidating how the regulatory process works in the management of high-level waste (HLW). Throughout the waste management cycle, starting with packaging and transportation, and continuing to final closure of a repository, these activities are directed at taking advantage of the prelicensing consultation period, a period in which the NRC, DOE and others can interact in ways that will reduce regulatory, technical and institutional uncertainties, and open the path to development and construction of a deep geologic repository for permanent disposal of HLW. Needed interactions in the HLW program are highlighted. Examples of HLW regulatory activities are given in discussions of a multipurpose-cask concept and of current NRC work on the meaning of the term substantially complete containment

  1. Regulatory RNAs in Bacillus subtilis: a Gram-Positive Perspective on Bacterial RNA-Mediated Regulation of Gene Expression

    Science.gov (United States)

    Mars, Ruben A. T.; Nicolas, Pierre; Denham, Emma L.

    2016-01-01

    SUMMARY Bacteria can employ widely diverse RNA molecules to regulate their gene expression. Such molecules include trans-acting small regulatory RNAs, antisense RNAs, and a variety of transcriptional attenuation mechanisms in the 5′ untranslated region. Thus far, most regulatory RNA research has focused on Gram-negative bacteria, such as Escherichia coli and Salmonella. Hence, there is uncertainty about whether the resulting insights can be extrapolated directly to other bacteria, such as the Gram-positive soil bacterium Bacillus subtilis. A recent study identified 1,583 putative regulatory RNAs in B. subtilis, whose expression was assessed across 104 conditions. Here, we review the current understanding of RNA-based regulation in B. subtilis, and we categorize the newly identified putative regulatory RNAs on the basis of their conservation in other bacilli and the stability of their predicted secondary structures. Our present evaluation of the publicly available data indicates that RNA-mediated gene regulation in B. subtilis mostly involves elements at the 5′ ends of mRNA molecules. These can include 5′ secondary structure elements and metabolite-, tRNA-, or protein-binding sites. Importantly, sense-independent segments are identified as the most conserved and structured potential regulatory RNAs in B. subtilis. Altogether, the present survey provides many leads for the identification of new regulatory RNA functions in B. subtilis. PMID:27784798

  2. Regulatory RNAs in Bacillus subtilis: a Gram-Positive Perspective on Bacterial RNA-Mediated Regulation of Gene Expression.

    Science.gov (United States)

    Mars, Ruben A T; Nicolas, Pierre; Denham, Emma L; van Dijl, Jan Maarten

    2016-12-01

    Bacteria can employ widely diverse RNA molecules to regulate their gene expression. Such molecules include trans-acting small regulatory RNAs, antisense RNAs, and a variety of transcriptional attenuation mechanisms in the 5' untranslated region. Thus far, most regulatory RNA research has focused on Gram-negative bacteria, such as Escherichia coli and Salmonella. Hence, there is uncertainty about whether the resulting insights can be extrapolated directly to other bacteria, such as the Gram-positive soil bacterium Bacillus subtilis. A recent study identified 1,583 putative regulatory RNAs in B. subtilis, whose expression was assessed across 104 conditions. Here, we review the current understanding of RNA-based regulation in B. subtilis, and we categorize the newly identified putative regulatory RNAs on the basis of their conservation in other bacilli and the stability of their predicted secondary structures. Our present evaluation of the publicly available data indicates that RNA-mediated gene regulation in B. subtilis mostly involves elements at the 5' ends of mRNA molecules. These can include 5' secondary structure elements and metabolite-, tRNA-, or protein-binding sites. Importantly, sense-independent segments are identified as the most conserved and structured potential regulatory RNAs in B. subtilis. Altogether, the present survey provides many leads for the identification of new regulatory RNA functions in B. subtilis. Copyright © 2016, American Society for Microbiology. All Rights Reserved.

  3. Core damage frequency perspectives based on IPE results

    International Nuclear Information System (INIS)

    Dingman, S.E.; Camp, A.L.; LaChance, J.L.; Drouin, M.T.

    1996-01-01

    In November 1988, the US Nuclear Regulatory Commission (NRC) issued Generic Letter 88-20 requesting that all licensees perform an individual Plant Examination (IPE) to identify any plant-specific vulnerability to severe accidents and report the results to the Commission. This paper provides perspectives gained from reviewing 75 Individual Plant Examination (IPE) submittals covering 108 nuclear power plant units. Variability both within and among reactor types is examined to provide perspectives regarding plant-specific design and operational features, and modeling assumptions that play a significant role in the estimates of core damage frequencies in the IPEs

  4. Cloud based spectrum manager for future wireless regulatory environment

    CSIR Research Space (South Africa)

    Masonta, MT

    2015-12-01

    Full Text Available The regulatory environment in radio frequency spectrum management lags the advancement of wireless technologies, especially in the area of cognitive radio and dynamic spectrum access. In this paper we argue that the solution towards spectrum Pareto...

  5. Regulatory policy and structural change in the natural gas industry: A transaction cost perspective

    International Nuclear Information System (INIS)

    Sauer, D.G.

    1991-01-01

    The Federal Energy Regulatory Commission has recently promoted policy initiatives designed to substitute market responsive industry practices for the micro-management regulatory practices previously employed. These new policies are expected to generate a flexible gas pricing policy that more accurately reflects market supply and demand conditions. Historically, much of the regulation of this industry was enacted to ensure that pipeline companies would be able to recover the very large up-front investments in immobile equipment that characterize the production, transportation, storage, and distribution of natural gas. The institutional detail available from historical accounts of the development of the industry are used to describe structural change over time. Regulatory policy, the level of asset specificity, and the extent of secondary environmental uncertainty are all shown to exert significant effects on the level of integration into production, storage and marketing

  6. Inference of time-delayed gene regulatory networks based on dynamic Bayesian network hybrid learning method.

    Science.gov (United States)

    Yu, Bin; Xu, Jia-Meng; Li, Shan; Chen, Cheng; Chen, Rui-Xin; Wang, Lei; Zhang, Yan; Wang, Ming-Hui

    2017-10-06

    Gene regulatory networks (GRNs) research reveals complex life phenomena from the perspective of gene interaction, which is an important research field in systems biology. Traditional Bayesian networks have a high computational complexity, and the network structure scoring model has a single feature. Information-based approaches cannot identify the direction of regulation. In order to make up for the shortcomings of the above methods, this paper presents a novel hybrid learning method (DBNCS) based on dynamic Bayesian network (DBN) to construct the multiple time-delayed GRNs for the first time, combining the comprehensive score (CS) with the DBN model. DBNCS algorithm first uses CMI2NI (conditional mutual inclusive information-based network inference) algorithm for network structure profiles learning, namely the construction of search space. Then the redundant regulations are removed by using the recursive optimization algorithm (RO), thereby reduce the false positive rate. Secondly, the network structure profiles are decomposed into a set of cliques without loss, which can significantly reduce the computational complexity. Finally, DBN model is used to identify the direction of gene regulation within the cliques and search for the optimal network structure. The performance of DBNCS algorithm is evaluated by the benchmark GRN datasets from DREAM challenge as well as the SOS DNA repair network in Escherichia coli , and compared with other state-of-the-art methods. The experimental results show the rationality of the algorithm design and the outstanding performance of the GRNs.

  7. Regulatory challenges for the licensing of future nuclear plants: A public interest perspective

    International Nuclear Information System (INIS)

    Lyman, Edwin S.

    2001-01-01

    Regulatory challenges concerned with licensing of advanced NPPs must ensure that economic imperatives do not have adverse impacts on safety, risk of radiological sabotage, waste management and disposal, non-proliferation, full opportunity for public participation. This presentation explains the mentioned issues using pebble bed reactor as an example

  8. Regulatory Flexibility: An Individual Differences Perspective on Coping and Emotion Regulation.

    Science.gov (United States)

    Bonanno, George A; Burton, Charles L

    2013-11-01

    People respond to stressful events in different ways, depending on the event and on the regulatory strategies they choose. Coping and emotion regulation theorists have proposed dynamic models in which these two factors, the person and the situation, interact over time to inform adaptation. In practice, however, researchers have tended to assume that particular regulatory strategies are consistently beneficial or maladaptive. We label this assumption the fallacy of uniform efficacy and contrast it with findings from a number of related literatures that have suggested the emergence of a broader but as yet poorly defined construct that we refer to as regulatory flexibility. In this review, we articulate this broader construct and define both its features and limitations. Specifically, we propose a heuristic individual differences framework and review research on three sequential components of flexibility for which propensities and abilities vary: sensitivity to context, availability of a diverse repertoire of regulatory strategies, and responsiveness to feedback. We consider the methodological limitations of research on each component, review questions that future research on flexibility might address, and consider how the components might relate to each other and to broader conceptualizations about stability and change across persons and situations. © The Author(s) 2013.

  9. Implementation of in vitro replacement technologies in regulatory drug testing - An innovation systems perspective

    NARCIS (Netherlands)

    Kooijman, M.; Van Meer, P.J.K.; Moors, E.H.M.; Hekkert, M.P.; Schellekens, H.

    2011-01-01

    The replacement of in vivo methods by in vitro methods in regulatory drug testing is rare. The aim of this research is to identify barriers and drivers of the replacement of in vivo methods by in vitro methods in Europe. We studied two cases. The first case is the Draize eye test. Since 2009, the in

  10. Biosimilars in psoriasis: Clinical practice and regulatory perspectives in Latin America.

    Science.gov (United States)

    de la Cruz, Claudia; de Carvalho, André V E; Dorantes, Gladys L; Londoño Garcia, Angela M; Gonzalez, Cesar; Maskin, Matías; Podoswa, Nancy; Redfern, Jan S; Valenzuela, Fernando; van der Walt, Joelle; Romiti, Ricardo

    2017-01-01

    Latin American countries view biosimilar agents as an effective approach to curtail health-care expenditures while maintaining the safety and efficacy profile of their branded innovator comparators. To understand the complexities of the regulatory landscape and key therapeutic issues for use of biosimilars to treat moderate to severe psoriasis in Latin America, the International Psoriasis Council convened dermatology experts from Argentina, Brazil, Chile, Colombia and Mexico in October 2015 to review the definition, approval, marketing and future of biosimilars in each country and develop a consensus statement. The regulatory framework for marketing approval of biosimilars in Latin America is currently a mosaic of disparate, country-specific, regulatory review processes, rules and standards, with considerable heterogeneity in clarity and specificity. Regulations in Argentina, Brazil, Chile and Mexico have undergone multiple refinements whereas Colombia is finalizing draft guidelines. Verification of the similarity in quality, safety and efficacy of biosimilars to the innovator biologic remains a key challenge for policy makers and regulatory authorities. Other key regulatory challenges include: naming of agents and traceability, pharmacovigilance, extrapolation of indications, and interchangeability and substitution. An urgent need exists for more Latin American countries to establish national psoriasis registries and to integrate their common components into a multinational psoriasis network, thereby enhancing their interpretative power and impact. A Latin American psoriasis network similar to PSONET in Europe would assist health-care providers, pharmaceutical companies, regulators and patients to fully comprehend specific products being prescribed and dispensed and to identify potential regional trends or differences in safety or outcomes. © 2016 Japanese Dermatological Association.

  11. Structural radioactive waste from 'retubing/refurbishment' of Embalse nuclear power plant. Regulatory perspective

    International Nuclear Information System (INIS)

    Alvarez, Daniela E.; Lee Gonzales, Horacio M.; Medici, Marcela A.; Piumetti, Elsa H.

    2009-01-01

    Unlike the building of a new nuclear reactor, the 'retubing / refurbishment' of nuclear reactors that have been in operation for many years, involves the replacement of components in a radioactive environment. This requires a carefully planned radiation protection program to ensure protection of workers, the public and the environment as well as a radioactive waste management program for those radioactive waste generated during the process, which go beyond those generated during the normal operation and maintenance of the plant. Nucleoelectrica Argentina Sociedad Anonima (NA-SA) is scheduled to conduct the Life Extension Process of Embalse Nuclear Power Plant (CNE) which essentially consist of 'retubing / refurbishment' of the installation. The Nuclear Regulatory Authority (ARN) will then have an important activity related to the above process. In particular, this paper will describe some points of interest related to the generation and management of radioactive waste during the 'retubing / refurbishment' of the CNE, from the regulatory point of view. (author)

  12. Regulatory infrastructure in East and West Asia: Present status and perspectives

    International Nuclear Information System (INIS)

    Djermouni, B.

    2001-01-01

    A detailed assessment carried out by the IAEA showed that five Member States in East Asia (Bangladesh, Mongolia, Myanmar, Sri Lanka, Vietnam) and nine Member States in West Asia (Jordan, Kazakhstan, Lebanon, Qatar, Saudi Arabia, Syria, United Arab Emirates, Uzbekistan, Yemen) did not have an adequate radiation and waste safety infrastructure in general and a basic regulatory infrastructure in particular. This indicated the partial or complete lack of control of radiation sources, i.e. location, identification, registration, licensing and inspection. Since 1996, these countries have been participating in the Model Project on Upgrading Radiation and Waste Safety Infrastructure with the primary objective of establishing or upgrading their basic regulatory infrastructure. The results achieved in the establishment/upgrading of this infrastructure and the follow-up and extension to other Member States are presented in this paper. (author)

  13. Regulatory Perspectives on Risk Management for Lepse De-fuelling Operations

    International Nuclear Information System (INIS)

    Sneve, Malgorzata; Gordon, Boris

    2001-01-01

    The Lepse is a ship used for the storage of spent nuclear fuel from nuclear powered ice-breakers in the Murmansk region. Much of the stored spent fuel is damaged. While the status of the vessel may be considered reasonably secure for the present, it is well understood that, at some stage, it will be necessary to remove the spent fuel from the Lepse, so that the long term safe management of the spent fuel can be assured. Plans have been developed for unloading spent fuel from the Lepse. The operations to do this will be non-standard, because of the nature of the storage facilities within the vessel and the poor state of the majority of the spent fuel. For example, specialised equipment will be required for fuel handling, and special arrangements will have to be in place to avoid or mitigate the consequences of possible accidents. Regulatory supervision of these unique operations has also to be specifically provided. Concerning nuclear safety aspects, the Federal Nuclear and Radiation Safety Authority of Russia (Gosatomnadzor) has developed specific regulatory documents, with support from the Scientific and Engineering Centre of Gosatornnadzor and additional support from western agencies. Other regulatory bodies are also involved, concerned with the protection of the environment and other matters

  14. Clinical potential of regulatory T cell therapy in liver diseases: An overview and current perspectives

    Directory of Open Access Journals (Sweden)

    Hannah Claire Jeffery

    2016-09-01

    Full Text Available The increasing demand for liver transplantation and the decline in donor organs has highlighted the need for alternative novel therapies to prevent chronic active hepatitis, which eventually leads to liver cirrhosis and liver cancer. Liver histology of chronic hepatitis is composed of both effector and regulatory lymphocytes. The human liver contains different subsets of effector lymphocytes, that are kept in check by a subpopulation of T cells known as Regulatory T cells (Treg. The balance of effector and regulatory lymphocytes generally determines the outcome of hepatic inflammation: resolution, fulminant hepatitis or chronic active hepatitis. Thus, maintaining and adjusting this balance is crucial in immunological manipulation of liver diseases. One of the options to restore this balance is to enrich Treg in the liver disease patients.Advances in the knowledge of Treg biology and development of clinical grade isolation reagents, cell sorting equipment and Good Manufacturing Practice (GMP facilities have paved the way to apply Treg cells as a potential therapy to restore peripheral self-tolerance in autoimmune liver diseases, chronic rejection and post-transplantation. Past and on-going studies have applied Treg in type-1 diabetes mellitus, systemic lupus erythematosus, graft versus host diseases (GVHD and solid organ transplantations. There have not been any new therapies for the autoimmune liver diseases for more than three decades; thus the clinical potential for the application of autologous Treg cell therapy to treat autoimmune liver disease is an attractive and novel option. However, it is fundamental to understand the deep immunology, genetic profiles, biology, homing behavior and microenvironment of Treg before applying the cells to the patients.

  15. A developmental systems perspective on epistasis: computational exploration of mutational interactions in model developmental regulatory networks.

    Directory of Open Access Journals (Sweden)

    Jayson Gutiérrez

    2009-09-01

    Full Text Available The way in which the information contained in genotypes is translated into complex phenotypic traits (i.e. embryonic expression patterns depends on its decoding by a multilayered hierarchy of biomolecular systems (regulatory networks. Each layer of this hierarchy displays its own regulatory schemes (i.e. operational rules such as +/- feedback and associated control parameters, resulting in characteristic variational constraints. This process can be conceptualized as a mapping issue, and in the context of highly-dimensional genotype-phenotype mappings (GPMs epistatic events have been shown to be ubiquitous, manifested in non-linear correspondences between changes in the genotype and their phenotypic effects. In this study I concentrate on epistatic phenomena pervading levels of biological organization above the genetic material, more specifically the realm of molecular networks. At this level, systems approaches to studying GPMs are specially suitable to shed light on the mechanistic basis of epistatic phenomena. To this aim, I constructed and analyzed ensembles of highly-modular (fully interconnected networks with distinctive topologies, each displaying dynamic behaviors that were categorized as either arbitrary or functional according to early patterning processes in the Drosophila embryo. Spatio-temporal expression trajectories in virtual syncytial embryos were simulated via reaction-diffusion models. My in silico mutational experiments show that: 1 the average fitness decay tendency to successively accumulated mutations in ensembles of functional networks indicates the prevalence of positive epistasis, whereas in ensembles of arbitrary networks negative epistasis is the dominant tendency; and 2 the evaluation of epistatic coefficients of diverse interaction orders indicates that, both positive and negative epistasis are more prevalent in functional networks than in arbitrary ones. Overall, I conclude that the phenotypic and fitness effects of

  16. Companion diagnostics: a regulatory perspective from the last 5 years of molecular companion diagnostic approvals.

    Science.gov (United States)

    Roscoe, Donna M; Hu, Yun-Fu; Philip, Reena

    2015-01-01

    Companion diagnostics are essential for the safe and effective use of the corresponding therapeutic products. The US FDA has approved a number of companion diagnostics used to select cancer patients for treatment with contemporaneously approved novel therapeutics. The processes of co-development and co-approval of a therapeutic product and its companion diagnostic have been a learning experience that continues to evolve. Using several companion diagnostics as examples, this article describes the challenges associated with the scientific, clinical and regulatory hurdles faced by FDA and industry alike. Taken together, this discussion is intended to assist manufacturers toward a successful companion diagnostics development plan.

  17. School-based influenza vaccination: parents' perspectives.

    Directory of Open Access Journals (Sweden)

    Candace Lind

    Full Text Available School-age children are important drivers of annual influenza epidemics yet influenza vaccination coverage of this population is low despite universal publicly funded influenza vaccination in Alberta, Canada. Immunizing children at school may potentially increase vaccine uptake. As parents are a key stakeholder group for such a program, it is important to consider their concerns.We explored parents' perspectives on the acceptability of adding an annual influenza immunization to the immunization program that is currently delivered in Alberta schools, and obtained suggestions for structuring such a program.Forty-eight parents of children aged 5-18 years participated in 9 focus groups. Participants lived in urban areas of the Alberta Health Services Calgary Zone.Three major themes emerged: Advantages of school-based influenza vaccination (SBIV, Disadvantages of SBIV, and Implications for program design & delivery. Advantages were perceived to occur for different populations: children (e.g. emotional support, families (e.g. convenience, the community (e.g. benefits for school and multicultural communities, the health sector (e.g. reductions in costs due to burden of illness and to society at large (e.g. indirect conduit of information about health services, building structure for pandemic preparedness, building healthy lifestyles. Disadvantages, however, might also occur for children (e.g. older children less likely to be immunized, families (e.g. communication challenges, perceived loss of parental control over information, choices and decisions and the education sector (loss of instructional time. Nine second-level themes emerged within the major theme of Implications for program design & delivery: program goals/objectives, consent process, stakeholder consultation, age-appropriate program, education, communication, logistics, immunizing agent, and clinic process.Parents perceived advantages and disadvantages to delivering annual seasonal

  18. Regulatory perspective on digital instrumentation and control systems for future advanced nuclear power plants

    International Nuclear Information System (INIS)

    Chiramal, M.

    1993-01-01

    This paper deals with the question of using digital technology in instrumentation and control systems for modern nuclear power reactors. The general opinion in the industry and among NRC staff is that such technology provides the opportunity for enhanced safety and reliable reactor operations. The major concern is the safe application of this technology so as to avoid common mode or common cause failures in systems. There are great differences between digital and analog system components. SECY-91-292 identifies some general regulatory concerns with regard to digital systems. There is clearly a lack of adequate regulatory direction on the application of digital equipment at this time, but the issue is being addressed by the industry, outside experts, and NRC staff. NRC staff presents a position on the issue of defense-in-depth and diversity with regard to insuring plant safety. Independent manual controls and readouts must be available to allow safe shutdown and monitoring of the plant in the event of safety system failures

  19. Regulatory requirements related to risk-based inspection and maintenance

    International Nuclear Information System (INIS)

    Schroeder, H.C.; Kauer, R.

    2003-01-01

    By asking the question why new inspection and maintenance strategies have to be developed one can often be made aware that there is always a continue demand for cost reduction and optimisation. In this framework, general trends involving staff reduction, outsourcing, benchmarking etc. can often be observed nearly everywhere. Since inspection and maintenance are amongst the few cost factors, which could be actively influenced in the short term, and in combination with the recent regulatory fundamental changes (e.g. PED) yielding to considerably greater responsibilities for the operator of a plant, also the demand for documentation and comprehensibility of measures will increase. (orig.)

  20. Using Patient Avatars to Promote Health Data Sharing Applications: Perspectives and Regulatory Challenges.

    Science.gov (United States)

    Dahi, Alan; Forgó, Nikolaus; Jensen, Sarah; Stauch, Marc

    2016-04-01

    The potential of ICT to address problems in modern healthcare is considerable, and an ICT-driven revolution in healthcare appears imminent. Such developments maybe viewed largely in positive terms. Thus they should result in enhanced treatment and care options, empowering patients--including by permitting greater self-management of illness outside hospital, while offering economic benefits and costs savings over traditional healthcare provision. However, the new possibilities also present manifold risks, such as of data breaches, encroachments on subject autonomy, as well as of other harms. This article considers some of the key regulatory challenges against the background of the progress of the current EU Commission-sponsored 'MyHealthAvatar' project.

  1. Future regulatory research needs on risk-informed and performance-based regulation

    International Nuclear Information System (INIS)

    Kim, Wong Sik; Kim, Hho Jung

    2004-01-01

    The USNRC has pursued the incorporation of risk-informed and performance-based regulation (RIPBR) into nuclear safety regulatory system, as an alternative to improve existing nuclear safety regulation of nuclear power plants, which is deterministic and prescriptive. It focuses on the use of risk insight from probabilistic safety assessment (PSA). Recently, it becomes necessary to find a way to improve regulatory efficiency and effectiveness in order to cover the increasing regulatory needs in Korea. Also, the utility has optimized design and operation of the plant using PSA insight and equipment performance information. According to the increase of the necessity for regulatory improvement using risk and performance information, KINS (Korea Institute of Nuclear Safety) is developing, as a part of a mid and long-term project of Nuclear R and D program, how to adopt the RIPBR in Korean nuclear regulatory system. As the interim results, three basic directions and several principles that are necessary to implement RIPBR model were already identified from the previous study. This paper suggests a direction to future regulatory research on RIPBR based on the previous studies including the review of international trend of RIPBR and the evaluation of risk-informed regulatory environment

  2. Clinical trial regulation in Argentina: overview and analysis of regulatory framework, use of existing tools, and researchers' perspectives to identify potential barriers.

    Science.gov (United States)

    White, Lauren; Ortiz, Zulma; Cuervo, Luis G; Reveiz, Ludovic

    2011-11-01

    To review and analyze the regulatory framework of clinical trial registration, use of existing tools (publicly accessible national/international registration databases), and users' perspectives to identify possible barriers to registration compliance by sponsors and researchers in Argentina. Internationally registered trials recruiting patients in Argentina were found through clincialtrials.gov and the International Clinical Trial Registration Platform (ICTRP) and compared with publically available clinical trials registered through the National Administration of Drugs, Foods, and Medical Devices (ANMAT). A questionnaire addressing hypothesized attitudinal, knowledge-related, idiomatic, technical, economic, and regulatory barriers that could discourage or impede registration of clinical trials was developed, and semi-structured, in-depth interviews were conducted with a purposively selected sample of researchers (investigators, sponsors, and monitors) in Argentina. A response rate of 74.3% (n = 29) was achieved, and 27 interviews were ultimately used for analysis. Results suggested that the high proportion of foreign-sponsored or multinational trials (64.8% of all protocols approved by ANMAT from 1994-2006) may contribute to a communication gap between locally based investigators and foreign-based administrative officials. A lack of knowledge about available international registration tools and limited awareness of the importance of registration were also identified as limiting factors for local investigators and sponsors. To increase compliance and promote clinical trial registration in Argentina, national health authorities, sponsors, and local investigators could take the following steps: implement a grassroots educational campaign to improve clinical trial regulation, support local investigator-sponsor-initiated clinical trials, and/or encourage local and regional scientific journal compliance with standards from the International Committee of Medical Journal

  3. Procurement and control of spare and replacement parts - a regulatory perspective

    International Nuclear Information System (INIS)

    Baker, E.T.; Grimes, B.K.; Merschoff, E.W.

    1987-01-01

    As the nuclear industry shifts from a construction to an operations orientation, a number of fundamental changes have occurred in the type of safety-related procurements and the manner in which the utilities accomplish these procurements. Specifically, procurements have shifted from the purchase of large systems and components by architect-engineers, and nuclear steam supply system (NSSS) suppliers to the procurement by utilities of subassemblies, individual pieces of equipment (e.g., breakers, relays), and small parts for repairing individual pieces of equipment. To ensure that equipment will continue to perform its intended function and to satisfy regulatory requirements utilities must consider several things: (1) does the equipment perform a safety function; (2) does the replacement part affect the safety function; and (3) does the replacement part affect the seismic or environmental qualification. If the answer to any of these questions is yes, the purchaser has two alternatives. He may procure the item as safety-related and require the supplier or manufacturer to comply with all the applicable technical and quality requirements or he may purchase the item commercial grade and perform the necessary inspections and tests to ensure the item meets the requirements, i.e., dedicate the item

  4. REGULATORY IMPACT ASSESSMENT IN THE REPUBLIC OF CROATIA- SITUATION AND PERSPECTIVE

    Directory of Open Access Journals (Sweden)

    Danijela ROMIĆ

    2014-05-01

    Full Text Available The fundamental approach of modern, open public administration is the inclusion of the public in government, in the process of adopting regulations relevant to the fulfillment of their rights. In the process of adjustment of Croatian legislation for the full membership in the European Union significant reforms of the legal system have been made , in aim of achieving this ideal . In order to actively involve public in the process of adopting regulations there has been accepted a set of regulations that makes it possible. This paper presents a brief overview of these regulations and those we will also serve as an introduction to the main theme of our work. The purpose of this paper is to present the current situation and possibilities for the participation of public in the process of adopting regulations and to identify deficiencies that have already appeared in the short-term practice. We have set operational objectives on which the research was conducted. The main objective of this study is to determine the method of implementation of obligations as prescribed, particularly obligations of public discussion, public announcement and accessibility of information. With the aim of making this paper, we reviewed websites of the 20 ministries. We did a questionnaire which identified the essential elements of the publication and implementation of public discussion in the process of Regulatory impact assessment. The results were compared with publicly available Plan of normative activities. In data processing, we used descriptive and comparative method, and other classic statistical methods.

  5. A regulatory perspective on the abuse potential evaluation of novel stimulant drugs in the United States.

    Science.gov (United States)

    Calderon, Silvia N; Klein, Michael

    2014-12-01

    In the United States of America (USA), the abuse potential assessment of a drug is performed as part of the safety evaluation of a drug under development, and to evaluate if the drug needs to be subject to controls that would minimize the abuse of the drug once on the market. The assessment of the abuse potential of new drugs consists of a scientific and medical evaluation of all data related to abuse of the drug. This paper describes the regulatory framework for evaluating the abuse potential of new drugs, in general, including novel stimulants. The role of the United States Food and Drug Administration (FDA) in the evaluation of the abuse potential of drugs, and its role in drug control are also discussed. A definition of abuse potential, an overview of the currently accepted approaches to evaluating the abuse potential of a drug, as well as a description of the criteria that applies when recommending a specific level of control (i.e., a Schedule) for a drug under the Controlled Substances Act (CSA). This article is part of the Special Issue entitled 'CNS Stimulants'. Published by Elsevier Ltd.

  6. NRC [Nuclear Regulatory Commission] perspective of software QA [quality assurance] in the nuclear history

    International Nuclear Information System (INIS)

    Weiss, S.H.

    1988-01-01

    Computer technology has been a part of the nuclear industry since its inception. However, it is only recently that computers have been integrated into reactor operations. During the early history of commercial nuclear power in the United States, the US Nuclear Regulatory Commission (NRC) discouraged the use of digital computers for real-time control and monitoring of nuclear power plant operation. At the time, this position was justified since software engineering was in its infancy, and horror stories on computer crashes were plentiful. Since the advent of microprocessors and inexpensive computer memories, significant advances have been made in fault-tolerant computer architecture that have resulted in highly reliable, durable computer systems. The NRC's requirement for safety parameter display system (SPDS) stemmed form the results of studies and investigations conducted on the Three Mile Island Unit 2 (TMI-2) accident. An NRC contractor has prepared a handbook of software QA techniques applicable to the nuclear industry, published as NUREG/CR-4640 in August 1987. Currently, the NRC is considering development of an inspection program covering software QA. Future efforts may address verification and validation as applied to expert systems and artificial intelligence programs

  7. High-level waste program management: A ratepayers' and regulatory perspective

    International Nuclear Information System (INIS)

    Anderson, E.G.

    1986-01-01

    The nation's electric utility regulators have joined the effort to enhance the federal project to dispose of high-level nuclear waste. Because all financial support comes from ratepayers, the National Association of Regulatory Utility Commissioners (NARUC), through the mechanism of a subcommittee, seeks to investigate and monitor the federal program to provide to the Congress and the U.S. Department of Energy (DOE) the NARUC's unique expertise. Its views to enhance program management and improve cost control are its central contribution. While conveying no lack of confidence in the federal management, the NARUC is imparting its relevant experience derived from review of nuclear power plant construction and cost control. Recommendations are made for more cost-effective program direction and views on its management are given. Financial control, public input and cost responsibilities for disposal of defense and commercial wastes are separately identified. Needs for the DOE's heightened insight into and development of the monitored retrievable storage proposal to the Congress are described. Finally, with a warning that there exists a limit to ratepayer funding of this effort, the request is made for Congressional cost-control hearings and for expanded dialogue between the Department of Engery and financially responsible parties

  8. rSNPBase 3.0: an updated database of SNP-related regulatory elements, element-gene pairs and SNP-based gene regulatory networks.

    Science.gov (United States)

    Guo, Liyuan; Wang, Jing

    2018-01-04

    Here, we present the updated rSNPBase 3.0 database (http://rsnp3.psych.ac.cn), which provides human SNP-related regulatory elements, element-gene pairs and SNP-based regulatory networks. This database is the updated version of the SNP regulatory annotation database rSNPBase and rVarBase. In comparison to the last two versions, there are both structural and data adjustments in rSNPBase 3.0: (i) The most significant new feature is the expansion of analysis scope from SNP-related regulatory elements to include regulatory element-target gene pairs (E-G pairs), therefore it can provide SNP-based gene regulatory networks. (ii) Web function was modified according to data content and a new network search module is provided in the rSNPBase 3.0 in addition to the previous regulatory SNP (rSNP) search module. The two search modules support data query for detailed information (related-elements, element-gene pairs, and other extended annotations) on specific SNPs and SNP-related graphic networks constructed by interacting transcription factors (TFs), miRNAs and genes. (3) The type of regulatory elements was modified and enriched. To our best knowledge, the updated rSNPBase 3.0 is the first data tool supports SNP functional analysis from a regulatory network prospective, it will provide both a comprehensive understanding and concrete guidance for SNP-related regulatory studies. © The Author(s) 2017. Published by Oxford University Press on behalf of Nucleic Acids Research.

  9. Microresonator-Based Optical Frequency Combs: A Time Domain Perspective

    Science.gov (United States)

    2016-04-19

    AFRL-AFOSR-VA-TR-2016-0165 (BRI) Microresonator-Based Optical Frequency Combs: A Time Domain Perspective Andrew Weiner PURDUE UNIVERSITY 401 SOUTH...Optical Frequency Combs: A Time Domain Perspective 5a. CONTRACT NUMBER 5b. GRANT NUMBER FA9550-12-1-0236 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S...average 1 hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data

  10. An algebra-based method for inferring gene regulatory networks.

    Science.gov (United States)

    Vera-Licona, Paola; Jarrah, Abdul; Garcia-Puente, Luis David; McGee, John; Laubenbacher, Reinhard

    2014-03-26

    The inference of gene regulatory networks (GRNs) from experimental observations is at the heart of systems biology. This includes the inference of both the network topology and its dynamics. While there are many algorithms available to infer the network topology from experimental data, less emphasis has been placed on methods that infer network dynamics. Furthermore, since the network inference problem is typically underdetermined, it is essential to have the option of incorporating into the inference process, prior knowledge about the network, along with an effective description of the search space of dynamic models. Finally, it is also important to have an understanding of how a given inference method is affected by experimental and other noise in the data used. This paper contains a novel inference algorithm using the algebraic framework of Boolean polynomial dynamical systems (BPDS), meeting all these requirements. The algorithm takes as input time series data, including those from network perturbations, such as knock-out mutant strains and RNAi experiments. It allows for the incorporation of prior biological knowledge while being robust to significant levels of noise in the data used for inference. It uses an evolutionary algorithm for local optimization with an encoding of the mathematical models as BPDS. The BPDS framework allows an effective representation of the search space for algebraic dynamic models that improves computational performance. The algorithm is validated with both simulated and experimental microarray expression profile data. Robustness to noise is tested using a published mathematical model of the segment polarity gene network in Drosophila melanogaster. Benchmarking of the algorithm is done by comparison with a spectrum of state-of-the-art network inference methods on data from the synthetic IRMA network to demonstrate that our method has good precision and recall for the network reconstruction task, while also predicting several of the

  11. Analyzing policy support instruments and regulatory risk factors for wind energy deployment-A developers' perspective

    International Nuclear Information System (INIS)

    Luethi, Sonja; Praessler, Thomas

    2011-01-01

    A transition to a renewable energy system is high on the policy agenda in many countries. A promising energy source for a low-carbon energy future is wind. Policy-makers can attract wind energy development by providing attractive policy frameworks. This paper argues that apart from the level of financial support, both the risks stemming from the regulatory environment (legal security, administrative process and grid access) and the ability to finance projects play a critical role in determining the attractiveness of the development environment. It sheds light on how project developers trade off these different aspects and to what extent the attractiveness of a certain policy framework increases with the introduction of specific measures. Conjoint analysis is employed to provide empirical evidence on the preference of wind energy developers in the EU and the US. The analysis shows that developers' preferences are very similar across the studied regions and for different types of developers. Which policy measures could be most valuable depends on the specific existing environment. In some southeastern European countries, a reduction of administrative process duration may yield the highest utility gains, whereas, in the US, improvements in grid access regulation and an increase in remuneration levels may be more effective. - Highlights: → Paper suggests conjoint analysis as scenario tool for estimating potential effects of specific policy measures. → It provides a quantitative, empirical dataset of 119 onshore wind energy developers' preferences. → Results suggest that the aspects 'Legal security' and 'Remuneration' are important attributes. → Cluster analyses yields slightly different preferences for developers from EU and US.

  12. The local lymph node assay in practice: a current regulatory perspective.

    Science.gov (United States)

    Cockshott, A; Evans, P; Ryan, C A; Gerberick, G F; Betts, C J; Dearman, R J; Kimber, I; Basketter, D A

    2006-07-01

    Following the formal acceptance of the local lymph node assay (LLNA) as an Organization for Economic Cooperation and Development (OECD) guideline in April 2002, the UK Health and Safety Executive (HSE) informed notifiers that this was now the method of choice for the assessment of skin sensitization potential under the EU notification scheme for new industrial chemicals (NONS). This paper summarizes the experience of the HSE for the 2-year period immediately following the issuing of this statement, during which 48 LLNA study reports were assessed for notification purposes. The issues discussed here include adherence to the OECD guideline, interpretation of results, and classification outcomes. Generally, notifying laboratories followed the OECD guideline successfully, with regard to the sex/ strain/numbers of mice used, the precise process used for measurement of cell proliferation, and the use of recommended vehicles and positive controls. Initially, use of the individual animal approach (measuring the cell proliferation in each animal rather than for a pooled dose group) highlighted problems caused by technical inexperience, but these were overcome by practice. Toxicity or irritation were found to be minor factors in dose selection; more important was the choice of vehicle to correctly maximize the test substance concentration, while maintaining appropriate application properties. Contrary to concerns that the LLNA would prove to be less sensitive or more sensitive than the traditionally used Guinea Pig Maximization Test (GPMT), the proportion of new substances classified as skin sensitizers was within the range observed in previous years. Although the sample size is relatively small, the experience of the HSE indicates that the LLNA is satisfactory for routine regulatory use.

  13. Spanish regulatory perspective for the decommissioning of an old civilian nuclear research centre (CIEMAT)

    International Nuclear Information System (INIS)

    Gil, E.; Revilla, J.L.; Rodrigo, F.; Ortiz, J.

    1999-01-01

    The Center for Energy-related, Environmental and Technical Research (CIEMAT) is the main Spanish energy research center. CIEMAT is the heir of the former Nuclear Energy Board (Junta de Energia Nuclear - JEN), which was created in 1951 with a view to promoting the development and use of nuclear energy in Spain. Most of the centres for civilian nuclear research created in the fifties, like the JEN, had among their basic objectives to carry out investigations guided to the industrial development of the nuclear fuel cycle. The majority of them were endowed with experimental facilities that reproduced in a pilot scale the different stages of the full nuclear cycle facilities. The JEN main experimental facilities were: Plants for the treatment of uranium ores and for the concentration process; The manufacturing of fuel elements for research reactors; The JEN-1 thermal neutron experimental reactor, and CORAL fast reactor; The pilot plant for the treatment of irradiated fuel (M-1); The metallurgical hot cells for research relating to irradiated fuel; and Plants for the treatment and storage of liquid radioactive wastes. It should be pointed out that most of these installations were designed, built, operated, and even definitively shut down, prior a regulatory system as currently conceived is in force. The Science Act was passed in 1986, transforming the JEN into CIEMAT, and assigning to the latter a series of new functions, while making it the direct heir of the assets and strategic functions of its predecessor. The CIEMAT continued the process of 'denuclearization' of the installations inherited from the JEN, and used certain of them for the performance of research projects oriented towards the development of decontamination and dismantling techniques. (author)

  14. A New Algorithm for Identifying Cis-Regulatory Modules Based on Hidden Markov Model

    Directory of Open Access Journals (Sweden)

    Haitao Guo

    2017-01-01

    Full Text Available The discovery of cis-regulatory modules (CRMs is the key to understanding mechanisms of transcription regulation. Since CRMs have specific regulatory structures that are the basis for the regulation of gene expression, how to model the regulatory structure of CRMs has a considerable impact on the performance of CRM identification. The paper proposes a CRM discovery algorithm called ComSPS. ComSPS builds a regulatory structure model of CRMs based on HMM by exploring the rules of CRM transcriptional grammar that governs the internal motif site arrangement of CRMs. We test ComSPS on three benchmark datasets and compare it with five existing methods. Experimental results show that ComSPS performs better than them.

  15. A New Algorithm for Identifying Cis-Regulatory Modules Based on Hidden Markov Model

    Science.gov (United States)

    2017-01-01

    The discovery of cis-regulatory modules (CRMs) is the key to understanding mechanisms of transcription regulation. Since CRMs have specific regulatory structures that are the basis for the regulation of gene expression, how to model the regulatory structure of CRMs has a considerable impact on the performance of CRM identification. The paper proposes a CRM discovery algorithm called ComSPS. ComSPS builds a regulatory structure model of CRMs based on HMM by exploring the rules of CRM transcriptional grammar that governs the internal motif site arrangement of CRMs. We test ComSPS on three benchmark datasets and compare it with five existing methods. Experimental results show that ComSPS performs better than them. PMID:28497059

  16. A parallel attractor-finding algorithm based on Boolean satisfiability for genetic regulatory networks.

    Directory of Open Access Journals (Sweden)

    Wensheng Guo

    Full Text Available In biological systems, the dynamic analysis method has gained increasing attention in the past decade. The Boolean network is the most common model of a genetic regulatory network. The interactions of activation and inhibition in the genetic regulatory network are modeled as a set of functions of the Boolean network, while the state transitions in the Boolean network reflect the dynamic property of a genetic regulatory network. A difficult problem for state transition analysis is the finding of attractors. In this paper, we modeled the genetic regulatory network as a Boolean network and proposed a solving algorithm to tackle the attractor finding problem. In the proposed algorithm, we partitioned the Boolean network into several blocks consisting of the strongly connected components according to their gradients, and defined the connection between blocks as decision node. Based on the solutions calculated on the decision nodes and using a satisfiability solving algorithm, we identified the attractors in the state transition graph of each block. The proposed algorithm is benchmarked on a variety of genetic regulatory networks. Compared with existing algorithms, it achieved similar performance on small test cases, and outperformed it on larger and more complex ones, which happens to be the trend of the modern genetic regulatory network. Furthermore, while the existing satisfiability-based algorithms cannot be parallelized due to their inherent algorithm design, the proposed algorithm exhibits a good scalability on parallel computing architectures.

  17. Continuing Bonds in Bereavement: An Attachment Theory Based Perspective

    Science.gov (United States)

    Field, Nigel P.; Gao, Beryl; Paderna, Lisa

    2005-01-01

    An attachment theory based perspective on the continuing bond to the deceased (CB) is proposed. The value of attachment theory in specifying the normative course of CB expression and in identifying adaptive versus maladaptive variants of CB expression based on their deviation from this normative course is outlined. The role of individual…

  18. The development of regulatory expectations for computer-based safety systems for the UK nuclear programme

    Energy Technology Data Exchange (ETDEWEB)

    Hughes, P. J. [HM Nuclear Installations Inspectorate Marine Engineering Submarines Defence Nuclear Safety Regulator Serco Assurance Redgrave Court, Merton Road, Bootle L20 7HS (United Kingdom); Westwood, R.N; Mark, R. T. [FLEET HQ, Leach Building, Whale Island, Portsmouth, PO2 8BY (United Kingdom); Tapping, K. [Serco Assurance,Thomson House, Risley, Warrington, WA3 6GA (United Kingdom)

    2006-07-01

    The Nuclear Installations Inspectorate (NII) of the UK's Health and Safety Executive (HSE) has completed a review of their Safety Assessment Principles (SAPs) for Nuclear Installations recently. During the period of the SAPs review in 2004-2005 the designers of future UK naval reactor plant were optioneering the control and protection systems that might be implemented. Because there was insufficient regulatory guidance available in the naval sector to support this activity the Defence Nuclear Safety Regulator (DNSR) invited the NII to collaborate with the production of a guidance document that provides clarity of regulatory expectations for the production of safety cases for computer based safety systems. A key part of producing regulatory expectations was identifying the relevant extant standards and sector guidance that reflect good practice. The three principal sources of such good practice were: IAEA Safety Guide NS-G-1.1 (Software for Computer Based Systems Important to Safety in Nuclear Power Plants), European Commission consensus document (Common Position of European Nuclear Regulators for the Licensing of Safety Critical Software for Nuclear Reactors) and IEC nuclear sector standards such as IEC60880. A common understanding has been achieved between the NII and DNSR and regulatory guidance developed which will be used by both NII and DNSR in the assessment of computer-based safety systems and in the further development of more detailed joint technical assessment guidance for both regulatory organisations. (authors)

  19. The Regulatory Challenges and Opportunities of IP Telephony: Perspective on Malaysia

    OpenAIRE

    Md Khaled Shukran

    2011-01-01

    IP telephony is a transmission of voice and data over Packet Switched IP Networks and it has become a key issue in the telecommunication industry worldwide because of its higher efficiency and cheapest call rate. Hence, most of the countries in the world set up their telecommunication platform on IP based network as a fast revenue generating sources. Though Malaysia is on the way forward on IP based platform but the growth is not reached at satisfactory level due to the absence of effective r...

  20. Regulatory perspectives on model validation in high-level radioactive waste management programs: A joint NRC/SKI white paper

    Energy Technology Data Exchange (ETDEWEB)

    Wingefors, S.; Andersson, J.; Norrby, S. [Swedish Nuclear Power lnspectorate, Stockholm (Sweden). Office of Nuclear Waste Safety; Eisenberg, N.A.; Lee, M.P.; Federline, M.V. [U.S. Nuclear Regulatory Commission, Washington, DC (United States). Office of Nuclear Material Safety and Safeguards; Sagar, B.; Wittmeyer, G.W. [Center for Nuclear Waste Regulatory Analyses, San Antonio, TX (United States)

    1999-03-01

    Validation (or confidence building) should be an important aspect of the regulatory uses of mathematical models in the safety assessments of geologic repositories for the disposal of spent nuclear fuel and other high-level radioactive wastes (HLW). A substantial body of literature exists indicating the manner in which scientific validation of models is usually pursued. Because models for a geologic repository performance assessment cannot be tested over the spatial scales of interest and long time periods for which the models will make estimates of performance, the usual avenue for model validation- that is, comparison of model estimates with actual data at the space-time scales of interest- is precluded. Further complicating the model validation process in HLW programs are the uncertainties inherent in describing the geologic complexities of potential disposal sites, and their interactions with the engineered system, with a limited set of generally imprecise data, making it difficult to discriminate between model discrepancy and inadequacy of input data. A successful strategy for model validation, therefore, should attempt to recognize these difficulties, address their resolution, and document the resolution in a careful manner. The end result of validation efforts should be a documented enhancement of confidence in the model to an extent that the model's results can aid in regulatory decision-making. The level of validation needed should be determined by the intended uses of these models, rather than by the ideal of validation of a scientific theory. This white Paper presents a model validation strategy that can be implemented in a regulatory environment. It was prepared jointly by staff members of the U.S. Nuclear Regulatory Commission and the Swedish Nuclear Power Inspectorate-SKI. This document should not be viewed as, and is not intended to be formal guidance or as a staff position on this matter. Rather, based on a review of the literature and previous

  1. Regulatory perspectives on model validation in high-level radioactive waste management programs: A joint NRC/SKI white paper

    International Nuclear Information System (INIS)

    Wingefors, S.; Andersson, J.; Norrby, S.

    1999-03-01

    Validation (or confidence building) should be an important aspect of the regulatory uses of mathematical models in the safety assessments of geologic repositories for the disposal of spent nuclear fuel and other high-level radioactive wastes (HLW). A substantial body of literature exists indicating the manner in which scientific validation of models is usually pursued. Because models for a geologic repository performance assessment cannot be tested over the spatial scales of interest and long time periods for which the models will make estimates of performance, the usual avenue for model validation- that is, comparison of model estimates with actual data at the space-time scales of interest- is precluded. Further complicating the model validation process in HLW programs are the uncertainties inherent in describing the geologic complexities of potential disposal sites, and their interactions with the engineered system, with a limited set of generally imprecise data, making it difficult to discriminate between model discrepancy and inadequacy of input data. A successful strategy for model validation, therefore, should attempt to recognize these difficulties, address their resolution, and document the resolution in a careful manner. The end result of validation efforts should be a documented enhancement of confidence in the model to an extent that the model's results can aid in regulatory decision-making. The level of validation needed should be determined by the intended uses of these models, rather than by the ideal of validation of a scientific theory. This white Paper presents a model validation strategy that can be implemented in a regulatory environment. It was prepared jointly by staff members of the U.S. Nuclear Regulatory Commission and the Swedish Nuclear Power Inspectorate-SKI. This document should not be viewed as, and is not intended to be formal guidance or as a staff position on this matter. Rather, based on a review of the literature and previous

  2. The relationship between time perspective and self-regulatory processes, abilities and outcomes: a protocol for a meta-analytical review.

    Science.gov (United States)

    Baird, Harriet M; Webb, Thomas L; Martin, Jilly; Sirois, Fuschia M

    2017-07-05

    Both theoretical and empirical evidence suggests that time perspective is likely to influence self-regulatory processes and outcomes. Despite the theoretical and practical significance of such relations, the relationship between time perspective and self-regulatory processes and outcomes across different measures, samples and life domains, including health, has yet to be explored. The proposed review will develop a taxonomy for classifying measures according to the self-regulatory process, ability or outcome that they are likely to reflect. Electronic scientific databases will be searched, along with relevant conference abstract booklets and citation lists. Additionally, a call for unpublished data will be submitted to relevant bodies. To be eligible for inclusion, studies must include a measure of time perspective and a measure of at least one self-regulatory process, ability and/ or outcome. Eligibility will not be restricted by publication date, language, type of sample or setting. The bivariate correlations will be extracted (or calculated) and submitted to a random-effects meta-analysis. The sample-weighted average effect size, heterogeneity, risk of bias and publication bias will be calculated, and the effects of categorical and continuous moderator variables on the effect sizes will be determined. The proposed meta-analysis will synthesise previously conducted research; thus, ethical approval is not required. The findings will be submitted for publication in an international peer-reviewed journal and reported as part of the first author’s PhD thesis. The findings will also be disseminated to the research community and, where appropriate, to other interested parties through presentations at relevant academic and non-academic conferences. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  3. Analysis of regulatory networks constructed based on gene ...

    Indian Academy of Sciences (India)

    2013-12-09

    Dec 9, 2013 ... early diagnosis of complex diseases or cancer without obvious symptoms. [Gong J., Diao B., Yao G. J., ... expression levels of thousands of genes in a specific cell or tissue. Previous ..... base of the brain. It mainly controls the ...

  4. Ontology-based validation and identification of regulatory phenotypes

    KAUST Repository

    Kulmanov, Maxat

    2018-01-31

    Motivation: Function annotations of gene products, and phenotype annotations of genotypes, provide valuable information about molecular mechanisms that can be utilized by computational methods to identify functional and phenotypic relatedness, improve our understanding of disease and pathobiology, and lead to discovery of drug targets. Identifying functions and phenotypes commonly requires experiments which are time-consuming and expensive to carry out; creating the annotations additionally requires a curator to make an assertion based on reported evidence. Support to validate the mutual consistency of functional and phenotype annotations as well as a computational method to predict phenotypes from function annotations, would greatly improve the utility of function annotations Results: We developed a novel ontology-based method to validate the mutual consistency of function and phenotype annotations. We apply our method to mouse and human annotations, and identify several inconsistencies that can be resolved to improve overall annotation quality. Our method can also be applied to the rule-based prediction of phenotypes from functions. We show that the predicted phenotypes can be utilized for identification of protein-protein interactions and gene-disease associations. Based on experimental functional annotations, we predict phenotypes for 1,986 genes in mouse and 7,301 genes in human for which no experimental phenotypes have yet been determined.

  5. Ontology-based validation and identification of regulatory phenotypes

    KAUST Repository

    Kulmanov, Maxat; Schofield, Paul N; Gkoutos, Georgios V; Hoehndorf, Robert

    2018-01-01

    Motivation: Function annotations of gene products, and phenotype annotations of genotypes, provide valuable information about molecular mechanisms that can be utilized by computational methods to identify functional and phenotypic relatedness, improve our understanding of disease and pathobiology, and lead to discovery of drug targets. Identifying functions and phenotypes commonly requires experiments which are time-consuming and expensive to carry out; creating the annotations additionally requires a curator to make an assertion based on reported evidence. Support to validate the mutual consistency of functional and phenotype annotations as well as a computational method to predict phenotypes from function annotations, would greatly improve the utility of function annotations Results: We developed a novel ontology-based method to validate the mutual consistency of function and phenotype annotations. We apply our method to mouse and human annotations, and identify several inconsistencies that can be resolved to improve overall annotation quality. Our method can also be applied to the rule-based prediction of phenotypes from functions. We show that the predicted phenotypes can be utilized for identification of protein-protein interactions and gene-disease associations. Based on experimental functional annotations, we predict phenotypes for 1,986 genes in mouse and 7,301 genes in human for which no experimental phenotypes have yet been determined.

  6. The Servitization of Manufacturing: A Resource-Based Perspective

    DEFF Research Database (Denmark)

    Yang, Cheng; Boer, Harry; Johansen, John

    2010-01-01

    The traditional focus of manufacturing strategy is tremendously impacted by the emergence of servitization as a new empirical phenomenon and the resource-based view (RBV) as a (relatively) new theoretical perspective. In order to understand their influence, this paper firstly tracks the evolution....... Based on the case analyses and inspired by open source software (OSS) and open innovation, a new, open and capability (development) based role of manufacturing is suggested....

  7. A regulatory perspective on whether the system of radiation protection is fit for purpose

    International Nuclear Information System (INIS)

    Boyd, M.A.

    2012-01-01

    The system of radiation protection has its origins in the early efforts to protect people from x rays and radium. It was at the Second International Congress of Radiology in Stockholm in 1928 where the first radiation protection recommendations were adopted. The system of protection steadily evolved as new sources of exposure arose and understanding of radiation-related health risks improved. Safeguarding against these risks has required regulators to set enforceable (i.e. measurable) standards. From erythema dose to tolerance dose, critical organ dose to effective dose equivalent, and now effective dose, the units used to set these limits have evolved along with the science underpinning them. Similarly, the definition of the person or group being protected has changed – from Standard Man to Reference Man to Reference Person, with age and gender differences now considered explicitly. As regulators look towards implementing the changes in the 2007 Recommendations of the International Commission on Radiological Protection (ICRP), there remain questions about how to translate an optimisation-based system of constraints and reference levels into the more familiar regime of enforceable limits. Nevertheless, as the new ICRP Recommendations are refinements of a system that did the job it was designed to do more than adequately, so too will the new system of radiation protection be fit for purpose.

  8. In or out of regulatory systems? Situation at this time and perspectives

    International Nuclear Information System (INIS)

    Carboneras, P.; Martinez, M.; Ortiz Ramis, T.

    1998-01-01

    From a strictly physical point of view, almost all of the substances existing on the Earth have radioactive isotopes although sometimes the quantities are very small. Given that the ionizing rations pose a risk for human health, a radiology protection system has been devised over the years and forms the base of the Regulator Framework for the control of radioactive materials and for the human activities that use them. However, not all the situations in which there is exposure to ionizing radiations are susceptible to control, and in addition, there would be cases in which the radiology risk would be small enough or so incapable of being reduced that it is not worthwhile dedicating significant resources to control them that could otherwise be used for other tasks. This article analyzes the present situation regarding the existing criteria to decide what should be considered within and what should be excluded from the regulation Framework and examine what could occur with these in the near future in the light of the newest initiative in the international environment. (Author) 21 refs

  9. A dynamic usage based perspective on L2 writing

    NARCIS (Netherlands)

    Verspoor, M.H.; Schmid, M.S.; Xu, X.

    The goal of this study was to explore the contribution that a dynamic usage based (DUB) perspective can bring to the establishment of objective measures to assess L2 learners' written texts and at the same time to gain insight into the dynamic process of language development. Four hundred and thirty

  10. Relations between chronic regulatory focus and future time perspective: Results of a cross-lagged structural equation model

    NARCIS (Netherlands)

    Zacher, H.; Lange, A.H. de

    2011-01-01

    Future time perspective - the way individuals perceive their remaining time in life - importantly influences socio-emotional goals and motivational outcomes. Recently, researchers have called for studies that investigate relationships between personality and future time perspective. Using a

  11. Relations between chronic regulatory focus and future time perspective : Results of a cross-lagged structural equation model

    NARCIS (Netherlands)

    Zacher, Hannes; de Lange, Annet H.

    Future time perspective - the way individuals perceive their remaining time in life - importantly influences socio-emotional goals and motivational outcomes. Recently, researchers have called for studies that investigate relationships between personality and future time perspective. Using a

  12. Prediction of transcriptional regulatory elements for plant hormone responses based on microarray data

    Directory of Open Access Journals (Sweden)

    Yamaguchi-Shinozaki Kazuko

    2011-02-01

    Full Text Available Abstract Background Phytohormones organize plant development and environmental adaptation through cell-to-cell signal transduction, and their action involves transcriptional activation. Recent international efforts to establish and maintain public databases of Arabidopsis microarray data have enabled the utilization of this data in the analysis of various phytohormone responses, providing genome-wide identification of promoters targeted by phytohormones. Results We utilized such microarray data for prediction of cis-regulatory elements with an octamer-based approach. Our test prediction of a drought-responsive RD29A promoter with the aid of microarray data for response to drought, ABA and overexpression of DREB1A, a key regulator of cold and drought response, provided reasonable results that fit with the experimentally identified regulatory elements. With this succession, we expanded the prediction to various phytohormone responses, including those for abscisic acid, auxin, cytokinin, ethylene, brassinosteroid, jasmonic acid, and salicylic acid, as well as for hydrogen peroxide, drought and DREB1A overexpression. Totally 622 promoters that are activated by phytohormones were subjected to the prediction. In addition, we have assigned putative functions to 53 octamers of the Regulatory Element Group (REG that have been extracted as position-dependent cis-regulatory elements with the aid of their feature of preferential appearance in the promoter region. Conclusions Our prediction of Arabidopsis cis-regulatory elements for phytohormone responses provides guidance for experimental analysis of promoters to reveal the basis of the transcriptional network of phytohormone responses.

  13. Design of Knowledge Bases for Plant Gene Regulatory Networks.

    Science.gov (United States)

    Mukundi, Eric; Gomez-Cano, Fabio; Ouma, Wilberforce Zachary; Grotewold, Erich

    2017-01-01

    Developing a knowledge base that contains all the information necessary for the researcher studying gene regulation in a particular organism can be accomplished in four stages. This begins with defining the data scope. We describe here the necessary information and resources, and outline the methods for obtaining data. The second stage consists of designing the schema, which involves defining the entire arrangement of the database in a systematic plan. The third stage is the implementation, defined by actualization of the database by using software according to a predefined schema. The final stage is development, where the database is made available to users in a web-accessible system. The result is a knowledgebase that integrates all the information pertaining to gene regulation, and which is easily expandable and transferable.

  14. The role of self-regulatory efficacy, moral disengagement and guilt on doping likelihood: A social cognitive theory perspective.

    Science.gov (United States)

    Ring, Christopher; Kavussanu, Maria

    2018-03-01

    Given the concern over doping in sport, researchers have begun to explore the role played by self-regulatory processes in the decision whether to use banned performance-enhancing substances. Grounded on Bandura's (1991) theory of moral thought and action, this study examined the role of self-regulatory efficacy, moral disengagement and anticipated guilt on the likelihood to use a banned substance among college athletes. Doping self-regulatory efficacy was associated with doping likelihood both directly (b = -.16, P self-regulatory efficacy influences the likelihood to use banned performance-enhancing substances both directly and indirectly via moral disengagement.

  15. The role of effective communications in Nuclear Regulatory Commission licensing

    International Nuclear Information System (INIS)

    Counsil, W.G.

    1991-01-01

    Communications are essential to the licensing and general regulatory program of the Nuclear Regulatory Commission. This paper attempts to identify and address certain aspects of, and approaches to, maintaining effective and efficient communications. It considers, from the perspective of the high-level radioactive waste repository program, both internal communication within the DOE itself and external communication with the Nuclear Regulatory Commission and interested parties. Many of the points presented are based on lessons learned from electric utility experience with nuclear plants

  16. Gene regulatory network inference by point-based Gaussian approximation filters incorporating the prior information.

    Science.gov (United States)

    Jia, Bin; Wang, Xiaodong

    2013-12-17

    : The extended Kalman filter (EKF) has been applied to inferring gene regulatory networks. However, it is well known that the EKF becomes less accurate when the system exhibits high nonlinearity. In addition, certain prior information about the gene regulatory network exists in practice, and no systematic approach has been developed to incorporate such prior information into the Kalman-type filter for inferring the structure of the gene regulatory network. In this paper, an inference framework based on point-based Gaussian approximation filters that can exploit the prior information is developed to solve the gene regulatory network inference problem. Different point-based Gaussian approximation filters, including the unscented Kalman filter (UKF), the third-degree cubature Kalman filter (CKF3), and the fifth-degree cubature Kalman filter (CKF5) are employed. Several types of network prior information, including the existing network structure information, sparsity assumption, and the range constraint of parameters, are considered, and the corresponding filters incorporating the prior information are developed. Experiments on a synthetic network of eight genes and the yeast protein synthesis network of five genes are carried out to demonstrate the performance of the proposed framework. The results show that the proposed methods provide more accurate inference results than existing methods, such as the EKF and the traditional UKF.

  17. Game-Based Learning: A Different Perspective

    Science.gov (United States)

    Royle, Karl

    2008-01-01

    Because the goals of games and the object of school-based learning are fundamentally mismatched, efforts to integrate games into the curriculum have largely fallen flat despite the best intentions of teachers and the gaming industry. Arguing that educational game designers should be investigating ways to get education into games rather than…

  18. Thinking ethical and regulatory frameworks in medicine from the perspective of solidarity on both sides of the Atlantic.

    Science.gov (United States)

    Prainsack, Barbara; Buyx, Alena

    2016-12-01

    This article provides a concise overview of the history of scholarship on solidarity in Europe and North America. While recent decades have seen an increase in conceptual and scholarly interest in solidarity in North America and other parts of the Anglo-Saxon world, the concept is much more strongly anchored in Europe. Continental European politics in particular have given rise to two of the most influential traditions of solidarity, namely, socialism and Christian ethics. Solidarity has also guided important public instruments and institutions in Europe (e.g., welfare, healthcare, etc.). Despite the much stronger affinity of continental European societies to solidaristic thinking, we argue that solidarity has much to offer for addressing societal challenges on both sides of the Atlantic and beyond. After proposing a working definition of solidarity that highlights its utility for guiding policy and practice, we give an example of how a solidarity-based perspective can shape instruments for the governance of data use.

  19. Regulatory RNAs in Bacillus subtilis : a Gram-Positive Perspective on Bacterial RNA-Mediated Regulation of Gene Expression

    NARCIS (Netherlands)

    Mars, Ruben A. T.; Nicolas, Pierre; Denham, Emma L.; van Dijl, Jan Maarten

    2016-01-01

    Bacteria can employ widely diverse RNA molecules to regulate their gene expression. Such molecules include trans-acting small regulatory RNAs, antisense RNAs, and a variety of transcriptional attenuation mechanisms in the 5= untranslated region. Thus far, most regulatory RNA research has focused on

  20. Inferring regulatory networks from expression data using tree-based methods.

    Directory of Open Access Journals (Sweden)

    Vân Anh Huynh-Thu

    2010-09-01

    Full Text Available One of the pressing open problems of computational systems biology is the elucidation of the topology of genetic regulatory networks (GRNs using high throughput genomic data, in particular microarray gene expression data. The Dialogue for Reverse Engineering Assessments and Methods (DREAM challenge aims to evaluate the success of GRN inference algorithms on benchmarks of simulated data. In this article, we present GENIE3, a new algorithm for the inference of GRNs that was best performer in the DREAM4 In Silico Multifactorial challenge. GENIE3 decomposes the prediction of a regulatory network between p genes into p different regression problems. In each of the regression problems, the expression pattern of one of the genes (target gene is predicted from the expression patterns of all the other genes (input genes, using tree-based ensemble methods Random Forests or Extra-Trees. The importance of an input gene in the prediction of the target gene expression pattern is taken as an indication of a putative regulatory link. Putative regulatory links are then aggregated over all genes to provide a ranking of interactions from which the whole network is reconstructed. In addition to performing well on the DREAM4 In Silico Multifactorial challenge simulated data, we show that GENIE3 compares favorably with existing algorithms to decipher the genetic regulatory network of Escherichia coli. It doesn't make any assumption about the nature of gene regulation, can deal with combinatorial and non-linear interactions, produces directed GRNs, and is fast and scalable. In conclusion, we propose a new algorithm for GRN inference that performs well on both synthetic and real gene expression data. The algorithm, based on feature selection with tree-based ensemble methods, is simple and generic, making it adaptable to other types of genomic data and interactions.

  1. SLS Model Based Design: A Navigation Perspective

    Science.gov (United States)

    Oliver, T. Emerson; Anzalone, Evan; Park, Thomas; Geohagan, Kevin

    2018-01-01

    The SLS Program has implemented a Model-based Design (MBD) and Model-based Requirements approach for managing component design information and system requirements. This approach differs from previous large-scale design efforts at Marshall Space Flight Center where design documentation alone conveyed information required for vehicle design and analysis and where extensive requirements sets were used to scope and constrain the design. The SLS Navigation Team is responsible for the Program-controlled Design Math Models (DMMs) which describe and represent the performance of the Inertial Navigation System (INS) and the Rate Gyro Assemblies (RGAs) used by Guidance, Navigation, and Controls (GN&C). The SLS Navigation Team is also responsible for navigation algorithms. The navigation algorithms are delivered for implementation on the flight hardware as a DMM. For the SLS Block 1B design, the additional GPS Receiver hardware model is managed as a DMM at the vehicle design level. This paper describes the models, and discusses the processes and methods used to engineer, design, and coordinate engineering trades and performance assessments using SLS practices as applied to the GN&C system, with a particular focus on the navigation components.

  2. Commercial FPGA based multipurpose controller: implementation perspective

    International Nuclear Information System (INIS)

    Arredondo, I.; Campo, M. del; Echevarria, P.; Belver, D.; Muguira, L.; Garmendia, N.; Hassanzadegan, H.; Eguiraun, M.; Jugo, J.; Etxebarria, V.

    2012-01-01

    This work presents a fast acquisition multipurpose controller, focussing on its EPICS integration and on its XML based configuration. This controller is based on a Lyrtech VHS-ADC board which encloses an FPGA, connected to a Host PC. This Host acts as local controller and implements an IOC integrating the device in an EPICS network. These tasks have been performed using Java as the main tool to program the PC to make the device fit the desired application. All the process includes the use of different technologies: JNA to handle C functions i.e. FPGA API, JavaIOC to integrate EPICS and XML w3c DOM classes to easily configure the particular application. In order to manage the functions, Java specific tools have been developed: Methods to manage the FPGA (read/write registers, acquire data,...), methods to create and use the EPICS server (put, get, monitor,...), mathematical methods to process the data (numeric format conversions,...) and methods to create/ initialize the application structure by means of an XML file (parse elements, build the DOM and the specific application structure). This XML file has some common nodes and tags for all the applications: FPGA registers specifications definition and EPICS variables. This means that the user only has to include a node for the specific application and use the mentioned tools. A main class is in charge of managing the FPGA and EPICS server according to this XML file. This multipurpose controller has been successfully used to implement a BPM and an LLRF application for the ESS-Bilbao (European Spallation Source) facility. (authors)

  3. Impact of hepatitis C virus polymorphisms on direct-acting antiviral treatment efficacy: Regulatory analyses and perspectives.

    Science.gov (United States)

    Harrington, Patrick R; Komatsu, Takashi E; Deming, Damon J; Donaldson, Eric F; O'Rear, Julian J; Naeger, Lisa K

    2018-06-01

    Several highly effective, interferon-free, direct-acting antiviral (DAA)-based regimens are available for the treatment of chronic hepatitis C virus (HCV) infection. Despite impressive efficacy overall, a small proportion of patients in registrational trials experienced treatment failure, which in some cases was associated with the detection of HCV resistance-associated substitutions (RASs) at baseline. In this article, we describe methods and key findings from independent regulatory analyses investigating the impact of baseline nonstructural (NS) 3 Q80K and NS5A RASs on the efficacy of current United States Food and Drug Administration (FDA)-approved regimens for patients with HCV genotype (GT) 1 or GT3 infection. These analyses focused on clinical trials that included patients who were previously naïve to the DAA class(es) in their investigational regimen and characterized the impact of baseline RASs that were enriched in the viral population as natural or transmitted polymorphisms (i.e., not drug-selected RASs). We used a consistent approach to optimize comparability of results across different DAA regimens and patient populations, including the use of a 15% sensitivity cutoff for next-generation sequencing results and standardized lists of NS5A RASs. These analyses confirmed that detection of NS3 Q80K or NS5A baseline RASs was associated with reduced treatment efficacy for multiple DAA regimens, but their impact was often minimized with the use of an intensified treatment regimen, such as a longer treatment duration and/or addition of ribavirin. We discuss the drug resistance-related considerations that contributed to pretreatment resistance testing and treatment recommendations in drug labeling for FDA-approved DAA regimens. Independent regulatory analyses confirmed that baseline HCV RASs can reduce the efficacy of certain DAA-based regimens in selected patient groups. However, highly effective treatment options are available for patients with or without

  4. Self-Regulatory Imagery and Physical Activity in Middle-Aged and Older Adults: A Social-Cognitive Perspective.

    Science.gov (United States)

    Kosteli, Maria-Christina; Cumming, Jennifer; Williams, Sarah E

    2018-01-01

    Limited research has investigated exercise imagery use in middle-aged and older adults and its relationship with affective and behavioral correlates. The study examined the association between self-regulatory imagery and physical activity (PA) through key social cognitive variables. Middle-aged and older adults (N = 299; M age = 59.73 years, SD = 7.73, range = 50 to 80) completed self-report measures assessing self-regulatory imagery use, self-efficacy, outcome expectations, perceived barriers, self-regulatory behavior, enjoyment, and PA levels. Path analysis supported a model (χ² [14] = 21.76, p = .08, CFI = .99, TLI = .97, SRMR = .03, RMSEA = .04) whereby self-regulatory imagery positively predicted self-efficacy, outcome expectations, and self-regulatory behaviors. Furthermore, self-regulatory imagery indirectly predicted barriers, outcome expectations, self-regulation, enjoyment, and PA. This research highlights self-regulatory imagery as an effective strategy in modifying exercise-related cognitions and behaviors. Incorporating social cognitive constructs into the design of imagery interventions may increase PA engagement.

  5. A primer on thermodynamic-based models for deciphering transcriptional regulatory logic.

    Science.gov (United States)

    Dresch, Jacqueline M; Richards, Megan; Ay, Ahmet

    2013-09-01

    A rigorous analysis of transcriptional regulation at the DNA level is crucial to the understanding of many biological systems. Mathematical modeling has offered researchers a new approach to understanding this central process. In particular, thermodynamic-based modeling represents the most biophysically informed approach aimed at connecting DNA level regulatory sequences to the expression of specific genes. The goal of this review is to give biologists a thorough description of the steps involved in building, analyzing, and implementing a thermodynamic-based model of transcriptional regulation. The data requirements for this modeling approach are described, the derivation for a specific regulatory region is shown, and the challenges and future directions for the quantitative modeling of gene regulation are discussed. Copyright © 2013 Elsevier B.V. All rights reserved.

  6. Regulatory Perspectives on Continuous Pharmaceutical Manufacturing: Moving From Theory to Practice: September 26-27, 2016, International Symposium on the Continuous Manufacturing of Pharmaceuticals.

    Science.gov (United States)

    Nasr, Moheb M; Krumme, Markus; Matsuda, Yoshihiro; Trout, Bernhardt L; Badman, Clive; Mascia, Salvatore; Cooney, Charles L; Jensen, Keith D; Florence, Alastair; Johnston, Craig; Konstantinov, Konstantin; Lee, Sau L

    2017-11-01

    Continuous manufacturing plays a key role in enabling the modernization of pharmaceutical manufacturing. The fate of this emerging technology will rely, in large part, on the regulatory implementation of this novel technology. This paper, which is based on the 2nd International Symposium on the Continuous Manufacturing of Pharmaceuticals, describes not only the advances that have taken place since the first International Symposium on Continuous Manufacturing of Pharmaceuticals in 2014, but the regulatory landscape that exists today. Key regulatory concepts including quality risk management, batch definition, control strategy, process monitoring and control, real-time release testing, data processing and management, and process validation/verification are outlined. Support from regulatory agencies, particularly in the form of the harmonization of regulatory expectations, will be crucial to the successful implementation of continuous manufacturing. Collaborative efforts, among academia, industry, and regulatory agencies, are the optimal solution for ensuring a solid future for this promising manufacturing technology. Copyright © 2017 American Pharmacists Association®. All rights reserved.

  7. Challenges of regulatory rights of half-capacitated persons: A sociological perspective on the French Civil Code reform.

    Science.gov (United States)

    Eyraud, Benoît

    2016-01-01

    Democratic societies are based on the principle of equal legal capacity of all citizens to decide and act for themselves in all areas of social life. This "socio-civil capacity", which may involve both material property of an individual, as well as private life in matters ranging from health to personal relationships, is recognized by the law (both codified law and common law). These rights guarantee the autonomy and freedom of individuals in the name of respect for human dignity. Civil capacity of a person is legally diminished because his or her "natural" abilities, capacity, or competence are reduced. Recent social changes have lead to increased uses of legal measures of protection. The reasons for these changes are complex and they are accompanied by legislative reforms that modify the rights of half-capacitated persons. In this article, we examine certain issues of civil capacity rights based on the French example. We start present a perspective of the historical definition and practice of these rights as well as their democratization. Copyright © 2016. Published by Elsevier Ltd.

  8. Genotet: An Interactive Web-based Visual Exploration Framework to Support Validation of Gene Regulatory Networks.

    Science.gov (United States)

    Yu, Bowen; Doraiswamy, Harish; Chen, Xi; Miraldi, Emily; Arrieta-Ortiz, Mario Luis; Hafemeister, Christoph; Madar, Aviv; Bonneau, Richard; Silva, Cláudio T

    2014-12-01

    Elucidation of transcriptional regulatory networks (TRNs) is a fundamental goal in biology, and one of the most important components of TRNs are transcription factors (TFs), proteins that specifically bind to gene promoter and enhancer regions to alter target gene expression patterns. Advances in genomic technologies as well as advances in computational biology have led to multiple large regulatory network models (directed networks) each with a large corpus of supporting data and gene-annotation. There are multiple possible biological motivations for exploring large regulatory network models, including: validating TF-target gene relationships, figuring out co-regulation patterns, and exploring the coordination of cell processes in response to changes in cell state or environment. Here we focus on queries aimed at validating regulatory network models, and on coordinating visualization of primary data and directed weighted gene regulatory networks. The large size of both the network models and the primary data can make such coordinated queries cumbersome with existing tools and, in particular, inhibits the sharing of results between collaborators. In this work, we develop and demonstrate a web-based framework for coordinating visualization and exploration of expression data (RNA-seq, microarray), network models and gene-binding data (ChIP-seq). Using specialized data structures and multiple coordinated views, we design an efficient querying model to support interactive analysis of the data. Finally, we show the effectiveness of our framework through case studies for the mouse immune system (a dataset focused on a subset of key cellular functions) and a model bacteria (a small genome with high data-completeness).

  9. [Regulatory requirements regarding cell-based medicinal products for human and veterinary use - a comparison].

    Science.gov (United States)

    Kuhlmann-Gottke, Johanna; Duchow, Karin

    2015-11-01

    At present, there is no separate regulatory framework for cell-based medicinal products (CBMP) for veterinary use at the European or German level. Current European and national regulations exclusively apply to the corresponding medicinal products for human use. An increasing number of requests for the regulatory classification of CBMP for veterinary use, such as allogeneic stem cell preparations and dendritic cell-based autologous tumour vaccines, and a rise in scientific advice for companies developing these products, illustrate the need for adequate legislation. Currently, advice is given and decisions are made on a case-by-case basis regarding the regulatory classification and authorisation requirements.Since some of the CBMP - in particular in the area of stem-cell products - are developed in parallel for human and veterinary use, there is an urgent need to create specific legal definitions, regulations, and guidelines for these complex innovative products in the veterinary sector as well. Otherwise, there is a risk that that the current legal grey area regarding veterinary medicinal products will impede therapeutic innovations in the long run. A harmonised EU-wide approach is desirable. Currently the European legislation on veterinary medicinal products is under revision. In this context, veterinary therapeutics based on allogeneic cells and tissues will be defined and regulated. Certainly, the legal framework does not have to be as comprehensive as for human CBMP; a leaner solution is conceivable, similar to the special provisions for advanced-therapy medicinal products laid down in the German Medicines Act.

  10. Continuing bonds in bereavement: an attachment theory based perspective.

    Science.gov (United States)

    Field, Nigel P; Gao, Beryl; Paderna, Lisa

    2005-05-01

    An attachment theory based perspective on the continuing bond to the deceased (CB) is proposed. The value of attachment theory in specifying the normative course of CB expression and in identifying adaptive versus maladaptive variants of CB expression based on their deviation from this normative course is outlined. The role of individual differences in attachment security on effective versus ineffective use of CB in coping with bereavement also is addressed. Finally, the moderating influence of type of loss (e.g., death of a spouse vs. child), culture, and religion on type of CB expression within an overarching attachment framework is discussed.

  11. Cell therapy medicinal product regulatory framework in Europe and its application for MSC based therapy development

    Directory of Open Access Journals (Sweden)

    Janis eAncans

    2012-08-01

    Full Text Available Advanced therapy medicinal products (ATMPs, including cell therapy products, form a new class of medicines in the European Union. Since ATMPs are at the forefront of scientific innovation in medicine, specific regulatory framework has been developed for these medicines and implemented from 2009. The Committee for Advanced Therapies (CAT has been established at European Medicines Agency (EMA for centralized classification, certification and evaluation procedures, and other ATMP related tasks. Guidance documents, initiatives and interaction platforms are available to make the new framework more accessible for small and medium-sized enterprises, academia, hospitals and foundations. Good understanding of centralised and national components of the regulatory system is required to plan product development. It is in the best interests of cell therapy developers to utilise provided resources starting with the preclinical stage. Whilst there have not been mesenchymal stem cell (MSC based medicine authorisations in the EU, three MSC products have received marketing approval in other regions since 2011. Information provided on regulatory requirements, procedures and initiatives is aimed to facilitate MSC based medicinal product development and authorisation in the EU.

  12. Dynamic Regulatory Network Reconstruction for Alzheimer’s Disease Based on Matrix Decomposition Techniques

    Directory of Open Access Journals (Sweden)

    Wei Kong

    2014-01-01

    Full Text Available Alzheimer’s disease (AD is the most common form of dementia and leads to irreversible neurodegenerative damage of the brain. Finding the dynamic responses of genes, signaling proteins, transcription factor (TF activities, and regulatory networks of the progressively deteriorative progress of AD would represent a significant advance in discovering the pathogenesis of AD. However, the high throughput technologies of measuring TF activities are not yet available on a genome-wide scale. In this study, based on DNA microarray gene expression data and a priori information of TFs, network component analysis (NCA algorithm is applied to determining the TF activities and regulatory influences on TGs of incipient, moderate, and severe AD. Based on that, the dynamical gene regulatory networks of the deteriorative courses of AD were reconstructed. To select significant genes which are differentially expressed in different courses of AD, independent component analysis (ICA, which is better than the traditional clustering methods and can successfully group one gene in different meaningful biological processes, was used. The molecular biological analysis showed that the changes of TF activities and interactions of signaling proteins in mitosis, cell cycle, immune response, and inflammation play an important role in the deterioration of AD.

  13. A Personal Perspective on the Initial Federal Health-Based Regulation to Remove Lead from Gasoline

    Science.gov (United States)

    Bridbord, Kenneth; Hanson, David

    2009-01-01

    Objective This article describes the personal experience and perspective of the authors, who had primary responsibility for drafting the initial health-based regulation limiting lead content of gasoline during the early 1970s while employed by the U.S. Environmental Protection Agency (EPA). Data source Information used by the U.S. EPA in developing the initial health-based regulation limiting lead content of gasoline in December 1973 and studies documenting the impact of that and subsequent actions. Data extraction Among the lessons learned from this experience is the importance of having input from independent scientists to the regulatory decision-making process. This also demonstrates the critical role of independent peer-reviewed research, such as that supported by the National Institutes of Health, as well as research conducted by scientists from the Centers for Disease Control and Prevention, in delineating the consequences of lead exposure in the population. Data synthesis Removal of lead from gasoline in the United States has been described as one of the great public health achievements of the 20th century, but it almost did not happen. The experience of the authors in developing this regulation may be helpful to others involved in developing health-based regulatory policy in the future. Conclusion The initial U.S. EPA health-based regulation to remove lead from gasoline is clearly an example where science successfully affected public policy. The leadership of the U.S. EPA at that time deserves much credit for establishing an atmosphere in which this was possible. PMID:19672397

  14. A regulatory perspective on the radiological impact of NORM industries: the case of the Spanish phosphate industry

    International Nuclear Information System (INIS)

    Garcia-Talavera, M.; Matarranz, J.L.M.; Salas, R.; Ramos, L.

    2011-01-01

    Radioactive and chemical risks coexist in NORM industries although they are usually addressed separately by regulations. The European Union (EU) has developed extensive legislation concerning both matters, which has been diversely reflected in national policies. We consider the case of the Spanish phosphate industry and analyse to which extent regulatory mandates have reduced the historical and ongoing radiological impact on the environment of phosphate facilities. Although no specific radiological constraints on effluent monitoring and release or on waste disposal have yet been imposed on NORM industries in Spain, other environmental regulations have achieved a substantial reduction on the phosphate industry impact. Nevertheless, a more efficient control could be established by eliminating the current conceptual and practical separation of chemical and radioactive risks in NORM industries. We highlight research needs to accomplish so and propose shorter-term measures that require active cooperation among the regulatory bodies involved. - Research highlights: → The radiological impact of the Spanish phosphate industry has substantially decreased as a side result of environmental regulations on chemical pollution.→ A more efficient control of NORM industries could be established by eliminating the current conceptual and practical separation of chemical and radioactive risks.→ Further research is needed on how interactions between radiation and chemicals might affect regulatory limits and on a systematic way to input stakeholder preferences in MCDA.→ On shorter-term, administrative measures that require active cooperation among the regulatory bodies involved can be taken.

  15. Risk-based regulation - an NRC perspective and status

    International Nuclear Information System (INIS)

    King, T.L.; Murphy, J.A.

    1993-01-01

    The consideration of risk in regulatory decision making has traditionally been part of the US Nuclear Regulatory Commission's (NRC's) policy and practice. In the early days of regulation, this consideration was more qualitative in nature and was reflected in prescriptive/deterministic regulatory requirements. However, with the development of quantitative risk assessment methods, more detailed and comprehensive (although not complete) risk information on nuclear power plants is available to the designer, operator, and regulator. The availability of such information provides an opportunity to assess the need for change in the current regulatory structure and to develop future regulatory requirements in a less prescriptive, more performance-oriented fashion

  16. Inferring nonlinear gene regulatory networks from gene expression data based on distance correlation.

    Directory of Open Access Journals (Sweden)

    Xiaobo Guo

    Full Text Available Nonlinear dependence is general in regulation mechanism of gene regulatory networks (GRNs. It is vital to properly measure or test nonlinear dependence from real data for reconstructing GRNs and understanding the complex regulatory mechanisms within the cellular system. A recently developed measurement called the distance correlation (DC has been shown powerful and computationally effective in nonlinear dependence for many situations. In this work, we incorporate the DC into inferring GRNs from the gene expression data without any underling distribution assumptions. We propose three DC-based GRNs inference algorithms: CLR-DC, MRNET-DC and REL-DC, and then compare them with the mutual information (MI-based algorithms by analyzing two simulated data: benchmark GRNs from the DREAM challenge and GRNs generated by SynTReN network generator, and an experimentally determined SOS DNA repair network in Escherichia coli. According to both the receiver operator characteristic (ROC curve and the precision-recall (PR curve, our proposed algorithms significantly outperform the MI-based algorithms in GRNs inference.

  17. Regulatory requirements for clinical trial and marketing authorisation application for cell-based medicinal products.

    Science.gov (United States)

    Salmikangas, P; Flory, E; Reinhardt, J; Hinz, T; Maciulaitis, R

    2010-01-01

    The new era of regenerative medicine has led to rapid development of new innovative therapies especially for diseases and tissue/organ defects for which traditional therapies and medicinal products have not provided satisfactory outcome. Although the clinical use and developments of cell-based medicinal products (CBMPs) could be witnessed already for a decade, robust scientific and regulatory provisions for these products have only recently been enacted. The new Regulation for Advanced Therapies (EC) 1394/2007 together with the revised Annex I, Part IV of Directive 2001/83/EC provides the new legal framework for CBMPs. The wide variety of cell-based products and the foreseen limitations (small sample sizes, short shelf life) vs. particular risks (microbiological purity, variability, immunogenicity, tumourigenicity) associated with CBMPs have called for a flexible, case-by-case regulatory approach for these products. Consequently, a risk-based approach has been developed to allow definition of the amount of scientific data needed for a Marketing Authorisation Application (MAA) of each CBMP. The article provides further insight into the initial risk evaluation, as well as to the quality, non-clinical, and clinical requirements of CBMPs. Special somatic cell therapies designed for active immunotherapy are also addressed.

  18. Unproven stem cell-based interventions & physicians' professional obligations; a qualitative study with medical regulatory authorities in Canada.

    Science.gov (United States)

    Zarzeczny, Amy; Clark, Marianne

    2014-10-14

    The pursuit of unproven stem cell-based interventions ("stem cell tourism") is an emerging issue that raises various concerns. Physicians play different roles in this market, many of which engage their legal, ethical and professional obligations. In Canada, physicians are members of a self-regulated profession and their professional regulatory bodies are responsible for regulating the practice of medicine and protecting the public interest. They also provide policy guidance to their members and discipline members for unprofessional conduct. We conducted semi-structured telephone interviews with representatives from six different provincial Colleges of Physicians and Surgeons in Canada to discuss their experiences and perspectives regarding stem cell tourism. Our focus was on exploring how different types of physician involvement in this market would be viewed by physicians' professional regulatory bodies in Canada. When considering physicians' professional obligations, participants drew analogies between stem cell tourism and other areas of medical tourism as well as with some aspects of complementary alternative medicine where existing policies, codes of ethics and regulations provide some guidance. Canadian physicians are required to act in the best interests of their patients, respect patient autonomy, avoid conflicts of interest and pursue evidence-based practice in accordance with accepted standards of care. Physicians who provide unproven treatments falling outside the standard of care, not in the context of an approved research protocol, could be subject to professional discipline. Other types of problematic conduct include referrals involving financial conflict of interest and failure to provide urgent medically necessary care. Areas of ambiguity include physicians' obligations when asked for information and advice about seeking unproven medical treatments, in terms of providing non-urgent follow-up care, and when asked to support efforts to go abroad by

  19. Embracing First-Person Perspectives in Soma-Based Design

    Directory of Open Access Journals (Sweden)

    Kristina Höök

    2018-02-01

    Full Text Available A set of prominent designers embarked on a research journey to explore aesthetics in movement-based design. Here we unpack one of the design sensitivities unique to our practice: a strong first person perspective—where the movements, somatics and aesthetic sensibilities of the designer, design researcher and user are at the forefront. We present an annotated portfolio of design exemplars and a brief introduction to some of the design methods and theory we use, together substantiating and explaining the first-person perspective. At the same time, we show how this felt dimension, despite its subjective nature, is what provides rigor and structure to our design research. Our aim is to assist researchers in soma-based design and designers wanting to consider the multiple facets when designing for the aesthetics of movement. The applications span a large field of designs, including slow introspective, contemplative interactions, arts, dance, health applications, games, work applications and many others.

  20. KIRMES: kernel-based identification of regulatory modules in euchromatic sequences.

    Science.gov (United States)

    Schultheiss, Sebastian J; Busch, Wolfgang; Lohmann, Jan U; Kohlbacher, Oliver; Rätsch, Gunnar

    2009-08-15

    Understanding transcriptional regulation is one of the main challenges in computational biology. An important problem is the identification of transcription factor (TF) binding sites in promoter regions of potential TF target genes. It is typically approached by position weight matrix-based motif identification algorithms using Gibbs sampling, or heuristics to extend seed oligos. Such algorithms succeed in identifying single, relatively well-conserved binding sites, but tend to fail when it comes to the identification of combinations of several degenerate binding sites, as those often found in cis-regulatory modules. We propose a new algorithm that combines the benefits of existing motif finding with the ones of support vector machines (SVMs) to find degenerate motifs in order to improve the modeling of regulatory modules. In experiments on microarray data from Arabidopsis thaliana, we were able to show that the newly developed strategy significantly improves the recognition of TF targets. The python source code (open source-licensed under GPL), the data for the experiments and a Galaxy-based web service are available at http://www.fml.mpg.de/raetsch/suppl/kirmes/.

  1. Perspectives on source terms based on early research and development

    International Nuclear Information System (INIS)

    Pressesky, A.J.

    1985-07-01

    This report presents an overview of the key documentation of the research and development programs relevant to the source term issue which were undertaken by the Atomic Energy Commission between 1950 and 1970. The source term is taken to be the amount, composition (physical and chemical), and timing of the projected release of radioactivity to the environment in the hypothetical event of a severe reactor accident in a light water reactor of the type currently being licensed, built and operated. The objective is to illuminate and provide perspectives on (a) the maturity of the technical data base and the analytical methodology, (b) the extent to which remaining conservatisms can be applied to compensate for uncertainties, (c) the purpose for which the technology and methodology will be used, and (d) the need to keep problems and uncertainties in proper perspective. Comments that can provide some context for the difficult programmatic choices to be made are included, and technical considerations that may be inadequately applied or neglected in some current source term calculations were studied. This review has not uncovered any significant technical considerations that have been omitted or are being inadequately treated in current source term analyses, except perhaps the contribution made to in-containment aerosols by coolant comminution upon escape at pressure from the reactor coolant system. 11 refs

  2. Alignment and prediction of cis-regulatory modules based on a probabilistic model of evolution.

    Directory of Open Access Journals (Sweden)

    Xin He

    2009-03-01

    Full Text Available Cross-species comparison has emerged as a powerful paradigm for predicting cis-regulatory modules (CRMs and understanding their evolution. The comparison requires reliable sequence alignment, which remains a challenging task for less conserved noncoding sequences. Furthermore, the existing models of DNA sequence evolution generally do not explicitly treat the special properties of CRM sequences. To address these limitations, we propose a model of CRM evolution that captures different modes of evolution of functional transcription factor binding sites (TFBSs and the background sequences. A particularly novel aspect of our work is a probabilistic model of gains and losses of TFBSs, a process being recognized as an important part of regulatory sequence evolution. We present a computational framework that uses this model to solve the problems of CRM alignment and prediction. Our alignment method is similar to existing methods of statistical alignment but uses the conserved binding sites to improve alignment. Our CRM prediction method deals with the inherent uncertainties of binding site annotations and sequence alignment in a probabilistic framework. In simulated as well as real data, we demonstrate that our program is able to improve both alignment and prediction of CRM sequences over several state-of-the-art methods. Finally, we used alignments produced by our program to study binding site conservation in genome-wide binding data of key transcription factors in the Drosophila blastoderm, with two intriguing results: (i the factor-bound sequences are under strong evolutionary constraints even if their neighboring genes are not expressed in the blastoderm and (ii binding sites in distal bound sequences (relative to transcription start sites tend to be more conserved than those in proximal regions. Our approach is implemented as software, EMMA (Evolutionary Model-based cis-regulatory Module Analysis, ready to be applied in a broad biological context.

  3. UK regulatory perspective on the application of burn-up credit to the BNFL thorp head end plant

    International Nuclear Information System (INIS)

    Simister, D.N.; Clemson, P.D.

    2003-01-01

    In the UK the Health and Safety Executive, which incorporates the Nuclear Installations Inspectorate (NII), is responsible for regulation of safety on nuclear sites. This paper reports progress made in the application and development of a UK regulatory position for assessing licensee's plant safety caes which invoke the use of Burn-up Credit for criticality applications. The NII's principles and strategy for the assessment of this technical area have been developed over a period of time following expressions of interest from UK industry and subsequent involvement in the international collaborations and debate in this area. This experience has now been applied to the first main plant safety case application claiming Burn-up Credit. This case covers the BNFL Thermal Oxide Reprocessing Plant (THORP) dissolver at Sellafield, where dissolved gadolinium neutron poison is used as a criticality control. The case argues for a reduction in gadolinium content by taking credit for the burn-up of input fuel. The UK regulatory process, assessment principles and criteria are briefly outlined, showing the regulatory framework used to review the case. These issues include the fundamental requirement in UK Health and Safety law to demonstrate that risks have been reduced to as low as reasonably practicable (ALARP), the impact on safety margins, compliance and operability procedures, and the need for continuing review. Novel features of methodology, using a ''Residual Enrichment'' and ''Domain Boundary'' approach, were considered and accepted. The underlying validation, both of criticality methodology and isotopic determination, was also reviewed. Compliance was seen to rely heavily on local in-situ measurements of spent fuel used to determine ''Residual Enrichment'' and other parameters, requiring review of the development and basis of the correlations used to underpin the measurement process. Overall, it was concluded that the case as presented was adequate. Gadolinium reduction

  4. Regulatory framework and development perspectives of the mechanism of public participation in the management of Russia’s forests

    Directory of Open Access Journals (Sweden)

    Nikolay Mikhaylovich Shmatkov

    2014-03-01

    Full Text Available The article dwells on the current state of the regulatory framework of the Russian Federation and the mechanism of public participation in forest management. The examples of addressing the problems of public participation in forest management in individual regions are disclosed. The article deals with the issues concerning the provision of in-interests of the local population through the voluntary forest certification system under the FSC scheme. Recommendations on improving the mechanism of public participation in solving the forest management issues are suggested

  5. Future perspectives of resin-based dental materials.

    Science.gov (United States)

    Jandt, Klaus D; Sigusch, Bernd W

    2009-08-01

    This concise review and outlook paper gives a view of selected potential future developments in the area of resin-based biomaterials with an emphasis on dental composites. A selection of key publications (1 book, 35 scientific original publications and 1 website source) covering the areas nanotechnology, antimicrobial materials, stimuli responsive materials, self-repairing materials and materials for tissue engineering with direct or indirect relations and/or implications to resin-based dental materials is critically reviewed and discussed. Connections between these fields and their potential for resin-based dental materials are highlighted and put in perspective. The need to improve shrinkage properties and wear resistance is obvious for dental composites, and a vast number of attempts have been made to accomplish these aims. Future resin-based materials may be further improved in this respect if, for example nanotechnology is applied. Dental composites may, however, reach a completely new quality by utilizing new trends from materials science, such as introducing nanostructures, antimicrobial properties, stimuli responsive capabilities, the ability to promote tissue regeneration or repair of dental tissues if the composites were able to repair themselves. This paper shows selected potential future developments in the area of resin-based dental materials, gives basic and industrial researchers in dental materials science, and dental practitioners a glance into the potential future of these materials, and should stimulate discussion about needs and future developments in the area.

  6. Thorium-based nuclear fuel: current status and perspectives

    International Nuclear Information System (INIS)

    1987-03-01

    Until the present time considerable efforts have already been made in the area of fabrication, utilization and reprocessing of Th-based fuels for different types of reactors, namely: by FRG and USA - for HTRs; FRG and Brazil, Italy - for LWRs; India - for HWRs and FBRs. Basic research of thorium fuels and thorium fuel cycles are also being undertaken by Australia, Canada, China, France, FRG, Romania, USSR and other countries. Main emphasis has been given to the utilization of thorium fuels in once-through nuclear fuel cycles, but in some projects closed thorium-uranium or thorium-plutonium fuel cycles are also considered. The purpose of the Technical Committee on the Utilization of Thorium-Based Nuclear Fuel: Current Status and Perspective was to review the world thorium resources, incentives for further exploration, obtained experience in the utilization of Th-based fuels in different types of reactors, basic research, fabrication and reprocessing of Th-based fuels. As a result of the panel discussion the recommendations on future Agency activities and list of major worldwide activities in the area of Th-based fuel were developed. A separate abstract was prepared for each of the 9 papers in this proceedings series

  7. Safety Justification of Software Systems. Software Based Safety Systems. Regulatory Inspection Handbook

    International Nuclear Information System (INIS)

    Dahll, Gustav; Liwang, Bo; Wainwright, Norman

    2006-01-01

    The introduction of new software based technology in the safety systems in nuclear power plants also makes it necessary to develop new strategies for regulatory review and assessment of these new systems that is more focused on reviewing the processes at the different phases in design phases during the system life cycle. It is a general requirement that the licensee shall perform different kinds of reviews. From a regulatory point of view it is more cost effective to assess that the design activities at the suppliers and the review activities within the development project are performed with good quality. But the change from more technical reviews over to the development process oriented approach also cause problems. When reviewing development and quality aspects there are no 'hard facts' that can be judged against some specified criteria, the issues are more 'soft' and are more to build up structure of arguments and evidences that the requirements are met. The regulatory review strategy must therefore change to follow the development process over the whole life cycle from concept phase until installation and operation. Even if we know what factors that is of interest we need some guidance on how to interpret and judge the information.For that purpose SKl started research activities in this area at the end of the 1990s. In the first phase, in co-operation with Gustav Dahll at the Halden project, a life cycle model was selected. For the different phases a qualitative influence net was constructed of the type that is used in Bayesian Believe Network together with a discussion on different issues involved. In the second phase of the research work, in co-operation with Norman Wainwright, a former NII inspector, information from a selection of the most important sources as guidelines, IAEA and EC reports etc, was mapped into the influence net structure (the total list on used sources are in the report). The result is presented in the form of questions (Q) and a

  8. Safety Justification of Software Systems. Software Based Safety Systems. Regulatory Inspection Handbook

    Energy Technology Data Exchange (ETDEWEB)

    Dahll, Gustav (OECD Halden Project, Halden (NO)); Liwaang, Bo (Swedish Nuclear Power Inspectorate, Stockholm (Sweden)); Wainwright, Norman (Wainwright Safety Advice (GB))

    2006-07-01

    The introduction of new software based technology in the safety systems in nuclear power plants also makes it necessary to develop new strategies for regulatory review and assessment of these new systems that is more focused on reviewing the processes at the different phases in design phases during the system life cycle. It is a general requirement that the licensee shall perform different kinds of reviews. From a regulatory point of view it is more cost effective to assess that the design activities at the suppliers and the review activities within the development project are performed with good quality. But the change from more technical reviews over to the development process oriented approach also cause problems. When reviewing development and quality aspects there are no 'hard facts' that can be judged against some specified criteria, the issues are more 'soft' and are more to build up structure of arguments and evidences that the requirements are met. The regulatory review strategy must therefore change to follow the development process over the whole life cycle from concept phase until installation and operation. Even if we know what factors that is of interest we need some guidance on how to interpret and judge the information.For that purpose SKl started research activities in this area at the end of the 1990s. In the first phase, in co-operation with Gustav Dahll at the Halden project, a life cycle model was selected. For the different phases a qualitative influence net was constructed of the type that is used in Bayesian Believe Network together with a discussion on different issues involved. In the second phase of the research work, in co-operation with Norman Wainwright, a former NII inspector, information from a selection of the most important sources as guidelines, IAEA and EC reports etc, was mapped into the influence net structure (the total list on used sources are in the report). The result is presented in the form of

  9. MIRA: An R package for DNA methylation-based inference of regulatory activity.

    Science.gov (United States)

    Lawson, John T; Tomazou, Eleni M; Bock, Christoph; Sheffield, Nathan C

    2018-03-01

    DNA methylation contains information about the regulatory state of the cell. MIRA aggregates genome-scale DNA methylation data into a DNA methylation profile for independent region sets with shared biological annotation. Using this profile, MIRA infers and scores the collective regulatory activity for each region set. MIRA facilitates regulatory analysis in situations where classical regulatory assays would be difficult and allows public sources of open chromatin and protein binding regions to be leveraged for novel insight into the regulatory state of DNA methylation datasets. R package available on Bioconductor: http://bioconductor.org/packages/release/bioc/html/MIRA.html. nsheffield@virginia.edu.

  10. Consensus-based perspectives of pediatric inpatient eating disorder services.

    Science.gov (United States)

    O'Brien, Amy; McCormack, Julie; Hoiles, Kimberley J; Watson, Hunna J; Anderson, Rebecca A; Hay, Phillipa; Egan, Sarah J

    2018-03-14

    There are few evidence-based guidelines for inpatient pediatric eating disorders. The aim was to gain perspectives from those providing and receiving inpatient pediatric eating disorder care on the essential components treatment. A modified Delphi technique was used to develop consensus-based opinions. Participants (N = 74) were recruited for three panels: clinicians (n = 24), carers (n = 31), and patients (n = 19), who endorsed three rounds of statements online. A total of 167 statements were rated, 79 were accepted and reached a consensus level of at least 75% across all panels, and 87 were rejected. All agreed that families should be involved in treatment, and thatpsychological therapy be offered in specialist inpatient units. Areas of disagreement included that patients expressed a desire for autonomy in sessions being available without carers, and that weight gain should be gradual and admissions longer, in contrast to carers and clinicians. Carers endorsed that legal frameworks should be used to retain patients if required, and that inpatients are supervised at all times, in contrast to patients and clinicians. Clinicians endorsed that food access should be restricted outside meal times, in contrast to patients and carers. The findings indicate areas of consensus in admission criteria, and that families should be involved in treatment, family involvement in treatment, while there was disagreement across groups on topics including weight goals and nutrition management. Perspectives from patients, carers, and clinicians may be useful to consider during future revisions of best practice guidelines. © 2018 Wiley Periodicals, Inc.

  11. Regulatory Expectations for Safety Culture

    Energy Technology Data Exchange (ETDEWEB)

    Jung, Su Jin; Oh, Jang Jin; Choi, Young Sung [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

    2014-05-15

    The oversight of licensee's safety culture becomes an important issue that attracts great public and political concerns recently in Korea. Beginning from the intended violation of rules, a series of corruptions, documents forgery and disclosure of wrong-doings made the public think that the whole mindset of nuclear workers has been inadequate. Thus, they are demanding that safety culture shall be improved and that regulatory body shall play more roles and responsibilities for the improvements and oversight for them. This paper introduces, as an effort of regulatory side, recent changes in the role of regulators in safety culture, regulatory expectations on the desired status of licensee's safety culture, the pilot inspection program for safety culture and research activity for the development of oversight system. After the Fukushima accident in Japan 2011, many critics has searched for cultural factors that caused the unacceptable negligence pervaded in Japan nuclear society and the renewed emphasis has been placed on rebuilding safety culture by operators, regulators, and relevant institutions globally. Significant progress has been made in how to approach safety culture and led to a new perspective different from the existing normative assessment method both in operators and regulatory side. Regulatory expectations and oversight of them are based on such a new holistic concept for human, organizational and cultural elements to maintain and strengthen the integrity of defense in depth and consequently nuclear safety.

  12. Regulatory Expectations for Safety Culture

    International Nuclear Information System (INIS)

    Jung, Su Jin; Oh, Jang Jin; Choi, Young Sung

    2014-01-01

    The oversight of licensee's safety culture becomes an important issue that attracts great public and political concerns recently in Korea. Beginning from the intended violation of rules, a series of corruptions, documents forgery and disclosure of wrong-doings made the public think that the whole mindset of nuclear workers has been inadequate. Thus, they are demanding that safety culture shall be improved and that regulatory body shall play more roles and responsibilities for the improvements and oversight for them. This paper introduces, as an effort of regulatory side, recent changes in the role of regulators in safety culture, regulatory expectations on the desired status of licensee's safety culture, the pilot inspection program for safety culture and research activity for the development of oversight system. After the Fukushima accident in Japan 2011, many critics has searched for cultural factors that caused the unacceptable negligence pervaded in Japan nuclear society and the renewed emphasis has been placed on rebuilding safety culture by operators, regulators, and relevant institutions globally. Significant progress has been made in how to approach safety culture and led to a new perspective different from the existing normative assessment method both in operators and regulatory side. Regulatory expectations and oversight of them are based on such a new holistic concept for human, organizational and cultural elements to maintain and strengthen the integrity of defense in depth and consequently nuclear safety

  13. Is there a need for a universal benefit-risk assessment framework for medicines? Regulatory and industry perspectives.

    Science.gov (United States)

    Leong, James; McAuslane, Neil; Walker, Stuart; Salek, Sam

    2013-09-01

    To explore the current status and need for a universal benefit-risk framework for medicines in regulatory agencies and pharmaceutical companies. A questionnaire was developed and sent to 14 mature regulatory agencies and 24 major companies. The data were analysed using descriptive statistics, for a minority of questions preceded by manual grouping of the responses. Overall response rate was 82%, and study participants included key decision makers from agencies and companies. None used a fully quantitative system, most companies preferring a qualitative method. The major reasons for this group not using semi-quantitative or quantitative systems were lack of a universal and scientifically validated framework. The main advantages of a benefit-risk framework were that it provided a systematic standardised approach to decision-making and that it acted as a tool to enhance quality of communication. It was also reported that a framework should be of value to both agencies and companies throughout the life cycle of a product. They believed that it is possible to develop an overarching benefit-risk framework that should involve relevant stakeholders in the development, validation and application of a universal framework. The entire cohort indicated common barriers to implementing a framework were resource limitations, a lack of knowledge and a scientifically validated and acceptable framework. Stakeholders prefer a semi-quantitative, overarching framework that incorporates a toolbox of different methodologies. A coordinating committee of relevant stakeholders should be formed to guide its development and implementation. Through engaging the stakeholders, these outcomes confirm sentiments and need for developing a universal benefit-risk assessment framework. Copyright © 2013 John Wiley & Sons, Ltd.

  14. Bringing plant-based veterinary vaccines to market: Managing regulatory and commercial hurdles.

    Science.gov (United States)

    MacDonald, Jacqueline; Doshi, Ketan; Dussault, Marike; Hall, J Christopher; Holbrook, Larry; Jones, Ginny; Kaldis, Angelo; Klima, Cassidy L; Macdonald, Phil; McAllister, Tim; McLean, Michael D; Potter, Andrew; Richman, Alex; Shearer, Heather; Yarosh, Oksana; Yoo, Han Sang; Topp, Edward; Menassa, Rima

    2015-12-01

    The production of recombinant vaccines in plants may help to reduce the burden of veterinary diseases, which cause major economic losses and in some cases can affect human health. While there is abundant research in this area, a knowledge gap exists between the ability to create and evaluate plant-based products in the laboratory, and the ability to take these products on a path to commercialization. The current report, arising from a workshop sponsored by an Organisation for Economic Co-operation and Development (OECD) Co-operative Research Programme, addresses this gap by providing guidance in planning for the commercialization of plant-made vaccines for animal use. It includes relevant information on developing business plans, assessing market opportunities, manufacturing scale-up, financing, protecting and using intellectual property, and regulatory approval with a focus on Canadian regulations. Crown Copyright © 2015. Published by Elsevier Inc. All rights reserved.

  15. Determining e-learning success factor in higher education based on user perspective using Fuzzy AHP

    Directory of Open Access Journals (Sweden)

    Anggrainingsih Rini

    2018-01-01

    Full Text Available Recently almost all universities in the world have implemented E-learning to support their academic system. Previous studies have been conducted to determine CSF using Analytic Hierarchy Process (AHP method. However, AHP method cannot handle the uncertainty and vagueness of the human’s opinion, so then it causes less appropriate decision. Some researcher has proposed to use fuzzy sets theory with AHP to increase the ability of AHP to deal problem regarding the uncertainty/fuzziness. This study aims to determine ranks of priorities of the multiple factors which influence the E-learning success using FAHP method. The respondents consist of ten e-learning’s experts, 305 lecturers, and 4195 students at Sebelas Maret University. The result describes similar success factors ranking between both experienced and non-experienced user (lecturer and student. Then, the result shows that there are five most influencial success factors of e-learning at Sebelas Maret University based on the lectures perspective Financial Policy, Regulatory Policy, Course quality, Relevant Content and Technical Support. On the other hand, according to the student's point of view five most e-learning, critical success factors are Quality of Course, Relevant of Content, Completeness of Content, Attitudes toward Student, and Flexibility in taking Course. Therefore, this finding can be used by E-learning management of Sebelas Maret University to deteremine a strategy to to achieve successful implementation of e-learning at Sebelas Maret University with consider these factors.

  16. CoryneRegNet: an ontology-based data warehouse of corynebacterial transcription factors and regulatory networks.

    Science.gov (United States)

    Baumbach, Jan; Brinkrolf, Karina; Czaja, Lisa F; Rahmann, Sven; Tauch, Andreas

    2006-02-14

    The application of DNA microarray technology in post-genomic analysis of bacterial genome sequences has allowed the generation of huge amounts of data related to regulatory networks. This data along with literature-derived knowledge on regulation of gene expression has opened the way for genome-wide reconstruction of transcriptional regulatory networks. These large-scale reconstructions can be converted into in silico models of bacterial cells that allow a systematic analysis of network behavior in response to changing environmental conditions. CoryneRegNet was designed to facilitate the genome-wide reconstruction of transcriptional regulatory networks of corynebacteria relevant in biotechnology and human medicine. During the import and integration process of data derived from experimental studies or literature knowledge CoryneRegNet generates links to genome annotations, to identified transcription factors and to the corresponding cis-regulatory elements. CoryneRegNet is based on a multi-layered, hierarchical and modular concept of transcriptional regulation and was implemented by using the relational database management system MySQL and an ontology-based data structure. Reconstructed regulatory networks can be visualized by using the yFiles JAVA graph library. As an application example of CoryneRegNet, we have reconstructed the global transcriptional regulation of a cellular module involved in SOS and stress response of corynebacteria. CoryneRegNet is an ontology-based data warehouse that allows a pertinent data management of regulatory interactions along with the genome-scale reconstruction of transcriptional regulatory networks. These models can further be combined with metabolic networks to build integrated models of cellular function including both metabolism and its transcriptional regulation.

  17. CoryneRegNet: An ontology-based data warehouse of corynebacterial transcription factors and regulatory networks

    Directory of Open Access Journals (Sweden)

    Czaja Lisa F

    2006-02-01

    Full Text Available Abstract Background The application of DNA microarray technology in post-genomic analysis of bacterial genome sequences has allowed the generation of huge amounts of data related to regulatory networks. This data along with literature-derived knowledge on regulation of gene expression has opened the way for genome-wide reconstruction of transcriptional regulatory networks. These large-scale reconstructions can be converted into in silico models of bacterial cells that allow a systematic analysis of network behavior in response to changing environmental conditions. Description CoryneRegNet was designed to facilitate the genome-wide reconstruction of transcriptional regulatory networks of corynebacteria relevant in biotechnology and human medicine. During the import and integration process of data derived from experimental studies or literature knowledge CoryneRegNet generates links to genome annotations, to identified transcription factors and to the corresponding cis-regulatory elements. CoryneRegNet is based on a multi-layered, hierarchical and modular concept of transcriptional regulation and was implemented by using the relational database management system MySQL and an ontology-based data structure. Reconstructed regulatory networks can be visualized by using the yFiles JAVA graph library. As an application example of CoryneRegNet, we have reconstructed the global transcriptional regulation of a cellular module involved in SOS and stress response of corynebacteria. Conclusion CoryneRegNet is an ontology-based data warehouse that allows a pertinent data management of regulatory interactions along with the genome-scale reconstruction of transcriptional regulatory networks. These models can further be combined with metabolic networks to build integrated models of cellular function including both metabolism and its transcriptional regulation.

  18. Perspective

    DEFF Research Database (Denmark)

    Kussmann, Martin; Morine, Melissa J; Hager, Jörg

    2013-01-01

    We review here the status of human type 2 diabetes studies from a genetic, epidemiological, and clinical (intervention) perspective. Most studies limit analyses to one or a few omic technologies providing data of components of physiological processes. Since all chronic diseases are multifactorial...... at different time points along this longitudinal investigation are performed with a comprehensive set of omics platforms. These data sets are generated in a biological context, rather than biochemical compound class-driven manner, which we term "systems omics."...

  19. Current advances and future perspectives in extrusion-based bioprinting.

    Science.gov (United States)

    Ozbolat, Ibrahim T; Hospodiuk, Monika

    2016-01-01

    Extrusion-based bioprinting (EBB) is a rapidly growing technology that has made substantial progress during the last decade. It has great versatility in printing various biologics, including cells, tissues, tissue constructs, organ modules and microfluidic devices, in applications from basic research and pharmaceutics to clinics. Despite the great benefits and flexibility in printing a wide range of bioinks, including tissue spheroids, tissue strands, cell pellets, decellularized matrix components, micro-carriers and cell-laden hydrogels, the technology currently faces several limitations and challenges. These include impediments to organ fabrication, the limited resolution of printed features, the need for advanced bioprinting solutions to transition the technology bench to bedside, the necessity of new bioink development for rapid, safe and sustainable delivery of cells in a biomimetically organized microenvironment, and regulatory concerns to transform the technology into a product. This paper, presenting a first-time comprehensive review of EBB, discusses the current advancements in EBB technology and highlights future directions to transform the technology to generate viable end products for tissue engineering and regenerative medicine. Copyright © 2015 Elsevier Ltd. All rights reserved.

  20. Research and development and related capabilities for safety and licensing of nuclear power reactors: a regulatory perspective

    International Nuclear Information System (INIS)

    Newland, D.B.

    2001-01-01

    worsened to the point where regulatory intervention was considered necessary. It is therefore incumbent upon the regulator to ensure that minimum standards are set and that these are adhered to by the licensees. This will require more vigilant regulatory oversight of these issues than has been customary in the past. (author)

  1. Two Approaches to Reactor Decommissioning: 10 CFR Part 50 License Termination and License Amendment, Lessons Learned from the Regulatory Perspective

    International Nuclear Information System (INIS)

    Watson, B.A.; Buckley, J.T.; Craig, C.M.

    2006-01-01

    Trojan Nuclear Plant (Trojan) and Maine Yankee Nuclear Plant (Maine Yankee) were the first two power reactors to complete decommissioning under the U. S. Nuclear Regulatory Commission's (NRC's) License Termination Rule (LTR), 10 CFR Part 20, Subpart E. The respective owners' decisions to decommission the sites resulted in different approaches to both the physical aspects of the decommissioning, and the approach for obtaining approval for completing the decommissioning in accordance with regulations. Being in different States, the two single-unit pressurized water reactor sites had different State requirements and levels of public interest that impacted the decommissioning approaches. This resulted in significant differences in decommissioning planning, conduct of decommissioning operations, volumes of low- level radioactive waste disposed, and the final status survey (FSS) program. While both licensees have Independent Spent Fuel Storage Installations (ISFSIs), Trojan obtained a separate license for the ISFSI in accordance with the requirements of 10 CFR Part 72 and terminated their 10 CFR Part 50 license. Maine Yankee elected to obtain a general license under 10 CFR Part 50 for the ISFSI and reduce the physical site footprint to the ISFSI through a series of license amendments. While the NRC regulations are flexible and allow different approaches to ISFSI licensing there are separate licensing requirements that must be addressed. In 10 CFR 50.82, the NRC mandates public participation in the decommissioning process. For Maine Yankee, public input resulted in the licensee entering into an agreement with a concerned citizen group and resulted in State legislation that significantly lowered the dose limit below the NRC radiological criteria of 25 mrem (0.25 mSv) per year (yr) in 10 CFR 20.1402 for unrestricted use. The lowering of the radiological criteria resulted in a significant dose modeling effort using site-specific Derived Concentrations Guideline Levels (DCGLs

  2. Implementation of Evidence-Based Practice From a Learning Perspective.

    Science.gov (United States)

    Nilsen, Per; Neher, Margit; Ellström, Per-Erik; Gardner, Benjamin

    2017-06-01

    For many nurses and other health care practitioners, implementing evidence-based practice (EBP) presents two interlinked challenges: acquisition of EBP skills and adoption of evidence-based interventions and abandonment of ingrained non-evidence-based practices. The purpose of this study to describe two modes of learning and use these as lenses for analyzing the challenges of implementing EBP in health care. The article is theoretical, drawing on learning and habit theory. Adaptive learning involves a gradual shift from slower, deliberate behaviors to faster, smoother, and more efficient behaviors. Developmental learning is conceptualized as a process in the "opposite" direction, whereby more or less automatically enacted behaviors become deliberate and conscious. Achieving a more EBP depends on both adaptive and developmental learning, which involves both forming EBP-conducive habits and breaking clinical practice habits that do not contribute to realizing the goals of EBP. From a learning perspective, EBP will be best supported by means of adaptive learning that yields a habitual practice of EBP such that it becomes natural and instinctive to instigate EBP in appropriate contexts by means of seeking out, critiquing, and integrating research into everyday clinical practice as well as learning new interventions best supported by empirical evidence. However, the context must also support developmental learning that facilitates disruption of existing habits to ascertain that the execution of the EBP process or the use of evidence-based interventions in routine practice is carefully and consciously considered to arrive at the most appropriate response. © 2017 Sigma Theta Tau International.

  3. Recurrent neural network based hybrid model for reconstructing gene regulatory network.

    Science.gov (United States)

    Raza, Khalid; Alam, Mansaf

    2016-10-01

    One of the exciting problems in systems biology research is to decipher how genome controls the development of complex biological system. The gene regulatory networks (GRNs) help in the identification of regulatory interactions between genes and offer fruitful information related to functional role of individual gene in a cellular system. Discovering GRNs lead to a wide range of applications, including identification of disease related pathways providing novel tentative drug targets, helps to predict disease response, and also assists in diagnosing various diseases including cancer. Reconstruction of GRNs from available biological data is still an open problem. This paper proposes a recurrent neural network (RNN) based model of GRN, hybridized with generalized extended Kalman filter for weight update in backpropagation through time training algorithm. The RNN is a complex neural network that gives a better settlement between biological closeness and mathematical flexibility to model GRN; and is also able to capture complex, non-linear and dynamic relationships among variables. Gene expression data are inherently noisy and Kalman filter performs well for estimation problem even in noisy data. Hence, we applied non-linear version of Kalman filter, known as generalized extended Kalman filter, for weight update during RNN training. The developed model has been tested on four benchmark networks such as DNA SOS repair network, IRMA network, and two synthetic networks from DREAM Challenge. We performed a comparison of our results with other state-of-the-art techniques which shows superiority of our proposed model. Further, 5% Gaussian noise has been induced in the dataset and result of the proposed model shows negligible effect of noise on results, demonstrating the noise tolerance capability of the model. Copyright © 2016 Elsevier Ltd. All rights reserved.

  4. A Kalman-filter based approach to identification of time-varying gene regulatory networks.

    Directory of Open Access Journals (Sweden)

    Jie Xiong

    Full Text Available MOTIVATION: Conventional identification methods for gene regulatory networks (GRNs have overwhelmingly adopted static topology models, which remains unchanged over time to represent the underlying molecular interactions of a biological system. However, GRNs are dynamic in response to physiological and environmental changes. Although there is a rich literature in modeling static or temporally invariant networks, how to systematically recover these temporally changing networks remains a major and significant pressing challenge. The purpose of this study is to suggest a two-step strategy that recovers time-varying GRNs. RESULTS: It is suggested in this paper to utilize a switching auto-regressive model to describe the dynamics of time-varying GRNs, and a two-step strategy is proposed to recover the structure of time-varying GRNs. In the first step, the change points are detected by a Kalman-filter based method. The observed time series are divided into several segments using these detection results; and each time series segment belonging to two successive demarcating change points is associated with an individual static regulatory network. In the second step, conditional network structure identification methods are used to reconstruct the topology for each time interval. This two-step strategy efficiently decouples the change point detection problem and the topology inference problem. Simulation results show that the proposed strategy can detect the change points precisely and recover each individual topology structure effectively. Moreover, computation results with the developmental data of Drosophila Melanogaster show that the proposed change point detection procedure is also able to work effectively in real world applications and the change point estimation accuracy exceeds other existing approaches, which means the suggested strategy may also be helpful in solving actual GRN reconstruction problem.

  5. A European regulatory perspective on cystic fibrosis: current treatments, trends in drug development and translational challenges for CFTR modulators.

    Science.gov (United States)

    Ponzano, Stefano; Nigrelli, Giulia; Fregonese, Laura; Eichler, Irmgard; Bertozzi, Fabio; Bandiera, Tiziano; Galietta, Luis J V; Papaluca, Marisa

    2018-06-30

    In this article we analyse the current authorised treatments and trends in early drug development for cystic fibrosis (CF) in the European Union for the time period 2000-2016. The analysis indicates a significant improvement in the innovation and development of new potential medicines for CF, shifting from products that act on the symptoms of the disease towards new therapies targeting the cause of CF. However, within these new innovative medicines, results for CF transmembrane conductance regulator (CFTR) modulators indicate that one major challenge for turning a CF concept product into an actual medicine for the benefit of patients resides in the fact that, although pre-clinical models have shown good predictability for certain mutations, a good correlation to clinical end-points or biomarkers ( e.g. forced expiratory volume in 1 s and sweat chloride) for all mutations has not yet been achieved. In this respect, the use of alternative end-points and innovative nonclinical models could be helpful for the understanding of those translational discrepancies. Collaborative endeavours to promote further research and development in these areas as well as early dialogue with the regulatory bodies available at the European competent authorities are recommended. Copyright ©ERS 2018.

  6. RegTransBase - A Database Of Regulatory Sequences and Interactionsin a Wide Range of Prokaryotic Genomes

    Energy Technology Data Exchange (ETDEWEB)

    Kazakov, Alexei E.; Cipriano, Michael J.; Novichkov, Pavel S.; Minovitsky, Simon; Vinogradov, Dmitry V.; Arkin, Adam; Mironov, AndreyA.; Gelfand, Mikhail S.; Dubchak, Inna

    2006-07-01

    RegTransBase, a manually curated database of regulatoryinteractions in prokaryotes, captures the knowledge in publishedscientific literature using a controlled vocabulary. Although a number ofdatabases describing interactions between regulatory proteins and theirbinding sites are currently being maintained, they focus mostly on themodel organisms Escherichia coli and Bacillus subtilis, or are entirelycomputationally derived. RegTransBase describes a large number ofregulatory interactions reported in many organisms and contains varioustypes of experimental data, in particular: the activation or repressionof transcription by an identified direct regulator; determining thetranscriptional regulatory function of a protein (or RNA) directlybinding to DNA (RNA); mapping or prediction of binding site for aregulatory protein; characterization of regulatory mutations. Currently,the RegTransBase content is derived from about 3000 relevant articlesdescribing over 7000 experiments in relation to 128 microbes. It containsdata on the regulation of about 7500 genes and evidence for 6500interactions with 650 regulators. RegTransBase also contains manuallycreated position weight matrices (PWM) that can be used to identifycandidate regulatory sites in over 60 species. RegTransBase is availableat http://regtransbase.lbl.gov.

  7. Self-discrepancy and regulatory fit in avatar-based exergames.

    Science.gov (United States)

    Jin, Seung-A Annie

    2012-12-01

    Drawing from Higgins's self-discrepancy theory and regulatory focus theory, this study examined the use of activated selves and regulatory foci in health games. Utilizing the Wii's avatar-creating and exergaming features, a 2 (activated self: actual self versus ideal self) x 2 (regulatory focus: promotion versus prevention) x 2 (efficacy appeals: self-efficacy versus response-efficacy) between-subjects experiment tested the interactions of activated selves, regulatory foci, and efficacy appeals on low-calorie dieting intentions after health game playing. Results from an experiment with 156 participants demonstrated that a fit between regulatory focus and efficacy appeals induced greater dieting intentions when the actual self was activated while the opposite effect occurred when the ideal self was activated. Theoretical contributions to basic and applied social psychology as well as managerial implications for consumer behavior research are considered.

  8. Ecological accounting based on extended exergy: a sustainability perspective.

    Science.gov (United States)

    Dai, Jing; Chen, Bin; Sciubba, Enrico

    2014-08-19

    The excessive energy consumption, environmental pollution, and ecological destruction problems have gradually become huge obstacles for the development of societal-economic-natural complex ecosystems. Regarding the national ecological-economic system, how to make explicit the resource accounting, diagnose the resource conversion, and measure the disturbance of environmental emissions to the systems are the fundamental basis of sustainable development and coordinated management. This paper presents an extended exergy (EE) accounting including the material exergy and exergy equivalent of externalities consideration in a systematic process from production to consumption, and China in 2010 is chosen as a case study to foster an in-depth understanding of the conflict between high-speed development and the available resources. The whole society is decomposed into seven sectors (i.e., Agriculture, Extraction, Conversion, Industry, Transportation, Tertiary, and Domestic sectors) according to their distinct characteristics. An adaptive EE accounting database, which incorporates traditional energy, renewable energy, mineral element, and other natural resources as well as resource-based secondary products, is constructed on the basis of the internal flows in the system. In addition, the environmental emission accounting has been adjusted to calculate the externalities-equivalent exergy. The results show that the EE value for the year 2010 in China was 1.80 × 10(14) MJ, which is greatly increased. Furthermore, an EE-based sustainability indices system has been established to provide an epitomized exploration for evaluating the performance of flows and storages with the system from a sustainability perspective. The value of the EE-based sustainability indicator was calculated to be 0.23, much lower than the critical value of 1, implying that China is still developing in the stages of high energy consumption and a low sustainability level.

  9. The French regulatory experience and views on nickel-base alloy PWSCC prevention and treatment

    Energy Technology Data Exchange (ETDEWEB)

    Turluer, G.; Cattiaux, G.; Monnot, B. [Institut de Radioprotection et de Surete Nucleaire, IRSN, 92 - Fontenay aux Roses (France); Emond, D.; Reuchet, J.; Chartier, Ph. [Direction Generale de la Surete Nucleaire et de la Radioprotection, 75 - Paris (France)

    2003-10-01

    This paper presents the experience feedback and views of the French Regulatory Authority (ASN) and of the technical support institute (IRSN) on PWSCC prevention since the initiation in 1989 of the 'Inconel Zones Review' requested by ASN to Electricite de France (EDF), the national operator of a fleet of 58 PWRs. This proactive requirement, launched before the discovery, in September 1991, of the only CRDM nozzle leak in France, on Bugey unit 3, was then triggered by the recurrence of many alloy 600 rapid degradations and leaks, world wide, and also in France in the late 1980's, particularly on steam generator tubes and on some pressurizer penetrations. Thus, the ASN requested that EDF, perform a comprehensive (generic) proactive assessment on all the nickel-base alloy components and parts of the main primary circuits, which of course included vessel head penetrations and bottom vessel head penetrations, and some other zones as a first priority. This proactive 'review' did, a minima, include the following tasks and actions: - Update and complete, by an extensive R and D program, the understanding and characterization of the Ni base alloys prone to PWSCC, - Analyze the various materials, metallurgical features, mechanical stresses, and physicochemical conditions of the parts exposed to primary water, in order to predict the occurrence of PWSCC initiation and propagation, - Provide a prioritization of the zones to be inspected, - Implement by improved NDE techniques a practical inspection program on the 58 PWRs, - Prepare and implement any needed mitigation actions as a result of the components conditions assessment. The present paper relates the main features of the French regulatory experience over more than 13 years and recalls the main principles of the assessment, which were applied by ASN. These principles, which are formalized in the current regulation rules revised in 1999, are briefly listed hereunder: - It is based on avoiding and

  10. The French regulatory experience and views on nickel-base alloy PWSCC prevention and treatment

    International Nuclear Information System (INIS)

    Turluer, G.; Cattiaux, G.; Monnot, B.; Emond, D.; Reuchet, J.; Chartier, Ph.

    2003-10-01

    This paper presents the experience feedback and views of the French Regulatory Authority (ASN) and of the technical support institute (IRSN) on PWSCC prevention since the initiation in 1989 of the 'Inconel Zones Review' requested by ASN to Electricite de France (EDF), the national operator of a fleet of 58 PWRs. This proactive requirement, launched before the discovery, in September 1991, of the only CRDM nozzle leak in France, on Bugey unit 3, was then triggered by the recurrence of many alloy 600 rapid degradations and leaks, world wide, and also in France in the late 1980's, particularly on steam generator tubes and on some pressurizer penetrations. Thus, the ASN requested that EDF, perform a comprehensive (generic) proactive assessment on all the nickel-base alloy components and parts of the main primary circuits, which of course included vessel head penetrations and bottom vessel head penetrations, and some other zones as a first priority. This proactive 'review' did, a minima, include the following tasks and actions: - Update and complete, by an extensive R and D program, the understanding and characterization of the Ni base alloys prone to PWSCC, - Analyze the various materials, metallurgical features, mechanical stresses, and physicochemical conditions of the parts exposed to primary water, in order to predict the occurrence of PWSCC initiation and propagation, - Provide a prioritization of the zones to be inspected, - Implement by improved NDE techniques a practical inspection program on the 58 PWRs, - Prepare and implement any needed mitigation actions as a result of the components conditions assessment. The present paper relates the main features of the French regulatory experience over more than 13 years and recalls the main principles of the assessment, which were applied by ASN. These principles, which are formalized in the current regulation rules revised in 1999, are briefly listed hereunder: - It is based on avoiding and preventing any leaking on

  11. Analyzing policy support instruments and regulatory risk factors for wind energy deployment-A developers' perspective

    Energy Technology Data Exchange (ETDEWEB)

    Luethi, Sonja, E-mail: sonja.luethi@unisg.ch [University of St. Gallen, 9000 St. Gallen (Switzerland); Praessler, Thomas [Potsdam Institute for Climate Impact Research (Germany)

    2011-09-15

    A transition to a renewable energy system is high on the policy agenda in many countries. A promising energy source for a low-carbon energy future is wind. Policy-makers can attract wind energy development by providing attractive policy frameworks. This paper argues that apart from the level of financial support, both the risks stemming from the regulatory environment (legal security, administrative process and grid access) and the ability to finance projects play a critical role in determining the attractiveness of the development environment. It sheds light on how project developers trade off these different aspects and to what extent the attractiveness of a certain policy framework increases with the introduction of specific measures. Conjoint analysis is employed to provide empirical evidence on the preference of wind energy developers in the EU and the US. The analysis shows that developers' preferences are very similar across the studied regions and for different types of developers. Which policy measures could be most valuable depends on the specific existing environment. In some southeastern European countries, a reduction of administrative process duration may yield the highest utility gains, whereas, in the US, improvements in grid access regulation and an increase in remuneration levels may be more effective. - Highlights: > Paper suggests conjoint analysis as scenario tool for estimating potential effects of specific policy measures. > It provides a quantitative, empirical dataset of 119 onshore wind energy developers' preferences. > Results suggest that the aspects 'Legal security' and 'Remuneration' are important attributes. > Cluster analyses yields slightly different preferences for developers from EU and US.

  12. A developmental perspective on the neural bases of human empathy.

    Science.gov (United States)

    Tousignant, Béatrice; Eugène, Fanny; Jackson, Philip L

    2017-08-01

    While empathy has been widely studied in philosophical and psychological literatures, recent advances in social neuroscience have shed light on the neural correlates of this complex interpersonal phenomenon. In this review, we provide an overview of brain imaging studies that have investigated the neural substrates of human empathy. Based on existing models of the functional architecture of empathy, we review evidence of the neural underpinnings of each main component, as well as their development from infancy. Although early precursors of affective sharing and self-other distinction appear to be present from birth, recent findings also suggest that even higher-order components of empathy such as perspective-taking and emotion regulation demonstrate signs of development during infancy. This merging of developmental and social neuroscience literature thus supports the view that ontogenic development of empathy is rooted in early infancy, well before the emergence of verbal abilities. With age, the refinement of top-down mechanisms may foster more appropriate empathic responses, thus promoting greater altruistic motivation and prosocial behaviors. Copyright © 2016 Elsevier Inc. All rights reserved.

  13. Effects of implicit theories of ability and stereotype-inconsistent information on handgrip strength in older adults: A regulatory fit perspective.

    Science.gov (United States)

    Emile, Mélanie; Chalabaev, Aina; Colson, Serge S; Vaulerin, Jerome; Falzon, Charlene; D'Arripe-Longueville, Fabienne

    2017-03-01

    This study examined whether stereotype-inconsistent information interacts with implicit theories of ability to affect handgrip strength in older adults. Eighty-two retired older adults (13 men and 69 women) from 61 to 89 years old (M age = 75.8 years; SD = 6.9) performed maximum voluntary contractions (MVC) during a handgrip task in a design manipulating implicit theories of ability and stereotype-inconsistent information related to physical decline with aging. Participants were randomly assigned to one of three groups: incremental condition, entity condition, or control group. The results showed that in the incremental condition the stereotype-inconsistent information improved the peak MVC, the average MVC, the peak rate of force development (RFD), and RFD in the initial 50 ms of the MVC. This study therefore demonstrated that individuals with an incremental mindset who are exposed to stereotype-inconsistent information can boost their physical performance. These findings are discussed from the perspective of regulatory fit (i.e., when task framing is congruent with the individual's goal). © 2016 The Authors. Psychophysiology published by Wiley Periodicals, Inc. on behalf of Society for Psychophysiological Research.

  14. Promoting Prosocial Behavior and Self-Regulatory Skills in Preschool Children through a Mindfulness-Based Kindness Curriculum

    Science.gov (United States)

    Flook, Lisa; Goldberg, Simon B.; Pinger, Laura; Davidson, Richard J.

    2015-01-01

    Self-regulatory abilities are robust predictors of important outcomes across the life span, yet they are rarely taught explicitly in school. Using a randomized controlled design, the present study investigated the effects of a 12-week mindfulness-based Kindness Curriculum (KC) delivered in a public school setting on executive function,…

  15. Sieve-based relation extraction of gene regulatory networks from biological literature.

    Science.gov (United States)

    Žitnik, Slavko; Žitnik, Marinka; Zupan, Blaž; Bajec, Marko

    2015-01-01

    Relation extraction is an essential procedure in literature mining. It focuses on extracting semantic relations between parts of text, called mentions. Biomedical literature includes an enormous amount of textual descriptions of biological entities, their interactions and results of related experiments. To extract them in an explicit, computer readable format, these relations were at first extracted manually from databases. Manual curation was later replaced with automatic or semi-automatic tools with natural language processing capabilities. The current challenge is the development of information extraction procedures that can directly infer more complex relational structures, such as gene regulatory networks. We develop a computational approach for extraction of gene regulatory networks from textual data. Our method is designed as a sieve-based system and uses linear-chain conditional random fields and rules for relation extraction. With this method we successfully extracted the sporulation gene regulation network in the bacterium Bacillus subtilis for the information extraction challenge at the BioNLP 2013 conference. To enable extraction of distant relations using first-order models, we transform the data into skip-mention sequences. We infer multiple models, each of which is able to extract different relationship types. Following the shared task, we conducted additional analysis using different system settings that resulted in reducing the reconstruction error of bacterial sporulation network from 0.73 to 0.68, measured as the slot error rate between the predicted and the reference network. We observe that all relation extraction sieves contribute to the predictive performance of the proposed approach. Also, features constructed by considering mention words and their prefixes and suffixes are the most important features for higher accuracy of extraction. Analysis of distances between different mention types in the text shows that our choice of transforming

  16. A relative variation-based method to unraveling gene regulatory networks.

    Directory of Open Access Journals (Sweden)

    Yali Wang

    Full Text Available Gene regulatory network (GRN reconstruction is essential in understanding the functioning and pathology of a biological system. Extensive models and algorithms have been developed to unravel a GRN. The DREAM project aims to clarify both advantages and disadvantages of these methods from an application viewpoint. An interesting yet surprising observation is that compared with complicated methods like those based on nonlinear differential equations, etc., methods based on a simple statistics, such as the so-called Z-score, usually perform better. A fundamental problem with the Z-score, however, is that direct and indirect regulations can not be easily distinguished. To overcome this drawback, a relative expression level variation (RELV based GRN inference algorithm is suggested in this paper, which consists of three major steps. Firstly, on the basis of wild type and single gene knockout/knockdown experimental data, the magnitude of RELV of a gene is estimated. Secondly, probability for the existence of a direct regulation from a perturbed gene to a measured gene is estimated, which is further utilized to estimate whether a gene can be regulated by other genes. Finally, the normalized RELVs are modified to make genes with an estimated zero in-degree have smaller RELVs in magnitude than the other genes, which is used afterwards in queuing possibilities of the existence of direct regulations among genes and therefore leads to an estimate on the GRN topology. This method can in principle avoid the so-called cascade errors under certain situations. Computational results with the Size 100 sub-challenges of DREAM3 and DREAM4 show that, compared with the Z-score based method, prediction performances can be substantially improved, especially the AUPR specification. Moreover, it can even outperform the best team of both DREAM3 and DREAM4. Furthermore, the high precision of the obtained most reliable predictions shows that the suggested algorithm may be

  17. Ranking system for national regulatory jurisdictions based on pesticide standard values in major exposures

    Directory of Open Access Journals (Sweden)

    Zijian Li

    2017-07-01

    Full Text Available To control the risk of human exposure to pesticides, about 50 nations have promulgated pesticide soil regulatory guidance values (RGVs, and 104 nations have provided pesticide drinking water maximum concentration levels (MCLs. In addition, 90 nations have regulated pesticide agricultural commodity maximum residue limits (MRLs. Pesticide standard values (PSVs for one single pesticide varied in a range of six, seven, or even eight orders of magnitude. Some PSVs are too large to prevent the impact of pesticides on human health. Many nations have not provided PSVs for some commonly used pesticides until now. This research has introduced several completeness values and numerical values methods to evaluate the national jurisdiction’s performance on PSVs on a nation base. The national jurisdiction ranking system developed by these methods will be beneficial to the environmental regulation makers in the management of PSVs. Results also indicate that European countries perform better in the regulation of pesticide soil RGVs, drinking water MCLs, and agricultural commodity MRLs.

  18. Recurrent neural network-based modeling of gene regulatory network using elephant swarm water search algorithm.

    Science.gov (United States)

    Mandal, Sudip; Saha, Goutam; Pal, Rajat Kumar

    2017-08-01

    Correct inference of genetic regulations inside a cell from the biological database like time series microarray data is one of the greatest challenges in post genomic era for biologists and researchers. Recurrent Neural Network (RNN) is one of the most popular and simple approach to model the dynamics as well as to infer correct dependencies among genes. Inspired by the behavior of social elephants, we propose a new metaheuristic namely Elephant Swarm Water Search Algorithm (ESWSA) to infer Gene Regulatory Network (GRN). This algorithm is mainly based on the water search strategy of intelligent and social elephants during drought, utilizing the different types of communication techniques. Initially, the algorithm is tested against benchmark small and medium scale artificial genetic networks without and with presence of different noise levels and the efficiency was observed in term of parametric error, minimum fitness value, execution time, accuracy of prediction of true regulation, etc. Next, the proposed algorithm is tested against the real time gene expression data of Escherichia Coli SOS Network and results were also compared with others state of the art optimization methods. The experimental results suggest that ESWSA is very efficient for GRN inference problem and performs better than other methods in many ways.

  19. Improving the extraction of complex regulatory events from scientific text by using ontology-based inference.

    Science.gov (United States)

    Kim, Jung-Jae; Rebholz-Schuhmann, Dietrich

    2011-10-06

    The extraction of complex events from biomedical text is a challenging task and requires in-depth semantic analysis. Previous approaches associate lexical and syntactic resources with ontologies for the semantic analysis, but fall short in testing the benefits from the use of domain knowledge. We developed a system that deduces implicit events from explicitly expressed events by using inference rules that encode domain knowledge. We evaluated the system with the inference module on three tasks: First, when tested against a corpus with manually annotated events, the inference module of our system contributes 53.2% of correct extractions, but does not cause any incorrect results. Second, the system overall reproduces 33.1% of the transcription regulatory events contained in RegulonDB (up to 85.0% precision) and the inference module is required for 93.8% of the reproduced events. Third, we applied the system with minimum adaptations to the identification of cell activity regulation events, confirming that the inference improves the performance of the system also on this task. Our research shows that the inference based on domain knowledge plays a significant role in extracting complex events from text. This approach has great potential in recognizing the complex concepts of such biomedical ontologies as Gene Ontology in the literature.

  20. Improving the extraction of complex regulatory events from scientific text by using ontology-based inference

    Directory of Open Access Journals (Sweden)

    Kim Jung-jae

    2011-10-01

    Full Text Available Abstract Background The extraction of complex events from biomedical text is a challenging task and requires in-depth semantic analysis. Previous approaches associate lexical and syntactic resources with ontologies for the semantic analysis, but fall short in testing the benefits from the use of domain knowledge. Results We developed a system that deduces implicit events from explicitly expressed events by using inference rules that encode domain knowledge. We evaluated the system with the inference module on three tasks: First, when tested against a corpus with manually annotated events, the inference module of our system contributes 53.2% of correct extractions, but does not cause any incorrect results. Second, the system overall reproduces 33.1% of the transcription regulatory events contained in RegulonDB (up to 85.0% precision and the inference module is required for 93.8% of the reproduced events. Third, we applied the system with minimum adaptations to the identification of cell activity regulation events, confirming that the inference improves the performance of the system also on this task. Conclusions Our research shows that the inference based on domain knowledge plays a significant role in extracting complex events from text. This approach has great potential in recognizing the complex concepts of such biomedical ontologies as Gene Ontology in the literature.

  1. Character Education Based on Religious Values: an Islamic Perspective

    Directory of Open Access Journals (Sweden)

    Ismail Sukardi

    2016-09-01

    Full Text Available Character education in Indonesia has become a necessity that can not be negotiable. Various cases of crime and moral deviations become evident that the character of most citizens already at alarming stage. Therefore, since the beginning, national education is not only aimed at generating human intelligent and skilled, but also of noble character. This is realized through the introduction of 18 characters excel in school (religious, honest, disciplined, tolerance, and so on. In the Islamic perspective character education paired with akhlak (Islamic ethics education. Among the important characteristics are: it sourced from the Quran Hadith; Prophet Muhammad as a role model; priority-based methods of mental-spiritual (soul management, habituation, exemplary, and healthy environment; are simultaneous in which three education centers, namely schools, families, and communities should play a role in synergy. The government and the mass media also play a role in supporting the education of character.   Pendidikan karakter di Indonesia telah menjadi kebutuhan yang tidak dapat ditawar. Berbagai kasus kejahatan moral dan penyimpangan menjadi jelas bahwa karakter sebagian besar warga sudah pada tahap mengkhawatirkan. Oleh karena itu, sejak awal, pendidikan nasional tidak hanya bertujuan menghasilkan manusia cerdas dan terampil, tetapi juga karakter yang mulia. Hal ini diwujudkan melalui pengenalan 18 karakter berprestasi di sekolah (agama, jujur, disiplin, tolerann, dan sebagainya. Dalam pendidikan karakter perspektif Islam dipasangkan dengan pendidikan akhlak (etika Islam. Di antara karakteristik penting adalah: itu bersumber dari al-Quran Hadis; Nabi Muhammad sebagai panutan; metode berbasis prioritas mental-spiritual (manajemen jiwa, pembiasaan, keteladanan, dan lingkungan yang sehat; yang simultan di mana tiga pusat pendidikan, yaitu sekolah, keluarga, dan masyarakat harus berperan dalam sinergi. Pemerintah dan media massa juga berperan dalam mendukung

  2. The regulatory requirements, design bases, researches and assessments in the field of Ukrainian NPP's seismic safety

    International Nuclear Information System (INIS)

    Mykolaychuk, O.; Mayboroda, O.; Krytskyy, V.; Karnaukhov, O.

    2001-01-01

    State Nuclear Regulatory Authority of Ukraine (SNRA) pays large attention to problem of nuclear installations seismic stability. As a result the seismic design regulatory guides is revised, additional seismic researches of NPP sites are conducted, seismic reassessment of NPP designs were begun. The experts involved address all seismic related factors under close contact with the staff of NPP, design institutes and research organizations. This document takes stock on the situation and the research programs. (author)

  3. A flood-based information flow analysis and network minimization method for gene regulatory networks.

    Science.gov (United States)

    Pavlogiannis, Andreas; Mozhayskiy, Vadim; Tagkopoulos, Ilias

    2013-04-24

    Biological networks tend to have high interconnectivity, complex topologies and multiple types of interactions. This renders difficult the identification of sub-networks that are involved in condition- specific responses. In addition, we generally lack scalable methods that can reveal the information flow in gene regulatory and biochemical pathways. Doing so will help us to identify key participants and paths under specific environmental and cellular context. This paper introduces the theory of network flooding, which aims to address the problem of network minimization and regulatory information flow in gene regulatory networks. Given a regulatory biological network, a set of source (input) nodes and optionally a set of sink (output) nodes, our task is to find (a) the minimal sub-network that encodes the regulatory program involving all input and output nodes and (b) the information flow from the source to the sink nodes of the network. Here, we describe a novel, scalable, network traversal algorithm and we assess its potential to achieve significant network size reduction in both synthetic and E. coli networks. Scalability and sensitivity analysis show that the proposed method scales well with the size of the network, and is robust to noise and missing data. The method of network flooding proves to be a useful, practical approach towards information flow analysis in gene regulatory networks. Further extension of the proposed theory has the potential to lead in a unifying framework for the simultaneous network minimization and information flow analysis across various "omics" levels.

  4. Regulatory networks, legal federalism, and multi-level regulatory systems

    OpenAIRE

    Kerber, Wolfgang; Wendel, Julia

    2016-01-01

    Transnational regulatory networks play important roles in multi-level regulatory regimes, as e.g, the European Union. In this paper we analyze the role of regulatory networks from the perspective of the economic theory of legal federalism. Often sophisticated intermediate institutional solutions between pure centralisation and pure decentralisation can help to solve complex tradeoff problems between the benefits and problems of centralised and decentralised solutions. Drawing upon the insight...

  5. Implementing the Marine Strategy Framework Directive: A policy perspective on regulatory, institutional and stakeholder impediments to effective implementation

    NARCIS (Netherlands)

    Leeuwen, van J.; Raakjaer, J.; Hoof, van L.J.W.; Tatenhove, van J.P.M.; Long, R.; Ounanian, K.

    2014-01-01

    The implementation of the European Union (EU) Marine Strategy Framework Directive (MSFD) requires EU Member States to draft a program of measures to achieve Good Environmental Status (GES). Central argument of this paper, based on an analysis of the unique, holistic character of the MSFD, is that

  6. Groundwater contamination from waste management sites: The interaction between risk-based engineering design and regulatory policy: 1. Methodology

    Science.gov (United States)

    Massmann, Joel; Freeze, R. Allan

    1987-02-01

    This paper puts in place a risk-cost-benefit analysis for waste management facilities that explicitly recognizes the adversarial relationship that exists in a regulated market economy between the owner/operator of a waste management facility and the government regulatory agency under whose terms the facility must be licensed. The risk-cost-benefit analysis is set up from the perspective of the owner/operator. It can be used directly by the owner/operator to assess alternative design strategies. It can also be used by the regulatory agency to assess alternative regulatory policy, but only in an indirect manner, by examining the response of an owner/operator to the stimuli of various policies. The objective function is couched in terms of a discounted stream of benefits, costs, and risks over an engineering time horizon. Benefits are in the form of revenues for services provided; costs are those of construction and operation of the facility. Risk is defined as the cost associated with the probability of failure, with failure defined as the occurrence of a groundwater contamination event that violates the licensing requirements established for the facility. Failure requires a breach of the containment structure and contaminant migration through the hydrogeological environment to a compliance surface. The probability of failure can be estimated on the basis of reliability theory for the breach of containment and with a Monte-Carlo finite-element simulation for the advective contaminant transport. In the hydrogeological environment the hydraulic conductivity values are defined stochastically. The probability of failure is reduced by the presence of a monitoring network operated by the owner/operator and located between the source and the regulatory compliance surface. The level of reduction in the probability of failure depends on the probability of detection of the monitoring network, which can be calculated from the stochastic contaminant transport simulations. While

  7. As to achieve regulatory action, regulatory approaches

    International Nuclear Information System (INIS)

    Cid, R.; Encinas, D.

    2014-01-01

    The achievement of the effectiveness in the performance of a nuclear regulatory body has been a permanent challenge in the recent history of nuclear regulation. In the post-Fukushima era this challenge is even more important. This article addresses the subject from two complementary points of view: the characteristics of an effective regulatory body and the regulatory approaches. This work is based on the most recent studies carried out by the Committee on Nuclear Regulatory Activities, CNRA (OECD/NEA), as well as on the experience of the Consejo de Seguridad Nuclear, CSN, the Spanish regulatory body. Rafael Cid is the representative of CSN in these project: Diego Encinas has participated in the study on regulatory approaches. (Author)

  8. Core damage frequency (reactor design) perspectives based on IPE results

    International Nuclear Information System (INIS)

    Camp, A.L.; Dingman, S.E.; Forester, J.A.

    1996-01-01

    This paper provides perspectives gained from reviewing 75 Individual Plant Examination (IPE) submittals covering 108 nuclear power plant units. Variability both within and among reactor types is examined to provide perspectives regarding plant-specific design and operational features, and C, modeling assumptions that play a significant role in the estimates of core damage frequencies in the IPEs. Human actions found to be important in boiling water reactors (BWRs) and in pressurized water reactors (PWRs) are presented and the events most frequently found important are discussed

  9. Emissions to the Atmosphere from Amine-Based Post Combustion CO2 Capture Plant - Regulatory Aspects

    International Nuclear Information System (INIS)

    Azzi, Merched; Angove, Dennys; Dave, Narendra; Day, Stuart; Do, Thong; Feron, Paul; Sharma, Sunil; Attalla, Moetaz; Abu Zahra, Mohammad

    2014-01-01

    Amine-based Post Combustion Capture (PCC) of CO 2 is a readily available technology that can be deployed to reduce CO 2 emissions from coal fired power plants. However, PCC plants will likely release small quantities of amine and amine degradation products to the atmosphere along with the treated flue gas. The possible environmental effects of these emissions have been examined through different studies carried out around the world. Based on flue gas from a 400 MW ultra-supercritical coal fired power plant Aspen-Plus PCC process simulations were used to predict the potential atmospheric emissions from the plant. Different research initiatives carried out in this area have produced new knowledge that has significantly reduced the risk perception for the release of amine and amine degradation products to the atmosphere. In addition to the reduction of the CO 2 emissions, the PCC technology will also help in reducing SO x and NO 2 emissions. However, some other pollutants such as NH 3 and aerosols will increase if appropriate control technologies are not adopted. To study the atmospheric photo-oxidation of amines, attempts are being made to develop chemical reaction schemes that can be used for air quality assessment. However, more research is still required in this area to estimate the reactivity of amino solvents in the presence of other pollutants such as NO x and other volatile organic compounds in the background air. Current air quality guidelines may need to be updated to include limits for the additional pollutants such as NH 3 , nitrosamines and nitramines once more information related to their emissions is available. This paper focuses on describing the predicted concentrations of major pollutants that are expected to be released from a coal fired power plant obtained by ASPEN-Plus PCC process simulations in terms of current air quality regulations and other regulatory aspects. (authors)

  10. Generalizing Perspective-based Inspection to handle Object-Oriented Development Artifacts

    OpenAIRE

    Laitenberger, O.; Atkinson, C.

    1998-01-01

    The value of software inspection for uncovering defects early in the development lifecycle has been well documented. Of the various types of inspection methods published to date, experiments have shown perspective-based inspection to be one of the most effective, because of its enhanced coverage of the defect space. However, inspections in general, and perspective-based inspections in particular, have so far been applied predominantly in the context of conventional structured development meth...

  11. The Issue Animal in the Perspective of the Federal Supreme Court and the "Regulatory Aspects Of Legal Status

    Directory of Open Access Journals (Sweden)

    Mery Chalfun

    2016-12-01

    Full Text Available The present work aims to analyze the legal nature of nonhuman animals in the doctrine of Animal Law, legal order and position of the Federal Supreme Court based on judgments that deal with conflict between cultural manifestation and cruelty to animals. Brazilian legislation calls for a multiplicity of positions on the legal nature of animals, which may influence positively or negatively the treatment accorded to them. It can be seen that in the STF the predominance of two understandings: anthropocentric, equivalent to good, while of another biocentric, moral consideration as to the animals and possibility of change of the legal nature.

  12. Children's perspectives on cyberbullying: Insights based on participatory research

    NARCIS (Netherlands)

    Baas, N.; de Jong, Menno D.T.; Drossaert, Constance H.C.

    2013-01-01

    Cyberbullying is an emerging problem among youngsters. Although the current body of knowledge about cyberbullying is expanding rapidly, it lacks a more in-depth research approach honoring adolescents' perspectives on the problem. Moreover, very few studies have focused on cyberbullying among

  13. Reduction of regulatory risk: a network economic approach

    OpenAIRE

    Knieps, Günter; Weiß, Hans-Jörg

    2007-01-01

    Several definitions of regulatory risk are known from the literature. From the perspective of regulatory reform it is important to differentiate between the impact of a given regulatory scheme on the firm's risk exposure and the risk arising from discretionary behavior of regulatory agencies. Whereas the conse-quences of effective regulation in principle are known and accepted, excessive regulatory discretion may cause a strong need for regulatory reform. Regulatory reform focussing on the re...

  14. Deep sequencing-based identification of small regulatory RNAs in Synechocystis sp. PCC 6803.

    Directory of Open Access Journals (Sweden)

    Wen Xu

    Full Text Available Synechocystis sp. PCC 6803 is a genetically tractable model organism for photosynthesis research. The genome of Synechocystis sp. PCC 6803 consists of a circular chromosome and seven plasmids. The importance of small regulatory RNAs (sRNAs as mediators of a number of cellular processes in bacteria has begun to be recognized. However, little is known regarding sRNAs in Synechocystis sp. PCC 6803. To provide a comprehensive overview of sRNAs in this model organism, the sRNAs of Synechocystis sp. PCC 6803 were analyzed using deep sequencing, and 7,951,189 reads were obtained. High quality mapping reads (6,127,890 were mapped onto the genome and assembled into 16,192 transcribed regions (clusters based on read overlap. A total number of 5211 putative sRNAs were revealed from the genome and the 4 megaplasmids, and 27 of these molecules, including four from plasmids, were confirmed by RT-PCR. In addition, possible target genes regulated by all of the putative sRNAs identified in this study were predicted by IntaRNA and analyzed for functional categorization and biological pathways, which provided evidence that sRNAs are indeed involved in many different metabolic pathways, including basic metabolic pathways, such as glycolysis/gluconeogenesis, the citrate cycle, fatty acid metabolism and adaptations to environmentally stress-induced changes. The information from this study provides a valuable reservoir for understanding the sRNA-mediated regulation of the complex physiology and metabolic processes of cyanobacteria.

  15. Identification of direct regulatory targets of the transcription factor Sox10 based on function and conservation

    Directory of Open Access Journals (Sweden)

    Lee Sanghyuk

    2008-09-01

    Full Text Available Abstract Background Sox10, a member of the Sry-related HMG-Box gene family, is a critical transcription factor for several important cell lineages, most notably the neural crest stem cells and the derivative peripheral glial cells and melanocytes. Thus far, only a handful of direct target genes are known for this transcription factor limiting our understanding of the biological network it governs. Results We describe identification of multiple direct regulatory target genes of Sox10 through a procedure based on function and conservation. By combining RNA interference technique and DNA microarray technology, we have identified a set of genes that show significant down-regulation upon introduction of Sox10 specific siRNA into Schwannoma cells. Subsequent comparative genomics analyses led to potential binding sites for Sox10 protein conserved across several mammalian species within the genomic region proximal to these genes. Multiple sites belonging to 4 different genes (proteolipid protein, Sox10, extracellular superoxide dismutase, and pleiotrophin were shown to directly interact with Sox10 by chromatin immunoprecipitation assay. We further confirmed the direct regulation through the identified cis-element for one of the genes, extracellular superoxide dismutase, using electrophoretic mobility shift assay and reporter assay. Conclusion In sum, the process of combining differential expression profiling and comparative genomics successfully led to further defining the role of Sox10, a critical transcription factor for the development of peripheral glia. Our strategy utilizing relatively accessible techniques and tools should be applicable to studying the function of other transcription factors.

  16. iTRAQ-Based Quantitative Proteomics Identifies Potential Regulatory Proteins Involved in Chicken Eggshell Brownness.

    Directory of Open Access Journals (Sweden)

    Guangqi Li

    Full Text Available Brown eggs are popular in many countries and consumers regard eggshell brownness as an important indicator of egg quality. However, the potential regulatory proteins and detailed molecular mechanisms regulating eggshell brownness have yet to be clearly defined. In the present study, we performed quantitative proteomics analysis with iTRAQ technology in the shell gland epithelium of hens laying dark and light brown eggs to investigate the candidate proteins and molecular mechanisms underlying variation in chicken eggshell brownness. The results indicated 147 differentially expressed proteins between these two groups, among which 65 and 82 proteins were significantly up-regulated in the light and dark groups, respectively. Functional analysis indicated that in the light group, the down-regulated iron-sulfur cluster assembly protein (Iba57 would decrease the synthesis of protoporphyrin IX; furthermore, the up-regulated protein solute carrier family 25 (mitochondrial carrier; adenine nucleotide translocator, member 5 (SLC25A5 and down-regulated translocator protein (TSPO would lead to increased amounts of protoporphyrin IX transported into the mitochondria matrix to form heme with iron, which is supplied by ovotransferrin protein (TF. In other words, chickens from the light group produce less protoporphyrin IX, which is mainly used for heme synthesis. Therefore, the exported protoporphyrin IX available for eggshell deposition and brownness is reduced in the light group. The current study provides valuable information to elucidate variation of chicken eggshell brownness, and demonstrates the feasibility and sensitivity of iTRAQ-based quantitative proteomics analysis in providing useful insights into the molecular mechanisms underlying brown eggshell pigmentation.

  17. U.S. Nuclear Regulatory Commission bases for control of solid materials

    International Nuclear Information System (INIS)

    Meck, R.A.; Cardille, F.P.; Feldman, C.; Gnugnoli, G.N.; Huffert, A.M.; Klementowicz, S.P.

    2002-01-01

    The U.S. Nuclear Regulatory Commission (NRC) is considering whether to proceed with rulemaking on the control of solid materials with very low levels of associated radioactivity. The current implementation of clearance by NRC licensees is the context for the decision. Inputs to the decision include information gathering efforts of the Commission in the areas of public workshops, dose assessments and inventories, the recommendations of the National Academies' National Research Council (NAs) on regulatory alternatives, and participation in international efforts by the International Atomic Energy Agency (IAEA). (author)

  18. Comparison of Current Regulatory Status for Gene-Based Vaccines in the U.S., Europe and Japan

    Directory of Open Access Journals (Sweden)

    Yoshikazu Nakayama

    2015-03-01

    Full Text Available Gene-based vaccines as typified by plasmid DNA vaccines and recombinant viral-vectored vaccines are expected as promising solutions against infectious diseases for which no effective prophylactic vaccines exist such as HIV, dengue virus, Ebola virus and malaria, and for which more improved vaccines are needed such as tuberculosis and influenza virus. Although many preclinical and clinical trials have been conducted to date, no DNA vaccines or recombinant viral-vectored vaccines expressing heterologous antigens for human use have yet been licensed in the U.S., Europe or Japan. In this research, we describe the current regulatory context for gene-based prophylactic vaccines against infectious disease in the U.S., Europe, and Japan. We identify the important considerations, in particular, on the preclinical assessments that would allow these vaccines to proceed to clinical trials, and the differences on the regulatory pathway for the marketing authorization in each region.

  19. Stakeholder perspectives on workplace-based performance assessment: towards a better understanding of assessor behaviour.

    Science.gov (United States)

    de Jonge, Laury P J W M; Timmerman, Angelique A; Govaerts, Marjan J B; Muris, Jean W M; Muijtjens, Arno M M; Kramer, Anneke W M; van der Vleuten, Cees P M

    2017-12-01

    Workplace-Based Assessment (WBA) plays a pivotal role in present-day competency-based medical curricula. Validity in WBA mainly depends on how stakeholders (e.g. clinical supervisors and learners) use the assessments-rather than on the intrinsic qualities of instruments and methods. Current research on assessment in clinical contexts seems to imply that variable behaviours during performance assessment of both assessors and learners may well reflect their respective beliefs and perspectives towards WBA. We therefore performed a Q methodological study to explore perspectives underlying stakeholders' behaviours in WBA in a postgraduate medical training program. Five different perspectives on performance assessment were extracted: Agency, Mutuality, Objectivity, Adaptivity and Accountability. These perspectives reflect both differences and similarities in stakeholder perceptions and preferences regarding the utility of WBA. In comparing and contrasting the various perspectives, we identified two key areas of disagreement, specifically 'the locus of regulation of learning' (i.e., self-regulated versus externally regulated learning) and 'the extent to which assessment should be standardised' (i.e., tailored versus standardised assessment). Differing perspectives may variously affect stakeholders' acceptance, use-and, consequently, the effectiveness-of assessment programmes. Continuous interaction between all stakeholders is essential to monitor, adapt and improve assessment practices and to stimulate the development of a shared mental model. Better understanding of underlying stakeholder perspectives could be an important step in bridging the gap between psychometric and socio-constructivist approaches in WBA.

  20. [Cancer: Is it really so different? Particularities of oncologic drugs from the perspective of the pharmaceutical regulatory agency].

    Science.gov (United States)

    Enzmann, Harald; Broich, Karl

    2013-01-01

    For innovative oncological medicines the centralised procedure at the European Medicines Agency is mandatory for a marketing authorisation application for the European Union. As with other medical drugs, the marketing authorisation decision is based on the assessment of its efficacy, safety and pharmaceutical quality but does not consider price or reimbursement. More sophisticated diagnostic methods drive an increasing stratification of cancer into a multitude of different diseases. Regardless of their different pathogenesis and therapeutic options the most relevant clinical endpoints remain cure, overall survival and progression free survival. These endpoints include both efficacy and safety, as patient survival reflects the sum of the beneficial anti-tumour effects (increasing survival) AND the adverse effects (decreasing survival). The benefit of an anticancer medicine should be evident from both overall survival and progression free survival (e.g. used as primary and secondary endpoints). Mature data on overall survival may not be needed for marketing authorisation if a clear increase in progression free survival convincingly predicts a beneficial effect on overall survival. In these exceptional cases treatment of patients with an obviously beneficial medicine must not be delayed - possibly for years - until the exact size of the benefit has been established. The continued stratification of the disease cancer results in a lower prevalence for each of the newly distinguished disease entities and an ever increasing number of orphan designations for medicines for rare diseases. Incentives for the development of orphan medicines include market exclusivity for up to ten years. In specific circumstances, however, the orphan legislation may restrict the authorisation and marketing of competing generic products even beyond these ten years. Conditional approval and approval under exceptional circumstances may accelerate patients' access to a new medicine. Both postulate

  1. Severe accident progression perspectives based on IPE results

    International Nuclear Information System (INIS)

    Lehner, J.R.; Lin, C.C.; Pratt, W.T.; Drouin, M.

    1996-01-01

    Accident progression perspectives were gathered from the level 2 PRA analyses (the analysis of the accident after core damage has occurred involving the containment performance and the radionuclide release from the containment) described in the IPE submittals. Insights related to the containment failure modes, the releases associated with those failure modes, and the factors responsible for the types of containment failures and release sizes reported were obtained. Complete results are discussed in NUREG-1560 and summarized here

  2. Improvement gives the legislative and regulatory base for the use the nuclear energy in Cuba

    International Nuclear Information System (INIS)

    Ferrer Iglesias, R.; Sarabia Molina, I.; Guillen Campos, A.

    1998-01-01

    Presently work the activities are exposed that carries out the Cuban National Center of Nuclear Security in the improvement the mark regulatory for the regulation to the safety uses the nuclear energy on the implementation to the IAEA recommendations as regards security

  3. Perspectives

    African Journals Online (AJOL)

    abp

    2016-02-29

    Feb 29, 2016 ... This assumption was based on the erroneous premise that finance ministers ... colleagues, from Johns Hopkins, showing a benefit: cost ratio of. 16:1 for ... boycott, until the traditional leaders intervened in favor of the polio ...

  4. Clinical translation and regulatory aspects of CAR/TCR-based adoptive cell therapies-the German Cancer Consortium approach.

    Science.gov (United States)

    Krackhardt, Angela M; Anliker, Brigitte; Hildebrandt, Martin; Bachmann, Michael; Eichmüller, Stefan B; Nettelbeck, Dirk M; Renner, Matthias; Uharek, Lutz; Willimsky, Gerald; Schmitt, Michael; Wels, Winfried S; Schüssler-Lenz, Martina

    2018-04-01

    Adoptive transfer of T cells genetically modified by TCRs or CARs represents a highly attractive novel therapeutic strategy to treat malignant diseases. Various approaches for the development of such gene therapy medicinal products (GTMPs) have been initiated by scientists in recent years. To date, however, the number of clinical trials commenced in Germany and Europe is still low. Several hurdles may contribute to the delay in clinical translation of these therapeutic innovations including the significant complexity of manufacture and non-clinical testing of these novel medicinal products, the limited knowledge about the intricate regulatory requirements of the academic developers as well as limitations of funds for clinical testing. A suitable good manufacturing practice (GMP) environment is a key prerequisite and platform for the development, validation, and manufacture of such cell-based therapies, but may also represent a bottleneck for clinical translation. The German Cancer Consortium (DKTK) and the Paul-Ehrlich-Institut (PEI) have initiated joint efforts of researchers and regulators to facilitate and advance early phase, academia-driven clinical trials. Starting with a workshop held in 2016, stakeholders from academia and regulatory authorities in Germany have entered into continuing discussions on a diversity of scientific, manufacturing, and regulatory aspects, as well as the benefits and risks of clinical application of CAR/TCR-based cell therapies. This review summarizes the current state of discussions of this cooperative approach providing a basis for further policy-making and suitable modification of processes.

  5. Cell therapy medicinal product regulatory framework in Europe and its application for MSC-based therapy development

    Science.gov (United States)

    Ancans, Janis

    2012-01-01

    Advanced therapy medicinal products (ATMPs), including cell therapy products, form a new class of medicines in the European Union. Since the ATMPs are at the forefront of scientific innovation in medicine, specific regulatory framework has been developed for these medicines and implemented from 2009. The Committee for Advanced Therapies (CAT) has been established at the European Medicines Agency (EMA) for centralized classification, certification and evaluation procedures, and other ATMP-related tasks. Guidance documents, initiatives, and interaction platforms are available to make the new framework more accessible for small- and medium-sized enterprises, academia, hospitals, and foundations. Good understanding of the centralized and national components of the regulatory system is required to plan product development. It is in the best interests of the cell therapy developers to utilize the resources provided starting with the pre-clinical stage. Whilst there have been no mesenchymal stem cell (MSC)-based medicine authorizations in the EU, three MSC products have received marketing approval in other regions since 2011. The information provided on the regulatory requirements, procedures, and initiatives is aimed at facilitating MSC-based medicinal product development and authorization in the EU. PMID:22912639

  6. Establishing Base Elements of Perspective in Order to Reconstruct Architectural Buildings from Photographs

    Science.gov (United States)

    Dzwierzynska, Jolanta

    2017-12-01

    The use of perspective images, especially historical photographs for retrieving information about presented architectural environment is a fast developing field recently. The photography image is a perspective image with secure geometrical connection with reality, therefore it is possible to reverse this process. The aim of the herby study is establishing requirements which a photographic perspective representation should meet for a reconstruction purpose, as well as determination of base elements of perspective such as a horizon line and a circle of depth, which is a key issue in any reconstruction. The starting point in the reconstruction process is geometrical analysis of the photograph, especially determination of the kind of perspective projection applied, which is defined by the building location towards a projection plane. Next, proper constructions can be used. The paper addresses the problem of establishing base elements of perspective on the basis of the photograph image in the case when camera calibration is impossible to establish. It presents different geometric construction methods selected dependently on the starting assumptions. Therefore, the methods described in the paper seem to be universal. Moreover, they can be used even in the case of poor quality photographs with poor perspective geometry. Such constructions can be realized with computer aid when the photographs are in digital form as it is presented in the paper. The accuracy of the applied methods depends on the photography image accuracy, as well as drawing accuracy, however, it is sufficient for further reconstruction. Establishing base elements of perspective presented in the paper is especially useful in difficult cases of reconstruction, when one lacks information about reconstructed architectural form and it is necessary to lean on solid geometry.

  7. Inference of hierarchical regulatory network of estrogen-dependent breast cancer through ChIP-based data

    Directory of Open Access Journals (Sweden)

    Parvin Jeffrey

    2010-12-01

    Full Text Available Abstract Background Global profiling of in vivo protein-DNA interactions using ChIP-based technologies has evolved rapidly in recent years. Although many genome-wide studies have identified thousands of ERα binding sites and have revealed the associated transcription factor (TF partners, such as AP1, FOXA1 and CEBP, little is known about ERα associated hierarchical transcriptional regulatory networks. Results In this study, we applied computational approaches to analyze three public available ChIP-based datasets: ChIP-seq, ChIP-PET and ChIP-chip, and to investigate the hierarchical regulatory network for ERα and ERα partner TFs regulation in estrogen-dependent breast cancer MCF7 cells. 16 common TFs and two common new TF partners (RORA and PITX2 were found among ChIP-seq, ChIP-chip and ChIP-PET datasets. The regulatory networks were constructed by scanning the ChIP-peak region with TF specific position weight matrix (PWM. A permutation test was performed to test the reliability of each connection of the network. We then used DREM software to perform gene ontology function analysis on the common genes. We found that FOS, PITX2, RORA and FOXA1 were involved in the up-regulated genes. We also conducted the ERα and Pol-II ChIP-seq experiments in tamoxifen resistance MCF7 cells (denoted as MCF7-T in this study and compared the difference between MCF7 and MCF7-T cells. The result showed very little overlap between these two cells in terms of targeted genes (21.2% of common genes and targeted TFs (25% of common TFs. The significant dissimilarity may indicate totally different transcriptional regulatory mechanisms between these two cancer cells. Conclusions Our study uncovers new estrogen-mediated regulatory networks by mining three ChIP-based data in MCF7 cells and ChIP-seq data in MCF7-T cells. We compared the different ChIP-based technologies as well as different breast cancer cells. Our computational analytical approach may guide biologists to

  8. Knowledge-Based Economy in Argentina, Costa Rica and Mexico: A Comparative Analysis from the Bio-Economy Perspective

    Directory of Open Access Journals (Sweden)

    Ana Barbara MUNGARAY-MOCTEZUMA

    2015-06-01

    Full Text Available The objective of this article is to determine the necessary institutional characteristics of technology and human capital in Argentina, Costa Rica and Mexico in order to evolve towards a knowledge-based economy, addressing the importance of institutions for their development. In particular, the knowledge-based economy is analyzed from the perspective of bioeconomics. Based on the Knowledge Economy Index (KEI which considers 148 indicators, in the following categories: a economic performance and institutional regime; b education and human resources, c innovation, and d information and communication technologies, we selected 13 indicators. We aim to identify the strengths and opportunities for these countries in order to meet the challenges that arise from the paradoxes of technological progress and globalization. In this sense, bioeconomy is approached as part of the economy. This analysis shows, among other things, that Argentina has greater potential to compete in an economy sustained in the creation and dissemination of knowledge, while Costa Rica has an institutional and regulatory environment that is more conducive to the development of business activities, and Mexico faces significant challenges regarding its institutional structure, economic performance and human resources.

  9. Survey of past base isolation applications in nuclear power plants and challenges to industry/regulatory acceptance

    International Nuclear Information System (INIS)

    Malushte, S.R.; Whittaker, A.S.

    2005-01-01

    Seismic base isolation provides many benefits that can facilitate the standardization of future nuclear power plant structures and equipment while reducing the initial/life-cycle cost and construction schedule. This paper presents a survey of past seismic base isolation applications and studies related to nuclear applications and provides a discussion of the challenges that need to be overcome to gain industry and regulatory acceptance for deployment in future US nuclear power plants. Issues related to design, codes/standards/regulations, procurement, and construction, have been identified. (authors)

  10. Children's perspectives on cyberbullying: insights based on participatory research.

    Science.gov (United States)

    Baas, Niels; de Jong, Menno D T; Drossaert, Constance H C

    2013-04-01

    Cyberbullying is an emerging problem among youngsters. Although the current body of knowledge about cyberbullying is expanding rapidly, it lacks a more in-depth research approach honoring adolescents' perspectives on the problem. Moreover, very few studies have focused on cyberbullying among elementary school children. The purpose of this study therefore, was to explore children's perspectives on the problem of cyberbullying. A participatory research design was used in which 28 children (aged 11-12 from four elementary schools) actively participated for 6 weeks in weekly scheduled group sessions. In these sessions, different aspects of cyberbullying were discussed using various enabling techniques. Between sessions, the children were given preparation assignments. The research revealed several ambiguities that should be addressed in interventions against cyberbullying. First, it appears difficult for all parties involved to distinguish cyberbullying from innocent pranks. Frequency and intention are key variables, but these are ambiguous in the context of cyberbullying. Second, cyberbullies may have very different motives, not all of which have to do with their relationship with the victim. Third, the expectations children have of the way their parents or teachers will react to incidents of cyberbullying are an obstacle for seeking help. Children are particularly afraid of overreaction and the subsequent loss of their Internet privileges. These results confirm earlier insights from research on cyberbullying, and examine the ambiguities in more detail. In addition, the research demonstrates the usefulness of participatory research to investigate cyberbullying among younger children and demonstrates that the research led to mutual learning.

  11. Human action perspectives based on individual plant examination results

    International Nuclear Information System (INIS)

    Forester, J.; Thompson, C.; Drouin, M.; Lois, E.

    1996-01-01

    This paper provides perspectives on human actions gained from reviewing 76 individual plant examination (IPE) submittals. Human actions found to be important in boiling water reactors (BWRs) and in pressurized water reactors (PWRs) are presented and the events most frequently found important are discussed. Since there are numerous factors that can influence the quantification of human error probabilities (HEPs) and introduce significant variability in the resulting HEPs (which in turn can influence which events are found to be important), the variability in HEPs for similar events across IPEs is examined to assess the extent to which variability in results is due to real versus artifactual differences. Finally, similarities and differences in human action observations across BWRs and PWRs are examined

  12. Community-based Ecotourism in Tenganan Dauh Tukad: An Indigenous Conservation Perspective

    Directory of Open Access Journals (Sweden)

    I Ketut Sardiana

    2015-11-01

    Full Text Available Abstract Community-based ecotourism involves conservation, business, and community development. It is a subset of nature-based tourism that are owned and managed by the community and used to improve the well-being of its community members. Research conducted in Indigenous Tenganan Dauh Tukad Village, Bali. This paper examines the linkage of community participation in ecotourism with the conservation practices and perspectives. This study revealed that there is a positive linkage between community participation to their practices and perspective of conservation. This includes conservation of biodiversity environment and cultural heritage of the local community.

  13. Technical bases for regulatory review; comparison of practices, standards and guides

    International Nuclear Information System (INIS)

    Vinck, W.; Naurer, H.; Van Reijen, G.

    1979-01-01

    In first place, national licensing and regulatory scenes are presentd, as well as correlations between: a) Correlations and industrial standards; b) national and international developments. The purpose of harmonisation efforts and ongoing activities, especially within the EC, are highlighted. For the purpose of being sufficiently specific, three specific areas are dealt with as examples, explaining how actual application of practices and criteria in EC Member States correlate (or not) to one another including the points of convergence and divergences: protection against aircraft crash, seismic effects, protection against fuel handling accidents. Conclusive remarks deal with the origin in and relative importance of discrepancies in safety practices and criteria. (author)

  14. Regulatory activities

    International Nuclear Information System (INIS)

    2001-01-01

    This publication, compiled in 8 chapters, presents the regulatory system developed by the Nuclear Regulatory Authority (NRA) of the Argentine Republic. The following activities and developed topics in this document describe: the evolution of the nuclear regulatory activity in Argentina; the Argentine regulatory system; the nuclear regulatory laws and standards; the inspection and safeguards of nuclear facilities; the emergency systems; the environmental systems; the environmental monitoring; the analysis laboratories on physical and biological dosimetry, prenatal irradiation, internal irradiation, radiation measurements, detection techniques on nuclear testing, medical program on radiation protection; the institutional relations with national and international organization; the training courses and meeting; the technical information

  15. Perspectives on containment performance improvement based on the IPEs

    Energy Technology Data Exchange (ETDEWEB)

    Lehner, J.R.; Lin, C.C.; Pratt, W.T. [Brookhaven National Lab., Upton, NY (United States)] [and others

    1995-04-01

    Generic Letter 88-20, {open_quotes}Individual Plant Examination (IPE) for Severe Accident Vulnerabilities - 10CFR 50.54(f),{close_quotes} was issued by the NRC on November 23, 1988. In addition to assessing the core damage frequency from severe accidents, licensees were requested to report the results of their analyses regarding containment performance. Supplements to the Generic Letter forwarded technical insights obtained by the NRC staff through its Containment Performance Improvement (CPI) program. At this time, most of the IPEs have been submitted by the licensees. In a follow-on effort to support regulatory activities, the NRC staff with assistance from Brookhaven National Laboratory, has initiated a program involving a global examination of the containment performance results documented in the IPEs. The objective is to identify insights of potential generic safety significance relative to plant design, operation and maintenance, as well as to assess response to the previously forwarded CPI insights. The containment performance results of the IPEs are being categorized for commonalities and differences for different reactor and containment types. Preliminary results show that not only differences in plant design but also the methods, data, boundary conditions, and assumptions used in the different IPEs have a major impact on the containment performance results obtained. This paper presents preliminary results regarding the differences in containment performance observed in the IPEs and discusses some of the underlying reasons for these differences.

  16. Identifying significant genetic regulatory networks in the prostate cancer from microarray data based on transcription factor analysis and conditional independency

    Directory of Open Access Journals (Sweden)

    Yeh Cheng-Yu

    2009-12-01

    . Conclusions We provide a computational framework to reconstruct the genetic regulatory network from the microarray data using biological knowledge and constraint-based inferences. Our method is helpful in verifying possible interaction relations in gene regulatory networks and filtering out incorrect relations inferred by imperfect methods. We predicted not only individual gene related to cancer but also discovered significant gene regulation networks. Our method is also validated in several enriched published papers and databases and the significant gene regulatory networks perform critical biological functions and processes including cell adhesion molecules, androgen and estrogen metabolism, smooth muscle contraction, and GO-annotated processes. Those significant gene regulations and the critical concept of tumor progression are useful to understand cancer biology and disease treatment.

  17. Identifying significant genetic regulatory networks in the prostate cancer from microarray data based on transcription factor analysis and conditional independency.

    Science.gov (United States)

    Yeh, Hsiang-Yuan; Cheng, Shih-Wu; Lin, Yu-Chun; Yeh, Cheng-Yu; Lin, Shih-Fang; Soo, Von-Wun

    2009-12-21

    the genetic regulatory network from the microarray data using biological knowledge and constraint-based inferences. Our method is helpful in verifying possible interaction relations in gene regulatory networks and filtering out incorrect relations inferred by imperfect methods. We predicted not only individual gene related to cancer but also discovered significant gene regulation networks. Our method is also validated in several enriched published papers and databases and the significant gene regulatory networks perform critical biological functions and processes including cell adhesion molecules, androgen and estrogen metabolism, smooth muscle contraction, and GO-annotated processes. Those significant gene regulations and the critical concept of tumor progression are useful to understand cancer biology and disease treatment.

  18. Development of measures to assess the safety of existing NPPs and the effectiveness of regulations and regulatory actions (including 'prescriptive' and 'performance based' approaches). Peer discussions on regulatory practices

    International Nuclear Information System (INIS)

    1996-09-01

    This report arises from the fourth series of peer discussions on regulatory practices entitled D evelopment of measures to assess the safety of existing nuclear power plants and the effectiveness of regulations and regulatory actions (including 'prescriptive' and 'performance based' approaches) . Senior regulators from 23 Member States participated in four peer group discussions during 1995-1996. This report presents the outcome of these meetings and recommendations of good practices identified by these senior regulators. The purpose of this report is to disseminate the views which the senior regulators presented at the meetings relating to measures used for assessing the safety of existing nuclear power plants and evaluating the effectiveness of regulators and regulatory actions. The intention in doing this is to assist Member States in the enhancement of their regulatory practices by identifying commonly accepted good practices. This report is structured so that it covers the subject matter under the following main headings: 'Prescriptive and Performance Based' Approaches to Regulation; Common Features of Regulatory Approaches; Effectiveness of the Regulator and Regulatory Actions; Recommendations of Good Practice. It is important to note that recommendations of good practice are included if they have been identified by at least one of the groups. It does not follow that all of the groups or individual Member States would necessarily endorse all of the recommendations. However, it is considered that if a single group of senior regulators judge that a particular practice is worthy of recommendation then it should be included for serious consideration. In some cases the same recommendations arise from all of the Groups

  19. Regulatory activity based risk model identifies survival of stage II and III colorectal carcinoma.

    Science.gov (United States)

    Liu, Gang; Dong, Chuanpeng; Wang, Xing; Hou, Guojun; Zheng, Yu; Xu, Huilin; Zhan, Xiaohui; Liu, Lei

    2017-11-17

    Clinical and pathological indicators are inadequate for prognosis of stage II and III colorectal carcinoma (CRC). In this study, we utilized the activity of regulatory factors, univariate Cox regression and random forest for variable selection and developed a multivariate Cox model to predict the overall survival of Stage II/III colorectal carcinoma in GSE39582 datasets (469 samples). Patients in low-risk group showed a significant longer overall survival and recurrence-free survival time than those in high-risk group. This finding was further validated in five other independent datasets (GSE14333, GSE17536, GSE17537, GSE33113, and GSE37892). Besides, associations between clinicopathological information and risk score were analyzed. A nomogram including risk score was plotted to facilitate the utilization of risk score. The risk score model is also demonstrated to be effective on predicting both overall and recurrence-free survival of chemotherapy received patients. After performing Gene Set Enrichment Analysis (GSEA) between high and low risk groups, we found that several cell-cell interaction KEGG pathways were identified. Funnel plot results showed that there was no publication bias in these datasets. In summary, by utilizing the regulatory activity in stage II and III colorectal carcinoma, the risk score successfully predicts the survival of 1021 stage II/III CRC patients in six independent datasets.

  20. [Regulatory supervision and radiation survey in the area of location of former military technical bases].

    Science.gov (United States)

    Shandala, N K; Kiselev, S M; Titov, A V; Seregin, V A; Isaev, D V; Akhromeev, S V; Filonova, A A; Semenova, M P; Gimadova, T I; Aladova, R A; Kosnikov, A S; Shchelkanova, E S; Luk'ianets, A I

    2013-01-01

    Activities related to the rehabilitation of areas and facilities of the temporary storage of spent nuclear fuel and radioactive waste (SNF and RW) at Andreeva Bay and Gremikha on the Kola Peninsula and in the Primorsky Krai in the Russian Far East is an important component of the regulatory functions of the Federal Medical biological Agency (FMBA of Russia). Technical support to the FMBA of Russia in this activity is provided by A.L Burnazyan Federal Medical Biophysical Center Main research interests include evaluation of radiological threats to determine the priority directions of regulation, a detailed analysis of the radiation situation at areas, territories and in vicinity of temporary waste storage facilities, radiation control and environmental monitoring, the development of digital maps and geoinformation systems, project expertise in the field of rehabilitation of PVC including the management of SNF and RW Implementation of these natural, practical and theoretical works is completed by development a set of regulatory documents ensuring adherence to radiation safety for the stuff population and the environment, and the also documents governing the management of SNF and RW waste in the territories of PVC.

  1. [Regulatory policies on alcohol in Spain. Experience-based public health? 2008 SESPAS Report].

    Science.gov (United States)

    Villalbí, Joan R; Granero, Lluís; Brugal, M Teresa

    2008-04-01

    The present article reviews the proposal for alcohol regulation made in Spain in 2006 by the Ministry of Health and Consumer Affairs and dropped a few months later as adverse positions took over the debate in the political arena and the media. The background to these regulations, as well as their components, the process, and the actors involved are analyzed, and the factors leading to this outcome are discussed. A comparison is made with the tobacco regulation initiative in 2005, which resulted in a regulatory law with a highly favorable impact on public health. The actors interested in promoting alcohol consumption and opposed to any regulation have a privileged institutional presence, generating powerful resistance. Although these regulatory proposals would have marginal impacts on their trade, wine growers and wineries have been the most visible forces against regulation and have had the greatest political and media impact. Equally, manipulated messages on the health benefits of alcohol use have fed arguments against regulation. The lack of political and media consensus in this case stands in contrast with the tobacco regulation process, in which a certain political consensus had previously been reached and the smoking prevention movement had permeated the media with preventive messages, framing the issue in terms favorable for regulation. To gain ground, the sectors interested in expanding public policies for the prevention of the harm caused by alcohol need greater cohesion and organization. Professional public health organizations can substantially contribute to this field.

  2. Using a Design Science Perspective to Understand a Complex Design-Based Research Process

    DEFF Research Database (Denmark)

    Bækgaard, Lars

    2012-01-01

    The purpose of the paper is to demonstrate how a design science perspective can be used to describe and understand a set of related design-based research processes. We describe and analyze a case study in a manner that is inspired by design science. The case study involves the design of modeling......-based research processes. And we argue that a design science perspective may be useful for both researchers and practitioners....... tools and the redesign of an information service in a library. We use a set of guidelines from a design science perspective to organize the description and analysis of the case study. By doing this we demonstrate the usefulness of design science as an analytical tool for understanding related design...

  3. Perspectives of biotechnologies based on dormancy phenomenon for space researches

    Science.gov (United States)

    Alekseev, V.; Sychev, V.; Layus, D.; Levinsky, M.; Novikova, N.; Zakhodnova, T.

    Long term space missions will require a renewable source of food and an efficient method to recycle oxygen Plants especially aquatic micro algae provide an obvious solution to these problems However long duration plant growth and reproduction in space that is necessary for transportation of a control ecological life support system CELSS from Earth to other planets are problematic The introduction of heterotrophs in space CELSS is a more formidable problem as the absence of gravity creates additional difficulties for their life Dormancy phenomenon protected a great many animals and plants in harsh environmental conditions within a special resting phases of life cycle lasting from months up to hundred years This phenomenon can be quite perspective as a tool to overcome difficulties with CELSS transportation in space missions Cryptobiotic stages of microbes fungi unicellular algae and protists can survive in open space conditions that is important for interplanetary quarantine and biological security inside spacecraft Searching for life outside the Earth at such planet like Mars with extremely variable environment should be oriented on dormancy as crucial phases of a life cycle in such organisms Five major research programs aimed on study dormancy phenomenon for exobiology purposes and creation of new biotechnologies are discussed List of species candidate components of CELSS with dormancy in their life cycle used in space experiments at the Russian segment of International Space Station now includes 26 species from bacteria to fish The

  4. The implementation of DRG-based hospital reimbursement in Switzerland: A population-based perspective.

    Science.gov (United States)

    Busato, André; von Below, Georg

    2010-10-16

    Switzerland introduces a DRG (Diagnosis Related Groups) based system for hospital financing in 2012 in order to increase efficiency and transparency of Swiss health care. DRG-based hospital reimbursement is not simultaneously realized in all Swiss cantons and several cantons already implemented DRG-based financing irrespective of the national agenda, a setting that provides an opportunity to compare the situation in different cantons. Effects of introducing DRGs anticipated for providers and insurers are relatively well known but it remains less clear what effects DRGs will have on served populations. The objective of the study is therefore to analyze differences of volume and major quality indicators of care between areas with or without DRG-based hospital reimbursement from a population based perspective. Small area analysis of all hospitalizations in acute care hospitals and of all consultations reimbursed by mandatory basic health insurance for physicians in own practice during 2003-2007. The results show fewer hospitalizations and a relocation of resources to outpatient care in areas with DRG reimbursement. Overall burden of disease expressed as per capita DRG cost weights was almost identical between the two types of hospital reimbursement and no distinct temporal differences were detected in this respect. But the results show considerably higher 90-day rehospitalization rates in DRG areas. The study provides evidence of both desired and harmful effects related to the implementation of DRGs. Systematic monitoring of outcomes and quality of care are therefore essential elements to maintain in the Swiss health system after DRG's are implemented on a nationwide basis in 2012.

  5. Discovery of time-delayed gene regulatory networks based on temporal gene expression profiling

    Directory of Open Access Journals (Sweden)

    Guo Zheng

    2006-01-01

    Full Text Available Abstract Background It is one of the ultimate goals for modern biological research to fully elucidate the intricate interplays and the regulations of the molecular determinants that propel and characterize the progression of versatile life phenomena, to name a few, cell cycling, developmental biology, aging, and the progressive and recurrent pathogenesis of complex diseases. The vast amount of large-scale and genome-wide time-resolved data is becoming increasing available, which provides the golden opportunity to unravel the challenging reverse-engineering problem of time-delayed gene regulatory networks. Results In particular, this methodological paper aims to reconstruct regulatory networks from temporal gene expression data by using delayed correlations between genes, i.e., pairwise overlaps of expression levels shifted in time relative each other. We have thus developed a novel model-free computational toolbox termed TdGRN (Time-delayed Gene Regulatory Network to address the underlying regulations of genes that can span any unit(s of time intervals. This bioinformatics toolbox has provided a unified approach to uncovering time trends of gene regulations through decision analysis of the newly designed time-delayed gene expression matrix. We have applied the proposed method to yeast cell cycling and human HeLa cell cycling and have discovered most of the underlying time-delayed regulations that are supported by multiple lines of experimental evidence and that are remarkably consistent with the current knowledge on phase characteristics for the cell cyclings. Conclusion We established a usable and powerful model-free approach to dissecting high-order dynamic trends of gene-gene interactions. We have carefully validated the proposed algorithm by applying it to two publicly available cell cycling datasets. In addition to uncovering the time trends of gene regulations for cell cycling, this unified approach can also be used to study the complex

  6. Regulatory Physiology

    Science.gov (United States)

    Lane, Helen W.; Whitson, Peggy A.; Putcha, Lakshmi; Baker, Ellen; Smith, Scott M.; Stewart, Karen; Gretebeck, Randall; Nimmagudda, R. R.; Schoeller, Dale A.; Davis-Street, Janis

    1999-01-01

    As noted elsewhere in this report, a central goal of the Extended Duration Orbiter Medical Project (EDOMP) was to ensure that cardiovascular and muscle function were adequate to perform an emergency egress after 16 days of spaceflight. The goals of the Regulatory Physiology component of the EDOMP were to identify and subsequently ameliorate those biochemical and nutritional factors that deplete physiological reserves or increase risk for disease, and to facilitate the development of effective muscle, exercise, and cardiovascular countermeasures. The component investigations designed to meet these goals focused on biochemical and physiological aspects of nutrition and metabolism, the risk of renal (kidney) stone formation, gastrointestinal function, and sleep in space. Investigations involved both ground-based protocols to validate proposed methods and flight studies to test those methods. Two hardware tests were also completed.

  7. Application of risk-based value-impact analysis in a nuclear regulatory environment

    International Nuclear Information System (INIS)

    Dinnie, Keith; Land, Ronald; Stella, Mark

    1992-01-01

    Value-impact analysis (VIA) is a quantitative process that examines the benefits of proposed actions and the costs of implementing those actions to determine the potential for a net beneficial result. There is a point beyond which efforts to improve nuclear plant safety by implementing design changes will be unjustifiably expensive for the societal benefits obtained. Resources that would be used to obtain marginal improvements in public safety can then be used to obtain greater benefits for society in other areas. VIA can help to identify this point. What can not be accomplished by VIA is the definition of the level of risk (or safety) above which cost-benefit considerations are not applicable. This must be established separately, by political action or through promulgation of acceptable risk levels and safety goals by regulatory agencies. 18 refs

  8. Clinical Grade Regulatory CD4+ T Cells (Tregs: Moving Toward Cellular-Based Immunomodulatory Therapies

    Directory of Open Access Journals (Sweden)

    Richard Duggleby

    2018-02-01

    Full Text Available Regulatory T cells (Tregs are CD4+ T cells that are key players of immune tolerance. They are powerful suppressor cells, able to impact the function of numerous immune cells, including key effectors of inflammation such as effector T cells. For this reason, Tregs are an ideal candidate for the development of cell therapy approaches to modulate immune responses. Treg therapy has shown promising results so far, providing key knowledge on the conditions in which these cells can provide protection and demonstrating that they could be an alternative to current pharmacological immunosuppressive therapies. However, a more comprehensive understanding of their characteristics, isolation, activation, and expansion is needed to be able design cost effective therapies. Here, we review the practicalities of making Tregs a viable cell therapy, in particular, discussing the challenges faced in isolating and manufacturing Tregs and defining what are the most appropriate applications for this new therapy.

  9. A Simulation-Based Approach for Teaching the Systems Perspective of Strategic Performance Management

    Science.gov (United States)

    Capelo, Carlos; Lopes, Ana; Mata, Ana

    2015-01-01

    Kaplan and Norton introduced the balanced scorecard (BSC), which is based on a systems perspective of the business strategy and performance measurement. Many organisations around the world use the BSC to define, implement and manage strategy. Nevertheless, there are studies that identify problems and limitations associated with the implementation…

  10. Action Plan on Base Erosion and Profit Shifting: An Indian Perspective.

    OpenAIRE

    Rao, R. Kavita; Sengupta, D.P.

    2014-01-01

    The discussion in this paper highlights some evidence to support the notion that there is base erosion in India. On the specific action points listed in the OECD's Action Plan, a perspective from India's stand point has been presented along with a brief discussion on the steps needed to prepare for complying with likely proposed measures.

  11. Example-based learning: Integrating cognitive and social-cognitive research perspectives

    NARCIS (Netherlands)

    T.A.J.M. van Gog (Tamara); N. Rummel (Nikol)

    2010-01-01

    textabstractExample-based learning has been studied from different perspectives. Cognitive research has mainly focused on worked examples, which typically provide students with a written worked-out didactical solution to a problem to study. Social-cognitive research has mostly focused on modeling

  12. A perspective on multi-user interaction design based on an understanding of domestic lighting conflict

    NARCIS (Netherlands)

    Niemantsverdriet, K.; van Essen, H.A.; Eggen, J.H.

    2017-01-01

    More and more connected systems are entering the social and shared home environment. Interaction with these systems is often rather individual and based on personal preferences, leading to conflicts in multi-user situations. In this paper, we aim to develop a perspective on how to design for

  13. Game-Based Assessments: A Promising Way to Create Idiographic Perspectives

    Science.gov (United States)

    Walker, A. Adrienne; Engelhard, George, Jr.

    2014-01-01

    "Game-Based Assessments: A Promising Way to Create Idiographic Perspectives" (Adrienne Walker and George Englehard) comments on: "How Task Features Impact Evidence from Assessments Embedded in Simulations and Games" by Russell G. Almond, Yoon Jeon Kim, Gertrudes Velasquez, and Valerie J. Shute. Here, Walker and Englehard write…

  14. A thermodynamic perspective on food webs: Quantifying entropy production within detrital-based ecosystems

    NARCIS (Netherlands)

    Meysman, F.J.R.; Bruers, S.

    2007-01-01

    Because ecosystems fit so nicely the framework of a “dissipative system”, a better integration of thermodynamic and ecological perspectives could benefit the quantitative analysis of ecosystems. One obstacle is that traditional food web models are solely based upon the principles of mass and energy

  15. Design Students Perspectives on Assessment Rubric in Studio-Based Learning

    Science.gov (United States)

    Eshun, Eric F.; Osei-Poku, Patrick

    2013-01-01

    This study examined students' perspectives on the use of assessment criteria and rubrics in graphic design studio at Kwame Nkrumah University of Science and Technology, Ghana. This assessment strategy was introduced with the desire to improve students' participation and involvement in studio-based learning programme. At the end of the semester, a…

  16. Exploring Links between Empowerment and Community-Based Arts and Cultural Practices: Perspectives from Barcelona Practitioners

    Science.gov (United States)

    Carrasco, Ruben David Fernández; Monferrer, Moisés Carmona; Tarditi, Andrés Di Masso

    2016-01-01

    In this paper, we reflect on the development of community-based arts and cultural (CBAC) practices to promote psychosocial, group/organisational and community changes from the perspective of empowerment. We draw on findings from an initial exploratory phase of an ongoing action-research project in Spain about creative tools that empower artists…

  17. School-Based Health Promotion Intervention: Parent and School Staff Perspectives

    Science.gov (United States)

    Patino-Fernandez, Anna M.; Hernandez, Jennifer; Villa, Manuela; Delamater, Alan

    2013-01-01

    Background: The prevalence of childhood obesity is high, particularly among minority youth. The objective of this article was to evaluate parent and school staff perspectives of childhood health and weight qualitatively to guide the development of a school-based obesity prevention program for minority youth. Methods: Hispanic parents (N?=?9) of…

  18. Enhancing Student Motivation: A Longitudinal Intervention Study Based on Future Time Perspective Theory

    Science.gov (United States)

    Schuitema, Jaap; Peetsma, Thea; van der Veen, Ineke

    2014-01-01

    The authors investigated the effects of an intervention developed to enhance student motivation in the first years of secondary education. The intervention, based on future time perspective (FTP) theory, has been found to be effective in prevocational secondary education (T. T. D. Peetsma & I. Van der Veen, 2008, 2009). The authors extend the…

  19. Learner Perspectives of Online Problem-Based Learning and Applications from Cognitive Load Theory

    Science.gov (United States)

    Chen, Ruth

    2016-01-01

    Problem-based learning (PBL) courses have historically been situated in physical classrooms involving in-person interactions. As online learning is embraced in higher education, programs that use PBL can integrate online platforms to support curriculum delivery and facilitate student engagement. This report describes student perspectives of the…

  20. Ultrathin endoscopes based on multicore fibers and adaptive optics: a status review and perspectives.

    Science.gov (United States)

    Andresen, Esben Ravn; Sivankutty, Siddharth; Tsvirkun, Viktor; Bouwmans, Géraud; Rigneault, Hervé

    2016-12-01

    We take stock of the progress that has been made into developing ultrathin endoscopes assisted by wave front shaping. We focus our review on multicore fiber-based lensless endoscopes intended for multiphoton imaging applications. We put the work into perspective by comparing with alternative approaches and by outlining the challenges that lie ahead.

  1. Peeling the Onion of Auditory Processing Disorder: A Language/Curricular-Based Perspective

    Science.gov (United States)

    Wallach, Geraldine P.

    2011-01-01

    Purpose: This article addresses auditory processing disorder (APD) from a language-based perspective. The author asks speech-language pathologists to evaluate the functionality (or not) of APD as a diagnostic category for children and adolescents with language-learning and academic difficulties. Suggestions are offered from a…

  2. Discovering and Exploring State-based Models for Multi-perspective Processes

    NARCIS (Netherlands)

    van Eck, M.L.; Sidorova, N.; van der Aalst, W.M.P.; La Rosa, M.; Loos, P.; Pastor, O.

    2016-01-01

    Process mining provides fact-based insights into process behaviour captured in event data. In this work we aim to discover models for processes where different facets, or perspectives, of the process can be identified. Instead of focussing on the events or activities that are executed in the context

  3. Women and Computer Based Technologies: A Feminist Perspective.

    Science.gov (United States)

    Morritt, Hope

    The use of computer based technologies by professional women in education is examined through a feminist standpoint theory in this paper. The theory is grounded in eight claims which form the basis of the conceptual framework for the study. The experiences of nine women participants with computer based technologies were categorized using three…

  4. A model of gene expression based on random dynamical systems reveals modularity properties of gene regulatory networks.

    Science.gov (United States)

    Antoneli, Fernando; Ferreira, Renata C; Briones, Marcelo R S

    2016-06-01

    Here we propose a new approach to modeling gene expression based on the theory of random dynamical systems (RDS) that provides a general coupling prescription between the nodes of any given regulatory network given the dynamics of each node is modeled by a RDS. The main virtues of this approach are the following: (i) it provides a natural way to obtain arbitrarily large networks by coupling together simple basic pieces, thus revealing the modularity of regulatory networks; (ii) the assumptions about the stochastic processes used in the modeling are fairly general, in the sense that the only requirement is stationarity; (iii) there is a well developed mathematical theory, which is a blend of smooth dynamical systems theory, ergodic theory and stochastic analysis that allows one to extract relevant dynamical and statistical information without solving the system; (iv) one may obtain the classical rate equations form the corresponding stochastic version by averaging the dynamic random variables (small noise limit). It is important to emphasize that unlike the deterministic case, where coupling two equations is a trivial matter, coupling two RDS is non-trivial, specially in our case, where the coupling is performed between a state variable of one gene and the switching stochastic process of another gene and, hence, it is not a priori true that the resulting coupled system will satisfy the definition of a random dynamical system. We shall provide the necessary arguments that ensure that our coupling prescription does indeed furnish a coupled regulatory network of random dynamical systems. Finally, the fact that classical rate equations are the small noise limit of our stochastic model ensures that any validation or prediction made on the basis of the classical theory is also a validation or prediction of our model. We illustrate our framework with some simple examples of single-gene system and network motifs. Copyright © 2016 Elsevier Inc. All rights reserved.

  5. Regulatory and institutional challenges of corporate governance in ...

    African Journals Online (AJOL)

    Regulatory and institutional challenges of corporate governance in post banking consolidation Nigeria. ... PROMOTING ACCESS TO AFRICAN RESEARCH ... From a banking industry perspective, good corporate governance demands

  6. Perspectives on reactor safety

    Energy Technology Data Exchange (ETDEWEB)

    Haskin, F.E. [New Mexico Univ., Albuquerque, NM (United States). Dept. of Chemical and Nuclear Engineering; Camp, A.L. [Sandia National Labs., Albuquerque, NM (United States)

    1994-03-01

    The US Nuclear Regulatory Commission (NRC) maintains a technical training center at Chattanooga, Tennessee to provide appropriate training to both new and experienced NRC employees. This document describes a one-week course in reactor, safety concepts. The course consists of five modules: (1) historical perspective; (2) accident sequences; (3) accident progression in the reactor vessel; (4) containment characteristics and design bases; and (5) source terms and offsite consequences. The course text is accompanied by slides and videos during the actual presentation of the course.

  7. Perspectives on reactor safety

    International Nuclear Information System (INIS)

    Haskin, F.E.

    1994-03-01

    The US Nuclear Regulatory Commission (NRC) maintains a technical training center at Chattanooga, Tennessee to provide appropriate training to both new and experienced NRC employees. This document describes a one-week course in reactor, safety concepts. The course consists of five modules: (1) historical perspective; (2) accident sequences; (3) accident progression in the reactor vessel; (4) containment characteristics and design bases; and (5) source terms and offsite consequences. The course text is accompanied by slides and videos during the actual presentation of the course

  8. Team-based primary care: The medical assistant perspective.

    Science.gov (United States)

    Sheridan, Bethany; Chien, Alyna T; Peters, Antoinette S; Rosenthal, Meredith B; Brooks, Joanna Veazey; Singer, Sara J

    Team-based care has the potential to improve primary care quality and efficiency. In this model, medical assistants (MAs) take a more central role in patient care and population health management. MAs' traditionally low status may give them a unique view on changing organizational dynamics and teamwork. However, little empirical work exists on how team-based organizational designs affect the experiences of low-status health care workers like MAs. The aim of this study was to describe how team-based primary care affects the experiences of MAs. A secondary aim was to explore variation in these experiences. In late 2014, the authors interviewed 30 MAs from nine primary care practices transitioning to team-based care. Interviews addressed job responsibilities, teamwork, implementation, job satisfaction, and learning. Data were analyzed using a thematic networks approach. Interviews also included closed-ended questions about workload and job satisfaction. Most MAs reported both a higher workload (73%) and a greater job satisfaction (86%) under team-based primary care. Interview data surfaced four mechanisms for these results, which suggested more fulfilling work and greater respect for the MA role: (a) relationships with colleagues, (b) involvement with patients, (c) sense of control, and (d) sense of efficacy. Facilitators and barriers to these positive changes also emerged. Team-based care can provide low-status health care workers with more fulfilling work and strengthen relationships across status lines. The extent of this positive impact may depend on supporting factors at the organization, team, and individual worker levels. To maximize the benefits of team-based care, primary care leaders should recognize the larger role that MAs play under this model and support them as increasingly valuable team members. Contingent on organizational conditions, practices may find MAs who are willing to manage the increased workload that often accompanies team-based care.

  9. The Integrated Model of Sustainability Perspective in Spermatophyta Learning Based on Local Wisdom

    Science.gov (United States)

    Hartadiyati, E.; Rizqiyah, K.; Wiyanto; Rusilowati, A.; Prasetia, A. P. B.

    2017-09-01

    In present condition, culture is diminished, the change of social order toward the generation that has no policy and pro-sustainability; As well as the advancement of science and technology are often treated unwisely so as to excite local wisdom. It is therefore necessary to explore intra-curricular local wisdom in schools. This study aims to produce an integration model of sustainability perspectives based on local wisdom on spermatophyta material that is feasible and effective. This research uses define, design and develop stages to an integration model of sustainability perspectives based on local wisdom on spermatophyta material. The resulting product is an integration model of socio-cultural, economic and environmental sustainability perspective and formulated with preventive, preserve and build action on spermatophyta material consisting of identification and classification, metagenesis and the role of spermatophyta for human life. The integration model of sustainability perspective in learning spermatophyta based on local wisdom is considered proven to be effective in raising sustainability’s awareness of high school students.

  10. Historical perspective on the moon base: the British experience

    International Nuclear Information System (INIS)

    Jones, E.M.; Finney, B.R.

    1984-01-01

    Among the many historical episodes that have relevance to the establishment of a human base, the voyages of Captain Cook, and the founding of Britain's Botany Bay colony in Australia seems particularly appropriate. The process resulting in the selection of Cook rewards study, as do his relations with the Admiralty, with the scientific establishment and with the scientists who accompanies him. Britain's tight control of the Botany Bay settlement and its unwillingness to promote early self-sufficiency may have delayed the time when Australia became self-supporting. Structuring the lunar base to offer opportunities for private initiatives may hasten the day when it becomes a self-supporting settlement rather than an externally supported scientific base on an Antarctic model

  11. KNOWLEDGE BASE AND EFL TEACHER EDUCATION PROGRAMS: A COLOMBIAN PERSPECTIVE

    Directory of Open Access Journals (Sweden)

    Yamith Fandiño

    2013-04-01

    Full Text Available In the 21st century, Colombian pre-service EFL Teacher Education Programs (TEPs should study what constitutes the core knowledge base for language teachers to be effective in their profession. These programs must refrain from simply conceptualizing knowledge base as the acquisition of the basic skills required for teaching, the competency of educators in their subject matter area, and the use of pedagogical skills. Instead, they should strive to reflect on what Colombian language teachers need to know about teaching and learning, and study how their knowledge, beliefs, and attitudes inform their practices. A starting point to do so is to interpret the variety of proposals that have been generated through the years in the field. This paperoffers a review of what teacher knowledge base is, presents an overview of how Colombian EFL TEPs are working on teacher knowledge,and suggests some strategies to envision a more complete framework of reference for teacher formation in Colombia.

  12. Palliative home-based technology from a practitioner's perspective: benefits and disadvantages

    OpenAIRE

    Johnston, Bridget

    2014-01-01

    Bridget M Johnston Sue Ryder Care Centre for the Study of Supportive, Palliative, and End of Life Care, School of Health Sciences, University of Nottingham, Queen's Medical Centre, Nottingham, UK Abstract: This critical review paper explores the concept of palliative home-based technology from a practitioner's perspective. The aim of the critical review was to scope information available from published and unpublished research on the current state of palliative home-based tec...

  13. Interprovincial regulatory barriers to procurement in western Canada's oil and gas sector : potential standardization-based solutions : final report

    International Nuclear Information System (INIS)

    Hawkins, R.; Godin, M.; Josty, P.

    2008-01-01

    This study reviewed the regulatory environment related to the oil and gas industry in western Canada in order to identify factors limiting the procurement of goods and services required by the industry. The aim of the study was to identify solutions based on the development of voluntary industry standards. Literature and reports related to interprovincial trade and standards were reviewed. The procurement divisions of oil and gas companies and suppliers to the oil and gas industry were consulted in addition to government official and industry experts. A review of provincial technical regulations was completed. The study identified 3 candidates for specific action within the standards system: (1) modular transport platforms; (2) regulatory conformance procedures; and (3) the mobility of skilled workers. Results of the study indicated that the development of service standards for technical and inspection activities of importance to the petroleum industry will help to facilitate the increased mobility of skilled workers, while initiatives to develop a standard information disclosure and exchange format for all federal, provincial and territorial jurisdictions will address the conflicting regimes to which oil and gas products and services are subjected. 40 refs., 5 tabs.

  14. Comparative Probabilistic Assessment of Occupational Pesticide Exposures Based on Regulatory Assessments

    Science.gov (United States)

    Pouzou, Jane G.; Cullen, Alison C.; Yost, Michael G.; Kissel, John C.; Fenske, Richard A.

    2018-01-01

    Implementation of probabilistic analyses in exposure assessment can provide valuable insight into the risks of those at the extremes of population distributions, including more vulnerable or sensitive subgroups. Incorporation of these analyses into current regulatory methods for occupational pesticide exposure is enabled by the exposure data sets and associated data currently used in the risk assessment approach of the Environmental Protection Agency (EPA). Monte Carlo simulations were performed on exposure measurements from the Agricultural Handler Exposure Database and the Pesticide Handler Exposure Database along with data from the Exposure Factors Handbook and other sources to calculate exposure rates for three different neurotoxic compounds (azinphos methyl, acetamiprid, emamectin benzoate) across four pesticide-handling scenarios. Probabilistic estimates of doses were compared with the no observable effect levels used in the EPA occupational risk assessments. Some percentage of workers were predicted to exceed the level of concern for all three compounds: 54% for azinphos methyl, 5% for acetamiprid, and 20% for emamectin benzoate. This finding has implications for pesticide risk assessment and offers an alternative procedure that may be more protective of those at the extremes of exposure than the current approach. PMID:29105804

  15. Comparative Probabilistic Assessment of Occupational Pesticide Exposures Based on Regulatory Assessments.

    Science.gov (United States)

    Pouzou, Jane G; Cullen, Alison C; Yost, Michael G; Kissel, John C; Fenske, Richard A

    2017-11-06

    Implementation of probabilistic analyses in exposure assessment can provide valuable insight into the risks of those at the extremes of population distributions, including more vulnerable or sensitive subgroups. Incorporation of these analyses into current regulatory methods for occupational pesticide exposure is enabled by the exposure data sets and associated data currently used in the risk assessment approach of the Environmental Protection Agency (EPA). Monte Carlo simulations were performed on exposure measurements from the Agricultural Handler Exposure Database and the Pesticide Handler Exposure Database along with data from the Exposure Factors Handbook and other sources to calculate exposure rates for three different neurotoxic compounds (azinphos methyl, acetamiprid, emamectin benzoate) across four pesticide-handling scenarios. Probabilistic estimates of doses were compared with the no observable effect levels used in the EPA occupational risk assessments. Some percentage of workers were predicted to exceed the level of concern for all three compounds: 54% for azinphos methyl, 5% for acetamiprid, and 20% for emamectin benzoate. This finding has implications for pesticide risk assessment and offers an alternative procedure that may be more protective of those at the extremes of exposure than the current approach. © 2017 Society for Risk Analysis.

  16. Complementary Theoretical Perspectives on Task-Based Classroom Realities

    Science.gov (United States)

    Jackson, Daniel O.; Burch, Alfred Rue

    2017-01-01

    Tasks are viewed as a principled foundation for classroom teaching, social interaction, and language development. This special issue sheds new light on how task-based classroom practices are supported by a diverse range of principles. This introduction describes current trends in classroom practice and pedagogic research in relation to task-based…

  17. An end users perspective on activity-based office concepts

    NARCIS (Netherlands)

    Appel - Meulenbroek, H.A.J.A.; Groenen, P.J.M.; Janssen, I.I.

    2011-01-01

    Purpose – The activity-based office concept of the modern office is set to increase productivity through the stimulation of interaction and communication while retaining employee satisfaction and reducing the accommodation costs. Although some research has gone into understanding the added value,

  18. Medical student's perspective of problem based learning (PBL ...

    African Journals Online (AJOL)

    The Faculty of Health Sciences at the University of Transkei has completed the first 5 years of its problem-based community oriented teaching curriculum. The use of SWOT analysis to evaluate current and future directions can lead to the successful evolution of any organization. The aim of this study was to obtain a students' ...

  19. ICT-Based, Cross-Cultural Communication: A Methodological Perspective

    Science.gov (United States)

    Larsen, Niels; Bruselius-Jensen, Maria; Danielsen, Dina; Nyamai, Rachael; Otiende, James; Aagaard-Hansen, Jens

    2014-01-01

    The article discusses how cross-cultural communication based on information and communication technologies (ICT) may be used in participatory health promotion as well as in education in general. The analysis draws on experiences from a health education research project with grade 6 (approx. 12 years) pupils in Nairobi (Kenya) and Copenhagen…

  20. Product Liability: A Neo-Austrian Based Perspective

    NARCIS (Netherlands)

    Folmer, H.; Heijman, W.J.M.; Leen, A.R.

    2002-01-01

    The paper is an exercise in a neo-Austrian based economic analysis of product liability. After a short historical introduction, we take two of the basic premises of Austrian economic thought and see which system of product liability results. If costs are subjective and entrepreneurship is the

  1. Predicting nature-based tourist roles: a life span perspective

    Science.gov (United States)

    James J. Murdy; Heather J. Gibson; Andrew Yiannakis

    2003-01-01

    The concept of stable, clearly identifiable patterns of tourist behavior, or roles, is a relatively recent development. Yiannakis and Gibson (1988, 1992) identified fifteen tourist roles based on leisure travelers' vacation behaviors. Building on this work, Gibson (1994) used discriminant analysis to determine the combination of needs and demographics are...

  2. School-Based Decision-Making: The Canadian Perspective.

    Science.gov (United States)

    Peters, Frank

    1997-01-01

    In Canada, school-based decision making is a political expedient to co-opt public support for public education at the same time as financial resources to schools are being curtailed. School councils are advisory in nature and have no statutory position in either school or school-system decisions. (17 references) (MLF)

  3. Experiences of Practice-Based Learning in Phenomenographic Perspective

    Science.gov (United States)

    Rovio-Johansson, Airi

    2018-01-01

    Purpose: The paper aims to examine, within the context of professional practice and learning, how designers collaboratively working in international teams experience practice-based learning and how such occasions contribute to professional development. Design/methodology/approach: The paper introduces the cooperation project between Tibro Training…

  4. Evolution of IT Architecture: based on Taxonomy perspective

    NARCIS (Netherlands)

    Suh, Hanjun; van Hillegersberg, Jos

    2013-01-01

    This research aims to explore how latest IT architecture is evolving in real world. We reviewed historical IT structure and classified five IT architecture typology based on various dimensions of IT architectures such as processing decentralization, network connectivity, data and program

  5. Utility of registries for post-marketing evaluation of medicines. A survey of Swedish health care quality registries from a regulatory perspective.

    Science.gov (United States)

    Feltelius, Nils; Gedeborg, Rolf; Holm, Lennart; Zethelius, Björn

    2017-06-01

    The aim of this study was to describe content and procedures in some selected Swedish health care quality registries (QRs) of relevance to regulatory decision-making. A workshop was organized with participation of seven Swedish QRs which subsequently answered a questionnaire regarding registry content on drug treatments and outcomes. Patient populations, coverage, data handling and quality control, as well as legal and ethical aspects are presented. Scientific publications from the QRs are used as a complementary measure of quality and scientific relevance. The registries under study collect clinical data of high relevance to regulatory and health technology agencies. Five out of seven registries provide information on the drug of interest. When applying external quality criteria, we found a high degree of fulfillment, although information on medication was not sufficient to answer all questions of regulatory interest. A notable strength is the option for linkage to the Prescribed Drug Registry and to information on education and socioeconomic status. Data on drugs used during hospitalization were also collected to some extent. Outcome measures collected resemble those used in relevant clinical trials. All registries collected patient-reported outcome measures. The number of publications from the registries was substantial, with studies of appropriate design, including randomized registry trials. Quality registries may provide a valuable source of post-marketing data on drug effectiveness, safety, and cost-effectiveness. Closer collaboration between registries and regulators to improve quality and usefulness of registry data could benefit both regulatory utility and value for health care providers.

  6. Risk-based remediation of polluted sites: A critical perspective.

    Science.gov (United States)

    Kuppusamy, Saranya; Venkateswarlu, Kadiyala; Megharaj, Mallavarapu; Mayilswami, Srinithi; Lee, Yong Bok

    2017-11-01

    Sites contaminated with chemical pollutants represent a growing challenge, and remediation of such lands is of international concern. Risk-based land management (RBLM) is an emerging approach that integrates risk assessment practices with more traditional site-specific investigations and remediation activities. Developing countries are yet to adopt RBLM strategies for remediation. RBLM is considered to be practical, scientifically defensible and cost-efficient. However, it is inherently limited by: firstly, the accuracy of risk assessment models used; secondly, ramifications of the fact that they are more likely to leave contamination in place; and thirdly, uncertainties involved and having to consider the total concentrations of all contaminants in soils that overestimate the potential risks from exposure to the contaminants. Consideration of contaminant bioavailability as the underlying basis for risk assessment and setting remediation goals of those contaminated lands that pose a risk to environmental and human health may lead to the development of a more sophisticated risk-based approach. However, employing the bioavailability concept in RBLM has not been extensively studied and/or legalized. This review highlights the extent of global land contamination, and the concept of risk-based assessment and management of contaminated sites including its advantages and disadvantages. Furthermore, the concept of bioavailability-based RBLM strategy has been proposed, and the challenges of RBLM and the priority areas for future research are summarized. Thus, the present review may help achieve a better understanding and successful implementation of a sustainable bioavailability-based RBLM strategy. Copyright © 2017 Elsevier Ltd. All rights reserved.

  7. Protein sequencing via nanopore based devices: a nanofluidics perspective

    Science.gov (United States)

    Chinappi, Mauro; Cecconi, Fabio

    2018-05-01

    Proteins perform a huge number of central functions in living organisms, thus all the new techniques allowing their precise, fast and accurate characterization at single-molecule level certainly represent a burst in proteomics with important biomedical impact. In this review, we describe the recent progresses in the developing of nanopore based devices for protein sequencing. We start with a critical analysis of the main technical requirements for nanopore protein sequencing, summarizing some ideas and methodologies that have recently appeared in the literature. In the last sections, we focus on the physical modelling of the transport phenomena occurring in nanopore based devices. The multiscale nature of the problem is discussed and, in this respect, some of the main possible computational approaches are illustrated.

  8. Knowledge based decision making: perspective on natural gas production

    Energy Technology Data Exchange (ETDEWEB)

    Ydstie, B. Erik; Stuland, Kjetil M.

    2009-07-01

    Conclusions (drawn by the author): Decarbonization of energy sources - From coal to renewable. Natural Gas Abundantly available - Norway is no. 3 exporter. Natural gas important as - Hydrogen source for chemicals; - Electricity; - End consumer usage (heating etc). Large potential for application of model based decision making; - Where and when to install platforms and drill wells - How to operate platforms and pipeline systems; - How to operate and optimize chemical production; - Optimization of electricity generation systems. (author)

  9. Molecular–Genetic Imaging: A Nuclear Medicine–Based Perspective

    Directory of Open Access Journals (Sweden)

    Ronald G. Blasberg

    2002-07-01

    Full Text Available Molecular imaging is a relatively new discipline, which developed over the past decade, initially driven by in situ reporter imaging technology. Noninvasive in vivo molecular–genetic imaging developed more recently and is based on nuclear (positron emission tomography [PET], gamma camera, autoradiography imaging as well as magnetic resonance (MR and in vivo optical imaging. Molecular–genetic imaging has its roots in both molecular biology and cell biology, as well as in new imaging technologies. The focus of this presentation will be nuclear-based molecular–genetic imaging, but it will comment on the value and utility of combining different imaging modalities. Nuclear-based molecular imaging can be viewed in terms of three different imaging strategies: (1 “indirect” reporter gene imaging; (2 “direct” imaging of endogenous molecules; or (3 “surrogate” or “bio-marker” imaging. Examples of each imaging strategy will be presented and discussed. The rapid growth of in vivo molecular imaging is due to the established base of in vivo imaging technologies, the established programs in molecular and cell biology, and the convergence of these disciplines. The development of versatile and sensitive assays that do not require tissue samples will be of considerable value for monitoring molecular–genetic and cellular processes in animal models of human disease, as well as for studies in human subjects in the future. Noninvasive imaging of molecular–genetic and cellular processes will complement established ex vivo molecular–biological assays that require tissue sampling, and will provide a spatial as well as a temporal dimension to our understanding of various diseases and disease processes.

  10. Home-based telework in France: Characteristics, barriers and perspectives

    OpenAIRE

    AGUILERA, Anne; LETHIAIS, Virginie; RALLET, Alain; PROULHAC, Laurent

    2016-01-01

    The aim of this article is to explain the gap between high social expectations, particularly in terms of reducing commuting frequency, increasing productivity and improving work-life balance, and the reality of home-based telework. We use three French databases which give information about employers but also employees. We highlight that telework is not only a fairly restricted phenomenon but also one that lacks impetus; it is mainly an informal working arrangement. The main reasons raised by ...

  11. Workplace-based assessment; learner and assessor perspectives

    Directory of Open Access Journals (Sweden)

    Nair BR

    2015-04-01

    Full Text Available Balakrishnan (Kichu R Nair,1,2 Mulavana S Parvathy,2 Amanda Wilson,3 Justine Smith,1 Brooke Murphy1 1Centre for Medical Professional Development, Hunter New England Local Health District, Newcastle, NSW, Australia; 2School of Medicine and Public Health, 3School of Nursing and Midwifery, Faculty of Health, University of Newcastle, NSW, Australia Objective: To examine the acceptability and educational impact of the workplace-based assessment program for international medical graduates on candidates and assessors. Method: A grounded theory-based qualitative analysis of the experiences of 17 candidates and eleven assessors using focus groups, interviews, and surveys. Results: Both candidates and assessors identified positive opportunities for improved performance of international medical graduates. Their integration into the workforce was facilitated by improved communication and peer acceptance, from ongoing multifaceted feedback and time to practice skills. Conclusion: This study showed a high level of acceptability of the Newcastle workplace-based assessment program among candidates and assessors. Keywords: performance, competency, formative, feedback, international medical graduates, Australian Medical Council

  12. Systemic Risk and Optimal Regulatory Architecture

    NARCIS (Netherlands)

    Espinosa-Vega, M.A.; Kahn, C.; Matta, R.; Sole, J.

    2011-01-01

    Until the recent financial crisis, the safety and soundness of financial institutions was assessed from the perspective of the individual institution. The financial crisis highlighted the need to take systemic externalities seriously when rethinking prudential oversight and the regulatory

  13. Palliative home-based technology from a practitioner's perspective: benefits and disadvantages

    Directory of Open Access Journals (Sweden)

    Johnston BM

    2014-11-01

    Full Text Available Bridget M Johnston Sue Ryder Care Centre for the Study of Supportive, Palliative, and End of Life Care, School of Health Sciences, University of Nottingham, Queen's Medical Centre, Nottingham, UK Abstract: This critical review paper explores the concept of palliative home-based technology from a practitioner's perspective. The aim of the critical review was to scope information available from published and unpublished research on the current state of palliative home-based technology, practitioner-focused perspectives, patient-focused perspectives, quality of life, and the implications for clinical practice. Published and unpublished studies were included. An example of one UK patient-centered home-based technology is explored as an exemplar. The evidence suggests that despite the challenges, there are numerous examples of good practice in relation to palliative home-based technology. Improvements in technology mean that telehealth has much to offer people being cared for at home with palliative needs. However, some of the evaluative evidence is limited, and further rigor is needed when evaluating future technology-based solutions innovations. Keywords: technology, telehealth, telemedicine, information technology, palliative care, hospice, terminal illness

  14. Phos-tag-based analysis of myosin regulatory light chain phosphorylation in human uterine myocytes.

    Directory of Open Access Journals (Sweden)

    Hector N Aguilar

    Full Text Available The 'phosphate-binding tag' (phos-tag reagent enables separation of phospho-proteins during SDS-PAGE by impeding migration proportional to their phosphorylation stoichiometry. Western blotting can then be used to detect and quantify the bands corresponding to the phospho-states of a target protein. We present a method for quantification of data regarding phospho-states derived from phos-tag SDS-PAGE. The method incorporates corrections for lane-to-lane loading variability and for the effects of drug vehicles thus enabling the comparison of multiple treatments by using the untreated cellular set-point as a reference. This method is exemplified by quantifying the phosphorylation of myosin regulatory light chain (RLC in cultured human uterine myocytes.We have evaluated and validated the concept that, when using an antibody (Ab against the total-protein, the sum of all phosphorylation states in a single lane represents a 'closed system' since all possible phospho-states and phosphoisotypes are detected. Using this approach, we demonstrate that oxytocin (OT and calpeptin (Calp induce RLC kinase (MLCK- and rho-kinase (ROK-dependent enhancements in phosphorylation of RLC at T18 and S19. Treatment of myocytes with a phorbol ester (PMA induced phosphorylation of S1-RLC, which caused a mobility shift in the phos-tag matrices distinct from phosphorylation at S19.We have presented a method for analysis of phospho-state data that facilitates quantitative comparison to a reference control without the use of a traditional 'loading' or 'reference' standard. This analysis is useful for assessing effects of putative agonists and antagonists where all phospho-states are represented in control and experimental samples. We also demonstrated that phosphorylation of RLC at S1 is inducible in intact uterine myocytes, though the signal in the resting samples was not sufficiently abundant to allow quantification by the approach used here.

  15. Quality of alcohol-based hand disinfectants and their regulatory status. Development and marketing authorisation.

    Science.gov (United States)

    Stengele, Michael

    2008-10-01

    A 2005 survey showed that there are at least four legal product classifications for hand disinfectants in the European Union: medicinal products, biocidal products, cosmetics and medical devices. An internationally harmonized classification does not exist. The regulatory status of those products is defined at national level. In order to assure compliance with the regulations these four classifications provide different levels of official surveillance varying from product-specific marketing authorisations and production site audits to the obligation to just work in accordance with certain general guidelines. Biocidal product regulations cover eco-toxicological and toxicological aspects, but do not very much address to the customers' quality and efficacy expectations. In contrast, the medicinal product legislation is the most ambitious one claiming quality, safety, efficacy, and an independent benefit risk-assessment by an authority. In respect of ambition, the two remaining product categories--cosmetics and medical devices--rank between the both classifications mentioned above. For medical devices, it is the responsibility of the manufacturer to make sure the products meet defined essential requirements regarding quality, safety and performance and to have an appropriate quality assurance system implemented under third party control. For cosmetics there are some legal restrictions, but within these it is the sole responsibility of the manufacturer to ensure that the products are safe and fulfil their claims. This paper describes one way out of this increasingly complex situation, the definition of a single quality standard meeting the users' expectations as well as all legal requirements regardless of the specific sales country. This international quality standard for products would take priority over any individual national standard, to the benefit of users.

  16. Future Perspectives for Arts-Based Methods in Higher Education

    DEFF Research Database (Denmark)

    Chemi, Tatiana; Du, Xiangyun

    2018-01-01

    practices around the world while, on the other, addressing the challenges that these practices meet. Disruptive strategies must be given opportunities for reflection and reflexive spaces, opportunities for learning and teaching the artistic languages. The chapters show that long-term, systematic...... conversations between scholars and educators are needed, and that artists have a central role in the future developments of this field. Whether professional or amateur artists is no matter, but the craft and creativity of art practices in the flesh must lead any future direction of arts-based methods....

  17. A Danish Perspective on Problem Based Learning in Space Education

    DEFF Research Database (Denmark)

    Bhanderi, Dan D. V.; Bisgaard, Morten; Alminde, Lars

    2006-01-01

    This paper describes the goals of the Student Satellite Program at Aalborg University (AAU), and the means for implementing it, namely a concept called Problem Based Learning, which is the cornerstone in the education at AAU. AAU has within the last decade chosen to focus strongly on education...... in space technology, not because the country lacks aerospace engineers, but because space projects require the students to think about systems rather than individual modules, while providing problems that are technically challenging for the students to solve. This combination makes the graduates very...

  18. CELL-SELEX: Novel Perspectives of Aptamer-Based Therapeutics

    Directory of Open Access Journals (Sweden)

    Hans P. Wendel

    2008-04-01

    Full Text Available Aptamers, single stranded DNA or RNA molecules, generated by a method called SELEX (systematic evolution of ligands by exponential enrichment have been widely used in various biomedical applications. The newly developed Cell-SELEX (cell based-SELEX targeting whole living cells has raised great expectations for cancer biology, -therapy and regenerative medicine. Combining nanobiotechnology with aptamers, this technology opens the way to more sophisticated applications in molecular diagnosis. This paper gives a review of recent developments in SELEX technologies and new applications of aptamers.

  19. NY-ESO-1 Based Immunotherapy of Cancer: Current Perspectives

    Directory of Open Access Journals (Sweden)

    Remy Thomas

    2018-05-01

    Full Text Available NY-ESO-1 or New York esophageal squamous cell carcinoma 1 is a well-known cancer-testis antigen (CTAs with re-expression in numerous cancer types. Its ability to elicit spontaneous humoral and cellular immune responses, together with its restricted expression pattern, have rendered it a good candidate target for cancer immunotherapy. In this review, we provide background information on NY-ESO-1 expression and function in normal and cancerous tissues. Furthermore, NY-ESO-1-specific immune responses have been observed in various cancer types; however, their utility as biomarkers are not well determined. Finally, we describe the immune-based therapeutic options targeting NY-ESO-1 that are currently in clinical trial. We will highlight the recent advancements made in NY-ESO-1 cancer vaccines, adoptive T cell therapy, and combinatorial treatment with checkpoint inhibitors and will discuss the current trends for future NY-ESO-1 based immunotherapy. Cancer treatment has been revolutionized over the last few decades with immunotherapy emerging at the forefront. Immune-based interventions have shown promising results, providing a new treatment avenue for durable clinical responses in various cancer types. The majority of successful immunotherapy studies have been reported in liquid cancers, whereas these approaches have met many challenges in solid cancers. Effective immunotherapy in solid cancers is hampered by the complex, dynamic tumor microenvironment that modulates the extent and phenotype of the antitumor immune response. Furthermore, many solid tumor-associated antigens are not private but can be found in normal somatic tissues, resulting in minor to detrimental off-target toxicities. Therefore, there is an ongoing effort to identify tumor-specific antigens to target using various immune-based modalities. CTAs are considered good candidate targets for immunotherapy as they are characterized by a restricted expression in normal somatic tissues

  20. Benefits and challenges of international clinical education from a US-based physiotherapist faculty perspective.

    Science.gov (United States)

    Pechak, Celia; Black, Jill D

    2013-12-01

    The influence of internationalization on physiotherapist education in at least North American-based programmes has become more apparent. Faculty and students have been involved in various international activities. One category of activities includes international clinical education (ICE), where students earn clinical education credit for their learning activities at international sites. Although this educational strategy appears to be increasingly used in at least the United States and Canada, the related literature is limited in scope. The purpose of this portion of the present study was to investigate the benefits and challenges of ICE for US-based students, US-based physiotherapy programmes and international partners from the perspective of US-based faculty sending students for clinical education internationally. Content analysis was used for this qualitative study. Fifteen US-based faculty members who had experience in sending physiotherapist students for ICE were recruited. The primary researcher conducted semi-structured phone interviews, averaging approximately 60 minutes in length. The primary and secondary researchers completed data analysis using NVivo 8 software (QSR International Inc., Cambridge, MA). Benefits of ICE to the students included exposure to alternate health systems, broadening of student perspectives and clinical competence. Challenges consisted of funding and possible language barrier. Increased visibility, expanded global perspective and faculty collaborations were benefits to the programme. Ensuring a quality learning experience was the greatest programme challenge. Benefits to the international site included education and faculty collaborations/exchanges; challenges were language, student clinical preparation and unfamiliarity with the student evaluation tool. Because the sample was limited to 15 US-based faculty members, the results may not be relevant to all programmes inside or outside of the United States. Additionally, the study

  1. New perspectives on renewable energy systems based on hydrogen

    International Nuclear Information System (INIS)

    Bose, T. K.; Agbossou, K.; Benard, P.; St-Arnaud, J-M.

    1999-01-01

    Current hydrocarbon-based energy systems, current energy consumption and the push towards the utilization of renewable energy sources, fuelled by global warming and the need to reduce atmospheric pollution are discussed. The consequences of climatic change and the obligation of Annex B countries to reduce their greenhouse gas emissions in terms of the Kyoto Protocols are reviewed. The role that renewable energy sources such as hydrogen, solar and wind energy could play in avoiding the most catastrophic consequences of rapidly growing energy consumption and atmospheric pollution in the face of diminishing conventional fossil fuel resources are examined. The focus is on hydrogen energy as a means of storing and transporting primary energy. Some favorable characteristics of hydrogen is its abundance, the fact that it can be produced utilizing renewable or non-renewable sources, and the further fact that its combustion produces three times more energy per unit of mass than oil, and six times more than coal. The technology of converting hydrogen into energy, storing energy in the form of hydrogen, and its utilization, for example in the stabilization of wind energy by way of electrolytic conversion to hydrogen, are described. Development at Hydro-Quebec's Institute of Research of a hydrogen-based autonomous wind energy system to produce electricity is also discussed. 2 tabs., 11 refs

  2. Improving data retrieval quality: Evidence based medicine perspective.

    Science.gov (United States)

    Kamalov, M; Dobrynin, V; Balykina, J; Kolbin, A; Verbitskaya, E; Kasimova, M

    2015-01-01

    The actively developing approach in modern medicine is the approach focused on principles of evidence-based medicine. The assessment of quality and reliability of studies is needed. However, in some cases studies corresponding to the first level of evidence may contain errors in randomized control trials (RCTs). Solution of the problem is the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. Studies both in the fields of medicine and information retrieval are conducted for developing search engines for the MEDLINE database [1]; combined techniques for summarization and information retrieval targeted to solving problems of finding the best medication based on the levels of evidence are being developed [2]. Based on the relevance and demand for studies both in the field of medicine and information retrieval, it was decided to start the development of a search engine for the MEDLINE database search on the basis of the Saint-Petersburg State University with the support of Pavlov First Saint-Petersburg State Medical University and Tashkent Institute of Postgraduate Medical Education. Novelty and value of the proposed system are characterized by the use of ranking method of relevant abstracts. It is suggested that the system will be able to perform ranking based on studies level of evidence and to apply GRADE criteria for system evaluation. The assigned task falls within the domain of information retrieval and machine learning. Based on the results of implementation from previous work [3], in which the main goal was to cluster abstracts from MEDLINE database by subtypes of medical interventions, a set of algorithms for clustering in this study was selected: K-means, K-means ++, EM from the sklearn (http://scikit-learn.org) and WEKA (http://www.cs.waikato.ac.nz/~ml/weka/) libraries, together with the methods of Latent Semantic Analysis (LSA) [4] choosing the first 210 facts and the model "bag of words" [5] to represent clustered documents

  3. Current perspectives in fragment-based lead discovery (FBLD)

    Science.gov (United States)

    Lamoree, Bas; Hubbard, Roderick E.

    2017-01-01

    It is over 20 years since the first fragment-based discovery projects were disclosed. The methods are now mature for most ‘conventional’ targets in drug discovery such as enzymes (kinases and proteases) but there has also been growing success on more challenging targets, such as disruption of protein–protein interactions. The main application is to identify tractable chemical startpoints that non-covalently modulate the activity of a biological molecule. In this essay, we overview current practice in the methods and discuss how they have had an impact in lead discovery – generating a large number of fragment-derived compounds that are in clinical trials and two medicines treating patients. In addition, we discuss some of the more recent applications of the methods in chemical biology – providing chemical tools to investigate biological molecules, mechanisms and systems. PMID:29118093

  4. Event-based state estimation a stochastic perspective

    CERN Document Server

    Shi, Dawei; Chen, Tongwen

    2016-01-01

    This book explores event-based estimation problems. It shows how several stochastic approaches are developed to maintain estimation performance when sensors perform their updates at slower rates only when needed. The self-contained presentation makes this book suitable for readers with no more than a basic knowledge of probability analysis, matrix algebra and linear systems. The introduction and literature review provide information, while the main content deals with estimation problems from four distinct angles in a stochastic setting, using numerous illustrative examples and comparisons. The text elucidates both theoretical developments and their applications, and is rounded out by a review of open problems. This book is a valuable resource for researchers and students who wish to expand their knowledge and work in the area of event-triggered systems. At the same time, engineers and practitioners in industrial process control will benefit from the event-triggering technique that reduces communication costs ...

  5. Childhood blindness in India: a population based perspective

    Science.gov (United States)

    Dandona, R; Dandona, L

    2003-01-01

    Aim: To estimate the prevalence and causes of blindness in children in the southern Indian state of Andhra Pradesh. Methods: These data were obtained as part of two population based studies in which 6935 children ≤15 years of age participated. Blindness was defined as presenting distance visual acuity <6/60 in the better eye. Results: The prevalence of childhood blindness was 0.17% (95% confidence interval 0.09 to 0.30). Treatable refractive error caused 33.3% of the blindness, followed by 16.6% due to preventable causes (8.3% each due to vitamin A deficiency and amblyopia after cataract surgery). The major causes of the remaining blindness included congenital eye anomalies (16.7%) and retinal degeneration (16.7%). Conclusion: In the context of Vision 2020, the priorities for action to reduce childhood blindness in India are refractive error, cataract related amblyopia, and corneal diseases. PMID:12598433

  6. GPU Based Software Correlators - Perspectives for VLBI2010

    Science.gov (United States)

    Hobiger, Thomas; Kimura, Moritaka; Takefuji, Kazuhiro; Oyama, Tomoaki; Koyama, Yasuhiro; Kondo, Tetsuro; Gotoh, Tadahiro; Amagai, Jun

    2010-01-01

    Caused by historical separation and driven by the requirements of the PC gaming industry, Graphics Processing Units (GPUs) have evolved to massive parallel processing systems which entered the area of non-graphic related applications. Although a single processing core on the GPU is much slower and provides less functionality than its counterpart on the CPU, the huge number of these small processing entities outperforms the classical processors when the application can be parallelized. Thus, in recent years various radio astronomical projects have started to make use of this technology either to realize the correlator on this platform or to establish the post-processing pipeline with GPUs. Therefore, the feasibility of GPUs as a choice for a VLBI correlator is being investigated, including pros and cons of this technology. Additionally, a GPU based software correlator will be reviewed with respect to energy consumption/GFlop/sec and cost/GFlop/sec.

  7. Reliability and risk analysis data base development: an historical perspective

    International Nuclear Information System (INIS)

    Fragola, Joseph R.

    1996-01-01

    Collection of empirical data and data base development for use in the prediction of the probability of future events has a long history. Dating back at least to the 17th century, safe passage events and mortality events were collected and analyzed to uncover prospective underlying classes and associated class attributes. Tabulations of these developed classes and associated attributes formed the underwriting basis for the fledgling insurance industry. Much earlier, master masons and architects used design rules of thumb to capture the experience of the ages and thereby produce structures of incredible longevity and reliability (Antona, E., Fragola, J. and Galvagni, R. Risk based decision analysis in design. Fourth SRA Europe Conference Proceedings, Rome, Italy, 18-20 October 1993). These rules served so well in producing robust designs that it was not until almost the 19th century that the analysis (Charlton, T.M., A History Of Theory Of Structures In The 19th Century, Cambridge University Press, Cambridge, UK, 1982) of masonry voussoir arches, begun by Galileo some two centuries earlier (Galilei, G. Discorsi e dimostrazioni mathematiche intorno a due nuove science, (Discourses and mathematical demonstrations concerning two new sciences, Leiden, The Netherlands, 1638), was placed on a sound scientific basis. Still, with the introduction of new materials (such as wrought iron and steel) and the lack of theoretical knowledge and computational facilities, approximate methods of structural design abounded well into the second half of the 20th century. To this day structural designers account for material variations and gaps in theoretical knowledge by employing factors of safety (Benvenuto, E., An Introduction to the History of Structural Mechanics, Part II: Vaulted Structures and Elastic Systems, Springer-Verlag, NY, 1991) or codes of practice (ASME Boiler and Pressure Vessel Code, ASME, New York) originally developed in the 19th century (Antona, E., Fragola, J. and

  8. A Global Perspective on Trends in Nature-Based Tourism

    Science.gov (United States)

    Balmford, Andrew; Beresford, James; Green, Jonathan; Naidoo, Robin; Walpole, Matt; Manica, Andrea

    2009-01-01

    Reports of rapid growth in nature-based tourism and recreation add significant weight to the economic case for biodiversity conservation but seem to contradict widely voiced concerns that people are becoming increasingly isolated from nature. This apparent paradox has been highlighted by a recent study showing that on a per capita basis, visits to natural areas in the United States and Japan have declined over the last two decades. These results have been cited as evidence of “a fundamental and pervasive shift away from nature-based recreation”—but how widespread is this phenomenon? We address this question by looking at temporal trends in visitor numbers at 280 protected areas (PAs) from 20 countries. This more geographically representative dataset shows that while PA visitation (whether measured as total or per capita visit numbers) is indeed declining in the United States and Japan, it is generally increasing elsewhere. Total visit numbers are growing in 15 of the 20 countries for which we could get data, with the median national rate of change unrelated to the national rate of population growth but negatively associated with wealth. Reasons for this reversal of growth in the richest countries are difficult to pin down with existing data, but the pattern is mirrored by trends in international tourist arrivals as a whole and so may not necessarily be caused by disaffection with nature. Irrespective of the explanation, it is clear that despite important downturns in some countries, nature-related tourism is far from declining everywhere, and may still have considerable potential both to generate funds for conservation and to shape people's attitudes to the environment. PMID:19564896

  9. Organizational behavior of regulatory agencies: a case study of the Bureau of Consumer Services in the Pennsylvania Public Utility Commission

    Energy Technology Data Exchange (ETDEWEB)

    Silver, J.H.

    1981-01-01

    Regulatory agencies operate in a complex field of organizations and interest groups. The variety of behaviors that occur in the regulatory field are not satisfactorily explained by current interpretative frameworks. Regulatory agencies are at once criticized and praised. They flourish as organizational entities, yet they exhibit behavior that is often inexplicable. Notions like clientele capture, the politics of regulation, exchange theory, and institutionalized organizations do not singly explain the vagaries of regulatory behavior. A merger of these viewpoints, however, provides a foundation for a comprehensive interpretative framework. A bureau of consumer services within a state public utility commission is viewed as an institutionalized organization. From this perspective, a variety of ritual behaviors, based upon symbolic and tangible interorganizational exchanges are observed and characterized. The outcome of these exchanges is the establishment of the Bureau of Consumer Services as a legitimate regulatory agent with significant impact upon the formulation of regulatory policy in the formal proceedings of the Pennsylvania Public Utility Commission.

  10. Perovskite-Based Solar Cells: Materials, Methods, and Future Perspectives

    Directory of Open Access Journals (Sweden)

    Di Zhou

    2018-01-01

    Full Text Available A novel all-solid-state, hybrid solar cell based on organic-inorganic metal halide perovskite (CH3NH3PbX3 materials has attracted great attention from the researchers all over the world and is considered to be one of the top 10 scientific breakthroughs in 2013. The perovskite materials can be used not only as light-absorbing layer, but also as an electron/hole transport layer due to the advantages of its high extinction coefficient, high charge mobility, long carrier lifetime, and long carrier diffusion distance. The photoelectric power conversion efficiency of the perovskite solar cells has increased from 3.8% in 2009 to 22.1% in 2016, making perovskite solar cells the best potential candidate for the new generation of solar cells to replace traditional silicon solar cells in the future. In this paper, we introduce the development and mechanism of perovskite solar cells, describe the specific function of each layer, and focus on the improvement in the function of such layers and its influence on the cell performance. Next, the synthesis methods of the perovskite light-absorbing layer and the performance characteristics are discussed. Finally, the challenges and prospects for the development of perovskite solar cells are also briefly presented.

  11. A perspective of PC-based probabilistic risk assessment

    International Nuclear Information System (INIS)

    Sattison, M.B.; Rasmuson, D.M.; Robinson, R.C.; Russell, K.D.; Van Siclen, V.S.

    1987-01-01

    Probabilistic risk assessment (PRA) information has been under-utilized in the past due to the large effort required to input the PRA data and the large expense of the computers needed to run PRA codes. The microcomputer-based Integrated Reliability and Risk Analysis System (IRRAS) and the System Analysis and Risk Assessment (SARA) System, under development at the Idaho National Engineering Laboratory, have greatly enhanced the ability of managers to use PRA techniques in their decision-making. IRRAS is a tool that allows an analyst to create, modify, update, and reanalyze a plant PRA to keep the risk assessment current with the plant's configuration and operation. The SARA system is used to perform sensitivity studies on the results of a PRA. This type of analysis can be used to evaluate proposed changes to a plant or its operation. The success of these two software projects demonstrate that risk information can be made readily available to those that need it. This is the first step in the development of a true risk management capability

  12. Dialectical thinking and fairness-based perspectives of affirmative action.

    Science.gov (United States)

    Hideg, Ivona; Ferris, D Lance

    2017-05-01

    Affirmative action (AA) policies are among the most effective means for enhancing diversity and equality in the workplace, yet are also often viewed with scorn by the wider public. Fairness-based explanations for this scorn suggest AA policies provide preferential treatment to minorities, violating procedural fairness principles of consistent treatment. In other words, to promote equality in the workplace, effective AA policies promote inequality when selecting employees, and the broader public perceives this to be procedurally unfair. Given this inconsistency underlies negative reactions to AA policies, we argue that better preparing individuals to deal with inconsistencies can mitigate negative reactions to AA policies. Integrating theories from the fairness and cognitive styles literature, we demonstrate across 4 studies how dialectical thinking-a cognitive style associated with accepting inconsistencies in one's environment-increases support for AA policies via procedural fairness perceptions. Specifically, we found support for our propositions across a variety of AA policy types (i.e., strong and weak preference policies) and when conceptualizing dialectical thinking either as an individual difference or as a state that can be primed-including being primed by the framing of the AA policy itself. We discuss theoretical contributions and insights for policy-making at government and organizational levels. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  13. Teaching ethics to engineers - a research-based perspective

    Science.gov (United States)

    Bowden, Peter

    2010-10-01

    This paper describes research underpinning a course, developed in Australia, on ethics for engineers. The methodology used, that of identifying the principal ethical issues facing the discipline and designing the course around these issues, would be applicable to other disciplines and in other countries. The course was based on the assumption that identifying the major ethical issues in the discipline, and subsequently presenting and analysing them in the classroom, would provide the future professional with knowledge of the ethical problems that they were likely to face on graduation. The student has then to be given the skills and knowledge to combat these concerns, should he/she wish to. These findings feed into several components of the course, such as the development of a code of ethics, the role of a professional society or industry association and the role of ethical theory The sources employed to identify the issues were surveys of the literature and about 30 case studies, in Australia and overseas. The issues thus identified were then put before a sample of engineering managers to assess the relevance to the profession.

  14. Athlete brand construction: A perspective based on fans' perceptions

    Directory of Open Access Journals (Sweden)

    Ali Hasaan

    Full Text Available Abstract The purpose of this study was to develop a framework for understanding the antecedents and components of athlete brand. Based on a set of 21 interviews conducted in three different countries, a detailed framework is proposed including five antecedents and two components of athlete brand. The antecedents are media (social media, mass media, video games and major sport events, oral communications (word of mouth, and rumors and narratives, impression management, social agents (parents, family members, friends and community, and teams and sport (sport interest, team interest and team geographical location. In turn, the components of athlete brand are related with on-field attributes (behavior, team, achievements, style of play and skills and off-field attributes (physical attraction, lifestyle, personal appeal, ethnicity and entertainment. Complementarily, these components of athlete brand are proposed to have an impact on fans' loyalty towards the athlete. Implications of these findings for building and managing athlete brand are discussed, and directions for future studies are provided.

  15. Toxic neuropathies: Mechanistic insights based on a chemical perspective.

    Science.gov (United States)

    LoPachin, Richard M; Gavin, Terrence

    2015-06-02

    2,5-Hexanedione (HD) and acrylamide (ACR) are considered to be prototypical among chemical toxicants that cause central-peripheral axonopathies characterized by distal axon swelling and degeneration. Because the demise of distal regions was assumed to be causally related to the onset of neurotoxicity, substantial effort was devoted to deciphering the respective mechanisms. Continued research, however, revealed that expression of the presumed hallmark morphological features was dependent upon the daily rate of toxicant exposure. Indeed, many studies reported that the corresponding axonopathic changes were late developing effects that occurred independent of behavioral and/or functional neurotoxicity. This suggested that the toxic axonopathy classification might be based on epiphenomena related to dose-rate. Therefore, the goal of this mini-review is to discuss how quantitative morphometric analyses and the establishment of dose-dependent relationships helped distinguish primary, mechanistically relevant toxicant effects from non-specific consequences. Perhaps more importantly, we will discuss how knowledge of neurotoxicant chemical nature can guide molecular-level research toward a better, more rational understanding of mechanism. Our discussion will focus on HD, the neurotoxic γ-diketone metabolite of the industrial solvents n-hexane and methyl-n-butyl ketone. Early investigations suggested that HD caused giant neurofilamentous axonal swellings and eventual degeneration in CNS and PNS. However, as our review will point out, this interpretation underwent several iterations as the understanding of γ-diketone chemistry improved and more quantitative experimental approaches were implemented. The chemical concepts and design strategies discussed in this mini-review are broadly applicable to the mechanistic studies of other chemicals (e.g., n-propyl bromine, methyl methacrylate) that cause toxic neuropathies. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  16. Complexity Analysis of Industrial Organizations Based on a Perspective of Systems Engineering Analysts

    Directory of Open Access Journals (Sweden)

    I. H. Garbie

    2011-12-01

    Full Text Available Complexity in industrial organizations became more difficult and complex to be solved and it needs more attention from academicians and technicians. For these reasons, complexity in industrial organizations represents a new challenge in the next decades. Until now, analysis of industrial organizations complexity is still remaining a research topic of immense international interest and they require reduction in their complexity. In this paper, analysis of complexity in industrial organizations is shown based on the perspective of systems engineering analyst. In this perspective, analysis of complexity was divided into different levels and these levels were defined as complexity levels. A framework of analyzing these levels was proposed and suggested based on the complexity in industrial organizations. This analysis was divided into four main issues: industrial system vision, industrial system structure, industrial system operating, and industrial system evaluating. This analysis shows that the complexity of industrial organizations is still an ill-structured and a multi-dimensional problem.

  17. Creative economy and knowledge-based society. Perspectives for Romania

    Directory of Open Access Journals (Sweden)

    Istudor Laura Gabriela

    2017-07-01

    Full Text Available Creative economy is a rather new concept that started developing during the last decade, being currently applied to a variety of activities and professions. It has become an important sector of the global economy, being sustained and promoted by the European Union, especially in the context of an innovative and knowledge-based society. Within this new type of economy, creativity, innovation and knowledge management are essential factors that lead to a smart, sustainable and inclusive development in regard to the creation of new jobs and to the social inclusion requirements. According to John Howkins (2001, the creative industries / sectors include art, research, advertising, movies, theatre, software, with the possibility of the concept of creative economy to be extended to other non-artistic and IT related fields, where improvements are expected to arise through innovation and creativity. The Global Creativity Index (GCI and the European Innovation Scoreboard (EIS, are two benchmarking tools that measure the creativity and innovation degree of the countries in the European Union, placing Romania within the last positions, especially with respect to intellectual property rights and entrepreneurship. The research methodology consists of both qualitative and quantitative methods, while the research questions to be answered are What is the degree of innovation in Romania compared to other states? What can be done in order to increase the level of innovation in Romania? In this viewpoint, the paper analyzes the development of the creative industries / sectors in Romania, in the context of creative economy and innovation. The objective of the paper is to analyze the extent to which the concept of creative economy can be promoted and implemented in Romania, given its increasing importance at the international level, with countries such as the United Kingdom that already adopted strategies to sustain this kind of economy in the past years. In order to

  18. Management Control Systems and Strategy: A Resource based Perspective. Evidence from Greece

    OpenAIRE

    Nikolaos Theriou; Dimitrios Maditinos; Georgios N. Theriou

    2017-01-01

    Purpose: The purpose of this paper is to empirically examine from the resource-based perspective, the relationship between the use of management control systems (MCS) and organisational capabilities in the Greek context. Design/Methodology/Approach: The study follows Henri's (2006) methodology and explores the relationships between the diagnostic and interactive uses of performance measurement systems (PMS) and the five capabilities (e.g. market orientation, organisational learning, entrep...

  19. A New Pose Estimation Algorithm Using a Perspective-Ray-Based Scaled Orthographic Projection with Iteration.

    Directory of Open Access Journals (Sweden)

    Pengfei Sun

    Full Text Available Pose estimation aims at measuring the position and orientation of a calibrated camera using known image features. The pinhole model is the dominant camera model in this field. However, the imaging precision of this model is not accurate enough for an advanced pose estimation algorithm. In this paper, a new camera model, called incident ray tracking model, is introduced. More importantly, an advanced pose estimation algorithm based on the perspective ray in the new camera model, is proposed. The perspective ray, determined by two positioning points, is an abstract mathematical equivalent of the incident ray. In the proposed pose estimation algorithm, called perspective-ray-based scaled orthographic projection with iteration (PRSOI, an approximate ray-based projection is calculated by a linear system and refined by iteration. Experiments on the PRSOI have been conducted, and the results demonstrate that it is of high accuracy in the six degrees of freedom (DOF motion. And it outperforms three other state-of-the-art algorithms in terms of accuracy during the contrast experiment.

  20. Promoting Issues-based STSE Perspectives in Science Teacher Education: Problems of Identity and Ideology

    Science.gov (United States)

    Pedretti, Erminia G.; Bencze, Larry; Hewitt, Jim; Romkey, Lisa; Jivraj, Ashifa

    2008-09-01

    Although science, technology, society and environment (STSE) education has gained considerable force in the past few years, it has made fewer strides in practice. We suggest that science teacher identity plays a role in the adoption of STSE perspectives. Simply put, issues-based STSE education challenges traditional images of a science teacher and science instructional ideologies. In this paper, we briefly describe the development of a multimedia documentary depicting issues-based STSE education in a teacher’s class and its subsequent implementation with 64 secondary student-teachers at a large Canadian university. Specifically, we set out to explore: (1) science teacher candidates’ responses to a case of issues-based STSE teaching, and (2) how science teacher identity intersects with the adoption of STSE perspectives. Findings reveal that although teacher candidates expressed confidence and motivation regarding teaching STSE, they also indicated decreased likelihood to teach these perspectives in their early years of teaching. Particular tensions or problems of practice consistently emerged that helped explain this paradox including issues related to: control and autonomy; support and belonging; expertise and negotiating curriculum; politicization and action; and biases and ideological bents. We conclude our paper with a discussion regarding the lessons learned about STSE education, teacher identity and the role of multimedia case methods.

  1. Pathway-based analysis of genome-wide siRNA screens reveals the regulatory landscape of APP processing.

    Directory of Open Access Journals (Sweden)

    Luiz Miguel Camargo

    Full Text Available The progressive aggregation of Amyloid-β (Aβ in the brain is a major trait of Alzheimer's Disease (AD. Aβ is produced as a result of proteolytic processing of the β-amyloid precursor protein (APP. Processing of APP is mediated by multiple enzymes, resulting in the production of distinct peptide products: the non-amyloidogenic peptide sAPPα and the amyloidogenic peptides sAPPβ, Aβ40, and Aβ42. Using a pathway-based approach, we analyzed a large-scale siRNA screen that measured the production of different APP proteolytic products. Our analysis identified many of the biological processes/pathways that are known to regulate APP processing and have been implicated in AD pathogenesis, as well as revealing novel regulatory mechanisms. Furthermore, we also demonstrate that some of these processes differentially regulate APP processing, with some mechanisms favouring production of certain peptide species over others. For example, synaptic transmission having a bias towards regulating Aβ40 production over Aβ42 as well as processes involved in insulin and pancreatic biology having a bias for sAPPβ production over sAPPα. In addition, some of the pathways identified as regulators of APP processing contain genes (CLU, BIN1, CR1, PICALM, TREM2, SORL1, MEF2C, DSG2, EPH1A recently implicated with AD through genome wide association studies (GWAS and associated meta-analysis. In addition, we provide supporting evidence and a deeper mechanistic understanding of the role of diabetes in AD. The identification of these processes/pathways, their differential impact on APP processing, and their relationships to each other, provide a comprehensive systems biology view of the "regulatory landscape" of APP.

  2. Biofuel and other biomass based products from contaminated sites - Potentials and barriers from Swedish perspectives

    Energy Technology Data Exchange (ETDEWEB)

    Andersson-Skoeld, Yvonne; Enell, Anja; Rihm, Thomas; Haglund, Kristina; Wik, Ola [Swedish Geotechnical Institute, Linkoeping (Sweden); Blom, Sonja; Angelbratt, Alexandra [FB Engineering AB, Goeteborg (Sweden); Bardos, Paul [r3 Environmental Technology Ltd, Reading (United Kingdom); Track, Thomas [DECHEMA e. V., Frankfurt am Main (Germany); Keuning, Sytze [Bioclear b.v., Groningen (Netherlands)

    2009-07-01

    In this report, results are presented based on interviews and literature surveys on the triggers and stoppers for non food crop on contaminated land in Sweden. The report also includes a first estimate of potential marginal land for biofuel production in Sweden. The report is a first step to explore the feasibility of a range of possible approaches to combine risk based land management (RBLM) with non-food crop land-uses and organic matter re-use as appropriate in a Swedish context. The focus of the report is on the treatment of contaminated land by phyto-remediation and on biofuel cultivation. In Sweden, like all other countries in Europe, areas of land have been degraded by past use. Such previously developed land includes areas affected by mining, fallout from industrial processes such as smelting, areas elevated with contaminated dredged sediments, former landfill sites and many other areas where the decline of industrial activity has left a legacy of degraded land and communities. The extent of contamination may not be sufficient to trigger remediation under current regulatory conditions, and there may be little economic incentive to regenerate the affected areas. An ideal solution would be a land management approach that is able to pay for itself. Biomass from coppice or other plantations has long been seen as a possible means of achieving this goal. Phyto remediation offers a low cost method for remediation of areas that are not candidates for conventional regeneration. The optimal conditions for phyto remediation are large land areas of low or mediate contamination. Phyto remediation is also suitable to prevent spreading of contaminants, for example in green areas such as in cities, as waste water buffer and small size remediation areas with diffuse spreading. Phyto remediation implies that plants, fungi or algae are used to remediate, control or increase the natural attenuation of contaminants. Depending on the contaminating species and the site conditions

  3. Biofuel and other biomass based products from contaminated sites - Potentials and barriers from Swedish perspectives

    Energy Technology Data Exchange (ETDEWEB)

    Andersson-Skoeld, Yvonne; Enell, Anja; Rihm, Thomas; Haglund, Kristina; Wik, Ola (Swedish Geotechnical Institute, Linkoeping (Sweden)); Blom, Sonja; Angelbratt, Alexandra (FB Engineering AB, Goeteborg (Sweden)); Bardos, Paul (r3 Environmental Technology Ltd, Reading (United Kingdom)); Track, Thomas (DECHEMA e. V., Frankfurt am Main (Germany)); Keuning, Sytze (Bioclear b.v., Groningen (Netherlands))

    2009-07-01

    In this report, results are presented based on interviews and literature surveys on the triggers and stoppers for non food crop on contaminated land in Sweden. The report also includes a first estimate of potential marginal land for biofuel production in Sweden. The report is a first step to explore the feasibility of a range of possible approaches to combine risk based land management (RBLM) with non-food crop land-uses and organic matter re-use as appropriate in a Swedish context. The focus of the report is on the treatment of contaminated land by phyto-remediation and on biofuel cultivation. In Sweden, like all other countries in Europe, areas of land have been degraded by past use. Such previously developed land includes areas affected by mining, fallout from industrial processes such as smelting, areas elevated with contaminated dredged sediments, former landfill sites and many other areas where the decline of industrial activity has left a legacy of degraded land and communities. The extent of contamination may not be sufficient to trigger remediation under current regulatory conditions, and there may be little economic incentive to regenerate the affected areas. An ideal solution would be a land management approach that is able to pay for itself. Biomass from coppice or other plantations has long been seen as a possible means of achieving this goal. Phyto remediation offers a low cost method for remediation of areas that are not candidates for conventional regeneration. The optimal conditions for phyto remediation are large land areas of low or mediate contamination. Phyto remediation is also suitable to prevent spreading of contaminants, for example in green areas such as in cities, as waste water buffer and small size remediation areas with diffuse spreading. Phyto remediation implies that plants, fungi or algae are used to remediate, control or increase the natural attenuation of contaminants. Depending on the contaminating species and the site conditions

  4. Evidence for Constructive, Self-Regulatory, and Collaborative Processes in Problem-Based Learning

    Science.gov (United States)

    Yew, Elaine H. J.; Schmidt, Henk G.

    2009-01-01

    The goal of this study was to increase our understanding of the learning-oriented verbal interactions taking place between students during the problem-based learning (PBL) cycle. The verbal interactions of one PBL group of five students throughout an entire PBL cycle were recorded in this data-intensive case study. The verbatim transcript…

  5. A watershed-based environmental and regulatory data analysis system for the forest products industry

    Science.gov (United States)

    John Beebe

    2012-01-01

    A watershed-based data analysis system was created as a tool for forest product companies to better understand potential implications from environmental regulations. Also known as the Receiving Water Database (RWDB), this data system was designed with the purpose of assisting companies that own pulp and paper mills, wood product facilities, and commercial timberlands...

  6. Education based thinking and behaving? Towards an identity perspective for studying education differentials in public opinion and political participation

    NARCIS (Netherlands)

    Spruyt, Bram; Kuppens, Toon

    2015-01-01

    Education based thinking and behaving? Towards and identity perspective for studying education differentials in public opinion and political participation Abstract Ever since scholars started studying public opinion and political behaviour, they have reported substantial educational differences.

  7. An inquiry into the concept of infancy care based on the perspective of Islam.

    Science.gov (United States)

    Jafari-Mianaei, Soheila; Alimohammadi, Nasrollah; Banki-Poorfard, Amir-Hossein; Hasanpour, Marzieh

    2017-10-01

    All schools of thought believe that infancy is crucial to the formation and development of the human character. Nevertheless, a search of literature revealed the lack of a clear definition of the concept of 'infancy care based on an Islamic perspective' in nursing texts. As the lack of a clear definition of a concept conveys the inapplicability of that concept to its relevant field and community, this study was conducted to explore and determine the characteristic features of the concept of infancy care based on the perspective of Islam. Walker and Avant's (Strategies for theory construction in nursing. Prentice Hall, Boston, 2011) literary concept synthesis as the manner of concept development approach was conducted. Islamic documents were surveyed without any time limitation. Findings involved the extraction of six main concepts, including God as the Merciful Nurturer, mother as the symbol of the Creativity and Divinity of God, infant as a person with dignity and potential for excellence, parents as the nurture way paver, basic principles of nurturing, and holistic lifelong health promotion. The theoretical definition of each concept was presented. From the perspective of Islam, infant care is the nurturing of a human who has been conceived with dignity, certain rights, identity, and the capacity for development and excellence. © 2017 John Wiley & Sons Ltd.

  8. Advantages and disadvantages of a risk - based regulatory requirement (the experience in Argentina)

    International Nuclear Information System (INIS)

    Baron, Jorge

    2006-01-01

    Argentina has its own nuclear regulations, which include a risk-based criterion curve for the licensing of nuclear installations. This requirement, established in the early '70s, must be fulfilled with a PSA study. It has been applied to several installations, and the advantages and disadvantages of this approach are discussed in the paper through several examples. The main disadvantage is a somehow large amount of PSA work that needs to be performed for the licensing of a nuclear installation. The main advantage is the effective risk reduction that can be achieved by retrofitting the risk-based lessons learned into the design teams (not only for design of systems and components, but also for design of operation, testing and maintenance schemes). (author)

  9. Increasing self-regulatory energy using an Internet-based training application delivered by smartphone technology.

    Science.gov (United States)

    Cranwell, Jo; Benford, Steve; Houghton, Robert J; Golembewski, Michael; Golembewksi, Michael; Fischer, Joel E; Hagger, Martin S

    2014-03-01

    Self-control resources can be defined in terms of "energy." Repeated attempts to override desires and impulses can result in a state of reduced self-control energy termed "ego depletion" leading to a reduced capacity to regulate future self-control behaviors effectively. Regular practice or "training" on self-control tasks may improve an individual's capacity to overcome ego depletion effectively. The current research tested the effectiveness of training using a novel Internet-based smartphone application to improve self-control and reduce ego depletion. In two experiments, participants were randomly assigned to either an experimental group, which received a daily program of self-control training using a modified Stroop-task Internet-based application delivered via smartphone to participants over a 4-week period, or a no-training control group. Participants assigned to the experimental group performed significantly better on post-training laboratory self-control tasks relative to participants in the control group. Findings support the hypothesized training effect on self-control and highlight the effectiveness of a novel Internet-based application delivered by smartphone as a practical means to administer and monitor a self-control training program. The smartphone training application has considerable advantages over other means to train self-control adopted in previous studies in that it has increased ecological validity and enables effective monitoring of compliance with the training program.

  10. Mass spectrometry based proteomics profiling as diagnostic tool in oncology: current status and future perspective.

    Science.gov (United States)

    Findeisen, Peter; Neumaier, Michael

    2009-01-01

    Proteomics analysis has been heralded as a novel tool for identifying new and specific biomarkers that may improve diagnosis and monitoring of various disease states. Recent years have brought a number of proteomics profiling technologies. Although proteomics profiling has resulted in the detection of disease-associated differences and modification of proteins, current proteomics technologies display certain limitations that are hampering the introduction of these new technologies into clinical laboratory diagnostics and routine applications. In this review, we summarize current advances in mass spectrometry based biomarker discovery. The promises and challenges of this new technology are discussed with particular emphasis on diagnostic perspectives of mass-spectrometry based proteomics profiling for malignant diseases.

  11. Barriers to electricity load shift in companies: A survey-based exploration of the end-user perspective

    International Nuclear Information System (INIS)

    Olsthoorn, Mark; Schleich, Joachim; Klobasa, Marian

    2015-01-01

    As countries move toward larger shares of renewable electricity, the slow diffusion of active electricity load management should concern energy policy makers and users alike. Active load management can increase capacity factors and thereby reduce the need for new capacity, improve reliability, and lower electricity prices. This paper conceptually and empirically explores barriers to load shift in industry from an end-user perspective. An online survey, based on a taxonomy of barriers developed in the realm of energy efficiency, was carried out among manufacturing sites in mostly Southern Germany. Findings suggest that the most important barriers are risk of disruption of operations, impact on product quality, and uncertainty about cost savings. Of little concern are access to capital, lack of employee skills, and data security. Statistical tests suggest that companies for which electricity has higher strategic value rate financial and regulatory risk higher than smaller ones. Companies with a continuous production process report lower barrier scores than companies using batch or just-in-time production. A principal component analysis clusters the barriers and multivariate analysis with the factor scores confirms the prominence of technical risk as a barrier to load shift. The results provide guidance for policy making and future empirical studies. - Highlights: • We quantitatively assess barriers to load shift adoption among manufacturing firms. • Conceptually, we build on the literature on barriers to energy efficiency. • The most important barriers are interference with production and with product quality. • Companies with a continuous production process report lower barrier scores. • The barriers to load shift may be organized in distinct clusters via principal component analysis

  12. One safety critical indicators model for regulatory actions on nuclear power plants based on a level 1 PSA

    International Nuclear Information System (INIS)

    Araujo, Jefferson Borges

    2006-03-01

    This study presents a general methodology to the establishment, selection and use of safety indicators for a two loop PWR plant, as Angra 1. The study performed identifies areas considered critical for the plant operational safety. For each of these areas, strategic sub-areas are defined. For each strategic sub-area, specific safety indicators are defined. These proposed Safety Indicators are based on the contribution to risk considering a quantitative risk analysis. For each safety indicator, a goal, a bounded interval and proper bases are developed, to allow for a clear and comprehensive individual behavior evaluation. Additionally, an integrated evaluation of the indicators, using expert systems, was done to obtain an overview of the plant general safety. This methodology can be used for identifying situations where the plant safety is challenged, by giving a general overview of the plant operational condition. Additionally, this study can also identify eventual room for improvements by generating suggestions and recommendations, as a complement for regulatory actions and inspections, focusing resources on eventual existing weaknesses, in order to increase or maintain a high pattern of operational safety. (author)

  13. 77 FR 50172 - Expert Forum on the Use of Performance-Based Regulatory Models in the U.S. Oil and Gas Industry...

    Science.gov (United States)

    2012-08-20

    ... Transportation, Pipeline and Hazardous Materials Safety Administration (PHMSA) invite interested parties to...] Expert Forum on the Use of Performance-Based Regulatory Models in the U.S. Oil and Gas Industry, Offshore... and gas industry. The meeting will take place at the College of the Mainland, and hosted by the Gulf...

  14. Developing Mindfulness in College Students through Movement-Based Courses: Effects on Self-Regulatory Self-Efficacy, Mood, Stress, and Sleep Quality

    Science.gov (United States)

    Caldwell, Karen; Harrison, Mandy; Adams, Marianne; Quin, Rebecca H.; Greeson, Jeffrey

    2010-01-01

    Objective: This study examined whether mindfulness increased through participation in movement-based courses and whether changes in self-regulatory self-efficacy, mood, and perceived stress mediated the relationship between increased mindfulness and better sleep. Participants: 166 college students enrolled in the 2007-2008 academic year in 15 week…

  15. Prediction of Marital Satisfaction based on Coping Skills and Time Perspective

    Directory of Open Access Journals (Sweden)

    سپیده حق شناس

    2018-03-01

    Full Text Available The purpose of this study was to predict marital satisfaction based on coping skills and time perspective. The research method was correlation and the statistical population composed of couples living in the 2nddistrict of Tehran. By convenience sampling method, 250 individuals were selected and were asked to complete the ENRICH Marital Satisfaction Scale, the Lazarus & Folkman’s Coping Styles Questionnaire and the Zimbardo’s Time Perspective Inventory. The results showed that 12.5% of variance of marital satisfa-ction can be explained by the time perspective and the use of coping strategies in couples. The findings also indicated that there was a negative association between emotional coping strategies and marital satisfaction; while, there was no significant relationship between problem-oriented strategies and marital satisfaction. In examining the relationship between views of time and marital satisfaction, the results indicated that there was a negative significant relationship between marital satisfaction with past negative view of time, present hedonistic and believing in present fatalistic. According to the results of t-test for gender differences, there was no significant difference between men and women in marital satisfaction, using coping strategies and time views.

  16. Agent-based modeling of autophagy reveals emergent regulatory behavior of spatio-temporal autophagy dynamics.

    Science.gov (United States)

    Börlin, Christoph S; Lang, Verena; Hamacher-Brady, Anne; Brady, Nathan R

    2014-09-10

    Autophagy is a vesicle-mediated pathway for lysosomal degradation, essential under basal and stressed conditions. Various cellular components, including specific proteins, protein aggregates, organelles and intracellular pathogens, are targets for autophagic degradation. Thereby, autophagy controls numerous vital physiological and pathophysiological functions, including cell signaling, differentiation, turnover of cellular components and pathogen defense. Moreover, autophagy enables the cell to recycle cellular components to metabolic substrates, thereby permitting prolonged survival under low nutrient conditions. Due to the multi-faceted roles for autophagy in maintaining cellular and organismal homeostasis and responding to diverse stresses, malfunction of autophagy contributes to both chronic and acute pathologies. We applied a systems biology approach to improve the understanding of this complex cellular process of autophagy. All autophagy pathway vesicle activities, i.e. creation, movement, fusion and degradation, are highly dynamic, temporally and spatially, and under various forms of regulation. We therefore developed an agent-based model (ABM) to represent individual components of the autophagy pathway, subcellular vesicle dynamics and metabolic feedback with the cellular environment, thereby providing a framework to investigate spatio-temporal aspects of autophagy regulation and dynamic behavior. The rules defining our ABM were derived from literature and from high-resolution images of autophagy markers under basal and activated conditions. Key model parameters were fit with an iterative method using a genetic algorithm and a predefined fitness function. From this approach, we found that accurate prediction of spatio-temporal behavior required increasing model complexity by implementing functional integration of autophagy with the cellular nutrient state. The resulting model is able to reproduce short-term autophagic flux measurements (up to 3

  17. How to Avoid Stereotypes? Evaluation of a Strategy based on Self-Regulatory Processes.

    Science.gov (United States)

    Aranda, María; Montes-Berges, Beatriz

    2016-06-10

    Based on research on the motivational processes involved in preventing and controlling stereotypes, we aimed to assess whether temporary activation of egalitarian goals - by means of a task that gives respondents exposure to a text on gender inequality - can prevent stereotyped answers on the task. The task asks participants to place women and men into a hierarchical organizational structure. Two specific objectives were established: first, to control the effect of prejudice and egalitarian commitment on the dependent variable; and second, to study gender differences in task responses. The study included 474 college students, 153 men and 321 women. Their mean age was 20.04 (SD = 4.43). ANCOVA indicated main effects of condition, F(1) = 4.15, p = .042, η2 = .081 (control condition without goal activation vs. experimental condition with goal activation) and sex, F(1) = 40.46, p stereotyped answers more than participants in the control condition. Furthermore, women's performance on the task was more egalitarian than men's. Finally, there was a significant interaction effect of condition and type of organization, F(2) = 3.97, p = .019, η2 = .017; participants assigning candidates to the feminized organization differed the most across conditions.

  18. Historical perspective, economic analysis, and regulatory analysis of the impacts of waste partitioning-transmutation on the disposal of radioactive wastes

    International Nuclear Information System (INIS)

    Forsberg, C.W.; Croff, A.G.; Kocher, D.C.

    1990-10-01

    Partitioning-transmutation, sometimes called actinide burning, is an alternative approach to high-level radioactive waste management. It consists of removing long-lived radionuclides from wastes and destroying those radionuclides, thus reducing the long-term hazards of radioactive waste. It was studied in detail in the 1970's. New developments in technology and other factors are resulting in a reexamination of this waste management option. This report consists of three papers which summarize the historical work, update the analysis of the costs of waste disposal, and describe current regulatory requirements which might be impacted by P-T. The papers provide a starting point for future research on P-T. 152 refs., 2 figs., 19 tabs

  19. Gym-based exoskeleton walking: A preliminary exploration of non-ambulatory end-user perspectives.

    Science.gov (United States)

    Cahill, Aoife; Ginley, Orna Mc; Bertrand, Courtney; Lennon, Olive

    2018-07-01

    Robotic walking devices (RWD) have shown many physical benefits in Spinal Cord Injury (SCI) rehabilitation. No study to date has explored end-user perceptions of these devices or gained insight into the use of these devices in a gym-based setting. This preliminary study explores the perspectives of four non-ambulatory individuals with SCI on using an exoskeleton walking device in a gym-based community setting. In-depth, semi-structured interviews were conducted with four SCI individuals living in the community. Interviews were audio-recorded and transcribed verbatim. Inductive thematic analysis established common overarching themes and subthemes. Four primary themes emerged addressing "The Psychological Adjustments Around Using RWDs with Respect to Disability", "Perceived Physical, Social and Psychological Benefits of Using an Exoskeleton", "The Role of External Influences", and "A Wellness Model to Health". A fully integrated gym setting was found to provide a positive and encouraging space to utilise the device. In addition, both the ability to set training goals and the positive attitude of robotic trainers were deemed to be important factors. This preliminary study provides detailed perspectives of four non-ambulatory individuals with SCI on utilising an exoskeleton walking device in a community setting. It suggests that gym-based RWDs impact positively on the users' lives and enhance their perceived wellbeing and sense of community integration. Enabling access to similar, community-based facilities should be prioritised for those with longstanding SCI disability. Copyright © 2018 Elsevier Inc. All rights reserved.

  20. SU-F-P-10: A Web-Based Radiation Safety Relational Database Module for Regulatory Compliance

    Energy Technology Data Exchange (ETDEWEB)

    Rosen, C; Ramsay, B; Konerth, S; Roller, D; Ramsay, A [Dade Moeller Health Group, Kalamazoo, MI (United States)

    2016-06-15

    Purpose: Maintaining compliance with Radioactive Materials Licenses is inherently a time-consuming task requiring focus and attention to detail. Staff tasked with these responsibilities, such as the Radiation Safety Officer and associated personnel must retain disparate records for eventual placement into one or more annual reports. Entering results and records in a relational database using a web browser as the interface, and storing that data in a cloud-based storage site, removes procedural barriers. The data becomes more adaptable for mining and sharing. Methods: Web-based code was written utilizing the web framework Django, written in Python. Additionally, the application utilizes JavaScript for front-end interaction, SQL, HTML and CSS. Quality assurance code testing is performed in a sequential style, and new code is only added after the successful testing of the previous goals. Separate sections of the module include data entry and analysis for audits, surveys, quality management, and continuous quality improvement. Data elements can be adapted for quarterly and annual reporting, and for immediate notification of user determined alarm settings. Results: Current advances are focusing on user interface issues, and determining the simplest manner by which to teach the user to build query forms. One solution has been to prepare library documents that a user can select or edit in place of creation a new document. Forms are being developed based upon Nuclear Regulatory Commission federal code, and will be expanded to include State Regulations. Conclusion: Establishing a secure website to act as the portal for data entry, storage and manipulation can lead to added efficiencies for a Radiation Safety Program. Access to multiple databases can lead to mining for big data programs, and for determining safety issues before they occur. Overcoming web programming challenges, a category that includes mathematical handling, is providing challenges that are being overcome.

  1. SU-F-P-10: A Web-Based Radiation Safety Relational Database Module for Regulatory Compliance

    International Nuclear Information System (INIS)

    Rosen, C; Ramsay, B; Konerth, S; Roller, D; Ramsay, A

    2016-01-01

    Purpose: Maintaining compliance with Radioactive Materials Licenses is inherently a time-consuming task requiring focus and attention to detail. Staff tasked with these responsibilities, such as the Radiation Safety Officer and associated personnel must retain disparate records for eventual placement into one or more annual reports. Entering results and records in a relational database using a web browser as the interface, and storing that data in a cloud-based storage site, removes procedural barriers. The data becomes more adaptable for mining and sharing. Methods: Web-based code was written utilizing the web framework Django, written in Python. Additionally, the application utilizes JavaScript for front-end interaction, SQL, HTML and CSS. Quality assurance code testing is performed in a sequential style, and new code is only added after the successful testing of the previous goals. Separate sections of the module include data entry and analysis for audits, surveys, quality management, and continuous quality improvement. Data elements can be adapted for quarterly and annual reporting, and for immediate notification of user determined alarm settings. Results: Current advances are focusing on user interface issues, and determining the simplest manner by which to teach the user to build query forms. One solution has been to prepare library documents that a user can select or edit in place of creation a new document. Forms are being developed based upon Nuclear Regulatory Commission federal code, and will be expanded to include State Regulations. Conclusion: Establishing a secure website to act as the portal for data entry, storage and manipulation can lead to added efficiencies for a Radiation Safety Program. Access to multiple databases can lead to mining for big data programs, and for determining safety issues before they occur. Overcoming web programming challenges, a category that includes mathematical handling, is providing challenges that are being overcome.

  2. Uncovering packaging features of co-regulated modules based on human protein interaction and transcriptional regulatory networks

    Directory of Open Access Journals (Sweden)

    He Weiming

    2010-07-01

    Full Text Available Abstract Background Network co-regulated modules are believed to have the functionality of packaging multiple biological entities, and can thus be assumed to coordinate many biological functions in their network neighbouring regions. Results Here, we weighted edges of a human protein interaction network and a transcriptional regulatory network to construct an integrated network, and introduce a probabilistic model and a bipartite graph framework to exploit human co-regulated modules and uncover their specific features in packaging different biological entities (genes, protein complexes or metabolic pathways. Finally, we identified 96 human co-regulated modules based on this method, and evaluate its effectiveness by comparing it with four other methods. Conclusions Dysfunctions in co-regulated interactions often occur in the development of cancer. Therefore, we focussed on an example co-regulated module and found that it could integrate a number of cancer-related genes. This was extended to causal dysfunctions of some complexes maintained by several physically interacting proteins, thus coordinating several metabolic pathways that directly underlie cancer.

  3. Promoting prosocial behavior and self-regulatory skills in preschool children through a mindfulness-based Kindness Curriculum.

    Science.gov (United States)

    Flook, Lisa; Goldberg, Simon B; Pinger, Laura; Davidson, Richard J

    2015-01-01

    Self-regulatory abilities are robust predictors of important outcomes across the life span, yet they are rarely taught explicitly in school. Using a randomized controlled design, the present study investigated the effects of a 12-week mindfulness-based Kindness Curriculum (KC) delivered in a public school setting on executive function, self-regulation, and prosocial behavior in a sample of 68 preschool children. The KC intervention group showed greater improvements in social competence and earned higher report card grades in domains of learning, health, and social-emotional development, whereas the control group exhibited more selfish behavior over time. Interpretation of effect sizes overall indicate small to medium effects favoring the KC group on measures of cognitive flexibility and delay of gratification. Baseline functioning was found to moderate treatment effects with KC children initially lower in social competence and executive functioning demonstrating larger gains in social competence relative to the control group. These findings, observed over a relatively short intervention period, support the promise of this program for promoting self-regulation and prosocial behavior in young children. They also support the need for future investigation of program implementation across diverse settings.

  4. Perspectives on Resource Recovery from Bio-Based Production Processes: From Concept to Implementation

    DEFF Research Database (Denmark)

    S.B.A. Udugama, Isuru; Mansouri, Seyed Soheil; Mitic, Aleksandar

    2017-01-01

    Recovering valuable compounds from waste streams of bio-based production processes is in line with the circular economy paradigm, and is achievable by implementing “simple-to-use” and well-established process separation technologies. Such solutions are acceptable from industrial, economic...... and environmental points of view, implying relatively easy future implementation on pilot- and full-scale levels in the bio-based industry. Reviewing such technologies is therefore the focus here. Considerations about technology readiness level (TRL) and Net Present Value (NPV) are included in the review, since TRL...... and NPV contribute significantly to the techno-economic evaluation of future and promising process solutions. Based on the present review, a qualitative guideline for resource recovery from bio-based production processes is proposed. Finally, future approaches and perspectives toward identification...

  5. Canadian and international approaches to regulatory effectiveness

    International Nuclear Information System (INIS)

    Lojk, R.

    2014-01-01

    Regulatory effectiveness is an important attribute of any regulator, particularly nuclear regulators. As the nuclear industry has matured, and as the social landscape has changed, so have views on what constitutes regulatory effectiveness. Canada has evolved its regulatory structure and modernized its legislative framework and technical requirements and guidance over time. In addition, Canada continues to collaborate with international agencies, particularly the NEA and the IAEA, to ensure that there is a common understanding of the indicators and key attributes of regulatory effectiveness. This paper discusses Canadian and international views on the subject, including perspectives from other industries. (author)

  6. Nuclear regulatory decision making

    International Nuclear Information System (INIS)

    Wieland, Patricia; Almeida, Ivan Pedro Salati de

    2011-01-01

    The scientific considerations upon which the nuclear regulations are based provide objective criteria for decisions on nuclear safety matters. However, the decisions that a regulatory agency takes go far beyond granting or not an operating license based on assessment of compliance. It may involve decisions about hiring experts or research, appeals, responses to other government agencies, international agreements, etc.. In all cases, top management of the regulatory agency should hear and decide the best balance between the benefits of regulatory action and undue risks and other associated impacts that may arise, including issues of credibility and reputation. The establishment of a decision framework based on well established principles and criteria ensures performance stability and consistency, preventing individual subjectivity. This article analyzes the challenges to the decision-making by regulatory agencies to ensure coherence and consistency in decisions, even in situations where there is uncertainty, lack of reliable information and even divergence of opinions among experts. The article explores the basic elements for a framework for regulatory decision-making. (author)

  7. Regulatory Anatomy

    DEFF Research Database (Denmark)

    Hoeyer, Klaus

    2015-01-01

    This article proposes the term “safety logics” to understand attempts within the European Union (EU) to harmonize member state legislation to ensure a safe and stable supply of human biological material for transplants and transfusions. With safety logics, I refer to assemblages of discourses, le...... they arise. In short, I expose the regulatory anatomy of the policy landscape....

  8. Regulatory Governance

    DEFF Research Database (Denmark)

    Kjær, Poul F.; Vetterlein, Antje

    2018-01-01

    Regulatory governance frameworks have become essential building blocks of world society. From supply chains to the regimes surrounding international organizations, extensive governance frameworks have emerged which structure and channel a variety of social exchanges, including economic, political...... by the International Transitional Administrations (ITAs) in Kosovo and Iraq as well as global supply chains and their impact on the garment industry in Bangladesh....

  9. Is business strategy from a positioning and resource-based perspective relevant for national institutions?

    Directory of Open Access Journals (Sweden)

    AJ Smit

    2014-01-01

    Full Text Available To ascertain whether business strategy is relevant for national institutions a distinction is made between private businesses and institutions as “social business units” of a country. In “social businesses” as well as in private businesses, efficiency is the desired outcome. However, in private businesses it is about sustainable competitive advantage while in institutions it is about policies to resolve the socio and economic problems that a country faces in order to increase welfare of society as a whole. The conclusion is that business strategy form the positioning and resource-based perspectives, does not apply to social businesses such as national institutions.

  10. Model-based nonlinear control of hydraulic servo systems: Challenges, developments and perspectives

    Science.gov (United States)

    Yao, Jianyong

    2018-06-01

    Hydraulic servo system plays a significant role in industries, and usually acts as a core point in control and power transmission. Although linear theory-based control methods have been well established, advanced controller design methods for hydraulic servo system to achieve high performance is still an unending pursuit along with the development of modern industry. Essential nonlinearity is a unique feature and makes model-based nonlinear control more attractive, due to benefit from prior knowledge of the servo valve controlled hydraulic system. In this paper, a discussion for challenges in model-based nonlinear control, latest developments and brief perspectives of hydraulic servo systems are presented: Modelling uncertainty in hydraulic system is a major challenge, which includes parametric uncertainty and time-varying disturbance; some specific requirements also arise ad hoc difficulties such as nonlinear friction during low velocity tracking, severe disturbance, periodic disturbance, etc.; to handle various challenges, nonlinear solutions including parameter adaptation, nonlinear robust control, state and disturbance observation, backstepping design and so on, are proposed and integrated, theoretical analysis and lots of applications reveal their powerful capability to solve pertinent problems; and at the end, some perspectives and associated research topics (measurement noise, constraints, inner valve dynamics, input nonlinearity, etc.) in nonlinear hydraulic servo control are briefly explored and discussed.

  11. Application of a Q Method Study to Understanding Nurses' Perspective of Adopting Evidence-Based Nursing

    Directory of Open Access Journals (Sweden)

    Ruo-Nan Jueng, Ph.D., RN

    2017-12-01

    Full Text Available s u m m a r y: Purpose: This study applied the Q method to identify and describe the various types of nurse perceptions that are crucially associated with their engagement in evidence-based nursing (EBN. Methods: The study participants were nurses at a medical center and a regional teaching hospital. A series of Q sorts was performed by nurses to subjectively rank the Q statements. Q statements were constructed based on the literature related to EBN adoption by nurses and face-to-face interviews. Results: A total of 60 participants were invited to rank 44 Q statements related to EBN. Factor analysis was conducted on the rankings of the Q statements. The following are the five prominent shared perspectives: (1 emphasized the obstacles to evidence searching and reading ability; (2 emphasized the organizational promotive strategies; (3 emphasized the available supportive resources; (4 emphasized the significance of EBN; and (5 emphasized the evidence-searching ability and external incentives. The five identified groups of perspectives can enhance hospital administrators to acknowledge the barriers and incentives associated with EBN practices. Conclusion: The exploration of clustering nurses' perceptions may facilitate the development of customized strategies to enable more appropriate training. Keywords: clinical competence, evidence-based nursing, methods, nursing care

  12. Training Therapists in Evidence-Based Practice: A Critical Review of Studies From a Systems-Contextual Perspective

    OpenAIRE

    Beidas, Rinad S.; Kendall, Philip C.

    2010-01-01

    Evidence-based practice (EBP), a preferred psychological treatment approach, requires training of community providers. The systems-contextual (SC) perspective, a model for dissemination and implementation efforts, underscores the importance of the therapist, client, and organizational variables that influence training and consequent therapist uptake and adoption of EBP. This review critiques the extant research on training in EBP from an SC perspective. Findings suggest that therapist knowled...

  13. Rethinking capital markets reform: a reassessment of Olson problem and regulatory dualism in the German capital markets from a varieties of capitalism perspective

    Directory of Open Access Journals (Sweden)

    André Ziccardi de Carvalho

    2015-09-01

    Full Text Available Since its proposition by Peter A. Hall and David Soskice the Varieties of Capitalism (VoC approach has been particularly important to explain the relationship between economic agents and sets of institutional arrangements that, even in regulatory scenarios that Law and Finance’s school would consider “less than optimal”, are able to generate sustainable economic growth. In this context the VoC approach has been consistently challenging the traditional “one fits all” approach towards capital markets reform usually endorsed by institutions such as the World Bank and the International Monetary Fund, as well as by many scholars and capital markets regulators associated with La Porta’s Law and Finance School. As any theoretical framework, however, the VoC approach also faces its own challenges and still lacks the scientific maturity achieved by the Law and Finance School. Consequently a conciliation between the relational view of the firm proposed by the VoC approach and the overview of corporate governance practices throughout the world presented by the Law and Finance School would be instrumental to construe a more clear understanding of the competitive advantages generated by certain sets of institutions and, at the same time, more accurately assess impacts of reforms that, even if implemented with the legitimate goal of promoting firms’ transparency and higher corporate governance standards, may counter-intuitively generate unprecedented corporate and capital markets crisis. By analyzing two concepts proposed by Ronald J. Gilson, Henry Hansmann and Mariana Pargendler that have an apparent fundamental link to La Porta’s school of Law and Finance (i.e. Olson Problem and Regulatory Dualism through a varieties of capitalism approach, this study aims at rethinking the traditional “one fits all” approach towards capital markets reform and taking a further step in the direction of conciliating the VoC approach with La Porta’s Law

  14. Detecting Internal Control Problems Based on COSO and Islamic Perspective: Case on SMEs

    Directory of Open Access Journals (Sweden)

    Yuniarti Hidayah Suyoso Putra

    2014-03-01

    Full Text Available Objective – The presence of Small Medium Enterprises (SMEs has been able to be livelihoods sources and absorb more labor, even though it has a relative smaller contribution of additional value compared to the Large-scale Enterprises. The number of economic actors of SMEs spread across area from urban to rural. However, SMEs have faced several serious problems. These problems are caused by the unique characteristics of SMEs itself. First, lack of managerial skills due to limited human resources and lack of monitoring which it is rarely conducted by the manager or the owner. Second, lack of information and technology to carry out operations. Both problems have great impacts in lack of internal controls. Third, SMEs also face problems in developing business scale, limited access to capital to the banks and financial institutions due to the lack of transparency. Therefore, this research aimed to detect to what extent of the problems arising in the application and assessment of internal controls performed by SMEs.Method – The research employs descriptive qualitative research method through direct observation, interview and business documentation owned by the company. Research materials are 29 SMEs consisting of 19 trading SMEs and 10 service SMEs. All SMEs are located in Malang city. Detection of application and assessment of internal controls in this study is based on the COSO framework and the Islamic perspective.Result – Internal control activities indicators apply the five principles of COSO framework which focused on three layers. First layer is self-assessment control area. Second layer is environment control area and the third layer is independent control area. While the Islamic perspective is focused on the internal control of business activities based on the Qur'an and Hadith. The results derive from application and assessment based on COSO framework and Islamic perspectives are complementary in improving the practice of internal

  15. Perspective: Toward efficient GaN-based red light emitting diodes using europium doping

    Science.gov (United States)

    Mitchell, Brandon; Dierolf, Volkmar; Gregorkiewicz, Tom; Fujiwara, Yasufumi

    2018-04-01

    While InGaN/GaN blue and green light-emitting diodes (LEDs) are commercially available, the search for an efficient red LED based on GaN is ongoing. The realization of this LED is crucial for the monolithic integration of the three primary colors and the development of nitride-based full-color high-resolution displays. In this perspective, we will address the challenges of attaining red luminescence from GaN under current injection and the methods that have been developed to circumvent them. While several approaches will be mentioned, a large emphasis will be placed on the recent developments of doping GaN with Eu3+ to achieve an efficient red GaN-based LED. Finally, we will provide an outlook to the future of this material as a candidate for small scale displays such as mobile device screens or micro-LED displays.

  16. SCOR based key success factors in cooking oil supply chain buyers perspective in Padang City

    Science.gov (United States)

    Zahara, Fatimah; Hadiguna, Rika Ampuh

    2017-11-01

    Supply chain of cooking oil is a network of companies from palm oil as raw material to retailers which work to create the value and deliver products into the end consumers. This paper is aimed to study key success factors based on consumer's perspective as the last stage in the supply chain. Consumers who are examined in this study are restaurants management or owners. Restaurant is the biggest consumption of cooking oil. The factors is studied based on Supply Chain Operation Reference (SCOR) version 10.0. Factors used are formulated based on the third-level metrics of SCOR Model. Factors are analyzed using factors analysis. This study found factors which become key success factors in managing supply chain of cooking oil encompass reliability, responsiveness and agility. Key success factors can be applied by governments as policy making and cooking oil companies as formulation of the distribution strategies.

  17. Engaging parents in evidence-based treatments in schools: Community perspectives from implementing CBITS.

    Science.gov (United States)

    Santiago, Catherine Decarlo; Pears, Gillian; Baweja, Shilpa; Vona, Pamela; Tang, Jennifer; Kataoka, Sheryl H

    2013-12-01

    This study explored parent engagement in an evidence-based treatment, the Cognitive Behavioral Intervention for Trauma in Schools (CBITS), which was delivered in a school setting. To examine the successes and challenges in engaging parents in this school-based program, we conducted qualitative interviews by phone to obtain data from clinicians, parents, and other school personnel across eleven schools from 3 different regions of the United States. Almost all of these schools served low-income and ethnically diverse communities. We describe general impressions of parent engagement, parent reactions and preferences with regard to CBITS, barriers to parent engagement, and how to overcome barriers from multiple perspectives. Parent engagement across schools varied, with extensive outreach and relatively good parent engagement in CBITS described in some schools, while in other schools, efforts to engage parents were not as consistent. Implications for future efforts to engage parents in school-based treatments are discussed.

  18. BaTiO3-based piezoelectrics: Fundamentals, current status, and perspectives

    Science.gov (United States)

    Acosta, M.; Novak, N.; Rojas, V.; Patel, S.; Vaish, R.; Koruza, J.; Rossetti, G. A.; Rödel, J.

    2017-12-01

    We present a critical review that encompasses the fundamentals and state-of-the-art knowledge of barium titanate-based piezoelectrics. First, the essential crystallography, thermodynamic relations, and concepts necessary to understand piezoelectricity and ferroelectricity in barium titanate are discussed. Strategies to optimize piezoelectric properties through microstructure control and chemical modification are also introduced. Thereafter, we systematically review the synthesis, microstructure, and phase diagrams of barium titanate-based piezoelectrics and provide a detailed compilation of their functional and mechanical properties. The most salient materials treated include the (Ba,Ca)(Zr,Ti)O3, (Ba,Ca)(Sn,Ti)O3, and (Ba,Ca)(Hf,Ti)O3 solid solution systems. The technological relevance of barium titanate-based piezoelectrics is also discussed and some potential market indicators are outlined. Finally, perspectives on productive lines of future research and promising areas for the applications of these materials are presented.

  19. Regulatory and institutional issues impending cleanup at US Department of Energy sites: Perspectives gained from an office of environmental restoration workshop

    Energy Technology Data Exchange (ETDEWEB)

    Fallon, W E; Gephart, J M; Gephart, R E; Quinn, R D; Stevenson, L A

    1991-05-01

    The US Department of Energy's (DOE) nuclear weapons and energy operations are conducted across a nation-wide industrial complex engaged in a variety of manufacturing, processing, testing, and research and development activities. The overall mission of DOE Office of Environmental Restoration and Waste Management (EM) is to protect workers, the public, and the environment from waste materials generated by past, current, and future DOE activities and to bring the DOE complex into compliance with all applicable laws, regulations, and agreements related to health, safety, and the environment. EM addresses this broad mandate through related and interdependent programs that include corrective actions, waste operations, environmental restoration, and technology development. The EM Office of Environmental Restoration (EM-40) recognizes the importance of implementing a complex-wide process to identify and resolve those issues that may impede progress towards site cleanup. As a first step in this process, FM-40 sponsored an exercise to identify and characterize major regulatory and institutional issues and to formulate integrated action steps towards their resolution. This report is the first product of that exercise. It is intended that the exercise described here will mark the beginning of an ongoing process of issue identification, tracking, and resolution that will benefit cleanup activities across the DOE complex.

  20. Regulatory on the corporate social responsibility in the context of sustainable development by mandatory in the world trade organization law perspective (case study in Indonesia

    Directory of Open Access Journals (Sweden)

    SH. M. Hum. TAUFIQURRAHMAN

    2013-12-01

    Full Text Available Regulatory on the Corporate Social Responsibility (CSR by mandatory in Indonesia as stipulated in Article 74 of Law No. 40/2007 on the Limited Liability Company (hereafter the Company Law raises a contradiction. Those who agree argue that the company is not solely for profit, but more than that are participating in social issues and the preservation of the environment within the framework of sustainable development. Conversely, those who disagree view that social issues and the environment are the full responsibility of state. The involvement of a corporation in social and environmental activities is voluntary. Verdict of the Indonesian Constitutional Court in case no. 53/PUU-VI / / 2008 dated 13 April 2009 which rejected a requesting of material test of the Article 74 paragraph (1, (2 and (3 of the Company Law confirms the existence of the CSR by mandatory in international trade traffic today. The analytical results indicates that mandatory CSR regulation in the Company Law is not a form of a state intervention to the private activities. In addition, the arrangement is not contrary to the principles of free trade within the framework of the General Agreement on Tariffs and Trade (GATT / World Trade Organization (WTO.

  1. Strengthening Regulatory Competence in Pakistan

    International Nuclear Information System (INIS)

    Sadiq, M.

    2016-01-01

    Capacity building of Pakistan Nuclear Regulatory Authority is considered an essential element in pursuit of its vision to become a world class regulatory body. Since its inception in 2001, PNRA has continuously endeavoured to invest in its people, develop training infrastructure and impart sound knowledge and professional skills with the aim to improve its regulatory effectiveness. The use of nuclear and radioactive material in Pakistan has increased manifold in recent years, thus induction of more manpower was needed for regulatory oversight. PNRA adopted two pronged approach for meeting the manpower demand (a) employment of university graduates through fast track recruitment drive and (b) induction of graduates by offering fellowships for Master degree programs. Although, the newly employed staff was selected on the basis of their excellent academic qualifications in basic and applied sciences, but they required rigorous knowledge and skills in regulatory perspectives. In order to implement a structured training program, PNRA conducted Training Needs Assessment (TNA) and identified competency gaps of the regulatory staff in legal, technical, regulatory practice and behavioural domains. PNRA took several initiatives for capacity building which included establishment of a training centre for sustainability of trainings, initiation of a fellowship scheme for Master program, attachment of staff at local institutes for on-the-job training and placement at foreign regulatory bodies and organizations for technical development with the assistance of IAEA. The above strategies have been very beneficial in competence building of the PNRA staff to perform all regulatory activities indigenously for nuclear power plants, research reactors and radiation facilities. Provision of vibrant technical support to IAEA and Member States in various programs by PNRA is a landmark of these competence development efforts. This paper summarizes PNRA initiatives and the International Atomic

  2. The core to regulatory reform

    International Nuclear Information System (INIS)

    Partridge, J.W. Jr.

    1993-01-01

    Federal Energy Regulatory Commission (FERC) Orders 436, 500, and 636, the Clean Air Act Amendments of 1990, Public Utility Holding Company Act reform, and the 1992 Energy Policy Act all can have significant effects on an LDC's operations. Such changes in an LDC's environments must be balanced by changes within the utility, its marketplace, and its state regulatory environment. The question is where to start. For Columbia Gas Distribution Cos., based in Columbus, OH, the new operating foundation begins with each employee. Internal strength is critical in designing initiatives that meet the needs of the marketplace and are well-received by regulators. Employees must understand not only the regulatory environment in which the LDC operates, but also how their work contributes to a positive regulatory relationship. To achieve this, Columbia initiated the COntinuing Regulatory Education program, or CORE, in 1991. CORE is a regulatory-focused, information-initiative program coordinated by Columbia's Regulatory Policy, Planning, and Government Affairs Department. The CORE programs can take many forms, such as emerging issue discussions, dialogues with regulators and key parties, updates on regulatory fillings, regulatory policy meetings, and formal training classes. The speakers and discussion facilitators can range from human resource department trainers to senior officers, from regulatory department staff members to external experts, or from state commissioners to executives from other LDCs. The goals of CORE initiatives are to: Support a professional level of regulatory expertise through employee participation in well-developed regulatory programs presented by credible experts. Encourage a constructive state regulatory environment founded on communication and cooperation. CORE achieves these goals via five program levels: introductory basics, advanced learning, professional expertise, crossfunctional dialogues, and external idea exchanges

  3. Perceptions of regulatory approaches

    International Nuclear Information System (INIS)

    Halin, Magnus; Leinonen, Ruusaliisa

    2012-01-01

    Ms. Ruusaliisa Leinonen and Mr. Magnus Halin from Fortum gave a joint presentation on industry perceptions of regulatory oversight of LMfS/SC. It was concluded that an open culture of discussion exists between the regulator (STUK) and the licensee, based on the common goal of nuclear safety. An example was provided of on how regulatory interventions helped foster improvements to individual and collective dose rate trends, which had remained static. Regulatory interventions included discussions on the ALARA concept to reinforce the requirement to continuously strive for improvements in safety performance. Safety culture has also been built into regulatory inspections in recent years. Training days have also been organised by the regulatory body to help develop a shared understanding of safety culture between licensee and regulatory personnel. Fortum has also developed their own training for managers and supervisors. Training and ongoing discussion on LMfS/SC safety culture is considered particularly important because both Fortum and the regulatory body are experiencing an influx of new staff due to the demographic profile of their organisations. It was noted that further work is needed to reach a common understanding of safety culture on a practical level (e.g., for a mechanic setting to work), and in relation to the inspection criteria used by the regulator. The challenges associated with companies with a mix of energy types were also discussed. This can make it more difficult to understand responsibilities and decision making processes, including the role of the parent body organisation. It also makes communication more challenging due to increased complexity and a larger number of stakeholders

  4. A canonical correlation analysis-based dynamic bayesian network prior to infer gene regulatory networks from multiple types of biological data.

    Science.gov (United States)

    Baur, Brittany; Bozdag, Serdar

    2015-04-01

    One of the challenging and important computational problems in systems biology is to infer gene regulatory networks (GRNs) of biological systems. Several methods that exploit gene expression data have been developed to tackle this problem. In this study, we propose the use of copy number and DNA methylation data to infer GRNs. We developed an algorithm that scores regulatory interactions between genes based on canonical correlation analysis. In this algorithm, copy number or DNA methylation variables are treated as potential regulator variables, and expression variables are treated as potential target variables. We first validated that the canonical correlation analysis method is able to infer true interactions in high accuracy. We showed that the use of DNA methylation or copy number datasets leads to improved inference over steady-state expression. Our results also showed that epigenetic and structural information could be used to infer directionality of regulatory interactions. Additional improvements in GRN inference can be gleaned from incorporating the result in an informative prior in a dynamic Bayesian algorithm. This is the first study that incorporates copy number and DNA methylation into an informative prior in dynamic Bayesian framework. By closely examining top-scoring interactions with different sources of epigenetic or structural information, we also identified potential novel regulatory interactions.

  5. A novel method for predicting activity of cis-regulatory modules, based on a diverse training set.

    Science.gov (United States)

    Yang, Wei; Sinha, Saurabh

    2017-01-01

    With the rapid emergence of technologies for locating cis-regulatory modules (CRMs) genome-wide, the next pressing challenge is to assign precise functions to each CRM, i.e. to determine the spatiotemporal domains or cell-types where it drives expression. A popular approach to this task is to model the typical k-mer composition of a set of CRMs known to drive a common expression pattern, and assign that pattern to other CRMs exhibiting a similar k-mer composition. This approach does not rely on prior knowledge of transcription factors relevant to the CRM or their binding motifs, and is thus more widely applicable than motif-based methods for predicting CRM activity, but is also prone to false positive predictions. We present a novel strategy to improve the above-mentioned approach: to predict if a CRM drives a specific gene expression pattern, assess not only how similar the CRM is to other CRMs with similar activity but also to CRMs with distinct activities. We use a state-of-the-art statistical method to quantify a CRM's sequence similarity to many different training sets of CRMs, and employ a classification algorithm to integrate these similarity scores into a single prediction of the CRM's activity. This strategy is shown to significantly improve CRM activity prediction over current approaches. Our implementation of the new method, called IMMBoost, is freely available as source code, at https://github.com/weiyangedward/IMMBoost CONTACT: sinhas@illinois.eduSupplementary information: Supplementary data are available at Bioinformatics online. © The Author 2016. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

  6. Hemoglobin-Based Oxygen Carrier (HBOC) Development in Trauma: Previous Regulatory Challenges, Lessons Learned, and a Path Forward.

    Science.gov (United States)

    Keipert, Peter E

    2017-01-01

    Historically, hemoglobin-based oxygen carriers (HBOCs) were being developed as "blood substitutes," despite their transient circulatory half-life (~ 24 h) vs. transfused red blood cells (RBCs). More recently, HBOC commercial development focused on "oxygen therapeutic" indications to provide a temporary oxygenation bridge until medical or surgical interventions (including RBC transfusion, if required) can be initiated. This included the early trauma trials with HemAssist ® (BAXTER), Hemopure ® (BIOPURE) and PolyHeme ® (NORTHFIELD) for resuscitating hypotensive shock. These trials all failed due to safety concerns (e.g., cardiac events, mortality) and certain protocol design limitations. In 2008 the Food and Drug Administration (FDA) put all HBOC trials in the US on clinical hold due to the unfavorable benefit:risk profile demonstrated by various HBOCs in different clinical studies in a meta-analysis published by Natanson et al. (2008). During standard resuscitation in trauma, organ dysfunction and failure can occur due to ischemia in critical tissues, which can be detected by the degree of lactic acidosis. SANGART'S Phase 2 trauma program with MP4OX therefore added lactate >5 mmol/L as an inclusion criterion to enroll patients who had lost sufficient blood to cause a tissue oxygen debt. This was key to the successful conduct of their Phase 2 program (ex-US, from 2009 to 2012) to evaluate MP4OX as an adjunct to standard fluid resuscitation and transfusion of RBCs. In 2013, SANGART shared their Phase 2b results with the FDA, and succeeded in getting the FDA to agree that a planned Phase 2c higher dose comparison study of MP4OX in trauma could include clinical sites in the US. Unfortunately, SANGART failed to secure new funding and was forced to terminate development and operations in Dec 2013, even though a regulatory path forward with FDA approval to proceed in trauma had been achieved.

  7. Identification of the miRNA-mRNA regulatory network of small cell osteosarcoma based on RNA-seq.

    Science.gov (United States)

    Xie, Lin; Liao, Yedan; Shen, Lida; Hu, Fengdi; Yu, Sunlin; Zhou, Yonghong; Zhang, Ya; Yang, Yihao; Li, Dongqi; Ren, Minyan; Yuan, Zhongqin; Yang, Zuozhang

    2017-06-27

    Small cell osteosarcoma (SCO) is a rare subtype of osteosarcoma characterized by highly aggressive progression and a poor prognosis. The miRNA and mRNA expression profiles of peripheral blood mononuclear cells (PBMCs) were obtained in 3 patients with SCO and 10 healthy individuals using high-throughput RNA-sequencing. We identified 37 dysregulated miRNAs and 1636 dysregulated mRNAs in patients with SCO compared to the healthy controls. Specifically, the 37 dysregulated miRNAs consisted of 27 up-regulated miRNAs and 10 down-regulated miRNAs; the 1636 dysregulated mRNAs consisted of 555 up-regulated mRNAs and 1081 down-regulated mRNAs. The target-genes of miRNAs were predicted, and 1334 negative correlations between miRNAs and mRNAs were used to construct an miRNA-mRNA regulatory network. Dysregulated genes were significantly enriched in pathways related to cancer, mTOR signaling and cell cycle signaling. Specifically, hsa-miR-26b-5p, hsa-miR-221-3p and hsa-miR-125b-2-3p were significantly dysregulated miRNAs and exhibited a high degree of connectivity with target genes. Overall, the expression of dysregulated genes in tumor tissues and peripheral blood samples of patients with SCO measured by quantitative real-time polymerase chain reaction corroborated with our bioinformatics analyses based on the expression profiles of PBMCs from patients with SCO. Thus, hsa-miR-26b-5p, hsa-miR-221-3p and hsa-miR-125b-2-3p may be involved in SCO tumorigenesis.

  8. Lessons from pandemic influenza A(H1N1): the research-based vaccine industry's perspective.

    Science.gov (United States)

    Abelin, Atika; Colegate, Tony; Gardner, Stephen; Hehme, Norbert; Palache, Abraham

    2011-02-01

    As A(H1N1) influenza enters the post-pandemic phase, health authorities around the world are reviewing the response to the pandemic. To ensure this process enhances future preparations, it is essential that perspectives are included from all relevant stakeholders, including vaccine manufacturers. This paper outlines the contribution of R&D-based influenza vaccine producers to the pandemic response, and explores lessons that can be learned to improve future preparedness. The emergence of 2009 A(H1N1) influenza led to unprecedented collaboration between global health authorities, scientists and manufacturers, resulting in the most comprehensive pandemic response ever undertaken, with a number of vaccines approved for use three months after the pandemic declaration. This response was only possible because of the extensive preparations undertaken during the last decade. During this period, manufacturers greatly increased influenza vaccine production capacity, and estimates suggest a further doubling of capacity by 2014. Producers also introduced cell-culture technology, while adjuvant and whole virion technologies significantly reduced pandemic vaccine antigen content. This substantially increased pandemic vaccine production capacity, which in July 2009 WHO estimated reached 4.9 billion doses per annum. Manufacturers also worked with health authorities to establish risk management plans for robust vaccine surveillance during the pandemic. Individual producers pledged significant donations of vaccine doses and tiered-pricing approaches for developing country supply. Based on the pandemic experience, a number of improvements would strengthen future preparedness. Technical improvements to rapidly select optimal vaccine viruses, and processes to speed up vaccine standardization, could accelerate and extend vaccine availability. Establishing vaccine supply agreements beforehand would avoid the need for complex discussions during a period of intense time pressure. Enhancing

  9. Severe accident progression perspectives for Mark I containments based on the IPE results

    International Nuclear Information System (INIS)

    Lin, C.C.; Lehner, J.R.; Pratt, W.T.; Drouin, M.

    1995-01-01

    Based on level 2 analyses in IPE (Individual Plant Examination) submittals accident progression, perspectives were obtained for all containment types. These perspectives consisted of insights on containment failure modes, releases therein, and factors responsible for the results. To illustrate the types of perspectives acquired on severe accident progresssion, insights obtained for (BWR) Mark I containments are discussed here. Mark I containments have high strength but small volumes and rely on pressure suppression pools to condense steam released from the reactor coolant system during an accident. Accidents causing structural failure of the drywell shortly after the core debris melts through the reactor vessel were found to be dominant contributors to risk. Importance of individual containment failure mechanisms depends on plant features and in some cases on modeling assumptions; however the following mechanisms were found important: drywell shell melt-through caused by direct contact with core debris and drywell failure caused by rapid pressure/temperature pulses at time of vessel melt-through. Drywell failure caused by gradual pressure/temperature buildup due to gases and steam released during core/concrete interactions is important in some IPEs. In other IPEs vent was an important contributor. However, accidents that bypass containment (eg interfacing systems LOCA)or involve containment isolation failure were not important contributors to the CDF in any of the IPEs for Mark I plants. These accidents are also not important to risk (even though they can involve large fission product release) because their frequencies of occurrence are so much lower than frequencies of early structural failure caused by other accidents that dominate the CDF

  10. Neuroanatomical correlates of time perspective: A voxel-based morphometry study.

    Science.gov (United States)

    Chen, Zhiyi; Guo, Yiqun; Feng, Tingyong

    2018-02-26

    Previous studies indicated that time perspective can affect many behaviors, such as decisions, risk taking, substance abuse and health behaviors. However, very little is known about the neural substrates of time perspective (TP). To address this question, we characterized different dimensions of TP (including the Past, Present, and Future TP) using standardized Zimbardo Time Perspective Inventory (ZTPI), and quantified the gray matter volume using voxel-based morphometry (VBM) method across two independent samples. Our whole-brain analysis (sample 1, N=150) revealed Past-Negative TP was positively correlated with the GMV of a cluster in LPFC whereas Past-Positive was negatively correlated with the GMV in OFC, and Future TP was negatively correlated with GMV in mPFC. Moreover, two present scales (Present-Hedonistic and Present-Fatalistic TPs) were positively correlated with the GMV of regions in MTG and precuneus, respectively. We further examined the reliability of these correlations between multidimensional TPs and neuroanatomical structures in another independent sample (sample 2, N=58). Results verified our findings that GMV in LPFC could predict Past-Negative TP while GMV in OFC could predict Past-Positive TP, and the GMV in MTG could predict Present-Hedonistic while the GMV in presuneus could predict Present-Fatalistic, as well as the GMV in mPFC could predict Future TP. Thus, our findings suggest that the existence of selective neural basis underlying TPs, and further provide the stable biomarkers for multidimensional TPs. Copyright © 2017 Elsevier B.V. All rights reserved.

  11. Process of Fragment-Based Lead Discovery—A Perspective from NMR

    Directory of Open Access Journals (Sweden)

    Rongsheng Ma

    2016-07-01

    Full Text Available Fragment-based lead discovery (FBLD has proven fruitful during the past two decades for a variety of targets, even challenging protein–protein interaction (PPI systems. Nuclear magnetic resonance (NMR spectroscopy plays a vital role, from initial fragment-based screening to lead generation, because of its power to probe the intrinsically weak interactions between targets and low-molecular-weight fragments. Here, we review the NMR FBLD process from initial library construction to lead generation. We describe technical aspects regarding fragment library design, ligand- and protein-observed screening, and protein–ligand structure model generation. For weak binders, the initial hit-to-lead evolution can be guided by structural information retrieved from NMR spectroscopy, including chemical shift perturbation, transferred pseudocontact shifts, and paramagnetic relaxation enhancement. This perspective examines structure-guided optimization from weak fragment screening hits to potent leads for challenging PPI targets.

  12. Student’s perspectives on Education for Sustainable Development in a problem based learning environment

    DEFF Research Database (Denmark)

    Guerra, Aida; Holgaard, Jette Egelund

    2013-01-01

    at these PBL institutions experience the strength of this pedagogy when being educated for sustainability. This paper aims to investigate how students perceive and integrate ESD in a PBL environment. Results exemplify how PBL moves beyond awareness about sustainability as the problem based learning model......In a society characterized by fast technological advances and increasing pressure on economic, ecological as well as social systems, it is important to educate engineers with a broader, reflective and sustainable perspective in alignment with their professional practice. This poses challenges...... to most engineering programmes, and scholars argue that a paradigm shift is needed to developing engineering education (EE) to embrace education for sustainable development (ESD). However, some of the more innovative pedagogies as for example problem based and project organised learning (PBL) already seem...

  13. [Health promotion based on assets: how to work with this perspective in local interventions?

    Science.gov (United States)

    Cofiño, Rafael; Aviñó, Dory; Benedé, Carmen Belén; Botello, Blanca; Cubillo, Jara; Morgan, Antony; Paredes-Carbonell, Joan Josep; Hernán, Mariano

    2016-11-01

    An asset-based approach could be useful to revitalise health promotion or community health interventions combining work with multiple partnerships, positive health, community engagement, equity and orientation of health determinants. We set some recommendations about how to incorporate the assets model in programmes, projects and interventions in health promotion. Some techniques are described for assets mapping and some experiences with this methodology being developed in different regions are systematised. We propose the term "Asset-based Health Promotion/Community Health" as an operational definition to work at the local level with a community engagement and participatory approach, building alliances between different institutions at the state-regional level and trying to create a framework for action with the generation of evaluations and evidence to work on population interventions from the perspective of positive health. Copyright © 2016 SESPAS. All rights reserved.

  14. Youth Perspectives on Meaningful Participation in Community Based Programs: A Qualitative Assessment

    Directory of Open Access Journals (Sweden)

    Sherer W. Royce

    2009-12-01

    Full Text Available Allowing the voiceless to have a voice is a tenet of empowerment. This paper highlights research that employed a participatory action research framework to gain a better understanding of young people’s perceptions about youth empowerment and acquire their perspective (voice about the meaningfulness of participation in out-of-school advocacy and volunteer program activities. Using Photovoice, the research provides a missing point of view in youth empowerment model development. Results indicate that the quality of a youth’s participation in a community-based program is determined by 1 youth expressing themselves without censorship, 2 occasions for youth to expand their social networks with youth and adults, and 3 adults observing and valuing youth contributions. These findings raise implications for community-based, youth empowerment programs including program philosophy, program procedures, youth empowerment content and activities, and adult leadership style. The findings may assist practitioners when designing youth empowering activities and researchers when operationalizing youth empowerment.

  15. Nuclear regulatory decision making

    International Nuclear Information System (INIS)

    2005-01-01

    The fundamental objective of all nuclear safety regulatory bodies is to ensure that nuclear utilities operate their plants at all times in an acceptably safe manner. In meeting this objective, the regulatory body should strive to ensure that its regulatory decisions are technically sound, consistent from case to case, and timely. In addition, the regulator must be aware that its decisions and the circumstances surrounding those decisions can affect how its stakeholders, such as government policy makers, the industry it regulates, and the public, view it as an effective and credible regulator. In order to maintain the confidence of those stakeholders, the regulator should make sure that its decisions are transparent, have a clear basis in law and regulations, and are seen by impartial observers to be fair to all parties. Based on the work of a Nuclear Energy Agency (NEA) expert group, this report discusses some of the basic principles and criteria that a regulatory body should consider in making decisions and describes the elements of an integrated framework for regulatory decision making. (author)

  16. Impact of regulatory spin of pioglitazone on prescription of antidiabetic drugs among physicians in India: A multicentre questionnaire-based observational study

    Directory of Open Access Journals (Sweden)

    Aman Goyal

    2017-01-01

    Interpretation & conclusions: Majority of the physicians though were aware of the regulatory changes with regard to pioglitazone, but their prescribing patterns were not changed for this drug. However, it was being used at lower than the recommended dose. There is a need for generating more evidence through improved pharmacovigilance activities and large-scale population-based prospective studies regarding the safety issues of pioglitazone, so as to make effectual risk-benefit analysis for its continual use in T2DM.

  17. A completely new design and regulatory process - A risk-based approach for new nuclear power plants. Annex 17

    International Nuclear Information System (INIS)

    Ritterbusch, S.E.

    2002-01-01

    In the de-regulated electric power market place that is developing in the USA, competition from alternative electric power sources has provided significant downward pressure on the costs of new construction projects. Studies by the Electric Power Research Institute have shown that, in the USA, the capital cost of new nuclear plants must be decreased by at least 35% to 40% relative to the cost of Advanced Light Water Reactors designed in the early 1990s in order to be competitive with capital costs of gas-fired electric power plants. The underlying reasons for the high capital costs estimated for some nuclear plants are (1) long construction times, (2) the high level of 'defense-in-depth' or safety margin, included throughout the design and licensing process, and (3) the use of out-dated design methods and information. Probabilistic Safety Assessments are being used to develop a more accurate assessment of real plant risk and to provide relief if it can be demonstrated that plant equipment is not providing a significant contribution to plant safety. Westinghouse addressed some of these cost drivers in the development of the AP-600 passive plant design. However, because of relatively inexpensive natural gas plant alternative, we need to reduce the costs even further. Therefore, the AP-600 design is now being up-rated to a 1000 MWe design, AP-1000. The development of AP1000 is described in another paper being presented at this meeting. Westinghouse is also managing a project, sponsored by the US Department of Energy, which is aimed at developing an all-new 'risk-based' approach to design and regulation. Methodologies being developed use risk-based information to the extent practical and 'defense-in-depth' only when necessary to address uncertainties in models and equipment performance. Early results, summarized in this paper, include (1) the initial framework for a new design and regulatory process and (2) a sample design analysis which shows that the Emergency Core

  18. Understanding the Pathological Basis of Neurological Diseases Through Diagnostic Platforms Based on Innovations in Biomedical Engineering: New Concepts and Theranostics Perspectives

    Directory of Open Access Journals (Sweden)

    Laura Ganau

    2018-02-01

    Full Text Available The pace of advancement of genomics and proteomics together with the recent understanding of the molecular basis behind rare diseases could lead in the near future to significant advances in the diagnosing and treating of many pathological conditions. Innovative diagnostic platforms based on biomedical engineering (microdialysis and proteomics, biochip analysis, non-invasive impedance spectroscopy, etc. are introduced at a rapid speed in clinical practice: this article primarily aims to highlight how such platforms will advance our understanding of the pathological basis of neurological diseases. An overview of the clinical challenges and regulatory hurdles facing the introduction of such platforms in clinical practice, as well as their potential impact on patient management, will complement the discussion on foreseeable theranostic perspectives. Indeed, the techniques outlined in this article are revolutionizing how we (1 identify biomarkers that better define the diagnostic criteria of any given disease, (2 develop research models, and (3 exploit the externalities coming from innovative pharmacological protocols (i.e., those based on monoclonal antibodies, nanodrugs, etc. meant to tackle the molecular cascade so far identified.

  19. Moving from Rule-based to Principle-based in Public Sector: Preparers' Perspective

    OpenAIRE

    Roshayani Arshad; Normah Omar; Siti Fatimah Awang

    2013-01-01

    The move from cash accounting to accrual accounting, or rule-based to principle-based accounting, by many governments is part of an ongoing efforts in promoting a more business-like and performance-focused public sector. Using questionnaire responses from preparers of financial statements of public universities in Malaysia, this study examines the implementation challenges and benefits of principle-based accounting. Results from these responses suggest that most respondents perceived signific...

  20. Perspectives of Community- and Faith-Based Organizations about Partnering with Local Health Departments for Disasters

    Directory of Open Access Journals (Sweden)

    Michael Stajura

    2012-06-01

    Full Text Available Public health emergency planners can better perform their mission if they develop and maintain effective relationships with community- and faith-based organizations in their jurisdictions. This qualitative study presents six themes that emerged from 20 key informant interviews representing a wide range of American community- and faith-based organizations across different types of jurisdictions, organizational types, and missions. This research seeks to provide local health department public health emergency planners with tools to assess and improve their inter-organizational community relationships. The themes identified address the importance of community engagement, leadership, intergroup dynamics and communication, and resources. Community- and faith-based organizations perceive that they are underutilized or untapped resources with respect to public health emergencies and disasters. One key reason for this is that many public health departments limit their engagement with community- and faith-based organizations to a one-way “push” model for information dissemination, rather than engaging them in other ways or improving their capacity. Beyond a reprioritization of staff time, few other resources would be required. From the perspective of community- and faith-based organizations, the quality of relationships seems to matter more than discrete resources provided by such ties.

  1. [The Perspectives and Expectations of New Nursing Graduates Regarding the Hospital-Based Nursing Students Scholarship].

    Science.gov (United States)

    Chen, Kuan-Ling; Tsai, Yun-Fang; Shao, Jung-Hua; Shyu, Yea-Ing

    2016-10-01

    The hospital-based scholarship is a relatively recent incentive used by hospitals to recruit new nursing graduates. Few studies have explored the impact of these scholarship programs on hospital recruitment. To explore the perspectives and expectations of new nursing graduates on the application of a hospital-based scholarship for nursing students. This study used a qualitative research approach. Purposive sampling was used to recruit 20 new nursing graduates from one university in northern Taiwan in 2013. Content analysis was applied to analyze the data. Two themes were identified by participants who had applied for a hospital-based scholarship: "aspire to be a nursing-scholarship recipient and work towards this aspiration" and "look forward to receiving a nursing-scholarship and imagine possible features of the future life." One theme was identified by participants who had not applied for a hospital-based scholarship: "agree with the policy of hospital-based scholarship but resist the restrictions on their life." Although both groups agreed that the scholarship program helped relieve financial stresses, participants who had applied for the scholarship tended to hold positive and aggressive attitudes towards the nursing scholarship. Conversely, participants who had not applied for the scholarship did so due to the perceived conflicts between the scholarship and their career plans. It is recommended to consider providing career-planning assistance to new graduates and to arrange that students who sign a scholarship contract have their clinical practice in their working unit in order to improve adaptation.

  2. Perspectives of community- and faith-based organizations about partnering with local health departments for disasters.

    Science.gov (United States)

    Stajura, Michael; Glik, Deborah; Eisenman, David; Prelip, Michael; Martel, Andrea; Sammartinova, Jitka

    2012-07-01

    Public health emergency planners can better perform their mission if they develop and maintain effective relationships with community- and faith-based organizations in their jurisdictions. This qualitative study presents six themes that emerged from 20 key informant interviews representing a wide range of American community- and faith-based organizations across different types of jurisdictions, organizational types, and missions. This research seeks to provide local health department public health emergency planners with tools to assess and improve their inter-organizational community relationships. The themes identified address the importance of community engagement, leadership, intergroup dynamics and communication, and resources. Community- and faith-based organizations perceive that they are underutilized or untapped resources with respect to public health emergencies and disasters. One key reason for this is that many public health departments limit their engagement with community- and faith-based organizations to a one-way "push" model for information dissemination, rather than engaging them in other ways or improving their capacity. Beyond a reprioritization of staff time, few other resources would be required. From the perspective of community- and faith-based organizations, the quality of relationships seems to matter more than discrete resources provided by such ties.

  3. Elucidating the hard/soft acid/base principle: A perspective based on half-reactions

    International Nuclear Information System (INIS)

    Ayers, Paul W.; Parr, Robert G.; Pearson, Ralph G.

    2006-01-01

    A comprehensive analysis is presented for the acid-base double-exchange reaction as well as the associated acid-displacement and base-displacement 'half-reactions' with the goal of elucidating the meaning of the hard/soft acid/base (HSAB) principle and the conditions for its validity. When electron-transfer effects are important and other effects are negligible, the HSAB principle is driven by the surpassing stability of the soft acid/soft base product. When electrostatic effects dominate the reactivity, the HSAB principle is driven by the surpassing stability of the hard acid/hard base product. Because electron-transfer effects favor soft/soft interactions, while electrostatic effects favor hard/hard interactions, acid-base exchange reactions may be used to determine whether a reagent's reactivity is dominated by electron-transfer or by electrostatic effects. Because electron-transfer and electrostatic considerations separately favor the HSAB principle whenever the electronic chemical potentials of the acids and bases involved in the reaction are similar, our analysis provides strong support for the HSAB principle. The electronic chemical potential measures the intrinsic strength of acids and bases

  4. Blockchains and Bitcoin: Regulatory responses to cryptocurrencies

    OpenAIRE

    Guadamuz, Andres; Marsden, Chris

    2015-01-01

    This paper examines Bitcoin from a legal and regulatory perspective, answering several important questions.\\ud \\ud We begin by explaining what Bitcoin is, and why it matters. We describe problems with Bitcoin as a method of implementing a cryptocurrency. This introduction to cryptocurrencies allows us eventually to ask the inevitable question: is it legal? What are the regulatory responses to the currency? Can it be regulated?\\ud \\ud We make clear why virtual currencies are of interest, how s...

  5. Determination of the Regulatory Asset Base of power distribution companies. Background report of 'Guidelines for price cap regulation in the Dutch electricity sector'

    International Nuclear Information System (INIS)

    Tjin, T.; Buitelaar, T.

    2000-02-01

    July 1999 The Netherlands Electricity Regulatory Service (DtE) published an Information and Consultation Document on the subject of 'Price Cap Regulation in the Dutch Electricity Sector'. By means of price cap regulation tariffs are determined such that businesses are stimulated continuously to organize their total processes and operation as efficient as possible. In the consultation document a large number of questions with respect to the future organization and planning of the system of economic regulation of the electricity sector in the Netherlands can be found. Many reactions and answers were received, compiled and analyzed. The results are presented in the main report, which forms the framework for the DtE to shape the economic regulation of the Dutch electricity sector. In this background document attention is paid to a method to determine the Regulatory Asset Base (RAB)

  6. INQUIRY –BASED LEARNING FOR ENHANCING CRITICAL THINKING SKILLS: INDONESIAN STUDENTS‘ PERSPECTIVES

    Directory of Open Access Journals (Sweden)

    Hersulastuti Hersulastuti

    2017-12-01

    Full Text Available This paper was mainly intended to shed light on students‘ response towards the implementation of Inquiry-Based Learning (IBL in Reading and Writing subject, and explore its benefits for enhancing critical thinking skills from students‘perspectives in ELT context. This research was conducted through a qualitative case study approach. Three students of graduate program were purposively selected to be the participants. Data were gathered primarily from observation notes and interviews, and then further analyzed using interractive model analysis as proposed by Miles & Huberman (1994. The findings demonstrate that students have good responses towards the implementation of IBL. Moreover, IBL is beneficial to make students become more self-directed, selfdisciplined, self-monitored thinkers. Through IBL, students develop their critical thinking abilities: 1 raise vital questions and problems; 2 gather and assess relevant information; 3 drawing well-reasoned conclusions; and 4 communicate effectively with others to seek solution to complex problems.

  7. [Psychotherapy of patients with brain lesions: an integrative model based on neuropsychological and psychodynamic perspectives].

    Science.gov (United States)

    Ouss-Ryngaert, Lisa

    2010-12-01

    Our model of psychotherapy for patients with brain lesions is based on an integrative approach of psychobehavioral symptoms, especially from the neuropsychological and psychodynamic perspectives. Adjustment of technical modalities and aims of psychoanalytical therapy is required for these patients. The analysis of the influence of cognitive disorders on transference and contre-transference plays a major role, including the role of procedural processes in changes in the intersubjective relationship between the patient and the therapist. Two vignettes are presented to illustrate our model, which respects the integrity of the cognitive and psychodynamic approaches and can be implemented by only one therapist, using alternatively each lecture, or by a working team bringing to light the different aspects of the same symptom.

  8. Analysis of Different Feature Selection Criteria Based on a Covariance Convergence Perspective for a SLAM Algorithm

    Science.gov (United States)

    Auat Cheein, Fernando A.; Carelli, Ricardo

    2011-01-01

    This paper introduces several non-arbitrary feature selection techniques for a Simultaneous Localization and Mapping (SLAM) algorithm. The feature selection criteria are based on the determination of the most significant features from a SLAM convergence perspective. The SLAM algorithm implemented in this work is a sequential EKF (Extended Kalman filter) SLAM. The feature selection criteria are applied on the correction stage of the SLAM algorithm, restricting it to correct the SLAM algorithm with the most significant features. This restriction also causes a decrement in the processing time of the SLAM. Several experiments with a mobile robot are shown in this work. The experiments concern the map reconstruction and a comparison between the different proposed techniques performance. The experiments were carried out at an outdoor environment composed by trees, although the results shown herein are not restricted to a special type of features. PMID:22346568

  9. Broadening the cancer and cognition landscape: the role of self-regulatory challenges.

    Science.gov (United States)

    Arndt, Jamie; Das, Enny; Schagen, Sanne B; Reid-Arndt, Stephanie A; Cameron, Linda D; Ahles, Tim A

    2014-01-01

    The potentially detrimental effects of cancer and related treatments on cognitive functioning have emerged as one of the key foci of cancer survivorship research, but little is known about how psychological variables other than depression influence these relationships. To illustrate the potential of social psychological perspectives, we examine how a self-regulatory analysis and specific self-regulatory challenges of contending with cancer-related expectancies and stereotypes provide conceptual frameworks for understanding some of the potential causes and consequences of cancer-related cognitive deficits. Literatures on cancer-related cognitive deficits, self-regulatory ego depletion, expectancy stereotypes, and their points of convergence are briefly reviewed. A review and conceptual integration of relevant literatures suggest that coping with cancer can impair self-regulatory capacity. There is an overlap between cognitive deficits associated with self-regulatory challenge and with cancer and its treatment, and restoring self-regulatory resources can attenuate cancer-related cognitive deficits. Examination of specific regulatory challenges of contending with expectancies and stereotypes related to treatment suggests insights that can inform when and among whom cognitive deficits may most likely emerge. Integrating social psychological ideas with a substantial knowledge base can illustrate novel research trajectories that can deepen our understanding of cancer-related cognitive deficits and their impact on psychosocial well-being. Copyright © 2013 John Wiley & Sons, Ltd.

  10. The Political Economy of Regulatory Change

    DEFF Research Database (Denmark)

    Buch-Hansen, Hubert

    2012-01-01

    This article aims to explain the broader evolution of British merger control. To this end it outlines a novel critical political economy perspective on regulation and regulatory change which differs from established political economy approaches, such as the regulatory capitalism/state perspectives...... to the analysis of the evolution of British merger control provides some important new insights, most notably that the content, form, and scope of merger control in Britain have been deeply transformed in accordance with neoliberal ideas since the 1980s and that this process, which was part of a broader...

  11. Perspectives on the changing healthcare system: teaching systems-based practice to medical residents

    Directory of Open Access Journals (Sweden)

    Johanna Martinez

    2013-09-01

    Full Text Available Purpose: The Accreditation Council for Graduate Medical Education restructured its accreditation system to be based on educational outcomes in six core competencies. Systems-based practice is one of the six core competencies. The purpose of this report is to describe Weill Cornell Medical College's Internal Medicine Residency program curriculum for systems-based practice (SBP and its evaluation process. Methods: To examine potential outcomes of the POCHS curriculum, an evaluation was conducted, examining participants': (1 knowledge gain; (2 course ratings; and (3 qualitative feedback. Results: On average, there was a 19 percentage point increase in knowledge test scores for all three cohorts. The course was rated overall highly, receiving an average of 4.6 on a 1–5 scale. Lastly, the qualitative comments supported that the material is needed and valued. Conclusion: The course, entitled Perspectives on the Changing Healthcare System (POCHS and its evaluation process support that systems-based practice is crucial to residency education. The course is designed not only to educate residents about the current health care system but also to enable them to think critically about the risk and benefits of the changes. POCHS provides a framework for teaching and assessing this competency and can serve as a template for other residency programs looking to create or restructure their SBP curriculum.

  12. A Versatile Method to Design Stem-Loop Primer-Based Quantitative PCR Assays for Detecting Small Regulatory RNA Molecules

    OpenAIRE

    Czimmerer, Zsolt; Hulvely, Julianna; Simandi, Zoltan; Varallyay, Eva; Havelda, Zoltan; Szabo, Erzsebet; Varga, Attila; Dezso, Balazs; Balogh, Maria; Horvath, Attila; Domokos, Balint; Torok, Zsolt; Nagy, Laszlo; Balint, Balint L.

    2013-01-01

    Short regulatory RNA-s have been identified as key regulators of gene expression in eukaryotes. They have been involved in the regulation of both physiological and pathological processes such as embryonal development, immunoregulation and cancer. One of their relevant characteristics is their high stability, which makes them excellent candidates for use as biomarkers. Their number is constantly increasing as next generation sequencing methods reveal more and more details of their synthesis. T...

  13. Engineering nucleases for gene targeting: safety and regulatory considerations.

    Science.gov (United States)

    Pauwels, Katia; Podevin, Nancy; Breyer, Didier; Carroll, Dana; Herman, Philippe

    2014-01-25

    Nuclease-based gene targeting (NBGT) represents a significant breakthrough in targeted genome editing since it is applicable from single-celled protozoa to human, including several species of economic importance. Along with the fast progress in NBGT and the increasing availability of customized nucleases, more data are available about off-target effects associated with the use of this approach. We discuss how NBGT may offer a new perspective for genetic modification, we address some aspects crucial for a safety improvement of the corresponding techniques and we also briefly relate the use of NBGT applications and products to the regulatory oversight. Copyright © 2013 Elsevier B.V. All rights reserved.

  14. Cis-regulatory signatures of orthologous stress-associated bZIP transcription factors from rice, sorghum and Arabidopsis based on phylogenetic footprints

    Directory of Open Access Journals (Sweden)

    Xu Fuyu

    2012-09-01

    Full Text Available Abstract Background The potential contribution of upstream sequence variation to the unique features of orthologous genes is just beginning to be unraveled. A core subset of stress-associated bZIP transcription factors from rice (Oryza sativa formed ten clusters of orthologous groups (COG with genes from the monocot sorghum (Sorghum bicolor and dicot Arabidopsis (Arabidopsis thaliana. The total cis-regulatory information content of each stress-associated COG was examined by phylogenetic footprinting to reveal ortholog-specific, lineage-specific and species-specific conservation patterns. Results The most apparent pattern observed was the occurrence of spatially conserved ‘core modules’ among the COGs but not among paralogs. These core modules are comprised of various combinations of two to four putative transcription factor binding site (TFBS classes associated with either developmental or stress-related functions. Outside the core modules are specific stress (ABA, oxidative, abiotic, biotic or organ-associated signals, which may be functioning as ‘regulatory fine-tuners’ and further define lineage-specific and species-specific cis-regulatory signatures. Orthologous monocot and dicot promoters have distinct TFBS classes involved in disease and oxidative-regulated expression, while the orthologous rice and sorghum promoters have distinct combinations of root-specific signals, a pattern that is not particularly conserved in Arabidopsis. Conclusions Patterns of cis-regulatory conservation imply that each ortholog has distinct signatures, further suggesting that they are potentially unique in a regulatory context despite the presumed conservation of broad biological function during speciation. Based on the observed patterns of conservation, we postulate that core modules are likely primary determinants of basal developmental programming, which may be integrated with and further elaborated by additional intrinsic or extrinsic signals in

  15. A versatile method to design stem-loop primer-based quantitative PCR assays for detecting small regulatory RNA molecules.

    Directory of Open Access Journals (Sweden)

    Zsolt Czimmerer

    Full Text Available Short regulatory RNA-s have been identified as key regulators of gene expression in eukaryotes. They have been involved in the regulation of both physiological and pathological processes such as embryonal development, immunoregulation and cancer. One of their relevant characteristics is their high stability, which makes them excellent candidates for use as biomarkers. Their number is constantly increasing as next generation sequencing methods reveal more and more details of their synthesis. These novel findings aim for new detection methods for the individual short regulatory RNA-s in order to be able to confirm the primary data and characterize newly identified subtypes in different biological conditions. We have developed a flexible method to design RT-qPCR assays that are very sensitive and robust. The newly designed assays were tested extensively in samples from plant, mouse and even human formalin fixed paraffin embedded tissues. Moreover, we have shown that these assays are able to quantify endogenously generated shRNA molecules. The assay design method is freely available for anyone who wishes to use a robust and flexible system for the quantitative analysis of matured regulatory RNA-s.

  16. Regulatory Benchmarking

    DEFF Research Database (Denmark)

    Agrell, Per J.; Bogetoft, Peter

    2017-01-01

    Benchmarking methods, and in particular Data Envelopment Analysis (DEA), have become well-established and informative tools for economic regulation. DEA is now routinely used by European regulators to set reasonable revenue caps for energy transmission and distribution system operators. The appli......Benchmarking methods, and in particular Data Envelopment Analysis (DEA), have become well-established and informative tools for economic regulation. DEA is now routinely used by European regulators to set reasonable revenue caps for energy transmission and distribution system operators....... The application of bench-marking in regulation, however, requires specific steps in terms of data validation, model specification and outlier detection that are not systematically documented in open publications, leading to discussions about regulatory stability and economic feasibility of these techniques...

  17. Regulatory Benchmarking

    DEFF Research Database (Denmark)

    Agrell, Per J.; Bogetoft, Peter

    2017-01-01

    Benchmarking methods, and in particular Data Envelopment Analysis (DEA), have become well-established and informative tools for economic regulation. DEA is now routinely used by European regulators to set reasonable revenue caps for energy transmission and distribution system operators. The appli......Benchmarking methods, and in particular Data Envelopment Analysis (DEA), have become well-established and informative tools for economic regulation. DEA is now routinely used by European regulators to set reasonable revenue caps for energy transmission and distribution system operators....... The application of benchmarking in regulation, however, requires specific steps in terms of data validation, model specification and outlier detection that are not systematically documented in open publications, leading to discussions about regulatory stability and economic feasibility of these techniques...

  18. Anti-regulatory T cells

    DEFF Research Database (Denmark)

    Andersen, Mads Hald

    2017-01-01

    responses to tumours or inhibiting autoimmunity development. However, recent studies report the discovery of self-reactive pro-inflammatory T cells—termed anti-regulatory T cells (anti-Tregs)—that target immune-suppressive cells. Thus, regulatory cells can now be defined as both cells that suppress immune...... reactions as well as effector cells that counteract the effects of suppressor cells and support immune reactions. Self-reactive anti-Tregs have been described that specifically recognize human leukocyte antigen-restricted epitopes derived from proteins that are normally expressed by regulatory immune cells......Our initial understanding of immune-regulatory cells was based on the discovery of suppressor cells that assure peripheral T-cell tolerance and promote immune homeostasis. Research has particularly focused on the importance of regulatory T cells (Tregs) for immune modulation, e.g. directing host...

  19. Trans-sialidase-based vaccine candidate protects against Trypanosoma cruzi infection, not only inducing an effector immune response but also affecting cells with regulatory/suppressor phenotype

    Science.gov (United States)

    Prochetto, Estefanía; Roldán, Carolina; Bontempi, Iván A.; Bertona, Daiana; Peverengo, Luz; Vicco, Miguel H.; Rodeles, Luz M.; Pérez, Ana R.; Marcipar, Iván S.; Cabrera, Gabriel

    2017-01-01

    Prophylactic and/or therapeutic vaccines have an important potential to control Trypanosoma cruzi (T. cruzi)infection. The involvement of regulatory/suppressor immune cells after an immunization treatment and T. cruzi infection has never been addressed. Here we show that a new trans-sialidase-based immunogen (TSf) was able to confer protection, correlating not only with beneficial changes in effector immune parameters, but also influencing populations of cells related to immune control. Regarding the effector response, mice immunized with TSf showed a TS-specific antibody response, significant delayed-type hypersensitivity (DTH) reactivity and increased production of IFN-γ by CD8+ splenocytes. After a challenge with T. cruzi, TSf-immunized mice showed 90% survival and low parasitemia as compared with 40% survival and high parasitemia in PBS-immunized mice. In relation to the regulatory/suppressor arm of the immune system, after T. cruzi infection TSf-immunized mice showed an increase in spleen CD4+ Foxp3+ regulatory T cells (Treg) as compared to PBS-inoculated and infected mice. Moreover, although T. cruzi infection elicited a notable increase in myeloid derived suppressor cells (MDSC) in the spleen of PBS-inoculated mice, TSf-immunized mice showed a significantly lower increase of MDSC. Results presented herein highlight the need of studying the immune response as a whole when a vaccine candidate is rationally tested. PMID:28938533

  20. RNA-ID, a highly sensitive and robust method to identify cis-regulatory sequences using superfolder GFP and a fluorescence-based assay.

    Science.gov (United States)

    Dean, Kimberly M; Grayhack, Elizabeth J

    2012-12-01

    We have developed a robust and sensitive method, called RNA-ID, to screen for cis-regulatory sequences in RNA using fluorescence-activated cell sorting (FACS) of yeast cells bearing a reporter in which expression of both superfolder green fluorescent protein (GFP) and yeast codon-optimized mCherry red fluorescent protein (RFP) is driven by the bidirectional GAL1,10 promoter. This method recapitulates previously reported progressive inhibition of translation mediated by increasing numbers of CGA codon pairs, and restoration of expression by introduction of a tRNA with an anticodon that base pairs exactly with the CGA codon. This method also reproduces effects of paromomycin and context on stop codon read-through. Five key features of this method contribute to its effectiveness as a selection for regulatory sequences: The system exhibits greater than a 250-fold dynamic range, a quantitative and dose-dependent response to known inhibitory sequences, exquisite resolution that allows nearly complete physical separation of distinct populations, and a reproducible signal between different cells transformed with the identical reporter, all of which are coupled with simple methods involving ligation-independent cloning, to create large libraries. Moreover, we provide evidence that there are sequences within a 9-nt library that cause reduced GFP fluorescence, suggesting that there are novel cis-regulatory sequences to be found even in this short sequence space. This method is widely applicable to the study of both RNA-mediated and codon-mediated effects on expression.

  1. The Relative Effect of Team-Based Learning on Motivation and Learning: A Self-Determination Theory Perspective

    Science.gov (United States)

    Jeno, Lucas M.; Raaheim, Arild; Kristensen, Sara Madeleine; Kristensen, Kjell Daniel; Hole, Torstein Nielsen; Haugland, Mildrid J.; Mæland, Silje

    2017-01-01

    We investigate the effects of team-based learning (TBL) on motivation and learning in a quasi-experimental study. The study employs a self-determination theory perspective to investigate the motivational effects of implementing TBL in a physiotherapy course in higher education. We adopted a one-group pretest-posttest design. The results show that…

  2. The Impact of Students' Temporal Perspectives on Time-on-Task and Learning Performance in Game Based Learning

    Science.gov (United States)

    Romero, Margarida; Usart, Mireia

    2013-01-01

    The use of games for educational purposes has been considered as a learning methodology that attracts the students' attention and may allow focusing individuals on the learning activity through the [serious games] SG game dynamic. Based on the hypothesis that students' Temporal Perspective has an impact on learning performance and time-on-task,…

  3. Time Series Analysis of Non-Gaussian Observations Based on State Space Models from Both Classical and Bayesian Perspectives

    NARCIS (Netherlands)

    Durbin, J.; Koopman, S.J.M.

    1998-01-01

    The analysis of non-Gaussian time series using state space models is considered from both classical and Bayesian perspectives. The treatment in both cases is based on simulation using importance sampling and antithetic variables; Monte Carlo Markov chain methods are not employed. Non-Gaussian

  4. Fresh Faces, New Places: Moving beyond Teacher-Researcher Perspectives in Hip-Hop-Based Education Research

    Science.gov (United States)

    Irby, Decoteau J.; Hall, H. Bernard

    2011-01-01

    Grounded in critical and culturally relevant theory, hip-hop-based education (HHBE) research documents the use of hip-hop in educational settings. Despite the richness of the emerging field, overreliance on teacher-researcher perspectives leaves much to be desired. Little is known of the extent and ways HHBE is used by nonresearching K-12…

  5. How Perspective-Taking Helps and Hinders Group-Based Guilt as a Function of Group Identification

    NARCIS (Netherlands)

    Zebel, Sven; Doosje, Bertjan; Spears, Russell

    In two studies we hypothesized that outgroup perspective-taking promotes group-based guilt among weakly identified perpetrator group members, but hinders it among higher identifiers. In Study 1, native Dutch participants (N = 153) confronted their group's past mistreatment of outgroups, while

  6. Work-based assessment: qualitative perspectives of novice nutrition and dietetics educators.

    Science.gov (United States)

    Palermo, C; Beck, E J; Chung, A; Ash, S; Capra, S; Truby, H; Jolly, B

    2014-10-01

    The assessment of competence for health professionals including nutrition and dietetics professionals in work-based settings is challenging. The present study aimed to explore the experiences of educators involved in the assessment of nutrition and dietetics students in the practice setting and to identify barriers and enablers to effective assessment. A qualitative research approach using in-depth interviews was employed with a convenience sample of inexperienced dietitian assessors. Interviews explored assessment practices and challenges. Data were analysed using a thematic approach within a phenomenological framework. Twelve relatively inexperienced practice educators were purposefully sampled to take part in the present study. Three themes emerged from these data. (i) Student learning and thus assessment is hindered by a number of barriers, including workload demands and case-mix. Some workplaces are challenged to provide appropriate learning opportunities and environment. Adequate support for placement educators from the university, managers and their peers and planning are enablers to effective assessment. (ii) The role of the assessor and their relationship with students impacts on competence assessment. (iii) There is a lack of clarity in the tasks and responsibilities of competency-based assessment. The present study provides perspectives on barriers and enablers to effective assessment. It highlights the importance of reflective practice and feedback in assessment practices that are synonymous with evidence from other disciplines, which can be used to better support a work-based competency assessment of student performance. © 2013 The British Dietetic Association Ltd.

  7. EFFECTIVE BLENDED LEARNING PRACTICES: Evidence-based Perspectives in ICT-facilitated Education

    Directory of Open Access Journals (Sweden)

    Reviewed by Yasin OZARSLAN

    2009-07-01

    Full Text Available EFFECTIVE BLENDED LEARNING PRACTICES:Evidence-based Perspectives in ICT-facilitated EducationEdited by Elizabeth Stacey and Philippa Gerbic, Information ScienceReference; 1 edition (March 30, 2009, ISBN-10: 1605662968, 358 pp.Reviewed by Yasin OZARSLANFaculty of Education,Eskisehir Osmangazi University,Eskisehir-TURKEYBlended learning refers to the integration of faceto-face and online learning activities with the goal of maximizing the value of students' experiences in both settings. This book collects new international research into many aspects of blended learningfrom the perspectives of learners, teachers, designers, and professional and academic developers in various disciplines, learningcommunities and universities from around the world. This book addresses the relative newness of online learning within blended environments. The book's broader audience is anyone who isinterested in areas such as blended learning, communities of learning, virtual education, professional learning and community development, instructional technology, flexible learning, distance education and collaborative learning.Blended approaches in teacher education, blending collaborative online learning,blended learning and teaching philosophies, campus-based student learning environments, ICT-enhanced blended learning, learning communities for K-12 teachers, professional development for blended learning, reciprocal mentoring,redesigning initial teacher education, responses to blended environments, strategiesfor blended teaching and learning, virtual learning and real communities are the topics covered in this book.It reviews literature about blended learning in relation to the three sections of the book and discusses strategies for teaching and learning and establishing communities in its different contexts. The chapters of this book provide research perspectives on a range of blended learning issues and contexts and discuss implications for teaching and learning. The

  8. Perspective of Value-Based Management of Spinal Disorders in Brazil.

    Science.gov (United States)

    Teles, Alisson R; Righesso, Orlando; Gullo, Maria Carolina R; Ghogawala, Zoher; Falavigna, Asdrubal

    2016-03-01

    The state of value-based management of spinal disorders and ongoing Brazilian strategies toward its implementation are highlighted in this article. The health care system, economic impact of spine surgery, use of patient-reported outcomes, ongoing studies about health economics, and current strategies toward implementation of quality assessment of spine care in Brazil are reviewed. During the past 20 years, there has been an increase of 226% in the number and 540% in the total cost of spine surgeries in the public health system. Examples of economic regulatory mechanisms involve the process of health technology assessment and the auditing processes imposed by health insurance companies. Some barriers to implementing clinical registries were identified from a large Latin American survey. Strategies based on education and technical support have been conducted to improve the quality of comparative-effectiveness research in spine care. Only 1 cost-utility study on spine care has been published until now. The paradigm of value-based management of spinal disorders is still incipient in Brazil. Some issues from our analysis must be emphasized: (1) Brazil presents many regional disparities and scarce resources for health care; it is crucial for the health system to allocate resources based on the value of interventions; (2) because of the high economic and social burden of developing new technologies for diagnosis and treatment, research in health economics of spine care in Brazil should be prioritized; (3) these efforts would help to provide a more accessible and effective health system for patients with spinal problems. Copyright © 2016 Elsevier Inc. All rights reserved.

  9. Studying Vegetation Salinity: From the Field View to a Satellite-Based Perspective

    Directory of Open Access Journals (Sweden)

    Rachel Lugassi

    2017-02-01

    Full Text Available Salinization of irrigated lands in the semi-arid Jezreel Valley, Northern Israel results in soil-structure deterioration and crop damage. We formulated a generic rule for estimating salinity of different vegetation types by studying the relationship between Cl/Na and different spectral slopes in the visible–near infrared–shortwave infrared (VIS–NIR–SWIR spectral range using both field measurements and satellite imagery (Sentinel-2. For the field study, the slope-based model was integrated with conventional partial least squares (PLS analyses. Differences in 14 spectral ranges, indicating changes in salinity levels, were identified across the VIS–NIR–SWIR region (350–2500 nm. Next, two different models were run using PLS regression: (i using spectral slope data across these ranges; and (ii using preprocessed spectral reflectance. The best model for predicting Cl content was based on continuum removal reflectance (R2 = 0.84. Satisfactory correlations were obtained using the slope-based PLS model (R2 = 0.77 for Cl and R2 = 0.63 for Na. Thus, salinity contents in fresh plants could be estimated, despite masking of some spectral regions by water absorbance. Finally, we estimated the most sensitive spectral channels for monitoring vegetation salinity from a satellite perspective. We evaluated the recently available Sentinel-2 imagery’s ability to distinguish variability in vegetation salinity levels. The best estimate of a Sentinel-2-based vegetation salinity index was generated based on a ratio between calculated slopes: the 490–665 nm and 705–1610 nm. This index was denoted as the Sentinel-2-based vegetation salinity index (SVSI (band 4 − band 2/(band 5 + band 11.

  10. Perspective on the Ongoing Replacement of Artificial and Animal-Based Dyes with Alternative Natural Pigments in Foods and Beverages.

    Science.gov (United States)

    Schweiggert, Ralf M

    2018-03-28

    This perspective highlights current trends, advances, and challenges related to the replacement of artificial dyes and the insect-based carmine with alternative natural pigments. Briefly reviewing the history of food coloration, key publications and public events leading to diverse concerns about artificial dyes and carmine will be summarized. An overview about promising alternatives in the market and those under development is provided, including a separate section on coloring foodstuffs. The perspective aims at supporting readers to keep abreast with the enormous efforts undertaken by the food and beverage industry to replace certain food dyes.

  11. Chemistry Based on Renewable Raw Materials: Perspectives for a Sugar Cane-Based Biorefinery

    Directory of Open Access Journals (Sweden)

    Murillo Villela Filho

    2011-01-01

    Full Text Available Carbohydrates are nowadays a very competitive feedstock for the chemical industry because their availability is compatible with world-scale chemical production and their price, based on the carbon content, is comparable to that of petrochemicals. At the same time, demand is rising for biobased products. Brazilian sugar cane is a competitive feedstock source that is opening the door to a wide range of bio-based products. This essay begins with the importance of the feedstock for the chemical industry and discusses developments in sugar cane processing that lead to low cost feedstocks. Thus, sugar cane enables a new chemical industry, as it delivers a competitive raw material and a source of energy. As a result, sugar mills are being transformed into sustainable biorefineries that fully exploit the potential of sugar cane.

  12. Network-based Modeling of Mesoscale Catchments - The Hydrology Perspective of Glowa-danube

    Science.gov (United States)

    Ludwig, R.; Escher-Vetter, H.; Hennicker, R.; Mauser, W.; Niemeyer, S.; Reichstein, M.; Tenhunen, J.

    Within the GLOWA initiative of the German Ministry for Research and Educa- tion (BMBF), the project GLOWA-Danube is funded to establish a transdisciplinary network-based decision support tool for water related issues in the Upper Danube wa- tershed. It aims to develop and validate integration techniques, integrated models and integrated monitoring procedures and to implement them in the network-based De- cision Support System DANUBIA. An accurate description of processes involved in energy, water and matter fluxes and turnovers requires an intense collaboration and exchange of water related expertise of different scientific disciplines. DANUBIA is conceived as a distributed expert network and is developed on the basis of re-useable, refineable, and documented sub-models. In order to synthesize a common understand- ing between the project partners, a standardized notation of parameters and functions and a platform-independent structure of computational methods and interfaces has been established using the Unified Modeling Language UML. DANUBIA is object- oriented, spatially distributed and raster-based at its core. It applies the concept of "proxels" (Process Pixel) as its basic object, which has different dimensions depend- ing on the viewing scale and connects to its environment through fluxes. The presented study excerpts the hydrological view point of GLOWA-Danube, its approach of model coupling and network based communication (using the Remote Method Invocation RMI), the object-oriented technology to simulate physical processes and interactions at the land surface and the methodology to treat the issue of spatial and temporal scal- ing in large, heterogeneous catchments. The mechanisms applied to communicate data and model parameters across the typical discipline borders will be demonstrated from the perspective of a land-surface object, which comprises the capabilities of interde- pendent expert models for snowmelt, soil water movement, runoff formation, plant

  13. Elucidating the Small Regulatory RNA Repertoire of the Sea Anemone Anemonia viridis Based on Whole Genome and Small RNA Sequencing.

    Science.gov (United States)

    Urbarova, Ilona; Patel, Hardip; Forêt, Sylvain; Karlsen, Bård Ove; Jørgensen, Tor Erik; Hall-Spencer, Jason M; Johansen, Steinar D

    2018-02-01

    Cnidarians harbor a variety of small regulatory RNAs that include microRNAs (miRNAs) and PIWI-interacting RNAs (piRNAs), but detailed information is limited. Here, we report the identification and expression of novel miRNAs and putative piRNAs, as well as their genomic loci, in the symbiotic sea anemone Anemonia viridis. We generated a draft assembly of the A. viridis genome with putative size of 313 Mb that appeared to be composed of about 36% repeats, including known transposable elements. We detected approximately equal fractions of DNA transposons and retrotransposons. Deep sequencing of small RNA libraries constructed from A. viridis adults sampled at a natural CO2 gradient off Vulcano Island, Italy, identified 70 distinct miRNAs. Eight were homologous to previously reported miRNAs in cnidarians, whereas 62 appeared novel. Nine miRNAs were recognized as differentially expressed along the natural seawater pH gradient. We found a highly abundant and diverse population of piRNAs, with a substantial fraction showing ping-pong signatures. We identified nearly 22% putative piRNAs potentially targeting transposable elements within the A. viridis genome. The A. viridis genome appeared similar in size to that of other hexacorals with a very high divergence of transposable elements resembling that of the sea anemone genus Exaiptasia. The genome encodes and expresses a high number of small regulatory RNAs, which include novel miRNAs and piRNAs. Differentially expressed small RNAs along the seawater pH gradient indicated regulatory gene responses to environmental stressors. © The Author(s) 2018. Published by Oxford University Press on behalf of the Society for Molecular Biology and Evolution.

  14. On the Origin of Pantepui montane biotas: A Perspective Based on the Phylogeny of Aulacorhynchus toucanets.

    Directory of Open Access Journals (Sweden)

    Elisa Bonaccorso

    Full Text Available To understand the origin of Pantepui montane biotas, we studied the biogeography of toucanets in the genus Aulacorhynchus. These birds are ideal for analyzing historical relationships among Neotropical montane regions, given their geographic distribution from Mexico south to Bolivia, including northern Venezuela (Cordillera de la Costa, and the Pantepui. Analyses were based on molecular phylogenies using mitochondrial and nuclear DNA sequences. Topology tests were applied to compare alternative hypotheses that may explain the current distribution of Aulacorhynchus toucanets, in the context of previous hypotheses of the origin of Pantepui montane biotas. Biogeographic reconstructions in RASP and Lagrange were used to estimate the ancestral area of the genus, and an analysis in BEAST was used to estimate a time framework for its diversification. A sister relationship between the Pantepui and Andes+Cordillera de la Costa was significantly more likely than topologies indicating other hypothesis for the origin of Pantepui populations. The Andes was inferred as the ancestral area for Aulacorhynchus, and the group has diversified since the late Miocene. The biogeographic patterns found herein, in which the Andes are the source for biotas of other regions, are consistent with those found for flowerpiercers and tanagers, and do not support the hypothesis of the geologically old Pantepui as a source of Neotropical montain diversity. Based on the high potential for cryptic speciation and isolation of Pantepui populations, we consider that phylogenetic studies of additional taxa are important from a conservation perspective.

  15. A Framework for Cloud Based E-Government from the Perspective of Developing Countries

    Directory of Open Access Journals (Sweden)

    Pusp Raj Joshi

    2017-11-01

    Full Text Available Despite significant efforts to initiate electronic government projects, developing countries are still struggling to reap the benefits of using e-government services. An effective implementation of e-government infrastructure is necessary to increase the efficiency and transparency of the government services. There are several studies that observed causes like lack of infrastructure support, lack of payment gateway and improper e-government service delivery channel as main barriers to a wider adoption of e-government services. The main contribution of this research is to propose a cloud-based G2G (Government-to-government e-government framework for a viable e-government solution from the perspective of developing countries. We have introduced a list of concepts and a systematic process to guide the implementation of e-government project based on the government’s vision, goals, chosen services through the service delivery channel to the appropriate cloud service and deployment model. We have used Nepal as a context of the case study and applied the framework to a real e-government project of driving licensing department using action research methodology. The results from the study show that the G2G approach of e-government implementation would be the best for providing effective government services to the stakeholders of developing countries. The proposed framework also supports a smooth integration of government services and reduces the time of the overall project.

  16. VALIDITY IN COMPUTER-BASED TESTING: A LITERATURE REVIEW OF COMPARABILITY ISSUES AND EXAMINEE PERSPECTIVES

    Directory of Open Access Journals (Sweden)

    Ika Kana Trisnawati

    2015-05-01

    Full Text Available These past years have seen the growing popularity of the Computer-Based Tests (CBTs in various disciplines, for various purposes, although the Paper-and Pencil Based Tests (P&Ps are still in use. However, many question on whether the use of CBTs outperform the effectiveness of the P&Ps or if the CBTs can become a valid measuring tool compared to the PBTs. This paper tries to present the comparison on both the CBTs and the P&Ps and their respective examinee perspectives in order to figure out if doubts should arise to the emergence of the CBTs over the classic P&Ps. Findings showed that the CBTs are advantageous in that they are both efficient (reducing testing time and effective (maintaining the test reliability over the P&P versions. Nevertheless, the CBTs still need to have their variables well-designed (e.g., study design, computer algorithm in order for the scores to be comparable to those in the P&P tests since the score equivalence is one of the validity evidences needed in a CBT.

  17. Empirical research on risk taking of listed financial institutions based on the perspective of corporate governance

    Directory of Open Access Journals (Sweden)

    Chen Hao

    2017-03-01

    Full Text Available After the financial crisis in 2008, the risk control of financial institutions has once again become the focus of attention. This paper selects the unbalanced panel data of 44 listed financial institutions in China from 2009 to 2013 for empirical analysis to study the risk taking of China’s listed financial institutions based on the perspective of corporate governance. Then the paper analyzes the effect of corporate governance on the risk taking of listed financial institutions based on the empirical analysis from four aspects. The results indicate that there is a significant negative correlation between the proportion of the largest shareholder’s shareholding and risk taking; a significant positive correlation between the size of the board of supervisors and risk taking; a significant positive correlation between the executive pay and risk taking, and a significant negative correlation between the equity incentive and risk taking. By comparison, the factors related to governance of board of directors have no significant effect on the risk taking of listed financial institutions.

  18. Scientific, economic, regulatory, and ethical challenges of bringing science-based pediatric nutrition products to the U.S. market and ensuring their availability for patients.

    Science.gov (United States)

    Merritt, Russell J; Goldsmith, Arthur H

    2014-11-01

    Many nutrition products and related drugs are unavailable or not consistently available to clinicians despite a body of clinical data and experience supporting their use. Many of these can be related to drug shortages that have increased since 2009. In addition, there are potentially useful products that are not approved for a specific use or are no longer being manufactured. This review broadly examines the product availability gap from the perspectives of a clinician/former nutrition industry medical director and an economist. The process of pediatric nutrition product and related drug innovation, as well as its drivers and the steps involved in bringing a product to market, is first described. This is followed by an assessment of factors influencing product availability beyond the innovation process, including regulatory issues, manufacturing compliance, purchasing practices, and other factors related to drug and nutrition product pricing and reimbursement. Three pediatric case examples are reviewed and placed in the context of the prior review. Last, recent and future possible steps toward closing the product availability gap are discussed. © 2014 American Society for Parenteral and Enteral Nutrition.

  19. Empirical investigation to explore factors that achieve high quality of mobile learning system based on students’ perspectives

    Directory of Open Access Journals (Sweden)

    Mohammed Amin Almaiah

    2016-09-01

    Full Text Available This study presents three frameworks for mobile learning system based on quality factors derived from the updated DeLone and McLean information system success model. This study used the questionnaire as a quantitative method to explore quality factors for mobile learning system based on perspectives of 392 students. This study opens future work for using the identified quality factors as guidelines for researchers and designers to design and develop mobile learning applications.

  20. Students' Perceptions of Teaching in Context-based and Traditional Chemistry Classrooms: Comparing content, learning activities, and interpersonal perspectives

    Science.gov (United States)

    Overman, Michelle; Vermunt, Jan D.; Meijer, Paulien C.; Bulte, Astrid M. W.; Brekelmans, Mieke

    2014-07-01

    Context-based curriculum reforms in chemistry education are thought to bring greater diversity to the ways in which chemistry teachers organize their teaching. First and foremost, students are expected to perceive this diversity. However, empirical research on how students perceive their teacher's teaching in context-based chemistry classrooms, and whether this teaching differs from traditional chemistry lessons, is scarce. This study aims to develop our understanding of what teaching looks like, according to students, in context-based chemistry classrooms compared with traditional chemistry classrooms. As such, it might also provide a better understanding of whether teachers implement and attain the intentions of curriculum developers. To study teacher behaviour we used three theoretical perspectives deemed to be important for student learning: a content perspective, a learning activities perspective, and an interpersonal perspective. Data were collected from 480 students in 24 secondary chemistry classes in the Netherlands. Our findings suggest that, according to the students, the changes in teaching in context-based chemistry classrooms imply a lessening of the emphasis on fundamental chemistry and the use of a teacher-centred approach, compared with traditional chemistry classrooms. However, teachers in context-based chemistry classrooms seem not to display more 'context-based' teaching behaviour, such as emphasizing the relation between chemistry, technology, and society and using a student-centred approach. Furthermore, students in context-based chemistry classrooms perceive their teachers as having less interpersonal control and showing less affiliation than teachers in traditional chemistry classrooms. Our findings should be interpreted in the context of former and daily experiences of both teachers and students. As only chemistry is reformed in the schools in which context-based chemistry is implemented, it is challenging for both students and teachers to

  1. Cis-regulatory element based targeted gene finding: genome-wide identification of abscisic acid- and abiotic stress-responsive genes in Arabidopsis thaliana.

    Science.gov (United States)

    Zhang, Weixiong; Ruan, Jianhua; Ho, Tuan-Hua David; You, Youngsook; Yu, Taotao; Quatrano, Ralph S

    2005-07-15

    A fundamental problem of computational genomics is identifying the genes that respond to certain endogenous cues and environmental stimuli. This problem can be referred to as targeted gene finding. Since gene regulation is mainly determined by the binding of transcription factors and cis-regulatory DNA sequences, most existing gene annotation methods, which exploit the conservation of open reading frames, are not effective in finding target genes. A viable approach to targeted gene finding is to exploit the cis-regulatory elements that are known to be responsible for the transcription of target genes. Given such cis-elements, putative target genes whose promoters contain the elements can be identified. As a case study, we apply the above approach to predict the genes in model plant Arabidopsis thaliana which are inducible by a phytohormone, abscisic acid (ABA), and abiotic stress, such as drought, cold and salinity. We first construct and analyze two ABA specific cis-elements, ABA-responsive element (ABRE) and its coupling element (CE), in A.thaliana, based on their conservation in rice and other cereal plants. We then use the ABRE-CE module to identify putative ABA-responsive genes in A.thaliana. Based on RT-PCR verification and the results from literature, this method has an accuracy rate of 67.5% for the top 40 predictions. The cis-element based targeted gene finding approach is expected to be widely applicable since a large number of cis-elements in many species are available.

  2. Regulatory RNAs derived from transfer RNA?

    Science.gov (United States)

    Pederson, Thoru

    2010-10-01

    Four recent studies suggest that cleavages of transfer RNAs generate products with microRNA-like features, with some evidence of function. If their regulatory functions were to be confirmed, these newly revealed RNAs would add to the expanding repertoire of small noncoding RNAs and would also provide new perspectives on the coevolution of transfer RNA and messenger RNA.

  3. Characteristics and Impact of Imperviousness From a GIS-based Hydrological Perspective

    Science.gov (United States)

    Moglen, G. E.; Kim, S.

    2005-12-01

    hydrological response is more sensitive to spatially distributed imperviousness or aggregate (lumped) imperviousness. The regressions between indicators of hydrological response and imperviousness-descriptors were evaluated by examining goodness-of-fit measures such as explained variance or relative standard error. The results show that imperviousness estimates using land use are better predictors of flow variability and thermal variability than imperviousness estimates using land cover. Also, this study reveals that flow variability is more sensitive to spatially distributed models than lumped models, while thermal variability is equally responsive to both models. The findings from this study can be further examined from a policy perspective with regard to policies that are based on a threshold concept for imperviousness impacts on the ecological and hydrological system.

  4. Regulatory perspective on accident management issues

    International Nuclear Information System (INIS)

    Barrett, R.J.

    1988-01-01

    Effective response to reactor accidents requires a combination of emergency operations, technical support and emergency response. The NRC and industry have actively pursued programs to assure the adequacy of emergency operations and emergency response. These programs will continue to receive high priority. By contrast, the technical support function has received relatively little attention from NRC and the industry. The results from numerous PRA studies and the severe accident programs of NRC and the industry have yielded a wealth of insights on prevention and mitigation of severe accidents. The NRC intends to work with the industry to make these insights available to the technical support staffs through a combination of guidance, training and periodic drills

  5. Regulatory perspectives on human factors validation

    International Nuclear Information System (INIS)

    Harrison, F.; Staples, L.

    2001-01-01

    Validation is an important avenue for controlling the genesis of human error, and thus managing loss, in a human-machine system. Since there are many ways in which error may intrude upon system operation, it is necessary to consider the performance-shaping factors that could introduce error and compromise system effectiveness. Validation works to this end by examining, through objective testing and measurement, the newly developed system, procedure or staffing level, in order to identify and eliminate those factors which may negatively influence human performance. It is essential that validation be done in a high-fidelity setting, in an objective and systematic manner, using appropriate measures, if meaningful results are to be obtained, In addition, inclusion of validation work in any design process can be seen as contributing to a good safety culture, since such activity allows licensees to eliminate elements which may negatively impact on human behaviour. (author)

  6. Senior executives' perspectives of integrated reporting regulatory ...

    African Journals Online (AJOL)

    kirstam

    2014-12-09

    Dec 9, 2014 ... that integrated thinking and integrated reporting principles will have ... in response to financial, governance and other crises; heightened expectations of ... The Prince's Accounting for Sustainability Project suggests a concept.

  7. Using Logarithmic Fuzzy Preference Programming To Prioritization Social Media Utilization Based On Tourists’ Perspective

    Directory of Open Access Journals (Sweden)

    Balouchi Mina

    2015-06-01

    Full Text Available The advent of Web 2.0 or social media technologies gives travelers a chance to access quickly and conveniently to a mass of travel-related information. This study investigates the importance of social media in travel process in three different phases (pre-visit, on site, post-visit from the perspective of Iranian travelers. It is worthwhile to know the level of influence of social media on respondents’ travel behavior. Logarithmic fuzzy preference programming methodology is used in this article to determine the importance of social media usage in each phase of travel process and its subcategories. Fuzzy analytic hierarchy process methodology, based on Chang’s Fuzzy Extent Analysis is also used for the data analysis, then the results of these two methods are presented for comparison and better understanding. The results of this study suggest that the most usage of social media is on pre-visit phase while post-visit has the least usage. This study shows that Iranian travelers use social media mainly to share experiences (post-visit phase, get help in different circumstances and gain travel advice.

  8. Faith-based perspectives on the use of chimeric organisms for medical research.

    Science.gov (United States)

    Degeling, Chris; Irvine, Rob; Kerridge, Ian

    2014-04-01

    Efforts to advance our understanding of neurodegenerative diseases involve the creation chimeric organisms from human neural stem cells and primate embryos--known as prenatal chimeras. The existence of potential mentally complex beings with human and non-human neural apparatus raises fundamental questions as to the ethical permissibility of chimeric research and the moral status of the creatures it creates. Even as bioethicists find fewer reasons to be troubled by most types of chimeric organisms, social attitudes towards the non-human world are often influenced by religious beliefs. In this paper scholars representing eight major religious traditions provide a brief commentary on a hypothetical case concerning the development and use of prenatal human-animal chimeric primates in medical research. These commentaries reflect the plurality and complexity within and between religious discourses of our relationships with other species. Views on the moral status and permissibility of research on neural human animal chimeras vary. The authors provide an introduction to those who seek a better understanding of how faith-based perspectives might enter into biomedical ethics and public discourse towards forms of biomedical research that involves chimeric organisms.

  9. The bacterial rhizobiome of hyperaccumulators: future perspectives based on omics analysis and advanced microscopy

    Directory of Open Access Journals (Sweden)

    Giovanna eVisioli

    2015-01-01

    Full Text Available Hyperaccumulators are plants that can extract heavy metal ions from the soil and translocate those ions to the shoots, where they are sequestered and detoxified. Hyperaccumulation depends not only on the availability of mobilized metal ions in the soil, but also on the enhanced activity of metal transporters and metal chelators which may be provided by the plant or its associated microbes. The rhizobiome is captured by plant root exudates from the complex microbial community in the soil, and may colonize the root surface or infiltrate the root cortex. This community can increase the root surface area by inducing hairy root proliferation. It may also increase the solubility of metals in the rhizosphere and promote the uptake of soluble metals by the plant. The bacterial rhizobiome, a subset of specialized microorganisms that colonize the plant rhizosphere and endosphere, makes an important contribution to the hyperaccumulator phenotype. In this review, we discuss classic and more recent tools that are used to study the interactions between hyperaccumulators and the bacterial rhizobiome, and consider future perspectives based on the use of omics analysis and microscopy to study plant metabolism in the context of metal accumulation. Recent data suggest that metal-resistant bacteria isolated from the hyperaccumulator rhizosphere and endosphere could be useful in applications such as phytoextraction and phytoremediation, although more research is required to determine whether such properties can be transferred successfully to non-accumulator species.

  10. Corrosion in PWR stainless steel components: a TSO perspective based on operating experience and expertises

    International Nuclear Information System (INIS)

    Curieres, I. de

    2015-01-01

    Stainless steels are used commonly in many circuits of a nuclear power plant. Particularly, they are the prime materials for the inside surface of the primary circuit. Their operating experience has been good, though a number of cases of degradations due to corrosion have been reported the last ten years. This number of events is increasing and many studies of damaged parts become available. Based on the operating experience and these studies, IRSN will provide its perspective on the safety-related issues associated with the corrosion of stainless steel components. It appears that today's knowledge is not sufficient to define relevant criteria or to determine the exact set of parameters which leads to SCC (Stress Corrosion Cracking) of stainless steels. As a consequence, the best strategy remains an inspection and repair/replacement one. Moreover many cases show the influence of pollutants in the SCC events. This emphasizes the fact that chemistry parameters are strongly connected to safety issues, with respect to the stainless steels integrity

  11. Management Control Systems and Strategy: A Resource based Perspective. Evidence from Greece

    Directory of Open Access Journals (Sweden)

    Nikolaos Theriou

    2017-06-01

    Full Text Available Purpose: The purpose of this paper is to empirically examine from the resource-based perspective, the relationship between the use of management control systems (MCS and organisational capabilities in the Greek context. Design/Methodology/Approach: The study follows Henri's (2006 methodology and explores the relationships between the diagnostic and interactive uses of performance measurement systems (PMS and the five capabilities (e.g. market orientation, organisational learning, entrepreneurship, innovativeness and market responsiveness leading to strategic choice. Structural equation modelling represents the relationships between the variables and data collected from the survey, which was analysed as a statistical tool with AMOS. Findings: Results revealed that diagnostic use of PMS negatively influence only the organisational learning, while the interactive use positively interacts with most of the capabilities. Research limitations/implications: This study can be further extended by incorporating more factors in the proposed model, such as environmental uncertainty, size and organisational culture, and examine their possible effect on the relationship between PMS uses, organisational capabilities and performance. Originality/Value: There is no similar empirical research in the context of Greece.

  12. Food waste conversion options in Singapore: environmental impacts based on an LCA perspective.

    Science.gov (United States)

    Khoo, Hsien H; Lim, Teik Z; Tan, Reginald B H

    2010-02-15

    Proper management and recycling of huge volumes of food waste is one of the challenges faced by Singapore. Semakau island - the only offshore landfill of the nation - only accepts inert, inorganic solid waste and therefore a large bulk of food waste is directed to incinerators. A remaining small percent is sent for recycling via anaerobic digestion (AD), followed by composting of the digestate material. This article investigates the environmental performance of four food waste conversion scenarios - based on a life cycle assessment perspective - taking into account air emissions, useful energy from the incinerators and AD process, as well as carbon dioxide mitigation from the compost products derived from the digestate material and a proposed aerobic composting system. The life cycle impact results were generated for global warming, acidification, eutrophication, photochemical oxidation and energy use. The total normalized results showed that a small-scale proposed aerobic composting system is more environmentally favorable than incinerators, but less ideal compared to the AD process. By making full use of the AD's Recycling Phase II process alone, the Singapore Green Plan's 2012 aim to increase the recycling of food waste to 30% can easily be achieved, along with reduced global warming impacts.

  13. The hormetic zone: an ecological and evolutionary perspective based upon habitat characteristics and fitness selection.

    Science.gov (United States)

    Parsons, P A

    2001-12-01

    Fitness varies nonlinearly with environmental variables such as temperature, water availability, and nutrition, with maximum fitness at intermediate levels between more stressful extremes. For environmental agents that are highly toxic at exposures that substantially exceed background levels, fitness is maximized at concentrations near zero--a phenomenon often referred to as hormesis. Two main components are suggested: (1) background hormesis, which derives from the direct adaptation of organisms to their habitats; and (2) stress-derived hormonesis, which derives from metabolic reserves that are maintained as an adaptation to environmental stresses through evolutionary time. These reserves provide protection from lesser correlated stresses. This article discusses illustrative examples, including ethanol and ionizing radiation, aimed at placing hormesis into an ecological and evolutionary context. A unifying approach comes from fitness-stress continua that underlie responses to abiotic variables, whereby selection for maximum metabolic efficiency and hence fitness in adaptation to habitats in nature underlies hormetic zones. Within this reductionist model, more specific metabolic mechanisms to explain hormesis are beginning to emerge, depending upon the agent and the taxon in question. Some limited research possibilities based upon this evolutionary perspective are indicated.

  14. A comparative Kano analysis on customer satisfaction based on customer and employment perspectives

    Directory of Open Access Journals (Sweden)

    Sakineh Noorinasab

    2012-08-01

    Full Text Available These days, there is a tight competition among business units and all production units or service businesses attempt to use different techniques to increase their market shares. In such environment, customer normally says the last word, in fact, customer plays an important role and in many organizations, it is considered as part of their assets. The purpose of this paper is to propose a hybrid method to detect important criteria using Kano three-dimensional method and prioritize them using analytical hierarchy process. We implement the proposed model of this paper for one of Iranian banks called Bank Melli Iran. The study determines 25 different attributes, categorizes them in three different groups based on Kano model, and ranks them in terms of customers and employees' perspective. The results of the survey indicate that customer and employees mostly have similar views since there are 21 common attributes between them. However, the priorities of these 21 items are often different in terms of two groups of employees and customers.

  15. Population-based health promotion perspective for older driver safety: Conceptual framework to intervention plan

    Science.gov (United States)

    Classen, Sherrilene; Lopez, Ellen DS; Winter, Sandra; Awadzi, Kezia D; Ferree, Nita; Garvan, Cynthia W

    2007-01-01

    The topic of motor vehicle crashes among the elderly is dynamic and multi-faceted requiring a comprehensive and synergistic approach to intervention planning. This approach must be based on the values of a given population as well as health statistics and asserted through community, organizational and policy strategies. An integrated summary of the predictors (quantitative research), and views (qualitative research) of the older drivers and their stakeholders, does not currently exist. This study provided an explicit socio-ecological view explaining the interrelation of possible causative factors, an integrated summary of these causative factors, and empirical guidelines for developing public health interventions to promote older driver safety. Using a mixed methods approach, we were able to compare and integrate main findings from a national crash dataset with perspectives of stakeholders. We identified: 11 multi-causal factors for safe elderly driving; the importance of the environmental factors - previously underrated in the literature- interacting with behavioral and health factors; and the interrelatedness among many socio-ecological factors. For the first time, to our knowledge, we conceptualized the fundamental elements of a multi-causal health promotion plan, with measurable intermediate and long-term outcomes. After completing the detailed plan we will test the effectiveness of this intervention on multiple levels. PMID:18225470

  16. Lesbian, gay, bisexual, transgender, queer, and questioning youths' perspectives of inclusive school-based sexuality education.

    Science.gov (United States)

    Gowen, L Kris; Winges-Yanez, Nichole

    2014-01-01

    Sexuality education is perceived as one way to prevent unhealthy sexual behaviors. However, current sexuality education materials are not tailored to fit the needs of lesbian, gay, bisexual, transgender, and queer/questioning (LGBTQ) youth, and many have been critiqued for disenfranchising these populations. This study solicited the perspectives of LGBTQ youth on their experiences with school-based sexuality education in order to create a framework of LGBTQ-inclusive sexuality education. Five semistructured focus groups (N = 30 LGBTQ participants) were conducted to investigate the sexuality education experiences of LGBTQ youth and to solicit youth suggestions for improving the inclusiveness of sexuality education curricula. Results indicate that LGBTQ youth perceive current sexuality education as primarily "exclusive," although examples of "inclusive" sexuality education were provided. In addition, participants provided suggestions for creating a more inclusive experience, such as directly discussing LGBTQ issues, emphasizing sexually transmitted infection (STI) prevention over pregnancy prevention, and addressing healthy relationships. Educators and policymakers can use these ideas to help improve the quality of sexuality education-not only to make it more inclusive for LGBTQ youth but to make sexuality education more inclusive for all young people.

  17. An analysis of primary school students’ representational ability in mathematics based on gender perspective

    Science.gov (United States)

    Kowiyah; Mulyawati, I.

    2018-01-01

    Mathematic representation is one of the basic mathematic skills that allows students to communicate their mathematic ideas through visual realities such as pictures, tables, mathematic expressions and mathematic equities. The present research aims at: 1) analysing students’ mathematic representation ability in solving mathematic problems and 2) examining the difference of students’ mathematic ability based on their gender. A total of sixty primary school students participated in this study comprising of thirty males and thirty females. Data required in this study were collected through mathematic representation tests, interviews and test evaluation rubric. Findings of this study showed that students’ mathematic representation of visual realities (image and tables) was reported higher at 62.3% than at in the form of description (or statement) at 8.6%. From gender perspective, male students performed better than the females at action planning stage. The percentage of males was reported at 68% (the highest), 33% (medium) and 21.3% (the lowest) while the females were at 36% (the highest), 37.7% (medium) and 32.6% (the lowest).

  18. Valuing Trial Designs from a Pharmaceutical Perspective Using Value-Based Pricing.

    Science.gov (United States)

    Breeze, Penny; Brennan, Alan

    2015-11-01

    Our aim was to adapt the traditional framework for expected net benefit of sampling (ENBS) to be more compatible with drug development trials from the pharmaceutical perspective. We modify the traditional framework for conducting ENBS and assume that the price of the drug is conditional on the trial outcomes. We use a value-based pricing (VBP) criterion to determine price conditional on trial data using Bayesian updating of cost-effectiveness (CE) model parameters. We assume that there is a threshold price below which the company would not market the new intervention. We present a case study in which a phase III trial sample size and trial duration are varied. For each trial design, we sampled 10,000 trial outcomes and estimated VBP using a CE model. The expected commercial net benefit is calculated as the expected profits minus the trial costs. A clinical trial with shorter follow-up, and larger sample size, generated the greatest expected commercial net benefit. Increasing the duration of follow-up had a modest impact on profit forecasts. Expected net benefit of sampling can be adapted to value clinical trials in the pharmaceutical industry to optimise the expected commercial net benefit. However, the analyses can be very time consuming for complex CE models. © 2014 The Authors. Health Economics published by John Wiley & Sons Ltd.

  19. Family Based Premarital Teenager Education in Islamic Education Perspective in Kaili Community in Palu

    Directory of Open Access Journals (Sweden)

    Andi Markarma

    2017-06-01

    Full Text Available The widespread of premarital pregnancy is caused by rampant  promiscuity among female teenagers. The promiscuity occurs due to lack parents’ supervision. Female teenagers  often break  religious, ethical, moral and customary norms. Therefore,  it is important to provide teenagers with pre-marriage education materials. Islam teaches its adherents not to be in hurry in everything except in five things: burial of corpse, paying debts, serving travelers, repenting, and marrying. This study attempts to examine family-based premarital sex education in Islamic education perspectives in the Kaili community in the Palu Valley. The researcher used a quantitative-descriptive approach to see the relationship of research variables. The results show that, the majority of housewife knowledge about premarital education is very low. This certainly affect the lack of premarital sex  education of their young daughters. Low knowledge of housewives and young female regarding premarital sex  education because families do  not teach and socialize moral, ethical, and ethical values effectively in their communities.

  20. User Perspectives of Reference Management Software in a Context-Based Learning Situation

    Directory of Open Access Journals (Sweden)

    Sara Akramy

    2013-12-01

    Full Text Available Scientific writing is an important aspect of the student's education. Writing requires the student to give reference sources in a proper manner in accordance with a certain style. Experience has found that the process to deal with different styles requires time. Critical thinking is a fundamental requirement in scientific work and as such requires no detailed knowledge about different styles structure. Today's technology makes it possible to facilitate scientific writing using reference management software. The current reference management tools available are license-based and others are available free through the Internet. In recent years, social media, such as Facebook, Blogs and Wikipedia have received increasing attention. The discussion, in educational settings, has touched on the pros and cons, but also on the potential opportunities using social media in educational settings. Social media creates opportunities for communication, which in turn affects learning. This learning can be described as collaborative. Illeris (2007 points out that such learning refers to activities where a group of people strive to learn and develop something together. Thus, it is the technical possibilities that facilitate communication and learning. From an educational point of view Vygotsky appears to be central in terms of pedagogy and technology. His theoretical argument is based on a sociocultural perspective where people learn from each other and are believed to be active in its social context using technology as a helpful instrument. Individual knowledge thus grows between individuals (Vygotsky, 1978. The teacher's role, based on Vygotsky's sociocultural perspective, is to encourage good learning environments, and thus use existing technology in the educational setting. With this background, the purpose of this study was to examine two different reference management software tools, Zotero (a social media free downloaded from Internet and EndNote (license

  1. A Sequence and Structure Based Method to Predict Putative Substrates, Functions and Regulatory Networks of Endo Proteases

    Science.gov (United States)

    Venkatraman, Prasanna; Balakrishnan, Satish; Rao, Shashidhar; Hooda, Yogesh; Pol, Suyog

    2009-01-01

    Background Proteases play a central role in cellular homeostasis and are responsible for the spatio- temporal regulation of function. Many putative proteases have been recently identified through genomic approaches, leading to a surge in global profiling attempts to characterize their function. Through such efforts and others it has become evident that many proteases play non-traditional roles. Accordingly, the number and the variety of the substrate repertoire of proteases are expected to be much larger than previously assumed. In line with such global profiling attempts, we present here a method for the prediction of natural substrates of endo proteases (human proteases used as an example) by employing short peptide sequences as specificity determinants. Methodology/Principal Findings Our method incorporates specificity determinants unique to individual enzymes and physiologically relevant dual filters namely, solvent accessible surface area-a parameter dependent on protein three-dimensional structure and subcellular localization. By incorporating such hitherto unused principles in prediction methods, a novel ligand docking strategy to mimic substrate binding at the active site of the enzyme, and GO functions, we identify and perform subjective validation on putative substrates of matriptase and highlight new functions of the enzyme. Using relative solvent accessibility to rank order we show how new protease regulatory networks and enzyme cascades can be created. Conclusion We believe that our physiologically relevant computational approach would be a very useful complementary method in the current day attempts to profile proteases (endo proteases in particular) and their substrates. In addition, by using functional annotations, we have demonstrated how normal and unknown functions of a protease can be envisaged. We have developed a network which can be integrated to create a proteolytic world. This network can in turn be extended to integrate other regulatory

  2. Nuclear Regulatory Commission probabilistic risk assessment implementation program: A status report

    International Nuclear Information System (INIS)

    Rubin, M.P.; Caruso, M.A.

    1996-01-01

    The US Nuclear Regulatory Commission (NRC) is undertaking a number of activities intended to increase the consideration of risk significance in its decision processes and the effective use of risk-based technologies in its regulatory activities. Although the NRC is moving toward risk-informed regulation throughout its areas of responsibilities, this paper focuses primarily on those issues associated with reactor regulation. As the NRC completed significant milestones in its development of probabilistic risk assessment (PRA) methodology and gained considerable experience in the limited application of risk assessment to selected regulatory activities, it became evident that a much broader use of risk informed approaches offered advantages to both the NRC and the US commercial nuclear industry. This desire to enhance the use of risk assessment is driven by the clear belief that application of PRA methods will result in direct improvements in nuclear power plant operational safety from the perspective of both the regulator and the plant operator. The NRC believed that an overall policy on the use of PRA methods in nuclear regulatory activities should be established so that the many potential applications of PRA could be implemented in a consistent and predictable manner that would promote regulatory stability and efficiency. This paper describes the key activities that the NRC has undertaken to implement the initial stages of an integrated risk-informed regulatory framework

  3. Application of omics data in regulatory toxicology: report of an international BfR expert workshop.

    Science.gov (United States)

    Marx-Stoelting, P; Braeuning, A; Buhrke, T; Lampen, A; Niemann, L; Oelgeschlaeger, M; Rieke, S; Schmidt, F; Heise, T; Pfeil, R; Solecki, R

    2015-11-01

    Advances in omics techniques and molecular toxicology are necessary to provide new perspectives for regulatory toxicology. By the application of modern molecular techniques, more mechanistic information should be gained to support standard toxicity studies and to contribute to a reduction and refinement of animal experiments required for certain regulatory purposes. The relevance and applicability of data obtained by omics methods to regulatory purposes such as grouping of chemicals, mode of action analysis or classification and labelling needs further improvement, defined validation and cautious expert judgment. Based on the results of an international expert workshop organized 2014 by the Federal Institute for Risk Assessment in Berlin, this paper is aimed to provide a critical overview of the regulatory relevance and reliability of omics methods, basic requirements on data quality and validation, as well as regulatory criteria to decide which effects observed by omics methods should be considered adverse or non-adverse. As a way forward, it was concluded that the inclusion of omics data can facilitate a more flexible approach for regulatory risk assessment and may help to reduce or refine animal testing.

  4. Parent Perspectives on Home-Based Intervention for Young Children with Developmental Disabilities: The Parent-Implemented Communication Strategies (PiCS) Project in Illinois, USA

    Science.gov (United States)

    Meadan, Hedda; Stoner, Julia B.; Angell, Maureen E.

    2015-01-01

    Parents' perspectives on a home-based, parent-implemented social-pragmatic communication intervention for young children aged 37 to 60 months with limited expressive language are presented in this report. The researchers analyzed the perspectives of seven parent participants in the Institute of Education Sciences-funded Parent-Implemented…

  5. Autonomy and Accountability: Teacher Perspectives on Evidence-Based Practice and Decision-Making for Students with Intellectual and Developmental Disabilities

    Science.gov (United States)

    Greenway, Rosanne; McCollow, Meaghan; Hudson, Roxanne F.; Peck, Charles; Davis, Carol A.

    2013-01-01

    The purpose of this study was to examine teacher perspectives about evidence-based practices (EBP) and decision-making for students with intellectual and developmental disabilities. Given the current EBP movement, our study sought to understand practitioner definitions and perspectives on EBP and decision-making. Interview data from nine special…

  6. Implications of a consumer-based perspective for the estimation of GHG emissions. The illustrative case of Luxembourg

    Energy Technology Data Exchange (ETDEWEB)

    Caro, Dario, E-mail: caro2@unisi.it [Ecodynamics Group/DEEPS, Department of Environment, Earth and Physical Sciences, University of Siena, Via A. Moro, 2, I-53100 Siena (Italy); Department of Animal Science, University of California, Davis, CA 95616 (United States); Rugani, Benedetto [Public Research Centre Henri Tudor (CRPHT), Resource Centre for Environmental Technologies (CRTE), 6A, avenue des Hauts-Fourneaux, L-4362 Esch-sur-Alzette (Luxembourg); Pulselli, Federico Maria [Ecodynamics Group/DEEPS, Department of Environment, Earth and Physical Sciences, University of Siena, Via A. Moro, 2, I-53100 Siena (Italy); Benetto, Enrico [Public Research Centre Henri Tudor (CRPHT), Resource Centre for Environmental Technologies (CRTE), 6A, avenue des Hauts-Fourneaux, L-4362 Esch-sur-Alzette (Luxembourg)

    2015-03-01

    The Kyoto protocol has established an accounting system for national greenhouse gas (GHG) emissions according to a geographic criterion (producer perspective), such as that proposed by the IPCC guidelines for national GHG inventories. However, the representativeness of this approach is still being debated, because the role of final consumers (consumer perspective) is not considered in the emission allocation system. This paper explores the usefulness of a hybrid analysis, including input–output (IO) and process inventory data, as a complementary tool for estimating and allocating national GHG emissions according to both consumer- and producer-based perspectives. We assess the historical GHG impact profile (from 1995 to 2009) of Luxembourg, which is taken as a case study. The country's net consumption over time is estimated to generate about 28,700 Gg CO{sub 2}e/year on average. Compared to the conventional IPCC inventory, the IO-based framework typically shows much higher emission estimations. This relevant discrepancy is mainly due to the different points of view obtained from the hybrid model, in particular with regard to the contribution of imported goods and services. Detailing the GHG inventory by economic activity and considering a wider system boundary make the hybrid IO method advantageous as compared to the IPCC approach, but its effective implementation is still limited by the relatively complex modeling system, as well as the lack of coordination and scarce availability of datasets at the national level. - Highlights: • GHG emissions for Luxembourg are assessed using hybrid input–output (IO) modeling. • Consumer and producer perspectives are compared for the period 1995–2009. • IO-based GHG profiles are remarkably higher than traditional IPCC inventorying. • IO-based GHG accounting presents some advantages but is limited in implementation. • Key-aspects of IPCC and IO-based methods are extensively investigated and compared.

  7. Implications of a consumer-based perspective for the estimation of GHG emissions. The illustrative case of Luxembourg

    International Nuclear Information System (INIS)

    Caro, Dario; Rugani, Benedetto; Pulselli, Federico Maria; Benetto, Enrico

    2015-01-01

    The Kyoto protocol has established an accounting system for national greenhouse gas (GHG) emissions according to a geographic criterion (producer perspective), such as that proposed by the IPCC guidelines for national GHG inventories. However, the representativeness of this approach is still being debated, because the role of final consumers (consumer perspective) is not considered in the emission allocation system. This paper explores the usefulness of a hybrid analysis, including input–output (IO) and process inventory data, as a complementary tool for estimating and allocating national GHG emissions according to both consumer- and producer-based perspectives. We assess the historical GHG impact profile (from 1995 to 2009) of Luxembourg, which is taken as a case study. The country's net consumption over time is estimated to generate about 28,700 Gg CO 2 e/year on average. Compared to the conventional IPCC inventory, the IO-based framework typically shows much higher emission estimations. This relevant discrepancy is mainly due to the different points of view obtained from the hybrid model, in particular with regard to the contribution of imported goods and services. Detailing the GHG inventory by economic activity and considering a wider system boundary make the hybrid IO method advantageous as compared to the IPCC approach, but its effective implementation is still limited by the relatively complex modeling system, as well as the lack of coordination and scarce availability of datasets at the national level. - Highlights: • GHG emissions for Luxembourg are assessed using hybrid input–output (IO) modeling. • Consumer and producer perspectives are compared for the period 1995–2009. • IO-based GHG profiles are remarkably higher than traditional IPCC inventorying. • IO-based GHG accounting presents some advantages but is limited in implementation. • Key-aspects of IPCC and IO-based methods are extensively investigated and compared

  8. Finding common ground: perspectives on community-based childhood obesity prevention.

    Science.gov (United States)

    Porter, Christine M; Pelletier, David L

    2012-11-01

    To support successful and inclusive community organizing for childhood obesity prevention, this research identified stakeholder perspectives on what communities should do to prevent childhood obesity. It employed factor analysis on statement sorts (Q methodology) conducted by 95 people in an upstate New York community. These participants sorted 36 statements about the issue by how much he or she agreed or disagreed with each. Participants were recruited through strategic snowball sampling to sample a variety of perspectives. The four resulting factors, or perspectives, were interpreted in the context of presort demographic surveys and postsort interviews. This research found one stance that fits the environmental perspective common in public health. The other three factors indicate important variations among perspectives centered on individual responsibility, ranging from libertarian to technocratic views. However, overall, results revealed a substantial degree of agreement among the four perspectives, including on providing access to family activities and on making fruits and vegetables more available and affordable, for example, through subsidies. This article points to common ground for community action on childhood obesity prevention, highlights areas likely to generate considerable contention, and shows whose views are not being accounted for in, at least, this community's childhood obesity prevention project.

  9. Application of the perspective-based reading technique in the nuclear I and C context. CORSICA work report 2011

    Energy Technology Data Exchange (ETDEWEB)

    Lahtinen, J.

    2012-07-01

    Inspections and reviews are one of the most effective ways of detecting errors in software development. The methods are also cost-effective because defects can be spotted early in the development, and thus the cost of repairing the defects is lower. Reading techniques are the procedures that are used in the inspection or review of a software artefact. The most common procedures are simple ad-hoc reading and a checklist- based reading technique. However, more advanced and detailed procedures have been created for various purposes. This report reviews the state-of-the-art software reading techniques used in inspections and reviews, and briefly reviews some of the empirical research in this context. The majority of the empirical research results indicate that, for example, perspective-based reading is more cost-effective and can detect more defects than more basic reading techniques. This report also describes how perspective-based reading can be applied to the inspection of nuclear-domain requirement specifications. For this purpose, seven perspective-based reading scenarios have been created. (orig.)

  10. Unmanned Aerial Vehicle Remote Sensing for Field-Based Crop Phenotyping: Current Status and Perspectives

    Directory of Open Access Journals (Sweden)

    Guijun Yang

    2017-06-01

    Full Text Available Phenotyping plays an important role in crop science research; the accurate and rapid acquisition of phenotypic information of plants or cells in different environments is helpful for exploring the inheritance and expression patterns of the genome to determine the association of genomic and phenotypic information to increase the crop yield. Traditional methods for acquiring crop traits, such as plant height, leaf color, leaf area index (LAI, chlorophyll content, biomass and yield, rely on manual sampling, which is time-consuming and laborious. Unmanned aerial vehicle remote sensing platforms (UAV-RSPs equipped with different sensors have recently become an important approach for fast and non-destructive high throughput phenotyping and have the advantage of flexible and convenient operation, on-demand access to data and high spatial resolution. UAV-RSPs are a powerful tool for studying phenomics and genomics. As the methods and applications for field phenotyping using UAVs to users who willing to derive phenotypic parameters from large fields and tests with the minimum effort on field work and getting highly reliable results are necessary, the current status and perspectives on the topic of UAV-RSPs for field-based phenotyping were reviewed based on the literature survey of crop phenotyping using UAV-RSPs in the Web of Science™ Core Collection database and cases study by NERCITA. The reference for the selection of UAV platforms and remote sensing sensors, the commonly adopted methods and typical applications for analyzing phenotypic traits by UAV-RSPs, and the challenge for crop phenotyping by UAV-RSPs were considered. The review can provide theoretical and technical support to promote the applications of UAV-RSPs for crop phenotyping.

  11. Existing Regulatory Approaches to Reducing Exposures to Chemical- and Product-Based Risk and Their Applicability to Diet-Related Chronic Disease.

    Science.gov (United States)

    Cohen, Deborah A; Knopman, Debra S

    2018-04-17

    We aimed to identify and categorize the types of policies that have been adopted to protect Americans from harmful exposures that could also be relevant for addressing diet-related chronic diseases. This article examines and categorizes the rationales behind government regulation. Our interest in the historical analysis is to inform judgments about how best to address newly emergent risks involving diet-related chronic disease within existing regulatory and information-based frameworks. We assessed exemplars of regulation with respect to harmful exposures from air, water, and food, as well as regulations that are intended to modify voluntary behaviors. Following the comparative analysis, we explored how exposures that lead to diet-related chronic diseases among the general population fit within models of regulation adopted for other comparable risks. We identified five rationales and five approaches that protect people from harmful exposures. Reasons for regulation include: protection from involuntary exposure to risk, high risk of death or chronic illness, ubiquity of risk, counteraction to limit compulsive behaviors, and promotion of population health. Regulatory approaches include: mandatory limits on use, mandatory limits on exposure, mandatory controls on quality, mandatory labeling, and voluntary guidance. In contrast to the use of mandates, the prevention of diet-related chronic diseases thus far has largely relied on information-only approaches and voluntary adoption of guidelines. There is ample precedent for mandatory regulatory approaches that could address harms related to exposure to unhealthy diets, but several barriers to action would need to be overcome. © 2018 Society for Risk Analysis.

  12. Model uncertainty from a regulatory point of view

    International Nuclear Information System (INIS)

    Abramson, L.R.

    1994-01-01

    This paper discusses model uncertainty in the larger context of knowledge and random uncertainty. It explores some regulatory implications of model uncertainty and argues that, from a regulator's perspective, a conservative approach must be taken. As a consequence of this perspective, averaging over model results is ruled out

  13. Community Partner Perspectives on Benefits, Challenges, Facilitating Factors, and Lessons Learned from Community-Based Participatory Research Partnerships in Detroit.

    Science.gov (United States)

    Caldwell, Wilma Brakefield; Reyes, Angela G; Rowe, Zachary; Weinert, Julia; Israel, Barbara A

    2015-01-01

    There is an extensive body of literature on community-based participatory research (CBPR) and the role of community-academic partnerships, much of which has involved community partners in the conceptualization and preparation of publications. However, there has been a relative dearth of solely community voices addressing these topics, given the other roles and responsibilities which community members and leaders of community-based organizations (CBOs) have. The purpose of this article is to share the perspectives of three long-time (>20 years) community partners involved in the Detroit Community-Academic Urban Research Center and its affiliated partnerships. In this article, we community partners provide our assessment of the benefits and challenges in using a CBPR approach at the personal, organizational, and community levels; the factors that facilitate effective partnerships; and our lessons learned through engagement in CBPR. We also present specific recommendations from a community perspective to researchers and institutions interested in conducting CBPR.

  14. On the Development of a Computing Infrastructure that Facilitates IPPD from a Decision-Based Design Perspective

    Science.gov (United States)

    Hale, Mark A.; Craig, James I.; Mistree, Farrokh; Schrage, Daniel P.

    1995-01-01

    Integrated Product and Process Development (IPPD) embodies the simultaneous application of both system and quality engineering methods throughout an iterative design process. The use of IPPD results in the time-conscious, cost-saving development of engineering systems. Georgia Tech has proposed the development of an Integrated Design Engineering Simulator that will merge Integrated Product and Process Development with interdisciplinary analysis techniques and state-of-the-art computational technologies. To implement IPPD, a Decision-Based Design perspective is encapsulated in an approach that focuses on the role of the human designer in product development. The approach has two parts and is outlined in this paper. First, an architecture, called DREAMS, is being developed that facilitates design from a decision-based perspective. Second, a supporting computing infrastructure, called IMAGE, is being designed. The current status of development is given and future directions are outlined.

  15. Addressing the Right to Self-Determination: The Okinawans’ Claims from the Group-Based Rights Perspective

    OpenAIRE

    Tamura, Momoka

    2016-01-01

    This paper discusses the Japanese society from the group-based rights perspective. International human rights law provides the rights mostly in an individualistic form. But there is also a development of the international standards of rights with group-dimensions. The right to self-determination under the common article 1 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) and International Covenant on Civil and Political Rights (ICCPR) provide a collective right to...

  16. Regulatory difficulties in a developing country

    International Nuclear Information System (INIS)

    Jacobs, W.R. Jr.

    1978-01-01

    The regulatory agency assigned the task of regulating the initial entry into the field of nuclear power generation by a developing country has a very difficult job. Based on the authors' experience during the start-up and initial operation of Ko-Ri Unit I, the first power reactor in the Republic of Korea, observations on regulatory difficulties and recommendations for improved regulatory effectiveness are offered. The problem areas can be loosely grouped into three general categories: (1) Lack of adequate technical knowledge which is the basis for all effective regulation; (2) Difficulties with understanding and utilization of the required regulatory documentation; (3) Failure to establish the proper regulatory environment. Examples are cited from actual experience during the Ko-Ri Unit I start-up to demonstrate the impact that regulatory activities can have on a plant construction and testing programme. The problems encountered are not unique to developing countries but also exist in the United States of America. Recommendations are offered which should be beneficial to either newly formed regulatory agencies or agencies wishing to improve their abilities and effectiveness. These include: (1) Additional training of regulatory inspectors in plant operations; (2) Additional experience gained by participation in regulatory activities in other countries; (3) Increased attention given to regulatory documents, especially plant technical specifications; (4) Establishment of formal lines of communication between the utility and the regulatory agency; (5) Clear definition of regulatory responsibilities to avoid areas of overlapping jurisdiction; (6) Active participation by the regulatory staff very early in the project. It is hoped that these and other recommendations offered will greatly improve regulatory effectiveness and at the same time demonstrate that when the decision is made to 'go nuclear', a strong commitment must be made to develop and support a technically

  17. College Freshmen Students' Perspectives on Weight Gain Prevention in the Digital Age: Web-Based Survey.

    Science.gov (United States)

    Monroe, Courtney M; Turner-McGrievy, Gabrielle; Larsen, Chelsea A; Magradey, Karen; Brandt, Heather M; Wilcox, Sara; Sundstrom, Beth; West, Delia Smith

    2017-10-12

    College freshmen are highly vulnerable to experiencing weight gain, and this phenomenon is associated with an increased risk of chronic diseases and mortality in older adulthood. Technology offers an attractive and scalable way to deliver behavioral weight gain prevention interventions for this population. Weight gain prevention programs that harness the appeal and widespread reach of Web-based technologies (electronic health or eHealth) are increasingly being evaluated in college students. Yet, few of these interventions are informed by college students' perspectives on weight gain prevention and related lifestyle behaviors. The objective of this study was to assess college freshmen students' concern about weight gain and associated topics, as well as their interest in and delivery medium preferences for eHealth programs focused on these topics. Web-based surveys that addressed college freshmen students' (convenience sample of N=50) perspectives on weight gain prevention were administered at the beginning and end of the fall 2015 semester as part of a longitudinal investigation of health-related issues and experiences in first semester college freshmen. Data on weight gain prevention-related concerns and corresponding interest in eHealth programs targeting topics of potential concern, as well as preferred program delivery medium and current technology use were gathered and analyzed using descriptive statistics. A considerable proportion of the freshmen sample expressed concern about weight gain (74%, 37/50) and both traditional (healthy diet: 86%, 43/50; physical activity: 64%, 32/50) and less frequently addressed (stress: 82%, 41/50; sleep: 74%, 37/50; anxiety and depression: 60%, 30/50) associated topics within the context of behavioral weight gain prevention. The proportion of students who reported interest in eHealth promotion programs targeting these topics was also generally high (ranging from 52% [26/50] for stress management to 70% [35/50] for eating a

  18. Hybrid Materials Based on Magnetic Layered Double Hydroxides: A Molecular Perspective.

    Science.gov (United States)

    Abellán, Gonzalo; Martí-Gastaldo, Carlos; Ribera, Antonio; Coronado, Eugenio

    2015-06-16

    Design of functional hybrids lies at the very core of synthetic chemistry as it has enabled the development of an unlimited number of solids displaying unprecedented or even improved properties built upon the association at the molecular level of quite disparate components by chemical design. Multifunctional hybrids are a particularly appealing case among hybrid organic/inorganic materials. Here, chemical knowledge is used to deploy molecular components bearing different functionalities within a single solid so that these properties can coexist or event interact leading to unprecedented phenomena. From a molecular perspective, this can be done either by controlled assembly of organic/inorganic molecular tectons into an extended architecture of hybrid nature or by intercalation of organic moieties within the empty channels or interlamellar space offered by inorganic solids with three-dimensional (MOFs, zeolites, and mesoporous hosts) or layered structures (phosphates, silicates, metal dichalcogenides, or anionic clays). This Account specifically illustrates the use of layered double hydroxides (LDHs) in the preparation of magnetic hybrids, in line with the development of soft inorganic chemistry processes (also called "Chimie Douce"), which has significantly contributed to boost the preparation hybrid materials based on solid-state hosts and subsequent development of applications. Several features sustain the importance of LDHs in this context. Their magnetism can be manipulated at a molecular level by adequate choice of constituting metals and interlayer separation for tuning the nature and extent of magnetic interactions across and between planes. They display unparalleled versatility in accommodating a broad range of anionic species in their interlamellar space that encompasses not only simple anions but chemical systems of increasing dimensionality and functionalities. Their swelling characteristics allow for their exfoliation in organic solvents with high

  19. A Model of Yeast Cell-Cycle Regulation Based on a Standard Component Modeling Strategy for Protein Regulatory Networks.

    Directory of Open Access Journals (Sweden)

    Teeraphan Laomettachit

    Full Text Available To understand the molecular mechanisms that regulate cell cycle progression in eukaryotes, a variety of mathematical modeling approaches have been employed, ranging from Boolean networks and differential equations to stochastic simulations. Each approach has its own characteristic strengths and weaknesses. In this paper, we propose a "standard component" modeling strategy that combines advantageous features of Boolean networks, differential equations and stochastic simulations in a framework that acknowledges the typical sorts of reactions found in protein regulatory networks. Applying this strategy to a comprehensive mechanism of the budding yeast cell cycle, we illustrate the potential value of standard component modeling. The deterministic version of our model reproduces the phenotypic properties of wild-type cells and of 125 mutant strains. The stochastic version of our model reproduces the cell-to-cell variability of wild-type cells and the partial viability of the CLB2-dbΔ clb5Δ mutant strain. Our simulations show that mathematical modeling with "standard components" can capture in quantitative detail many essential properties of cell cycle control in budding yeast.

  20. Search for 5'-leader regulatory RNA structures based on gene annotation aided by the RiboGap database.

    Science.gov (United States)

    Naghdi, Mohammad Reza; Smail, Katia; Wang, Joy X; Wade, Fallou; Breaker, Ronald R; Perreault, Jonathan

    2017-03-15

    The discovery of noncoding RNAs (ncRNAs) and their importance for gene regulation led us to develop bioinformatics tools to pursue the discovery of novel ncRNAs. Finding ncRNAs de novo is challenging, first due to the difficulty of retrieving large numbers of sequences for given gene activities, and second due to exponential demands on calculation needed for comparative genomics on a large scale. Recently, several tools for the prediction of conserved RNA secondary structure were developed, but many of them are not designed to uncover new ncRNAs, or are too slow for conducting analyses on a large scale. Here we present various approaches using the database RiboGap as a primary tool for finding known ncRNAs and for uncovering simple sequence motifs with regulatory roles. This database also can be used to easily extract intergenic sequences of eubacteria and archaea to find conserved RNA structures upstream of given genes. We also show how to extend analysis further to choose the best candidate ncRNAs for experimental validation. Copyright © 2017 Elsevier Inc. All rights reserved.

  1. Thematic Analysis of Women's Perspectives on the Meaning of Safety During Hospital-Based Birth.

    Science.gov (United States)

    Lyndon, Audrey; Malana, Jennifer; Hedli, Laura C; Sherman, Jules; Lee, Henry C

    2018-05-01

    To explore women's birth experiences to develop an understanding of their perspectives on patient safety during hospital-based birth. Qualitative description using thematic analysis of interview data. Seventeen women ages 29 to 47 years. Women participated in individual or small group interviews about their birth experiences, the physical environment, interactions with clinicians, and what safety meant to them in the context of birth. An interdisciplinary group of five investigators from nursing, medicine, product design, and journalism analyzed transcripts thematically to examine how women experienced feeling safe or unsafe and identify opportunities for improvements in care. Participants experienced feelings of safety on a continuum. These feelings were affected by confidence in providers, the environment and organizational factors, interpersonal interactions, and actions people took during risk moments of rapid or confusing change. Well-organized teams and sensitive interpersonal interactions that demonstrated human connection supported feelings of safety, whereas some routine aspects of care threatened feelings of safety. Physical and emotional safety are inextricably embedded in the patient experience, yet this connection may be overlooked in some inpatient birth settings. Clinicians should be mindful of how the birth environment and their behaviors in it can affect a woman's feelings of safety during birth. Human connection is especially important during risk moments, which represent a liminal space at the intersection of physical and emotional safety. At least one team member should focus on the provision of emotional support during rapidly changing situations to mitigate the potential for negative experiences that can result in emotional harm. Copyright © 2018 AWHONN, the Association of Women's Health, Obstetric and Neonatal Nurses. Published by Elsevier Inc. All rights reserved.

  2. Tick-Borne Diseases in Turkey: A Review Based on One Health Perspective.

    Directory of Open Access Journals (Sweden)

    Abdullah Inci

    2016-12-01

    Full Text Available The importance of tick-borne diseases is increasing all over the world, including Turkey. Global warming, environmental and ecological changes and the existence of suitable habitats increase the impact of ticks and result in frequent emergence or re-emergence of tick-borne diseases (TBDs with zoonotic characteristics. In Turkey, almost 19 TBDs have been reported in animals and men, involving four protozoa (babesiosis, theileriosis, cytauxzoonosis, hepatozoonosis, one filarial nematode (acanthocheilonemasis, ten bacterial agents (anaplasmosis, ehrlichiosis, aegyptianellosis, tick-borne typhus, Candidatus Rickettsia vini, Lyme borreliosis, tick-borne relapsing fever [TBRF], tularaemia, bartonellosis, and hemoplasmosis, and four viral infections (tick-borne encephalitis [TBE], Crimean-Congo Haemorrhagic Fever [CCHF], louping-ill [LI], and lumpy skin disease [LSD]. The growing number of TBD cases, in particular the fatal viral epidemics in humans, have led to increased public awareness and concern against TBDs in recent years. The World Health Organization (WHO has developed a new political concept, called the "One Health" initiative, which is especially relevant for developing strategies against tick infestations and TBD control in humans and animals. It would be beneficial for Turkey to adopt this new strategy and establish specific research and control programs in coordination with international organizations like WHO, the World Organization for Animal Health (OIE, the Food and Agriculture Organization (FAO, the Centers for Disease Control and Prevention (CDC, and the European Center for Disease Prevention and Control (ECDC to combat TBDs based on the "One Health Initiative" concept. In this article, we review the occurrence of primary TBDs in man and animals in Turkey in light of the "One Health" perspective.

  3. Population-based health promotion perspective for older driver safety: Conceptual framework to intervention plan

    Directory of Open Access Journals (Sweden)

    Sherrilene Classen

    2008-01-01

    Full Text Available Sherrilene Classen1,2, Ellen DS Lopez3, Sandra Winter2, Kezia D Awadzi4, Nita Ferree5, Cynthia W Garvan61Department of Occupational Therapy, College of Public Health and Health Professions (CPHHP, University of Florida (UF, Gainesville, FL, USA; 2PhD Program in Rehabilitation Science, CPHHP, UF Gainesville, FL, USA; 3Department of Behavioral Science and Community Health, CPHHP, UF, Gainesville, FL, USA; 4Department of Health Services Research, Management, and Policy, CPHHP, UF, Gainesville, FL, USA; 5Health Science Center Libraries, UF, Gainesville, FL, USA; 6Division of Biostatistics, College of Medicine, UF, Gainesville, FL, USAAbstract: The topic of motor vehicle crashes among the elderly is dynamic and multi-faceted requiring a comprehensive and synergistic approach to intervention planning. This approach must be based on the values of a given population as well as health statistics and asserted through community, organizational and policy strategies. An integrated summary of the predictors (quantitative research, and views (qualitative research of the older drivers and their stakeholders, does not currently exist. This study provided an explicit socio-ecological view explaining the interrelation of possible causative factors, an integrated summary of these causative factors, and empirical guidelines for developing public health interventions to promote older driver safety. Using a mixed methods approach, we were able to compare and integrate main findings from a national crash dataset with perspectives of stakeholders. We identified: 11 multi-causal factors for safe elderly driving; the importance of the environmental factors - previously underrated in the literature- interacting with behavioral and health factors; and the interrelatedness among many socio-ecological factors. For the first time, to our knowledge, we conceptualized the fundamental elements of a multi-causal health promotion plan, with measurable intermediate and long

  4. Strengthening Regulatory Competence in a Changing Nuclear Regulatory Environment

    International Nuclear Information System (INIS)

    Illizastigui, P.F.

    2016-01-01

    The paper addresses the approach followed by the Cuban National Center for Nuclear Safety for the management of current and new competences of its regulatory staff with the aim of allowing those staff to effectively fulfill their core regulatory functions. The approach is realized through an Integrated System for Competence Building, which is based on the IAEA recommendations, shown to be effective in ensuring the necessary competence in the relevant areas. In the author’s opinion, competence of the regulatory staff in the area of human and organizational factors is of paramount importance and needs to be further strengthened in order to be able to assess safety performance at the facilities and detect early signs of deteriorating safety performance. The former is defined by the author as the core regulatory function “Analysis” which covers the entire spectrum of assessment tasks carried out by the regulatory staff to: a) detect declining safety performance, b) diagnose latent weaknesses (root causes) and c) make effective safety culture interventions. The author suggests that competence associated with the fulfillment of the analysis function is distinctly identified and dealt with separately in the current system of managing regulatory competence. (author)

  5. Regulatory pathways for vaccines for developing countries.

    Science.gov (United States)

    Milstien, Julie; Belgharbi, Lahouari

    2004-01-01

    Vaccines that are designed for use only in developing countries face regulatory hurdles that may restrict their use. There are two primary reasons for this: most regulatory authorities are set up to address regulation of products for use only within their jurisdictions and regulatory authorities in developing countries traditionally have been considered weak. Some options for regulatory pathways for such products have been identified: licensing in the country of manufacture, file review by the European Medicines Evaluation Agency on behalf of WHO, export to a country with a competent national regulatory authority (NRA) that could handle all regulatory functions for the developing country market, shared manufacturing and licensing in a developing country with competent manufacturing and regulatory capacity, and use of a contracted independent entity for global regulatory approval. These options have been evaluated on the basis of five criteria: assurance of all regulatory functions for the life of the product, appropriateness of epidemiological assessment, applicability to products no longer used in the domestic market of the manufacturing country, reduction of regulatory risk for the manufacturer, and existing rules and regulations for implementation. No one option satisfies all criteria. For all options, national infrastructures (including the underlying regulatory legislative framework, particularly to formulate and implement local evidence-based vaccine policy) must be developed. WHO has led work to develop this capacity with some success. The paper outlines additional areas of action required by the international community to assure development and use of vaccines needed for the developing world. PMID:15042235

  6. Perspectives on reactor safety. Revision 1

    International Nuclear Information System (INIS)

    Haskin, F.E.; Hodge, S.A.

    1997-11-01

    The US Nuclear Regulatory Commission (NRC) maintains a technical training center at Chattanooga, Tennessee to provide appropriate training to both new and experienced NRC employees. This document describes a one-week course in reactor safety concepts. The course consists of five modules: (1) the development of safety concepts; (2) severe accident perspectives; (3) accident progression in the reactor vessel; (4) containment characteristics and design bases; and (5) source terms and offsite consequences. The course text is accompanied by slides and videos during the actual presentation of the course

  7. Perspectives on reactor safety. Revision 1

    Energy Technology Data Exchange (ETDEWEB)

    Haskin, F.E. [New Mexico Univ., Albuquerque, NM (United States). Dept. of Chemical and Nuclear Engineering; Camp, A.L. [Sandia National Labs., Albuquerque, NM (United States); Hodge, S.A. [Oak Ridge National Lab., TN (United States). Engineering Technology Div.

    1997-11-01

    The US Nuclear Regulatory Commission (NRC) maintains a technical training center at Chattanooga, Tennessee to provide appropriate training to both new and experienced NRC employees. This document describes a one-week course in reactor safety concepts. The course consists of five modules: (1) the development of safety concepts; (2) severe accident perspectives; (3) accident progression in the reactor vessel; (4) containment characteristics and design bases; and (5) source terms and offsite consequences. The course text is accompanied by slides and videos during the actual presentation of the course.

  8. "Four legs instead of two"--perspectives on a Nordic walking-based walking programme among people with arthritis.

    Science.gov (United States)

    O'Donovan, Rhona; Kennedy, Norelee

    2015-01-01

    Nordic Walking (NW) is growing in popularity among people with arthritis. The aim of this study was to explore the perspectives of participants with arthritis on a NW-based walking programme including factors contributing to sustained participation in the programme. Three semi-structured focus groups were conducted with a total of 27 participants with various types of arthritis. The groups consisted of participants who completed a NW-based walking programme in the previous 4 years. Only participants who had sustained involvement in the walking group were included. Groups were audio-recorded, transcribed verbatim and thematic analysis was performed. Participants reported that the walking programme offered numerous benefits. Two distinct themes emerged: (1) "four legs instead of two legs" and (2) "a support group". Theme 1 incorporates the physical, psychological and educational benefits that stem from involvement in a walking group while Theme 2 incorporates the benefits of social support in group-based activity. Several benefits of a NW-based walking programme from the perspectives of individuals with arthritis who engage in group-based walking programmes were identified. The benefits may encourage sustained participation and justify the promotion of NW as an intervention for people with arthritis. Considering how to sustain exercise participation is important to ensure continued benefits from physical activity participation. A community-based Nordic walking-based walking programme for people with arthritis improved exercise knowledge and confidence to exercise. Group exercise is valuable in providing support and motivation to continue exercising.

  9. Importance of on-time decision making in energy sector based on perspectives: Case study new Stavalj project

    Directory of Open Access Journals (Sweden)

    Zlatanović Dragan M.

    2017-01-01

    Full Text Available Expression "Development conditions and perspectives" became important for numerous analyses in various industrial and social areas. Several strategic documents and studies in last two decades analysed projects with topics on perspectives of future development in Serbia. Various tools are used for development of such documents, based on recent scientific and numerical solutions, thus providing reliable assessment for strategic decision making. Almost all analyses tried to implement the theories and practical experiences through the prism of "sustainable development", which included establishment of most important sustainability parameters. Analysis and ranking presented in this paper considered the potential of the Stavalj coal deposit, near city of Sjenica in Serbia, and feasibility of construction project of new mine and thermal power plant. Basis for analysis was a hybrid assessment model which takes into account principles of sustainable development. The model incorporates quantified SWOT analysis, which applies to active underground mines in Serbia. Special attention was given to the parameters describing potential for development.

  10. The self-regulatory role of anticipated group-based shame and guilt in inhibiting in-group favoritism

    NARCIS (Netherlands)

    Shepherd, Lee; Spears, Russell; Manstead, Antony Stephen

    2013-01-01

    In three studies, we examined whether the anticipation of group-based guilt and shame inhibits in-group favoritism. In Studies 1 and 2, anticipated group-based shame negatively predicted in-group favoritism; in neither study did anticipated group-based guilt uniquely predict in-group favoritism. In

  11. Functional characterization of a three-component regulatory system involved in quorum sensing-based regulation of peptide antibiotic production in Carnobacterium maltaromaticum

    Directory of Open Access Journals (Sweden)

    Quadri Luis EN

    2006-10-01

    Full Text Available Abstract Background Quorum sensing is a form of cell-to-cell communication that allows bacteria to control a wide range of physiological processes in a population density-dependent manner. Production of peptide antibiotics is one of the processes regulated by quorum sensing in several species of Gram-positive bacteria, including strains of Carnobacterium maltaromaticum. This bacterium and its peptide antibiotics are of interest due to their potential applications in food preservation. The molecular bases of the quorum sensing phenomenon controlling peptide antibiotic production in C. maltaromaticum remain poorly understood. The present study was aimed at gaining a deeper insight into the molecular mechanism involved in quorum sensing-mediated regulation of peptide antibiotic (bacteriocin production by C. maltaromaticum. We report the functional analyses of the CS (autoinducer-CbnK (histidine protein kinase-CbnR (response regulator three-component regulatory system and the three regulated promoters involved in peptide antibiotic production in C. maltaromaticum LV17B. Results CS-CbnK-CbnR system-dependent activation of carnobacterial promoters was demonstrated in both homologous and heterologous hosts using a two-plasmid system with a β-glucuronidase (GusA reporter read-out. The results of our analyses support a model in which the CbnK-CbnR two-component signal transduction system is necessary and sufficient to transduce the signal of the peptide autoinducer CS into the activation of the promoters that drive the expression of the genes required for production of the carnobacterial peptide antibiotics and the immunity proteins that protect the producer bacterium. Conclusions The CS-CbnK-CbnR triad forms a three-component regulatory system by which production of peptide antibiotics by C. maltaromaticum LV17B is controlled in a population density-dependent (or cell proximity-dependent manner. This regulatory mechanism would permit the bacterial

  12. A global regulatory science agenda for vaccines.

    Science.gov (United States)

    Elmgren, Lindsay; Li, Xuguang; Wilson, Carolyn; Ball, Robert; Wang, Junzhi; Cichutek, Klaus; Pfleiderer, Michael; Kato, Atsushi; Cavaleri, Marco; Southern, James; Jivapaisarnpong, Teeranart; Minor, Philip; Griffiths, Elwyn; Sohn, Yeowon; Wood, David

    2013-04-18

    The Decade of Vaccines Collaboration and development of the Global Vaccine Action Plan provides a catalyst and unique opportunity for regulators worldwide to develop and propose a global regulatory science agenda for vaccines. Regulatory oversight is critical to allow access to vaccines that are safe, effective, and of assured quality. Methods used by regulators need to constantly evolve so that scientific and technological advances are applied to address challenges such as new products and technologies, and also to provide an increased understanding of benefits and risks of existing products. Regulatory science builds on high-quality basic research, and encompasses at least two broad categories. First, there is laboratory-based regulatory science. Illustrative examples include development of correlates of immunity; or correlates of safety; or of improved product characterization and potency assays. Included in such science would be tools to standardize assays used for regulatory purposes. Second, there is science to develop regulatory processes. Illustrative examples include adaptive clinical trial designs; or tools to analyze the benefit-risk decision-making process of regulators; or novel pharmacovigilance methodologies. Included in such science would be initiatives to standardize regulatory processes (e.g., definitions of terms for adverse events [AEs] following immunization). The aim of a global regulatory science agenda is to transform current national efforts, mainly by well-resourced regulatory agencies, into a coordinated action plan to support global immunization goals. This article provides examples of how regulatory science has, in the past, contributed to improved access to vaccines, and identifies gaps that could be addressed through a global regulatory science agenda. The article also identifies challenges to implementing a regulatory science agenda and proposes strategies and actions to fill these gaps. A global regulatory science agenda will enable

  13. A decade of marketing approval of gene and cell-based therapies in the United States, European Union and Japan: An evaluation of regulatory decision-making.

    Science.gov (United States)

    Coppens, D G M; de Wilde, S; Guchelaar, H J; De Bruin, M L; Leufkens, H G M; Meij, P; Hoekman, J

    2018-05-02

    There is a widely held expectation of clinical advance with the development of gene and cell-based therapies (GCTs). Yet, establishing benefits and risks is highly uncertain. We examine differences in decision-making for GCT approval between jurisdictions by comparing regulatory assessment procedures in the United States (US), European Union (EU) and Japan. A cohort of 18 assessment procedures was analyzed by comparing product characteristics, evidentiary and non-evidentiary factors considered for approval and post-marketing risk management. Product characteristics are very heterogeneous and only three products are marketed in multiple jurisdictions. Almost half of all approved GCTs received an orphan designation. Overall, confirmatory evidence or indications of clinical benefit were evident in US and EU applications, whereas in Japan approval was solely granted based on non-confirmatory evidence. Due to scientific uncertainties and safety risks, substantial post-marketing risk management activities were requested in the EU and Japan. EU and Japanese authorities often took unmet medical needs into consideration in decision-making for approval. These observations underline the effects of implemented legislation in these two jurisdictions that facilitate an adaptive approach to licensing. In the US, the recent assessments of two chimeric antigen receptor-T cell (CAR-T) products are suggestive of a trend toward a more permissive approach for GCT approval under recent reforms, in contrast to a more binary decision-making approach for previous approvals. It indicates that all three regulatory agencies are currently willing to take risks by approving GCTs with scientific uncertainties and safety risks, urging them to pay accurate attention to post-marketing risk management. Copyright © 2018 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

  14. Play-Based Interview Methods for Exploring Young Children's Perspectives on Inclusion

    Science.gov (United States)

    Koller, Donna; San Juan, Valerie

    2015-01-01

    Inclusive education provides learning opportunities for children with disabilities in regular settings with other children. Despite the prevalence of inclusive education, few qualitative studies have adequately explored young children's perspectives on inclusion. This paper reviews the findings of a preliminary qualitative study where play-based…

  15. Challenges Experienced by Korean Medical Students and Tutors during Problem-Based Learning: A Cultural Perspective

    Science.gov (United States)

    Ju, Hyunjung; Choi, Ikseon; Rhee, Byoung Doo; Tae-Lee, Jong

    2016-01-01

    How people learn is influenced by the cultural contexts in which their learning occurs. This qualitative case study explored challenges Korean medical students and tutors experienced during their PBL sessions from a cultural perspective using Hofstede's cultural dimensions. Twelve preclinical medical students and nine tutors from a large Korean…

  16. Youth and Adult Perspectives on Violence Prevention Strategies: A Community-Based Participatory Study

    Science.gov (United States)

    Dodington, James; Mollen, Cynthia; Woodlock, Joseph; Hausman, Alice; Richmond, Therese S.; Fein, Joel A.

    2012-01-01

    This project explores the beliefs and perspectives of urban adults and youth regarding community violence prevention strategies and identifies points of overlap and differences of opinion that can contribute to the development of successful youth violence prevention programs. We coded transcript data from adults and 10-16-year-old youth from the…

  17. Understanding Higher Education-Based Teacher Educators' Identities in Hong Kong: A Sociocultural Linguistic Perspective

    Science.gov (United States)

    Yuan, Rui

    2016-01-01

    While teacher educator identities have received increasing attention over the past decade, there is a lack of research on teacher educators' professional identities in the complex and shifting higher education contexts. Informed by the sociocultural linguistic perspective, this study investigates two language teacher educators' professional…

  18. PERSPECTIVES OF THE DEVELOPMENT OF MUCOSAL VACCINES AGAINST DANGEROUS INFECTIONS ON THE BASE OF TRANSGENIC PLANTS

    Directory of Open Access Journals (Sweden)

    A.V. Tretyakova

    2012-08-01

    Full Text Available Mucosal vaccines created on the base of transgenic plants reacting with mucosal layers of the intestines and other organs are considered to be the perspective method of the vaccination. These vaccines induce both mucosal and general humoral immunogenicity after the peroral administration. The folding of antigenic proteins synthesizing in plants occurs via eukaryotic type and has advantages before yeast and prokaryotic platforms. This feature results to more adequate synthesis of antibodies against pathogens and to the interaction with effector molecules of complement. Earlier we together with The State Scientific Center “Vector”, Institute of chemical biology and fundamental medicine SB RAS and Dr R.Hammond from Laboratory of Plant Pathology (Maryland, USA created two candidate vaccines : one of them against AIDS (HIV-1 and hepatitis B on the base of the chimeric gene TBI-HBS, encoding simultaneously 9 antigenic determinants of HIV-1 and the main surface antigen of hepatitis B (HBsAg. The second candidate vaccine was created against hepatitis B on the base of the genetic construct with the gene preS2-S encoding the synthesis of two subunits of the main surface antigen of hepatitis B and the signal peptide HDEL which directed antigens for the accumulation on ER. Both vaccines were tested on mice and confirmed their immunogenicity as the pronounced antibodies response. Twice vaccinated mice maintained the antibodies response during 11 months after there was little tendency to lowering. It was established that transgenic plants – vaccines (tomato kept the capability to the synthesis of antigenic determinants in seven seed generations during 7 years. The results of the development of the mucosal vaccine against cervical carcinoma (carcinoma of uterine cervix evoked by human papillomaviruses of high oncogenic risks were presented in this report. We created the genetic construct consisting of 35S CaMV promoter, Ώ (omega leader of TMV, the

  19. Development of a tripolar model of technology acceptance: Hospital-based physicians' perspective on EHR.

    Science.gov (United States)

    Beglaryan, Mher; Petrosyan, Varduhi; Bunker, Edward

    2017-06-01

    In health care, information technologies (IT) hold a promise to harness an ever-increasing flow of health related information and bring significant benefits including improved quality of care, efficiency, and cost containment. One of the main tools for collecting and utilizing health data is the Electronic Health Record (EHR). EHRs implementation can face numerous barriers to acceptance including attitudes and perceptions of potential users, required effort attributed to their implementation and usage, and resistance to change. Various theories explicate different aspects of technology deployment, implementation, and acceptance. One of the common theories is the Technology Acceptance Model (TAM), which helps to study the implementation of different healthcare IT applications. The objectives of this study are: to understand the barriers of EHR implementation from the perspective of physicians; to identify major determinants of physicians' acceptance of technology; and develop a model that explains better how EHRs (and technologies in general) are accepted by physicians. The proposed model derives from a cross-sectional survey of physicians selected through multi-stage cluster sampling from the hospitals of Yerevan, Armenia. The study team designed the survey instrument based on a literature review on barriers of EHR implementation. The analysis employed exploratory structural equation modeling (ESEM) with a robust weighted least squares (WLSMV) estimator for categorical indicators. The analysis progressed in two steps: appraisal of the measurement model and testing of the structural model. The derived model identifies the following factors as direct determinants of behavioral intention to use a novel technology: projected collective usefulness; personal innovativeness; patient influence; and resistance to change. Other factors (e.g., organizational change, professional relationships, administrative monitoring, organizational support and computer anxiety) exert their

  20. Professional and Regulatory Search

    Science.gov (United States)

    Professional and Regulatory search are designed for people who use EPA web resources to do their job. You will be searching collections where information that is not relevant to Environmental and Regulatory professionals.