WorldWideScience

Sample records for current regulatory framework

  1. A Framework for Organizing Current and Future Electric Utility Regulatory and Business Models

    Energy Technology Data Exchange (ETDEWEB)

    Satchwell, Andrew [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Cappers, Peter [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Schwartz, Lisa [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Fadrhonc, Emily Martin [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States)

    2015-06-01

    In this report, we will present a descriptive and organizational framework for incremental and fundamental changes to regulatory and utility business models in the context of clean energy public policy goals. We will also discuss the regulated utility's role in providing value-added services that relate to distributed energy resources, identify the "openness" of customer information and utility networks necessary to facilitate change, and discuss the relative risks, and the shifting of risks, for utilities and customers.

  2. Risk assessment of GM trees in the EU: current regulatory framework and guidance

    Directory of Open Access Journals (Sweden)

    Aguilera J

    2013-04-01

    Full Text Available The use of genetically modified organisms - their release into the environment, import, and utilisation as food/feed or food/feed ingredients - is regulated in the European Union (EU. For placing onto the market, current legislations require a comprehensive and science-based risk assessment. This risk assessment (RA is performed by applicants and then evaluated by national authorities in close cooperation with the European Food Safety Authority (EFSA. The EFSA Panel on Genetically Modified Organisms (GMO has published a comprehensive set of guidance documents for applicants and risk assessors for the RA of GM plants (GMP, their products for food and/or feed use, and their cultivation. In those documents, the strategy and the criteria to conduct the assessment are explained, as well as the scientific data to be provided by the applicant. The assessment starts with the molecular characterisation of the GMP. If the GMP or products derived from it are to be consumed, the evaluation of its composition, potential toxicity and/or allergenicity, and nutritional value constitute further cornerstones of the process. The environmental risk assessment (ERA considers biotic and abiotic interactions and the impacts of the management of the GM plant when it is intended for cultivation. In the case of GM trees special emphasis would be placed on assessing their characteristic features such as their longevity, ability to disperse and their ecological significance in a range of environments. The outcome of the assessment is reflected in a published opinion from the EFSA GMO panel that indicates whether the GMP and its products raise any safety issues. This scientific opinion constitutes one of the elements taken into account by the different European regulatory authorities prior to a decision regarding authorisation to commercialise the product.

  3. A Framework for Organizing Current and Future Electric Utility Regulatory and Business Models

    Energy Technology Data Exchange (ETDEWEB)

    Satchwell, Andrew [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Cappers, Peter [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Schwartz, Lisa C. [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Fadrhonc, Emily Martin [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States)

    2015-06-01

    Many regulators, utilities, customer groups, and other stakeholders are reevaluating existing regulatory models and the roles and financial implications for electric utilities in the context of today’s environment of increasing distributed energy resource (DER) penetrations, forecasts of significant T&D investment, and relatively flat or negative utility sales growth. When this is coupled with predictions about fewer grid-connected customers (i.e., customer defection), there is growing concern about the potential for serious negative impacts on the regulated utility business model. Among states engaged in these issues, the range of topics under consideration is broad. Most of these states are considering whether approaches that have been applied historically to mitigate the impacts of previous “disruptions” to the regulated utility business model (e.g., energy efficiency) as well as to align utility financial interests with increased adoption of such “disruptive technologies” (e.g., shareholder incentive mechanisms, lost revenue mechanisms) are appropriate and effective in the present context. A handful of states are presently considering more fundamental changes to regulatory models and the role of regulated utilities in the ownership, management, and operation of electric delivery systems (e.g., New York “Reforming the Energy Vision” proceeding).

  4. [Advanced therapy: from European regulatory framework to national regulatory framework].

    Science.gov (United States)

    Lucas-Samuel, S

    2013-05-01

    The European regulation n(o) 1394/2007/CE published on the 13th of November 2007 defined and harmonized the European regulatory framework for advanced therapy medicinal products. It creates a specialized committee located at the European Medicine Agency, in charge of the assessment of these medicinal products. The consequences of this regulation are introduced in the French regulation by the law n(o) 2011-302 published on the 22nd of March 2011. It detailed notably the possibility for public establishments (except health establishments) and nonprofit organisms to create pharmaceutical establishments. This law defined also a specific category of advanced therapy medicinal products, which fall under the "hospital exemption" framework. The rules regarding the authorizations of the establishments able to prepare these types of medicinal products and the authorization of the products are defined by the n(o) 2012-1236 decree published on the 6th of November 2012.

  5. Limits of the current EU regulatory framework on GMOs: risk of not authorized GM event-traces in imports

    Directory of Open Access Journals (Sweden)

    Roïz Julie

    2014-11-01

    Full Text Available Since their first commercialization in the 1990’s, the number of genetically modified organisms (GMOs cultivated around the world has steadily increased. This development has been accompanied by the development of regulatory and policy environments which vary from one country to another. Today, the European food and feed sectors are faced with the increasing risk of finding traces of not authorized GMOs in imports. Under the EU zero tolerance for unapproved GMOs, this situation may lead to trade disruptions with important cost implications. A regulatory environment which minimizes the risk of such disruption is therefore indispensable. To address this issue, the EU has adopted the “technical solution” but this remains insufficient to provide the necessary legal certainty which is needed to operate in such context. More comprehensive approaches are considered globally through low level presence policies.

  6. Highly Reliable Organizations in the Onshore Natural Gas Sector: An Assessment of Current Practices, Regulatory Frameworks, and Select Case Studies

    Energy Technology Data Exchange (ETDEWEB)

    Logan, Jeffrey S. [National Renewable Energy Laboratory (NREL), Golden, CO (United States); Paranhos, Elizabeth [Energy Innovation Partners, Seattle, WA (United States); Kozak, Tracy G. [Energy Innovation Partners, Seattle, WA (United States); Boyd, William [Univ. of Colorado, Boulder, CO (United States)

    2017-07-31

    This study focuses on onshore natural gas operations and examines the extent to which oil and gas firms have embraced certain organizational characteristics that lead to 'high reliability' - understood here as strong safety and reliability records over extended periods of operation. The key questions that motivated this study include whether onshore oil and gas firms engaged in exploration and production (E&P) and midstream (i.e., natural gas transmission and storage) are implementing practices characteristic of high reliability organizations (HROs) and the extent to which any such practices are being driven by industry innovations and standards and/or regulatory requirements.

  7. Recommendations on legislative and regulatory framework and regulatory body of nuclear security in China

    Institute of Scientific and Technical Information of China (English)

    PU Jilong; LI Xiaoyan

    2007-01-01

    This paper describes the definition of nuclear security that has been changing from the cold war age to the post-911 period, and clarifies the close relationship and yet a clear distinction between nuclear security, nuclear safety and nuclear safeguard. Based on analyses of the current state of nuclear security activities in China as well as the requirements and the law infrastructure, a legislative and regulatory framework of nuclear security and the mandate of a regulatory body in China are recommended.

  8. Environmental regulatory and policy framework in China: an overview

    Institute of Scientific and Technical Information of China (English)

    2001-01-01

    China has developed one of the most comprehensive environmental regulatory and policy framework in the world. This paper provides a description of the main institutions for environmental management in China, and overviews the regulatory and policy framework in place.

  9. Current Regulations and Regulatory Actions

    Science.gov (United States)

    This site will provide basic information on clean air permitting under the title V operating permits program, provide access to state and regional permitting programs, and maintain access to proposed and final regulatory requirements.

  10. m-government legal and regulatory framework

    African Journals Online (AJOL)

    Wondwossen Mulugeta

    The absence of such a ratified legal framework is one of the reasons for .... (for Addis Ababa city Administration education bureau) ... many more. Currently, the mobile network coverage in .... provide protection of consumers and personal data.

  11. Regulatory framework for NORM residues in Belgium

    Energy Technology Data Exchange (ETDEWEB)

    Pepin, S.; Dehandschutter, B.; Poffijn, A.; Sonck, M. [Federal Agency for Nuclear Control (FANC), Rue Ravenstein 36, 1000 Brussels (Belgium)

    2013-07-01

    The Belgian radiation protection authority (Federal Agency for Nuclear Control - FANC) has published in March 2013 a decree regulating the acceptance of NORM residues by nonradioactive waste treatment facilities. This regulation is based on the concept of 'work activities involving natural radiation sources' in the sense of article 40 of the 96/29/EURATOM directive. The disposal or processing facilities which accept NORM residues with an activity concentration above a generic exemption level will be considered as 'work activities' and submitted to declaration according to the Belgian radiation protection regulations. On basis of this declaration, specific acceptance criteria for the different types of processing/ disposal of the residues (disposal on landfill, recycling into building materials, etc.) are imposed. FANC has drafted guidelines for these acceptance criteria. A methodological guide for the operators of the concerned facilities was also published. Moreover, sites where significant quantities of NORM residues are or have been disposed, are subjected to an environmental monitoring in the framework of the national program of radiological surveillance of FANC. FANC also introduced in its regulations the concept of anthropogenic radon-prone areas: e.g. former phosphogypsum stacks have been defined as anthropogenic radon-prone areas, which allows some form of regulatory control of these sites. (authors)

  12. A Research Paper On The Impact Of Regulatory Framework On IPO Under Pricing

    OpenAIRE

    Thakur, Preeti

    2015-01-01

    As we all know initial public offering (IPO) underpricing and regulatory framework is the hottest topic in the current industry, mainly because of India being a developing country and lot of growth in various sectors which leads a country to ultimate success. The purpose of this study is to study whether Underpricing exists in Indian IPOs or not and to study the impact of regulatory framework on IPO Underpricing. In this research project the data is analyzed by descriptive and comparative met...

  13. Policy, Legal and Regulatory Framework for Records Management ...

    African Journals Online (AJOL)

    Policy, Legal and Regulatory Framework for Records Management in the ... They are fundamental to the efficient and effective operation of the legal system of any ... The data were collected through interviews, questionnaires and document ...

  14. New regulatory framework for wastewater quality control in Mexico.

    Science.gov (United States)

    Saade Hazin, L

    2000-01-01

    This paper analyses the new regulatory framework for wastewater quality control developed in Mexico. It provides a description of the Mexican government strategies for water pollution control. The discussion focuses on the policy instruments used, their evolution and the main difficulties encountered in their implementation. The new regulatory framework is discussed highlighting some of the economic implications of the reforms. The paper concludes that proper institutional development and monitoring are essential factors for the success of any policy instrument for wastewater quality control.

  15. Health claims on food products in Southeast Asia: regulatory frameworks, barriers, and opportunities.

    Science.gov (United States)

    Tan, Karin Y M; van der Beek, Eline M; Chan, M Y; Zhao, Xuejun; Stevenson, Leo

    2015-09-01

    The Association of Southeast Asian Nations aims to act as a single market and allow free movement of goods, services, and manpower. The purpose of this article is to present an overview of the current regulatory framework for health claims in Southeast Asia and to highlight the current barriers and opportunities in the regulatory frameworks in the Association of Southeast Asian Nations. To date, 5 countries in Southeast Asia, i.e., Indonesia, Malaysia, the Philippines, Singapore, and Thailand, have regulations and guidelines to permit the use of health claims on food products. There are inconsistencies in the regulations and the types of evidence required for health claim applications in these countries. A clear understanding of the regulatory frameworks in these countries may help to increase trade in this fast-growing region and to provide direction for the food industry and the regulatory community to develop and market food products with better nutritional quality tailored to the needs of Southeast Asian consumers.

  16. A risk-based regulatory framework for health IT: recommendations of the FDASIA working group.

    Science.gov (United States)

    Slight, Sarah P; Bates, David W

    2014-10-01

    The Secretary of Health and Human Services (HHS) acting through the Food and Drug Administration (FDA), and in collaboration with the Federal Communications Commission (FCC) and Office of the National Coordinator for Health IT (ONC) was tasked with delivering a report on an appropriate, risk-based regulatory framework for health information technology (IT). An expert stakeholder group was established under the auspices of the Health IT Policy Committee to help provide input into the development of this framework, including how healthcare IT systems could be stratified in terms of risk and recommendations about how the regulatory requirements currently in place should be adapted. In this paper, we summarize the public deliberations and final public report of the expert stakeholder group, and conclude with key suggestions intended to address the charge to recommend the features of a risk-based regulatory framework that promote innovation, protect patient safety, and avoid regulatory duplication.

  17. A Framework for Integrating Environmental Justice in Regulatory Analysis

    Directory of Open Access Journals (Sweden)

    Onyemaechi C. Nweke

    2011-06-01

    Full Text Available With increased interest in integrating environmental justice into the process for developing environmental regulations in the United States, analysts and decision makers are confronted with the question of what methods and data can be used to assess disproportionate environmental health impacts. However, as a first step to identifying data and methods, it is important that analysts understand what information on equity impacts is needed for decision making. Such knowledge originates from clearly stated equity objectives and the reflection of those objectives throughout the analytical activities that characterize Regulatory Impact Analysis (RIA, a process that is traditionally used to inform decision making. The framework proposed in this paper advocates structuring analyses to explicitly provide pre-defined output on equity impacts. Specifically, the proposed framework emphasizes: (a defining equity objectives for the proposed regulatory action at the onset of the regulatory process, (b identifying specific and related sub-objectives for key analytical steps in the RIA process, and (c developing explicit analytical/research questions to assure that stated sub-objectives and objectives are met. In proposing this framework, it is envisioned that information on equity impacts informs decision-making in regulatory development, and that this is achieved through a systematic and consistent approach that assures linkages between stated equity objectives, regulatory analyses, selection of policy options, and the design of compliance and enforcement activities.

  18. Analysis of regulatory-ethical framework of clinical trials

    OpenAIRE

    Milošević-Georgiev Andrijana; Krajnović Dušanka; Milovanović Srđan; Ignjatović Svetlana; Đurić Dušan; Marinković Valentina

    2013-01-01

    Introduction. Every clinical trial has to meet all ethical criteria in addition to the scientific ones. The basic ethical principles in the clinical trials are the following: nonmaleficence, beneficence, respect for autonomy and the principle of justice. Objective. The aim of the study was to analyze clinical cases with the outcomes leading to the changes in regulatory­ethical framework related to the clinical trials, as well as the outcomes of key clinical trials that influenced the in...

  19. 78 FR 49726 - International Framework for Nuclear Energy Cooperation Finance/Regulatory/Energy Planning...

    Science.gov (United States)

    2013-08-15

    ... International Trade Administration International Framework for Nuclear Energy Cooperation Finance/ Regulatory... International Framework for Nuclear Energy Cooperation (IFNEC)--to organize participation by representatives of... power projects, including national energy planning authorities, nuclear regulatory institutions, energy...

  20. Current status of developmental neurotoxicity: regulatory view

    DEFF Research Database (Denmark)

    Hass, Ulla

    2003-01-01

    . Until recently, however, developmental neurotoxicity testing of industrial chemicals has not been a clear regulatory requirement in EU, probably due to the lack of an accepted OECD TG. The revised EU Technical Guidance Document for Risk Assessment (EU-TGD) has now included the OECD draft TG 426...... in the testing strategy for new and existing substances, and biocides. Hopefully, this will lead to an improved database for risk assessment of potential developmental neurotoxicants. However, the regulatory authorities and toxicologists will also be faced with the challenge that decisions have to be made......The need for developmental neurotoxicity testing has been recognized for decades and guidelines are available, as the USEPA guideline and the OECD draft TG 426. Regulatory testing of industrial chemicals for developmental neurotoxicity is required to some extent, especially for pesticides in the US...

  1. Current approaches to gene regulatory network modelling

    Directory of Open Access Journals (Sweden)

    Brazma Alvis

    2007-09-01

    Full Text Available Abstract Many different approaches have been developed to model and simulate gene regulatory networks. We proposed the following categories for gene regulatory network models: network parts lists, network topology models, network control logic models, and dynamic models. Here we will describe some examples for each of these categories. We will study the topology of gene regulatory networks in yeast in more detail, comparing a direct network derived from transcription factor binding data and an indirect network derived from genome-wide expression data in mutants. Regarding the network dynamics we briefly describe discrete and continuous approaches to network modelling, then describe a hybrid model called Finite State Linear Model and demonstrate that some simple network dynamics can be simulated in this model.

  2. Favorable genomic environments for cis-regulatory evolution: A novel theoretical framework.

    Science.gov (United States)

    Maeso, Ignacio; Tena, Juan J

    2016-09-01

    Cis-regulatory changes are arguably the primary evolutionary source of animal morphological diversity. With the recent explosion of genome-wide comparisons of the cis-regulatory content in different animal species is now possible to infer general principles underlying enhancer evolution. However, these studies have also revealed numerous discrepancies and paradoxes, suggesting that the mechanistic causes and modes of cis-regulatory evolution are still not well understood and are probably much more complex than generally appreciated. Here, we argue that the mutational mechanisms and genomic regions generating new regulatory activities must comply with the constraints imposed by the molecular properties of cis-regulatory elements (CREs) and the organizational features of long-range chromatin interactions. Accordingly, we propose a new integrative evolutionary framework for cis-regulatory evolution based on two major premises for the origin of novel enhancer activity: (i) an accessible chromatin environment and (ii) compatibility with the 3D structure and interactions of pre-existing CREs. Mechanisms and DNA sequences not fulfilling these premises, will be less likely to have a measurable impact on gene expression and as such, will have a minor contribution to the evolution of gene regulation. Finally, we discuss current comparative cis-regulatory data under the light of this new evolutionary model, and propose that the two most prominent mechanisms for the evolution of cis-regulatory changes are the overprinting of ancestral CREs and the exaptation of transposable elements.

  3. Global regulatory framework for production and marketing of crops biofortified with vitamins and minerals.

    Science.gov (United States)

    Mejia, Luis A; Dary, Omar; Boukerdenna, Hala

    2017-02-01

    Biofortification of crops is being introduced in several countries as a strategy to reduce micronutrient deficiencies. Biofortified products, with increased contents of micronutrients, are currently produced by conventional plant breeding, genetic modification, or nutrient-enhanced fertilization. Corn, rice, wheat, beans, pearl millet, sweet potato, and cassava have been biofortified with increased contents of provitamin A carotenoids, iron, or zinc. However, regulatory considerations are rare or nonexistent. The objective of this paper is to review the regulatory framework for production and marketing of biofortified crops in countries that have adopted this strategy. The information was identified using Internet search engines and websites of health and nutrition organizations and nongovernmental organizations and by consulting scientists and government authorities. Thus far, biofortified products introduced in Latin America, Africa, and Asia have been produced only by conventional breeding. Cultivars using other techniques are still under testing. The production and marketing of these products have been conducted without regulatory framework and under limited government control or regulatory guidance. Nevertheless, some countries have integrated biofortified crops into their nutrition agendas. Although improvements by conventional breeding have not been subject to regulations, when biofortification becomes expanded by including other techniques, an appropriate regulatory framework will be necessary.

  4. Review of Legislation and Regulatory Framework in Ukraine with Regard to Environmental Radiation Monitoring

    Energy Technology Data Exchange (ETDEWEB)

    Goldammer, Wolfgang; Batandjieva, Borislava (Private Consultants (Ukraine)); Nasvit, Oleg (National Security and Defence Council of Ukraine, Kyiv (Ukraine)); German, Olga (Swedish Radiation Safety Authority, Stockholm (Sweden))

    2009-06-15

    The aim of this review is to compare the current legal basis and regulatory framework in Ukraine to the relevant international safety requirements and to identify shortcomings, such as deficiencies and internal contradictions. However, no assessment of its practical implementation is made beyond the aspects related to environmental radiation monitoring. The report focuses on 13 areas present in the in the Ukrainian legislation and regulatory framework: R-1 Radiation monitoring R-2 Definition of responsibilities R-3 Normal situations R-4 Emergencies R-5 Long-term monitoring R-6 Intervention in cases of lasting exposure R-7 Use of monitoring data R-8 Record keeping R-9 Reporting to the regulatory authority R-10 Public information R-11 Human and financial resources R-12 Transboundary aspects R-13 Quality assurance. For each topic a description of the current situation and an evaluation is carried out. Ranking is then supplied supported by its evaluation. In brief these categories are: A: The national legal and regulatory documents are harmonised in substance with the international safety requirements; B: Substantial differences exist between the national and international requirements which should be addressed with the view to harmonise the legislation; C: Substantial deficiencies exist in the legal and/or regulatory bases which results in no or at least partial compliance with international safety requirements. P: In addition practical issues are also provided to indicates where practical implementation of the legislation and regulatory basis is not adequate in all respects. This report then presents main observations and conclusions of the review. On this basis, the report derives general suggestions for improvement of the legal and regulatory bases. These should be considered by the Ukrainian Government and the regulatory authorities within an action plan to improve the legal basis for radiological monitoring of the environment and to facilitate its implementation

  5. Current european regulatory perspectives on insulin analogues

    Directory of Open Access Journals (Sweden)

    Enzmann Harald G

    2011-07-01

    Full Text Available Abstract Insulin analogues are increasingly considered as an alternative to human insulin in the therapy of diabetes mellitus. Insulin analogues (IAs are chemically different from human insulin and may have different pharmacokinetic or pharmacodynamic properties. The significance of the modifications of the insulin molecule for the safety profile of IAs must be considered. This review describes the regulatory procedure and the expectations for the scientific content of European marketing authorization applications for innovative IAs submitted to the European Medicines Agency. Particular consideration is given to a potential cancer hazard. Specific regulatory guidance on how to address a possible carcinogenic or tumor promoting effect of innovative IAs in non-clinical studies is available. After marketing authorization, the factual access of patients to the new product will be determined to great extent by health technology assessment bodies, reimbursement decisions and the price. Whereas the marketing authorization is a European decision, pricing and reimbursement are national or regional responsibilities. The assessment of benefit and risk by the European Medicines Agency is expected to influence future decisions on price and reimbursement on a national or regional level. Collaborations between regulatory agencies and health technology assessment bodies have been initiated on European and national level to facilitate the use of the European Medicines Agency's benefit risk assessment as basis on which to build the subsequent health technology assessment. The option for combined or joint scientific advice procedures with regulators and health technology assessment bodies on European level or on a national level in several European Member States may help applicants to optimize their development program and dossier preparation in regard of both European marketing authorization application and reimbursement decisions.

  6. Carbon capture and storage - legal and regulatory framework

    Energy Technology Data Exchange (ETDEWEB)

    Russial, T.J. [US Carbon Sequestration Council (United States)

    2011-01-15

    In 1998, a colleague introduced a paper on greenhouse gas (GHG) reduction with a famous Mark Twain quote: 'Everybody talks about the weather, but nobody does anything about it.' Humour aside, the colleague's point was to highlight the considerable body of work under way to develop technologies to address the climate change impacts of GHG emissions. One option is carbon capture and storage (CCS), a technology that has been in the making for over 50 years. Thousands of scientists, engineers, and policymakers throughout the world are not only talking about CCS, but also diligently pursuing the technical know-how and legal and regulatory frameworks needed to deploy CCS as a climate change solution. CCS has many passionate supporters, some equally passionate detractors, and some who view it as a technology that must be tolerated to bridge the gap to fossil-free energy. This is a progress report on CCS readiness throughout the world with regard to the legal and regulatory framework development that is critical to CCS deployment. 177 refs., 7

  7. Optimizing the European regulatory framework for sustainable bacteriophage therapy in human medicine.

    Science.gov (United States)

    Verbeken, Gilbert; Pirnay, Jean-Paul; De Vos, Daniel; Jennes, Serge; Zizi, Martin; Lavigne, Rob; Casteels, Minne; Huys, Isabelle

    2012-06-01

    For practitioners at hospitals seeking to use natural (not genetically modified, as appearing in nature) bacteriophages for treatment of antibiotic-resistant bacterial infections (bacteriophage therapy), Europe's current regulatory framework for medicinal products hinders more than it facilitates. Although many experts consider bacteriophage therapy to be a promising complementary (or alternative) treatment to antibiotic therapy, no bacteriophage-specific framework for documentation exists to date. Decades worth of historical clinical data on bacteriophage therapy (from Eastern Europe, particularly Poland, and the former Soviet republics, particularly Georgia and Russia, as well as from today's 27 EU member states and the US) have not been taken into account by European regulators because these data have not been validated under current Western regulatory standards. Consequently, applicants carrying out standard clinical trials on bacteriophages in Europe are obliged to initiate clinical work from scratch. This paper argues for a reduced documentation threshold for Phase 1 clinical trials of bacteriophages and maintains that bacteriophages should not be categorized as classical medicinal products for at least two reasons: (1) such a categorization is scientifically inappropriate for this specific therapy and (2) such a categorization limits the marketing authorization process to industry, the only stakeholder with sufficient financial resources to prepare a complete dossier for the competent authorities. This paper reflects on the current regulatory framework for medicines in Europe and assesses possible regulatory pathways for the (re-)introduction of bacteriophage therapy in a way that maintains its effectiveness and safety as well as its inherent characteristics of sustainability and in situ self-amplification and limitation.

  8. Radiofrequency identification and medical devices: the regulatory framework on electromagnetic compatibility. Part I: medical devices.

    Science.gov (United States)

    Censi, Federica; Mattei, Eugenio; Triventi, Michele; Bartolini, Pietro; Calcagnini, Giovanni

    2012-05-01

    Radiofrequency identification (RFID) technology has acheived significant success and has penetrated into various areas of healthcare. Several RFID-based applications are used in various modalities with the ultimate aim of improving patient care. When a wireless technology is used in a healthcare environment, attention must be paid to the potential risks deriving from its use; one of the most important being electromagnetic interference with medical devices. In this paper, the regulatory framework concerning the electromagnetic compatibility between RFID and medical devices is analyzed to understand whether and how the application of the current standards allows for the effective control of the risks of electromagnetic interference.

  9. Regulatory framework for access to safe, effective quality medicines

    NARCIS (Netherlands)

    Rägo, Lembit; Sillo, Hiiti; 't Hoen, Ellen; Zweygarth, Monika

    2014-01-01

    Medicines of uncertain quality, safety and efficacy can be worse than no treatment at all. It is the responsibility of national medicines regulatory authorities to protect patients from harm. Yet, there are great disparities in regulatory capacity globally, preventing large populations from accessin

  10. Regulatory framework in assisted reproductive technologies, relevance and main issues.

    Directory of Open Access Journals (Sweden)

    Françoise Merlet

    2010-01-01

    Full Text Available Assisted reproductive technologies (ART have changed life for the past 25 years and many ethical and social issues have emerged following this new method of conception. In order to protect individuals against scientific and ethical abuses without inhibiting scientific progress, a specific legal framework is necessary. The first French law on Bioethics was voted after an extensive debate in 1994 then reviewed in 2004. This review previously scheduled every five years is currently being discussed. Legal provisions applying to ART are part of a large framework including the protection of the patients' rights and biomedical research. The key principles consist of respect for human life and ban on commercial practices of human body parts, eugenic practices and any kind of cloning. These key principles apply to ART. Donation is anonymous and free. Created in 2004, the Agence de la biomĂŠdecine is a government agency and one of the main tools of the French regulations. The missions focus on improving the quality and the safety of the management of ART. Evaluation of activities is available to all from the annual report. The agency represents the French competent authority for medical and scientific aspects of ART. Substantial differences in European legislations exist from the open-up "laissez faire" to the most restrictive one. As a consequence a large reproductive tourism has developed particularly for egg donation or surrogacy. The medical and ethical conditions of management of patients and donors represent the main critical points. In order to avoid ethical abuses, homogenization regarding the key principles is necessary in Europe. It is an opportunity to reassert that human body parts should not be a source of financial gain.

  11. Regulatory framework in assisted reproductive technologies, relevance and main issues.

    Science.gov (United States)

    Merlet, Françoise

    2009-01-01

    Assisted reproductive technologies (ART) have changed life for the past 25 years and many ethical and social issues have emerged following this new method of conception. In order to protect individuals against scientific and ethical abuses without inhibiting scientific progress, a specific legal framework is necessary. The first French law on Bioethics was voted after an extensive debate in 1994 then reviewed in 2004. This review previously scheduled every five years is currently being discussed. Legal provisions applying to ART are part of a large framework including the protection of the patients' rights and biomedical research. The key principles consist of respect for human life and ban on commercial practices of human body parts, eugenic practices and any kind of cloning. These key principles apply to ART. Donation is anonymous and free. Created in 2004, the Agence de la biomédecine is a government agency and one of the main tools of the French regulations. The missions focus on improving the quality and the safety of the management of ART. Evaluation of activities is available to all from the annual report. The agency represents the French competent authority for medical and scientific aspects of ART. Substantial differences in European legislations exist from the open-up "laissez faire" to the most restrictive one. As a consequence a large reproductive tourism has developed particularly for egg donation or surrogacy. The medical and ethical conditions of management of patients and donors represent the main critical points. In order to avoid ethical abuses, homogenization regarding the key principles is necessary in Europe. It is an opportunity to reassert that human body parts should not be a source of financial gain.

  12. Current Algebra in the Path Integral framework

    CERN Document Server

    Cardenas, V H; Saavedra, J

    1998-01-01

    In this letter we describe an approach to the current algebra based in the Path Integral formalism. We use this method for abelian and non-abelian quantum field theories in 1+1 and 2+1 dimensions and the correct expressions are obtained. Our results show the independence of the regularization of the current algebras.

  13. Regulatory framework of pricing and estimate standards in the petroleum sector

    Science.gov (United States)

    Romanyuk, V.; Baitova, U.; Safronova, E.; Pozdeeva, G.

    2015-11-01

    The article is devoted to the improvement of the regulatory framework of pricing and estimate standards in the petroleum sector. Regulatory framework reform in the construction sector is necessary at the state, territorial and branch levels. Taking into account the provision and opportunity for potential relations between sellers and buyers, peculiarities of industrial sectors and investment projects, sources of financing, technology pre-investment studies, pre-project, project, tender and production documentation.

  14. Deciphering the genetic regulatory code using an inverse error control coding framework.

    Energy Technology Data Exchange (ETDEWEB)

    Rintoul, Mark Daniel; May, Elebeoba Eni; Brown, William Michael; Johnston, Anna Marie; Watson, Jean-Paul

    2005-03-01

    We have found that developing a computational framework for reconstructing error control codes for engineered data and ultimately for deciphering genetic regulatory coding sequences is a challenging and uncharted area that will require advances in computational technology for exact solutions. Although exact solutions are desired, computational approaches that yield plausible solutions would be considered sufficient as a proof of concept to the feasibility of reverse engineering error control codes and the possibility of developing a quantitative model for understanding and engineering genetic regulation. Such evidence would help move the idea of reconstructing error control codes for engineered and biological systems from the high risk high payoff realm into the highly probable high payoff domain. Additionally this work will impact biological sensor development and the ability to model and ultimately develop defense mechanisms against bioagents that can be engineered to cause catastrophic damage. Understanding how biological organisms are able to communicate their genetic message efficiently in the presence of noise can improve our current communication protocols, a continuing research interest. Towards this end, project goals include: (1) Develop parameter estimation methods for n for block codes and for n, k, and m for convolutional codes. Use methods to determine error control (EC) code parameters for gene regulatory sequence. (2) Develop an evolutionary computing computational framework for near-optimal solutions to the algebraic code reconstruction problem. Method will be tested on engineered and biological sequences.

  15. Liquid Biopsies in Oncology and the Current Regulatory Landscape.

    Science.gov (United States)

    Strotman, Lindsay N; Millner, Lori M; Valdes, Roland; Linder, Mark W

    2016-10-01

    There is a profound need in oncology to detect cancer earlier, guide individualized therapies, and better monitor progress during treatment. Currently, some of this information can be achieved through solid tissue biopsy and imaging. However, these techniques are limited because of the invasiveness of the procedure and the size of the tumor. A liquid biopsy can overcome these barriers as its non-invasive nature allows samples to be collected over time. Liquid biopsies may also allow earlier detection than traditional imaging. Liquid biopsies include the analysis of circulating tumor cells (CTCs), cell-free nucleic acid (cfNA), or extracellular vesicles obtained from a variety of biofluids, such as peripheral blood. In this review, we discuss different liquid biopsy types and how they fit into the current regulatory landscape.

  16. Extended evolution: A conceptual framework for integrating regulatory networks and niche construction.

    Science.gov (United States)

    Laubichler, Manfred D; Renn, Jürgen

    2015-11-01

    This paper introduces a conceptual framework for the evolution of complex systems based on the integration of regulatory network and niche construction theories. It is designed to apply equally to cases of biological, social and cultural evolution. Within the conceptual framework we focus especially on the transformation of complex networks through the linked processes of externalization and internalization of causal factors between regulatory networks and their corresponding niches and argue that these are an important part of evolutionary explanations. This conceptual framework extends previous evolutionary models and focuses on several challenges, such as the path-dependent nature of evolutionary change, the dynamics of evolutionary innovation and the expansion of inheritance systems.

  17. Regulatory framework for "gluten-free" foods in India: Magic bullet for celiac disease patients

    Directory of Open Access Journals (Sweden)

    Puja Dudeja

    2016-01-01

    Full Text Available Coeliac disease (CD remains largely unrecognized and actual burden is much more than reported or diagnosed. The treatment essentially remains ′gluten free′ foods. Adulteration of these foods with gluten can occur anywhere in the chain from farm to fork. The current Food Safety and Standards Regulations (FSSR 2011 brought a ray of hope for CD patients by including prevention of contamination of food with gluten and labeling of gluten-free items under regulatory framework. The definition of "gluten-free" includes food items containing <20 ppm of gluten. These guidelines are at par with those given in USA and Canada. These regulations provide a reference point for manufacturers, physicians, and CD patients and ensure easy availability, accessibility, and identification of "gluten-free" food items. This step forward by Government of India constitutes the first comprehensive step taken toward management of the disease.

  18. Orphan Sources. Extending Radiological Protection outside the Regulatory Framework

    Energy Technology Data Exchange (ETDEWEB)

    Eugenio Gil [Deputy Director for Emergency, Spanish Nuclear Safety Council (Spain)

    2006-07-01

    Radioactive sources that are not under appropriate regulatory control-Orphan sources- can result in a number of undesirable consequences including human health impacts, socio-psychological impacts, political and economic impacts, as well as environmental impacts. Many countries are now in the process of introducing the necessary measures to regain an appropriate level of control over them. For a variety of historical and economic reasons, there could already be sources in any specific country that are not within the usual regulatory system. Some of these may be known about, others may not. Therefore a national strategy is needed to ascertain the likelihood and magnitude of the issue of radioactive source control problem within a country and the priorities necessary to address the problems identified. A well-developed plan for improving control over all relevant radioactive sources tailored to the national situation will ensure optimum use of resources such as time, money and personnel. It will allow these limited resources to be allocated appropriately to ensure that control is first regained over those sources presenting the highest risks. This lecture shows a way to develop an appropriate national strategy for regaining control over orphan sources. The methodology described in this lecture is basically based in the IAEA Recommendations. (author)

  19. Upstream petroleum licensing: a comparative approach on regulatory frameworks and economic impacts

    Energy Technology Data Exchange (ETDEWEB)

    Cunha, Amanda L. [Felsberg e Associados, Sao Paulo, SP (Brazil)

    2008-07-01

    The recent discoveries hit in the pre-salt area, such as Tupi, Jupiter, Bem-te-vi and Carioca may place Brazil amongst the largest oil producers in the world. As a result, the Brazilian regulatory framework, which was originally envisaged in a scenario of higher exploration risk, has been under heavy public scrutiny. The Brazilian Government has already taken the first steps towards substantial changes in the country's contracting model for upstream activities. By means of Resolution No. 6/2007, the National Council for Energy Policy ('CNPE') not only determined the removal of 41 blocks with sub-salt geology from the ANP 9 Th Bid Round, but also stressed the need for a different regime for E and P activities in the country's continental shelf. At this moment, there is a great deal of controversy on the contracting model to be adopted, mainly whether the concession model should be maintained, but subject to higher levels of government take, or a production sharing model should apply. This paper goes through the evolution of international oil agreements, from early concessions to modern agreements. A special emphasis is placed on concession/license regimes as well as on production sharing agreements (PSAs). Besides drawing a comparative line between such models, this article assesses their economic impacts and whether the regulatory framework currently in force in Brazil is suitable for a scenario of lower risk, showing that any desired level of regulation may be achieved in the context of a PSA as easily as in a exclusive concession. (author)

  20. Refining Dynamics of Gene Regulatory Networks in a Stochastic π-Calculus Framework

    OpenAIRE

    Paulevé, Loïc; Magnin, Morgan; Roux, Olivier

    2011-01-01

    International audience; In this paper, we introduce a framework allowing to model and analyse efficiently Gene Regulatory Networks in their temporal and stochastic aspects. The analysis of stable states and inference of René Thomas' discrete parameters derives from this logical formalism. We offer a compositional approach which comes with a natural translation to the Stochastic π-Calculus. The method we propose consists in successive refinements of generalized dynamics of Gene Regulatory Netw...

  1. Four essays on offshore wind power potential, development, regulatory framework, and integration

    Science.gov (United States)

    Dhanju, Amardeep

    Offshore wind power is an energy resource whose potential in the US has been recognized only recently. There is now growing interest among the coastal states to harness the resource, particularly in states adjacent to the Mid-Atlantic Bight where the shallow continental shelf allows installation of wind turbines using the existing foundation technology. But the promise of bountiful clean energy from offshore wind could be delayed or forestalled due to policy and regulatory challenges. This dissertation is an effort to identify and address some of the important challenges. Focusing on Delaware as a case study it calculates the extent of the wind resource; considers one means to facilitate resource development---the establishment of statewide and regional public power authorities; analyzes possible regulatory frameworks to manage the resource in state-controlled waters; and assesses the use of distributed storage to manage intermittent output from wind turbines. In order to cover a diversity of topics, this research uses a multi-paper format with four essays forming the body of work. The first essay lays out an accessible methodology to calculate offshore wind resource potential using publicly available data, and uses this methodology to access wind resources off Delaware. The assessment suggests a wind resource approximately four times the average electrical load in Delaware. The second essay examines the potential role of a power authority, a quasi-public institution, in lowering the cost of capital, reducing financial risk of developing and operating a wind farm, and enhancing regional collaboration on resource development and management issues. The analysis suggests that a power authority can lower the cost of offshore wind power by as much as 1/3, thereby preserving the ability to pursue cost-competitive development even if the current federal incentives are removed. The third essay addresses the existing regulatory void in state-controlled waters of Delaware

  2. Shale gas development in Canada : the regulatory framework

    Energy Technology Data Exchange (ETDEWEB)

    Beaudoin, Y.; Serry, J.K. [Blake, Cassels and Graydon, Ottawa, ON (Canada)

    2010-07-01

    Engineering advances in Canada are making unconventional gas plays more attractive, and provincial governments are looking to tap the economic benefits. Regulators are adjusting existing oil and gas regulations or drafting completely new legislation. This paper presented an overview of the rules for shale gas development in provinces with shale gas development potential, with particular reference to the following 4 regions: (1) British Columbia, Alberta, and Saskatchewan where natural gas development is a relatively well-established and significant part of the local economy, (2) Nova Scotia and New Brunswick where shale gas stands to significantly change the regulatory environment, (3) Quebec where local opposition to shale gas development is challenging for a provincial government that has relatively little experience in the area of oil and gas regulation, and (4) Ontario, where development potential seems to be limited. The paper identified 3 areas that often receive the most attention from regulators, notably tenure and development approval, with a focus on lands where gas rights are owned by the provincial crown; royalties, including any shale-specific incentive programs; and environmental regulation, with a focus on sourcing and use of water, management of produced and recovered waste water, and rules regarding frac fluid. The paper provided a big picture of Canada's legal system and then discussed the provincial situations. The future of shale policy and the American experience concluded the report. It was concluded that it is unlikely that the federal government of Canada will play a lead role in regulating shale development in this country. refs., figs.

  3. Distance Education Regulatory Frameworks: Readiness for Openness in Southwest Pacific/South East Asia Region Nations

    Science.gov (United States)

    Tynan, Belinda; James, Rosalind

    2013-01-01

    This paper reports in brief the pilot study, Distance Education Regulatory Frameworks, undertaken by the International Council for Open and Distance Education (ICDE) in 2010-2012 and the implications for openness for higher education in Southwest Pacific/South East Asia region nations. The project developed a methodological approach to…

  4. Alberta's evolving water use regulatory framework for energy projects

    Energy Technology Data Exchange (ETDEWEB)

    Wills, J.; Sultan, R. [Waterline Resources Inc. (Canada)

    2011-07-01

    In the oil and gas industry, water is a critical component of production; in Alberta, 75% of oil production is water-assisted. The use of water in Alberta is regulated by two organisms, Alberta Environment (AENV) and the Energy Resources and Conservation Board (ERCB), with the goal of sustainable management of water resources. AENV regulates the use of non-saline water by the industry and the ERCB regulates access to saline water for energy projects. Non-saline water is defined as having a concentration of less than 4,000 mg/L of total dissolved solids and saline water as having a concentration above 4,000mg/L. The regulatory framework is in constant evolution and the aim of this paper is to provide detail and clarity on the current and future situations. This paper highlights current and emerging regulations on water use in Alberta so that industrial operators can better understand what is and will be asked of them.

  5. QUESTIONS TO REGULATORY FRAMEWORK ACCOUNTING AND FINANCIAL STATEMENTS UNDER IFRS

    Directory of Open Access Journals (Sweden)

    V. Shvets

    2015-10-01

    Full Text Available With the system approach in article analyzes the situation and problems of legal regulation and providing accounting and financial reporting in terms of standardization and harmonization of the principles of IFRS. The evaluation of the provisions and objectives of the strategy for reform of accounting and reporting rules and the requirements of European integration processes. Analyzed and determined the degree of influence of accounting and analytical science and education for the development and implementation of new approaches to the reform process and regulation of accounting, control and audit. critical analysis of the draft amendments to the existing regulations, current views on instytutsiynist accounting under uncertainty and systemic crisis outlined organizational problems and possible solutions to methodological council of accounting.

  6. 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

  7. ANALYSIS OF THE NEW REGULATORY BIOETHICAL REVIEW FRAMEWORK FOR CLINICAL TRIALS IN TURKEY.

    Science.gov (United States)

    Ilgili, Onder; Arda, Berna; Munir, Kerim

    2014-04-01

    We conducted a descriptive study of the existing research ethics committee (REC) review structure in Turkey with respect to clinical trials and discuss what can be expected in the future under the new regulation that came into effect in April 2013. We identified 78 RECs in Turkey under the Ministry of Health (MOH) as of September 2012, categorised under geographic location, type and institution. We identified REC member lists from the MOH in the same month and further characterize them under: membership number, gender, and speciality. MOH, universities, national nongovernmental organizations such as the Turkish Medical Association and the Turkish Bioethics Association, as well as clinical research and pharmaceutical bodies are intensively interested in the enhancement of the current system of research ethics review in the country. The European Union and Council directives have been important sources that have guided new developments. Proper evaluation of the existing system and introduction of new regulatory framework are expected to further clarify the obstacles and offer opportunities for institutions, researchers, REC members and administrators.

  8. The regulatory framework of special medical group students' physical education: identifying the problem.

    Directory of Open Access Journals (Sweden)

    Mazur Valerij Anatol'evich

    2011-09-01

    Full Text Available The question of regulatory framework for special medical group students' physical education, and their physical condition in particular is elaborated. It is found that in the current program the identified question is missing, although the assessment of individual performance standards for the physical condition of the students was envisaged in the programs of 1977 and 1982. The need for such an assessment is indicated by the large number of Ukrainian and foreign pediatricians and specialists in therapeutic physical culture. At the same time the standards for assessing these indicators are not developed. It complicates the formation of positive motivation of students to regular classes, and does not promote their self-confidence, capabilities and effectiveness of monitoring the effectiveness of exercise in various forms. The findings suggest the need to define the optimal composition of the bulk of tests and functional tests to assess the physical condition of special medical group students with various diseases and to develop appropriate indicators for their evaluation standards.

  9. A combined park management framework based on regulatory and behavioral strategies: use of visitors' knowledge to assess effectiveness.

    Science.gov (United States)

    Papageorgiou, K

    2001-07-01

    In light of the increasing mandate for greater efficiency in conservation of natural reserves such as national parks, the present study suggests educational approaches as a tool to achieve conservation purposes. Currently, the management of human-wildlife interactions is dominated by regulatory strategies, but considerable potential exists for environmental education to enhance knowledge in the short run and to prompt attitude change in the long run. A framework for conservation based on both traditional regulatory- and behavior-oriented strategies was proposed whereby the level of knowledge that park visitors have acquired comprises an obvious outcome and establishes a basis upon which the effectiveness of regulatory- and behavior-based regimes could be assessed. The perceptions regarding park-related issues of two distinct visitor groups (locals and nonlocals) are summarized from a survey undertaken in Vikos-Aoos national park. The findings suggest a superficial knowledge for certain concepts but little profound understanding of the content of such concepts, indicating that knowledge-raising efforts should go a long way towards establishing a positive attitude for the resource. Visitors' poor knowledge of the park's operation regulation contest the efficiency of the presently dominant regulatory management regime. While geographical distances did not appear to significantly differentiate knowledge between the two groups, wilderness experience (as certified by visits to other parks) was proved to be an impetus for generating substantial learner interest in critical park issues among nonlocal visitors. School education and media were found to be significant knowledge providers.

  10. Evolving PBPK applications in regulatory risk assessment: current situation and future goals

    Science.gov (United States)

    The presentation includes current applications of PBPK modeling in regulatory risk assessment and discussions on conflicts between assuring consistency with experimental data in current situation and the desire for animal-free model development.

  11. End of FY10 report - used fuel disposition technical bases and lessons learned : legal and regulatory framework for high-level waste disposition in the United States.

    Energy Technology Data Exchange (ETDEWEB)

    Weiner, Ruth F.; Blink, James A. (Lawrence Livermore National Laboratory, Livermore, CA); Rechard, Robert Paul; Perry, Frank (Los Alamos National Laboratory, Los Alamos, NM); Jenkins-Smith, Hank C. (University of Oklahoma, Norman, OK); Carter, Joe (Savannah River Nuclear Solutions, Aiken, SC); Nutt, Mark (Argonne National Laboratory, Argonne, IL); Cotton, Tom (Complex Systems Group, Washington DC)

    2010-09-01

    This report examines the current policy, legal, and regulatory framework pertaining to used nuclear fuel and high level waste management in the United States. The goal is to identify potential changes that if made could add flexibility and possibly improve the chances of successfully implementing technical aspects of a nuclear waste policy. Experience suggests that the regulatory framework should be established prior to initiating future repository development. Concerning specifics of the regulatory framework, reasonable expectation as the standard of proof was successfully implemented and could be retained in the future; yet, the current classification system for radioactive waste, including hazardous constituents, warrants reexamination. Whether or not consideration of multiple sites are considered simultaneously in the future, inclusion of mechanisms such as deliberate use of performance assessment to manage site characterization would be wise. Because of experience gained here and abroad, diversity of geologic media is not particularly necessary as a criterion in site selection guidelines for multiple sites. Stepwise development of the repository program that includes flexibility also warrants serious consideration. Furthermore, integration of the waste management system from storage, transportation, and disposition, should be examined and would be facilitated by integration of the legal and regulatory framework. Finally, in order to enhance acceptability of future repository development, the national policy should be cognizant of those policy and technical attributes that enhance initial acceptance, and those policy and technical attributes that maintain and broaden credibility.

  12. Regulatory Framework for Salt Waste Disposal and Tank Closure at the Savannah River Site - 13663

    Energy Technology Data Exchange (ETDEWEB)

    Thomas, Steve; Dickert, Ginger [Savannah River Remediation LLC, Savannah River Site, Aiken, SC 29808 (United States)

    2013-07-01

    The end of the Cold War has left a legacy of approximately 37 million gallons of radioactive waste in the aging waste tanks at the Department of Energy's Savannah River Site (SRS). A robust program is in place to remove waste from these tanks, treat the waste to separate into a relatively small volume of high-level waste and a large volume of low-level waste, and to actively dispose of the low-level waste on-site and close the waste tanks and associated ancillary structures. To support performance-based, risk-informed decision making and to ensure compliance with all regulatory requirements, the U.S. Department of Energy (DOE) and its current and past contractors have worked closely with the South Carolina Department of Health and Environmental Control (SCDHEC), the U.S. Environmental Protection Agency (EPA) and the Nuclear Regulatory Commission (NRC) to develop and implement a framework for on-site low-level waste disposal and closure of the SRS waste tanks. The Atomic Energy Act of 1954, as amended, provides DOE the authority to manage defense-related radioactive waste. DOE Order 435.1 and its associated manual and guidance documents detail this radioactive waste management process. The DOE also has a requirement to consult with the NRC in determining that waste that formerly was classified as high-level waste can be safely managed as either low-level waste or transuranic waste. Once DOE makes a determination, NRC then has a responsibility to monitor DOE's actions in coordination with SCDHEC to ensure compliance with the Title 10 Code of Federal Regulations Part 61 (10CFR61), Subpart C performance objectives. The management of hazardous waste substances or components at SRS is regulated by SCDHEC and the EPA. The foundation for the interactions between DOE, SCDHEC and EPA is the SRS Federal Facility Agreement (FFA). Managing this array of requirements and successfully interacting with regulators, consultants and stakeholders is a challenging task but

  13. An integrative and applicable phylogenetic footprinting framework for cis-regulatory motifs identification in prokaryotic genomes.

    Science.gov (United States)

    Liu, Bingqiang; Zhang, Hanyuan; Zhou, Chuan; Li, Guojun; Fennell, Anne; Wang, Guanghui; Kang, Yu; Liu, Qi; Ma, Qin

    2016-08-09

    Phylogenetic footprinting is an important computational technique for identifying cis-regulatory motifs in orthologous regulatory regions from multiple genomes, as motifs tend to evolve slower than their surrounding non-functional sequences. Its application, however, has several difficulties for optimizing the selection of orthologous data and reducing the false positives in motif prediction. Here we present an integrative phylogenetic footprinting framework for accurate motif predictions in prokaryotic genomes (MP(3)). The framework includes a new orthologous data preparation procedure, an additional promoter scoring and pruning method and an integration of six existing motif finding algorithms as basic motif search engines. Specifically, we collected orthologous genes from available prokaryotic genomes and built the orthologous regulatory regions based on sequence similarity of promoter regions. This procedure made full use of the large-scale genomic data and taxonomy information and filtered out the promoters with limited contribution to produce a high quality orthologous promoter set. The promoter scoring and pruning is implemented through motif voting by a set of complementary predicting tools that mine as many motif candidates as possible and simultaneously eliminate the effect of random noise. We have applied the framework to Escherichia coli k12 genome and evaluated the prediction performance through comparison with seven existing programs. This evaluation was systematically carried out at the nucleotide and binding site level, and the results showed that MP(3) consistently outperformed other popular motif finding tools. We have integrated MP(3) into our motif identification and analysis server DMINDA, allowing users to efficiently identify and analyze motifs in 2,072 completely sequenced prokaryotic genomes. The performance evaluation indicated that MP(3) is effective for predicting regulatory motifs in prokaryotic genomes. Its application may enhance

  14. Social theory and current affairs: a framework for intellectual engagement.

    Science.gov (United States)

    Stones, Rob

    2014-06-01

    The paper aims to facilitate more adequate critical engagement with current affairs events by journalists, and with current affairs texts by audiences. It draws on social theory to provide the intellectual resources to enable this. The academic ambition is for the framework to be adopted and developed by social thinkers in producing exemplary critical readings of news and current affairs texts. To this end it is offered as a research paradigm. The paper situates its argument in relation to the wider literature in media and cultural studies, acknowledging the subtle skills required to appreciate the relative autonomy of texts. However, it draws attention to the lack of an adequate perspective with which to assess the frames, representations, and judgments within news and current affairs texts. To address this lacuna it proposes the conception of a social-theoretical frame, based on a number of meta-theoretical approaches, designed to provide audiences with a systematic means of addressing the status and adequacy of individual texts. Social theoretical frames can reveal the shortcomings of media framing of the contextual fields within which news and current affairs events take place. Two illustrative case studies are used to indicate the value and potential of the approach: the analysis of a short newspaper report of the return of protesters to Cairo's Tahrir Square in 2011, and a critique of four current affairs reports from various genres on the political turmoil in Thailand leading up to the clashes of May 2010.

  15. Current and future applications of PRA in regulatory activities

    Energy Technology Data Exchange (ETDEWEB)

    Speis, T.P.; Murphy, J.A.; Cunningham, M.A. [Nuclear Regulatory Commission, Washington, DC (United States)] [and others

    1995-04-01

    Probabilistic Risk Assessments (PRAs) have proven valuable in providing the regulators, the nuclear plant operators, and the reactor designers insights into plant safety, reliability, design and operation. Both the NRC Commissioners and the staff have grown to appreciate the valuable contributions PRAs can have in the regulatory arena, though I will admit the existence of some tendencies for strict adherence to the deterministic approach within the agency and the public at large. Any call for change, particularly one involving a major adjustment in approach to the regulation of nuclear power, will meet with a certain degree of resistance and retrenchment. Change can appear threatening and can cause some to question whether the safety mission is being fulfilled. This skepticism is completely appropriate and is, in fact, essential to a proper transition towards risk and performance-based approaches. Our task in the Office of Nuclear Regulatory Research is to increase the PRA knowledge base within the agency and develop appropriate guidance and methods needed to support the transitioning process.

  16. 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.

  17. Regulatory framework for the availability and use of animal drugs in the United States.

    Science.gov (United States)

    Modric, Sanja

    2013-09-01

    The goal of this article is to help practitioners understand the regulatory framework and basis for the approval of new animal drugs, the terminology and specific meaning of terms related to drug approval, and the marketing and use of veterinary drugs in companion animal practice. Understanding the differences between approved versus unapproved drugs and their use helps practitioners make the appropriate clinical decisions on their patients' treatment. Only when buying approved animal drugs can clinicians be assured of product safety, effectiveness, and manufacturing to the strict standards for quality, purity, and potency, as well as truthful and complete labeling.

  18. French Current Plans for a National Space Legal Framework

    Science.gov (United States)

    Clerc, Philippe

    2002-01-01

    France bears the international obligation to authorise and supervise space activities under its jurisdiction and can be liable for damage caused by space objects launched from Kourou (French Guiana) and/or by companies registered in France. The current national framework for the activities carried by Arianespace, Starsem, Eutelsat and for the Ariane European launcher operated from the Guiana Space Centre (CSG) is adequately regulated on the basis of relevant programmatic, contractual and administrative legal regime. But in consequence of the liberalisation of the telecommunications market, of the privatisation of international organisations and State owned companies and of the increasing private demands to access CSG facilities, further regulations could be needed. In this context, the French Ministry of Research's Space Department has convened in 1999, during 2 years, more than 100 technical and legal experts organised in several working groups to propose an upgraded national legal framework for space activities. This constituted working groups dealt with: launching (to implement a licence procedure, considering the responsibility of France and international competition rules), earth observation (for licensing and data policy), telecommunications and navigation, and space objects property and security regime (linked to the registration convention and the Unidroit Space Protocol). Th report of this work named "Space Law Evolution in France Study" was presented to the Minister of Research by the beginnings of this year. The present author has driven the overall study on behalf of the French Research Ministry's Space Department. This paper presents the report's general content with following actions regarding the French national space legal framework.

  19. Current Status of Regulatory Science Education in Faculties of Pharmaceutical Science in Japan.

    Science.gov (United States)

    Tohkin, Masahiro

    2017-01-01

     I introduce the current pharmaceutical education system in Japan, focusing on regulatory science. University schools or faculties of pharmaceutical science in Japan offer two courses: a six-year course for pharmacists and a four-year course for scientists and technicians. Students in the six-year pharmaceutical course receive training in hospitals and pharmacies during their fifth year, and those in the four-year life science course start research activities during their third year. The current model core curriculum for pharmaceutical education requires them to "explain the necessity and significance of regulatory science" as a specific behavior object. This means that pharmacists should understand the significance of "regulatory science", which will lead to the proper use of pharmaceuticals in clinical practice. Most regulatory science laboratories are in the university schools or faculties of pharmaceutical sciences; however, there are too few to conduct regulatory science education. There are many problems in regulatory science education, and I hope that those problems will be resolved not only by university-based regulatory science researchers but also by those from the pharmaceutical industry and regulatory authorities.

  20. A classification-based framework for predicting and analyzing gene regulatory response.

    Science.gov (United States)

    Kundaje, Anshul; Middendorf, Manuel; Shah, Mihir; Wiggins, Chris H; Freund, Yoav; Leslie, Christina

    2006-03-20

    We have recently introduced a predictive framework for studying gene transcriptional regulation in simpler organisms using a novel supervised learning algorithm called GeneClass. GeneClass is motivated by the hypothesis that in model organisms such as Saccharomyces cerevisiae, we can learn a decision rule for predicting whether a gene is up- or down-regulated in a particular microarray experiment based on the presence of binding site subsequences ("motifs") in the gene's regulatory region and the expression levels of regulators such as transcription factors in the experiment ("parents"). GeneClass formulates the learning task as a classification problem--predicting +1 and -1 labels corresponding to up- and down-regulation beyond the levels of biological and measurement noise in microarray measurements. Using the Adaboost algorithm, GeneClass learns a prediction function in the form of an alternating decision tree, a margin-based generalization of a decision tree. In the current work, we introduce a new, robust version of the GeneClass algorithm that increases stability and computational efficiency, yielding a more scalable and reliable predictive model. The improved stability of the prediction tree enables us to introduce a detailed post-processing framework for biological interpretation, including individual and group target gene analysis to reveal condition-specific regulation programs and to suggest signaling pathways. Robust GeneClass uses a novel stabilized variant of boosting that allows a set of correlated features, rather than single features, to be included at nodes of the tree; in this way, biologically important features that are correlated with the single best feature are retained rather than decorrelated and lost in the next round of boosting. Other computational developments include fast matrix computation of the loss function for all features, allowing scalability to large datasets, and the use of abstaining weak rules, which results in a more

  1. Radiofrequency identification and medical devices: the regulatory framework on electromagnetic compatibility. Part II: active implantable medical devices.

    Science.gov (United States)

    Mattei, Eugenio; Censi, Federica; Triventi, Michele; Bartolini, Pietro; Calcagnini, Giovanni

    2012-05-01

    The number and the types of electromagnetic emitters to which patients with active implantable medical devices (AIMD) are exposed to in their daily activities have proliferated over the last decade. Radiofrequency identification (RFID) is an example of wireless technology applied in many fields. The interaction between RFID emitters and AIMD is an important issue for patients, industry and regulators, because of the risks associated with such interactions. The different AIMDs refer to different standards that address the electromagnetic immunity issue in different ways. Indeed, different test setups, immunity levels and rationales are used to guarantee that AIMDs are immune to electromagnetic nonionizing radiation. In this article, the regulatory framework concerning electromagnetic compatibility between RFID systems and AIMDs is analyzed to understand whether and how the application of the current AIMD standards allows for the effective control of the possible risks associated with RFID technology.

  2. Review of the regulatory framework on genetically modified food and feed in Albania: a policy perspective

    Directory of Open Access Journals (Sweden)

    ALBAN JAUPI

    2014-06-01

    Full Text Available Recent developments in food production and processing technologies have considerably enhanced man's ability to provide larger quantities and a wider variety of products. However, the recent development biotechnologies has also significantly increased controversy and dispute over the use of food and other goods derived from genetically modified crops instead of from conventional crops, and other uses of genetic engineering in food production. The dispute involves consumers, biotechnology companies, governmental regulators, non-governmental organizations, and scientists. The article reviews the regulatory measures and approaches taken by the government of Albania to assess and manage the risks associated with the development, release and use of genetically modified foods in the country. The review and analyzes is made in light of the processes for harmonization of Albanian’s food policies and its legal and regulatory framework with the EU legislation and Acquis Communautaires. It identifies several important legal and regulatory issues and proposes necessary measures and mechanisms to be put in place related to identification and protection of the public interest and increased ability of consumers to be informed about the foods they eat

  3. Regulatory Framework in the Insurance Industry – The Solvency II Project

    Directory of Open Access Journals (Sweden)

    Simona-Laura Dragos

    2013-05-01

    Full Text Available Insurance is of fundamental importance to both individuals and business because replaces insecurity with security and stability. The protection provided by insurance and the investments made by insurers contribute to economic growth and structural development. The role of public authorities is to provide an adequate regulatory framework allowing consumers to benefit from product innovation and to be protected. The study gives a brief review of the development of the insurance risk-management concept, analysis the goals and design of the Solvency II project and the solvency capital requirement formula according to the new regulation. In the end the results of the quantitative impact studies on the insurance industry are discussed.

  4. Regulatory framework and examples of ground-source heating/cooling technology in the Winnipeg area

    Energy Technology Data Exchange (ETDEWEB)

    Matthews, R. [Manitoba Conservation, Winnipeg, MB (Canada)

    2003-07-01

    Winnipeg, Manitoba lies over a highly transmissive Carbonate Aquifer of Ordovician age, which provides a suitable environment for groundwater supply and return wells. Many licensed ground-source heating cooling (GSHC) systems have been installed in and around the Winnipeg urban area over the last several decades. A water rights licence, issued by the Provincial Department of Conservation, is required for all groundwater supply and return wells. This licence comes with certain rights and responsibilities. This paper describes the regulatory framework which governs the licensing process. The author emphasized that the future use and success of the technology depends, in large part, on the development of a critical mass of experienced contractors, hydrogeologists and consulting engineers. 2 refs.

  5. Building a regulatory framework for geothermal energy development in the NWT

    Energy Technology Data Exchange (ETDEWEB)

    Holroyd, Peggy; Dagg, Jennifer [Pembina Institute (Canada)

    2011-03-15

    There is a high potential in Canada's Northwest Territories (NWT) for using geothermal energy, the thermal energy generated and stored in the Earth, and this could help the NWT meet their greenhouse gas emissions reduction targets. The Pembina Institute was engaged by the government of the NWT to perform a jurisdictional analysis of geothermal energy legislation and policy around the world; this report presents its findings. The jurisdictional review was carried out in 9 countries and interviews were conducted with various geothermal energy experts. Following this research, the Pembina Institute made recommendations to the NWT government on the development of a geothermal energy regulatory framework which would cover the need to define geothermal energy legislation and resource ownership as well as a plan and vision for geothermal energy use. This report highlighted that with an effective government policy in place, the use of geothermal energy in the NWT could provide the territories with a stable and secure energy supply.

  6. The oil rich Niger Delta region: a framework for improved performance of the Nigerian regulatory process.

    Science.gov (United States)

    Onu, N Chukemeka Hemanachi

    2003-06-01

    The adoption of this policy framework has the ability to reconcile industry, the environment and community interests, taking into account all factors that are relevant to managing developments that are both sustainable and contributory to the achievement of industrial and community stability. The management of resource development is crucial in sustaining the Niger Delta ecosystem and the human population resident in the Niger Delta region. If these separate bodies are constituted they would have the potential to reduce and discourage: i) the vulnerability of the regulatory body to influential and powerful multinational oil companies; ii) the proclivity for unaccountability to the people of the Niger Delta region, since the people of the Niger Delta would have access to the regulatory body's classified and unclassified information, and are part of the decision-making process; and iii) a reduction in conflict between the oil mining companies and the aggrieved youths of the oil rich Niger Delta region. This policy framework also has the added advantage of producing high quality decisions and more acceptable decisions than those for which the people of the Niger Delta region are excluded from the processes that concern their existence. The agency decision-making could now become a multilateral process and thus promote and enhance the accurate, impartial and rational application of legislative directives to given cases or classes of cases. Most importantly, the Minister of Petroleum Resources should be empowered by legislation to revoke any license or lease in respect of an area designated as marginal if left undeveloped for a period of 5 years and grant a lease or license for the area to a more responsible oil company.

  7. Sociotechnical systems as a framework for regulatory system design and evaluation: Using Work Domain Analysis to examine a new regulatory system.

    Science.gov (United States)

    Carden, Tony; Goode, Natassia; Read, Gemma J M; Salmon, Paul M

    2017-03-15

    Like most work systems, the domain of adventure activities has seen a series of serious incidents and subsequent calls to improve regulation. Safety regulation systems aim to promote safety and reduce accidents. However, there is scant evidence they have led to improved safety outcomes. In fact there is some evidence that the poor integration of regulatory system components has led to adverse safety outcomes in some contexts. Despite this, there is an absence of methods for evaluating regulatory and compliance systems. This article argues that sociotechnical systems theory and methods provide a suitable framework for evaluating regulatory systems. This is demonstrated through an analysis of a recently introduced set of adventure activity regulations. Work Domain Analysis (WDA) was used to describe the regulatory system in terms of its functional purposes, values and priority measures, purpose-related functions, object-related processes and cognitive objects. This allowed judgement to be made on the nature of the new regulatory system and on the constraints that may impact its efficacy following implementation. Importantly, the analysis suggests that the new system's functional purpose of ensuring safe activities is not fully supported in terms of the functions and objects available to fulfil them. Potential improvements to the design of the system are discussed along with the implications for regulatory system design and evaluation across the safety critical domains generally. Copyright © 2017 Elsevier Ltd. All rights reserved.

  8. Controlling Methane Emissions in the Natural Gas Sector. A Review of Federal and State Regulatory Frameworks Governing Production, Gathering, Processing, Transmission, and Distribution

    Energy Technology Data Exchange (ETDEWEB)

    Paranhos, Elizabeth [Energy Innovation Partners, Seoul (South Korea); Kozak, Tracy G. [Energy Innovation Partners, Seoul (South Korea); Boyd, William [Univ. of Colorado, Boulder, CO (United States); Bradbury, James [U.S. Department of Energy, Washington, DC (United States); Steinberg, D. C. [National Renewable Energy Laboratory (NREL), Golden, CO (United States); Arent, D. J. [Joint Inst. for Strategic Energy Alaysis, Washington, DC (United States)

    2015-04-23

    This report provides an overview of the regulatory frameworks governing natural gas supply chain infrastructure siting, construction, operation, and maintenance. Information was drawn from a number of sources, including published analyses, government reports, in addition to relevant statutes, court decisions and regulatory language, as needed. The scope includes all onshore facilities that contribute to methane emissions from the natural gas sector, focusing on three areas of state and federal regulations: (1) natural gas pipeline infrastructure siting and transportation service (including gathering, transmission, and distribution pipelines), (2) natural gas pipeline safety, and (3) air emissions associated with the natural gas supply chain. In addition, the report identifies the incentives under current regulatory frameworks to invest in measures to reduce leakage, as well as the barriers facing investment in infrastructure improvement to reduce leakage. Policy recommendations regarding how federal or state authorities could regulate methane emissions are not provided; rather, existing frameworks are identified and some of the options for modifying existing regulations or adopting new regulations to reduce methane leakage are discussed.

  9. Data Integrity-A Study of Current Regulatory Thinking and Action.

    Science.gov (United States)

    Shafiei, Nader; De Montardy, Regis; Rivera-Martinez, Edwin

    2015-01-01

    In reaction to breaches of data integrity in the pharmaceutical industry, regulatory authorities have introduced inspection approaches or initiatives with the aim of reducing occurrences of data integrity problems. This review article-based on study of 65 cases of regulatory action from 2002 to 2014-provides an overview of current regulatory thinking and action on breaches of data integrity affecting GxP (health-related regulations) processes supporting non-clinical studies, clinical studies, laboratory controls, and production controls. These case studies largely represent position of the U.S. Food and Drug Administration and the regulatory agencies affiliated with the European Medicines Agency. Also discussed is the role of human factors as a potential source of data integrity problems. The article concludes by recommending some remedial controls that could be established to avoid or reduce occurrences of data integrity problems.Lay Abstract: In fulfilling their mission to protect public health, regulatory agencies (e.g., U.S. Food and Drug Administration, European Medicines Agency) must establish confidence that medical products they approve are fit for their intended use. In so doing they rely on scientific and operational data generated during research, development, manufacturing, sales, marketing, distribution, and post-marketing surveillance activities. The level of confidence they build is directly proportional to the scientific validity and integrity of data presented to them by the sponsors of medical products. In this article we present analysis of 65 case studies that document regulatory action taken by various regulatory agencies on breach of data integrity between 2002 and 2014. The ensuing discussion on current trends largely represents position of the U.S. Food and Drug Administration and European Medicines Agency. The article concludes by proposing some remedial controls that could be established by pharmaceutical companies to avoid or reduce

  10. Cogeneration and the regulatory framework of energy law; Kraft-Waerme-Kopplung und der energiewirtschaftliche Ordnungsrahmen

    Energy Technology Data Exchange (ETDEWEB)

    Cornehl, Angelika Bettina

    2009-06-15

    The present publication shows that the existing regulatory framework poses numerous impediments to cogeneration plants. This holds especially for industrial operators, but also for municipalities. It has prevented cogeneration from developing its full potential both as an element of competition and as a relief for the environment. Unlike industrial cogeneration plants, those serving the public energy supply at least enjoy the privilege of regional monopoly rights. In today's liberalised electricity market, however, this can be a burden for existing municipal plants which were installed under territorial protection and in many cases have incurred high cost levels and become inflexible and lacking in entrepreneurial spirit as a result. On account of its tendency to promote optimal resource input and efficiency, competition promises positive impulses for the use of cogeneration in small-scale heat grids, where high fuel efficiency matters more. A reform of the competition regime in the power economy would eliminate numerous impediments, particularly for industrial cogeneration operators. Good hopes for the future of cogeneration in a liberalised electricity and gas market are also nurtured by cooperative supply concepts and, within the large domain of services, opportunities held out by special contracting offers.

  11. Impact of the Serbian Banking Regulatory Framework Development on the Economic Growth of Serbia

    Directory of Open Access Journals (Sweden)

    Nenad Milojević

    2013-04-01

    Full Text Available The dynamic relationship between the banking regulatory framework and Basel capital standards, on the one side and economic growth and other macroeconomic indicators on the other side, attracts international academic and business circles for many years. Perceived from the Serbian perspective, the impact of the banking regulation development, or the Basel standards application, on economic growth is one of the most actual issues, especially since Serbia starting from December 31st 2011, began the Basel II application. The fact that the National Bank of Serbia and the Serbian commercial banks, gradually directed attention to more actual Basel III standard, further increasing the importance of the topic that this paper will be addressed. Quantitative and qualitative analyzes that were performed during the research presented in this paper indicate a significant potential for further positive effects, including economic growth, due to the implementation of Basel standards in Serbia. Positive results of application largely depend on adequate preparation, analysis and actions of all relevant parties in Basel standards implementation.

  12. A bayesian framework that integrates heterogeneous data for inferring gene regulatory networks.

    Science.gov (United States)

    Santra, Tapesh

    2014-01-01

    Reconstruction of gene regulatory networks (GRNs) from experimental data is a fundamental challenge in systems biology. A number of computational approaches have been developed to infer GRNs from mRNA expression profiles. However, expression profiles alone are proving to be insufficient for inferring GRN topologies with reasonable accuracy. Recently, it has been shown that integration of external data sources (such as gene and protein sequence information, gene ontology data, protein-protein interactions) with mRNA expression profiles may increase the reliability of the inference process. Here, I propose a new approach that incorporates transcription factor binding sites (TFBS) and physical protein interactions (PPI) among transcription factors (TFs) in a Bayesian variable selection (BVS) algorithm which can infer GRNs from mRNA expression profiles subjected to genetic perturbations. Using real experimental data, I show that the integration of TFBS and PPI data with mRNA expression profiles leads to significantly more accurate networks than those inferred from expression profiles alone. Additionally, the performance of the proposed algorithm is compared with a series of least absolute shrinkage and selection operator (LASSO) regression-based network inference methods that can also incorporate prior knowledge in the inference framework. The results of this comparison suggest that BVS can outperform LASSO regression-based method in some circumstances.

  13. A Bayesian Framework that integrates heterogeneous data for inferring gene regulatory networks

    Directory of Open Access Journals (Sweden)

    Tapesh eSantra

    2014-05-01

    Full Text Available Reconstruction of gene regulatory networks (GRNs from experimental data is a fundamental challenge in systems biology. A number of computational approaches have been developed to infer GRNs from mRNA expression profiles. However, expression profiles alone are proving to be insufficient for inferring GRN topologies with reasonable accuracy. Recently, it has been shown that integration of external data sources (such as gene and protein sequence information, gene ontology data, protein protein interactions with mRNA expression profiles may increase the reliability of the inference process. Here, I propose a new approach that incorporates transcription factor binding sites (TFBS and physical protein interactions (PPI among transcription factors (TFs in a Bayesian Variable Selection (BVS algorithm which can infer GRNs from mRNA expression profiles subjected to genetic perturbations. Using real experimental data, I show that the integration of TFBS and PPI data with mRNA expression profiles leads to significantly more accurate networks than those inferred from expression profiles alone. Additionally, the performance of the proposed algorithm is compared with a series of LASSO regression based network inference methods that can also incorporate prior knowledge in the inference framework. The results of this comparison suggest that BVS can outperform LASSO regression based method in some circumstances.

  14. International migration flows. Framework for understanding and current features.

    Directory of Open Access Journals (Sweden)

    Colectivo IOÉ

    2016-10-01

    Full Text Available The present article aims to outline a framework for the understanding of the present international migratory flows as well as to outline their main traits. In order to do this, we first group together the different migratory flows produced since the sixteenth century up to the mid seventies in the twentieth  century, stopping then for a closer look at the present situation which register the impact of economic globalization, translating it into an increase of said flows and, above all, to their enormous diversification. To end, we make a brief balance of the present period and a critical evaluation on the meaning of one of the flows which attracts most attention, economic migrations south-north, because these are the ones which have the most impact on developed countries.

  15. Strategies of bringing drug product marketing applications to meet current regulatory standards.

    Science.gov (United States)

    Wu, Yan; Freed, Anita; Lavrich, David; Raghavachari, Ramesh; Huynh-Ba, Kim; Shah, Ketan; Alasandro, Mark

    2015-08-01

    In the past decade, many guidance documents have been issued through collaboration of global organizations and regulatory authorities. Most of these are applicable to new products, but there is a risk that currently marketed products will not meet the new compliance standards during audits and inspections while companies continue to make changes through the product life cycle for continuous improvement or market demands. This discussion presents different strategies to bringing drug product marketing applications to meet current and emerging standards. It also discusses stability and method designs to meet process validation and global development efforts.

  16. Minimising the harm from nicotine use: finding the right regulatory framework

    Science.gov (United States)

    Borland, Ron

    2013-01-01

    The tobacco problem can be usefully conceptualised as two problems: eliminating the most harmful forms of nicotine use (certainly cigarettes, and probably all smoked tobacco), and minimising the use and/or harms from use of lower-harm, but addictive forms of nicotine. A possible target would be to effectively eliminate use of the most harmful forms of nicotine within the next decade and then turn our focus to a long-term strategy for the low-harm forms. This paper focuses on the administrative framework(s) needed to accomplish these twin tasks. For a phase-out taking a long time and/or for dealing with residually net harmful and addictive products, there are severe limitations to allowing for-profit marketing of tobacco because such an arrangement (the current one in most countries) can markedly slow down progress and because of the difficulty of constraining marketing in ways that minimise undesirable use. A harm reduction model where the marketing is under the control of a non-profit entity (a regulated market) is required to curtail the incredible power of for-profit marketing and to allow tobacco marketing to be done in ways that further the goal of minimising tobacco-related harm. Countries with a nationalised industry can move their industry onto a harm minimisation framework if they have the political will. Countries with a for-profit industry should consider whether the time and effort required to reconstruct the market may, in the longer term, facilitate achieving their policy goals. PMID:23591515

  17. Minimising the harm from nicotine use: finding the right regulatory framework.

    Science.gov (United States)

    Borland, Ron

    2013-05-01

    The tobacco problem can be usefully conceptualised as two problems: eliminating the most harmful forms of nicotine use (certainly cigarettes, and probably all smoked tobacco), and minimising the use and/or harms from use of lower-harm, but addictive forms of nicotine. A possible target would be to effectively eliminate use of the most harmful forms of nicotine within the next decade and then turn our focus to a long-term strategy for the low-harm forms. This paper focuses on the administrative framework(s) needed to accomplish these twin tasks. For a phase-out taking a long time and/or for dealing with residually net harmful and addictive products, there are severe limitations to allowing for-profit marketing of tobacco because such an arrangement (the current one in most countries) can markedly slow down progress and because of the difficulty of constraining marketing in ways that minimise undesirable use. A harm reduction model where the marketing is under the control of a non-profit entity (a regulated market) is required to curtail the incredible power of for-profit marketing and to allow tobacco marketing to be done in ways that further the goal of minimising tobacco-related harm. Countries with a nationalised industry can move their industry onto a harm minimisation framework if they have the political will. Countries with a for-profit industry should consider whether the time and effort required to reconstruct the market may, in the longer term, facilitate achieving their policy goals.

  18. An Exposition of Current Mobile Learning Design Guidelines and Frameworks

    Science.gov (United States)

    Teall, Ed; Wang, Minjuan; Callaghan, Vic; Ng, Jason W. P.

    2014-01-01

    As mobile devices with wireless access become more readily available, learning delivered via mobile devices of all types must be designed to ensure successful learning. This paper first examines three questions related to the design of mobile learning: 1) what mobile learning (m-learning) guidelines can be identified in the current literature, 2)…

  19. An Exposition of Current Mobile Learning Design Guidelines and Frameworks

    Science.gov (United States)

    Teall, Ed; Wang, Minjuan; Callaghan, Vic; Ng, Jason W. P.

    2014-01-01

    As mobile devices with wireless access become more readily available, learning delivered via mobile devices of all types must be designed to ensure successful learning. This paper first examines three questions related to the design of mobile learning: 1) what mobile learning (m-learning) guidelines can be identified in the current literature, 2)…

  20. Prebiotics and the health benefits of fiber: current regulatory status, future research, and goals.

    Science.gov (United States)

    Brownawell, Amy M; Caers, Wim; Gibson, Glenn R; Kendall, Cyril W C; Lewis, Kara D; Ringel, Yehuda; Slavin, Joanne L

    2012-05-01

    First defined in the mid-1990s, prebiotics, which alter the composition and activity of gastrointestinal (GI) microbiota to improve health and well-being, have generated scientific and consumer interest and regulatory debate. The Life Sciences Research Organization, Inc. (LSRO) held a workshop, Prebiotics and the Health Benefits of Fiber: Future Research and Goals, in February 2011 to assess the current state of the science and the international regulatory environment for prebiotics, identify research gaps, and create a strategy for future research. A developing body of evidence supports a role for prebiotics in reducing the risk and severity of GI infection and inflammation, including diarrhea, inflammatory bowel disease, and ulcerative colitis as well as bowel function disorders, including irritable bowel syndrome. Prebiotics also increase the bioavailability and uptake of minerals and data suggest that they reduce the risk of obesity by promoting satiety and weight loss. Additional research is needed to define the relationship between the consumption of different prebiotics and improvement of human health. New information derived from the characterization of the composition and function of different prebiotics as well as the interactions among and between gut microbiota and the human host would improve our understanding of the effects of prebiotics on health and disease and could assist in surmounting regulatory issues related to prebiotic use.

  1. Regulatory framework and business models for charging plug-in electric vehicles: Infrastructure, agents, and commercial relationships

    Energy Technology Data Exchange (ETDEWEB)

    Gomez San Roman, Tomas [Instituto de Investigacion Tecnologica, Universidad Pontificia Comillas, Madrid (Spain); Momber, Ilan, E-mail: ilan.momber@iit.upcomillas.es [Instituto de Investigacion Tecnologica, Universidad Pontificia Comillas, Madrid (Spain); Rivier Abbad, Michel; Sanchez Miralles, Alvaro [Instituto de Investigacion Tecnologica, Universidad Pontificia Comillas, Madrid (Spain)

    2011-10-15

    Electric vehicles (EVs) present efficiency and environmental advantages over conventional transportation. It is expected that in the next decade this technology will progressively penetrate the market. The integration of plug-in electric vehicles in electric power systems poses new challenges in terms of regulation and business models. This paper proposes a conceptual regulatory framework for charging EVs. Two new electricity market agents, the EV charging manager and the EV aggregator, in charge of developing charging infrastructure and providing charging services are introduced. According to that, several charging modes such as EV home charging, public charging on streets, and dedicated charging stations are formulated. Involved market agents and their commercial relationships are analysed in detail. The paper elaborates the opportunities to formulate more sophisticated business models for vehicle-to-grid applications under which the storage capability of EV batteries is used for providing peak power or frequency regulation to support the power system operation. Finally penetration phase dependent policy and regulatory recommendations are given concerning time-of-use pricing, smart meter deployment, stable and simple regulation for reselling energy on private property, roll-out of public charging infrastructure as well as reviewing of grid codes and operational system procedures for interactions between network operators and vehicle aggregators. - Highlights: > A conceptual regulatory framework for charging EVs is proposed. > 2 new agents, EV charging point manager, EV aggregator and their functions are introduced. > Depending on private or public access of charging points, contractual relations change. > A classification of charging scenarios alludes implications on regulatory topics. > EV penetration phase dependent policy and regulatory recommendations are given.

  2. Governing Nanomedicine: lessons from within, and for, the EU Medical Technology Regulatory Framework : Guest Editors Introduction

    NARCIS (Netherlands)

    Dorbeck-Jung, Bärbel; Bowman, Diana M.; Calster, van Geert

    2011-01-01

    Rapidly emerging technologies, such as nanotechnologies, are posing significant challenges to regulatory governance due to the uncertainties of development trajectories, product properties, and potential risk problems (Davies 2009). While nanotechnology-based products and processes fall within the s

  3. 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.

  4. Risk Management And Liability For EnvironmentalL Harm Caused By GMOS – The South African Regulatory Framework

    Directory of Open Access Journals (Sweden)

    L Feris

    2006-05-01

    Full Text Available Biotechnology is still relatively new and as with any new technology, it carries some level of risk. This necessitates appropriate risk assessments and appropriate risk management. One element of risk management however, is taking into account that during the production, development, transport or release of a GMO it may cause injury to person, property or the environment, regardless of risk management procedures. This calls for the existence of a liability regime that will place some legal responsibility on the party responsible for the harm. This paper assesses the South African regulatory framework of relevance to GMOs, which is composed of a fragmented set of laws that deals with risk assessment, risk management and liability for damage to the environment. It discusses the GMO Act as the principle legislation regulation GMOs and also the recent amendment thereof and also consider other legislation such as the ECA, NEMA and NEMA Biodiversity Act in an attempt to determine whether the regulatory framework addresses risk management and liability in an effective and adequate manner. It comes to the conclusion that South Africa does not as yet have a satisfactory legal regime that provides for risk management and liability in the context of GMOs.

  5. Current status and regulatory perspective of chimeric antigen receptor-modified T cell therapeutics.

    Science.gov (United States)

    Kim, Mi-Gyeong; Kim, Dongyoon; Suh, Soo-Kyung; Park, Zewon; Choi, Min Joung; Oh, Yu-Kyoung

    2016-04-01

    Chimeric antigen receptor-modified T cells (CAR-T) have emerged as a new modality for cancer immunotherapy due to their potent efficacy against terminal cancers. CAR-Ts are reported to exert higher efficacy than monoclonal antibodies and antibody-drug conjugates, and act via mechanisms distinct from T cell receptor-engineered T cells. These cells are constructed by transducing genes encoding fusion proteins of cancer antigen-recognizing single-chain Fv linked to intracellular signaling domains of T cell receptors. CAR-Ts are classified as first-, second- and third-generation, depending on the intracellular signaling domain number of T cell receptors. This review covers the current status of CAR-T research, including basic proof-of-concept investigations at the cell and animal levels. Currently ongoing clinical trials of CAR-T worldwide are additionally discussed. Owing to the lack of existing approved products, several unresolved concerns remain with regard to safety, efficacy and manufacturing of CAR-T, as well as quality control issues. In particular, the cytokine release syndrome is the major side-effect impeding the successful development of CAR-T in clinical trials. Here, we have addressed the challenges and regulatory perspectives of CAR-T therapy.

  6. From Bioequivalence to Biosimilarity: The Rise of a Novel Regulatory Framework.

    Science.gov (United States)

    Karalis, V D

    2016-01-01

    One of the most crucial issues in pharmacotherapy is to address the query if a patient can be switched from one product to another of the same active substance. For the conventional small-molecule drugs, there is a consensus on the required bioequivalence criteria. However, proving equivalence in the field of biologicals is an issue with no clear harmony. The aim of this review is to highlight the differences between the biologicals and the conventional chemical drugs, as well as, to present the different regulatory requirements for the placement of biosimilars on the market.Biologicals are substantially larger than chemical compounds, their manufacturing process is very complex, and their protein structure may trigger immune reactions. For this reason, the conventional bioequivalence approach is not adequate, but further emphasis should be placed on the quality of the manufacturing process and the risks of immunogenicity. The assessment procedure of biosimilars should encompass their comparison with the innovator product using all available evidence derived from the development process. The latter includes analytical and animal studies, pharmacokinetic and pharmacodynamic data, as well as, clinical trials focusing on immunogenicity. The US FDA has established a step-wise approach to demonstrate biosimilarity, while the EMA has already issued many guidelines referring either to all biosimilars or to specific products/classes. Overall, a case-by-case assessment procedure is considered by the regulatory authorities. In any case the placement of a biosimilar on the market does not necessarily imply interchangeability with the innovator drug.

  7. The legal and ethical framework governing Body Donation in Europe - 1st update on current practice

    NARCIS (Netherlands)

    Riederer, B.M.; Bolt, S.H.; Brenner, E.; Bueno-López, J.L.; Circulescu, A.R.M.; Davies, D.C.; Caro, R. de; Gerrits, P.O.; McHanwell, S.; Pais, D.; Paulsen, F.; Plaisant, O.; Sendemir, E.; Stabile, I.; Moxham, B.J.

    2012-01-01

    Previously, we have reported on the legal and ethical aspects and current practice of body donation in several European countries, reflecting cultural and religious variations as well as different legal and constitutional frameworks. We have also established good practice in body donation. Here we s

  8. The legal and ethical framework governing Body Donation in Europe - 1st update on current practice

    NARCIS (Netherlands)

    Riederer, B.M.; Bolt, S.H.; Brenner, E.; Bueno-López, J.L.; Circulescu, A.R.M.; Davies, D.C.; Caro, R. de; Gerrits, P.O.; McHanwell, S.; Pais, D.; Paulsen, F.; Plaisant, O.; Sendemir, E.; Stabile, I.; Moxham, B.J.

    2012-01-01

    Previously, we have reported on the legal and ethical aspects and current practice of body donation in several European countries, reflecting cultural and religious variations as well as different legal and constitutional frameworks. We have also established good practice in body donation. Here we

  9. Regulatory and scientific frameworks for zoonosis control in Japan--contributing to International Health Regulations (2005).

    Science.gov (United States)

    Takahashi-Omoe, H; Omoe, K

    2009-12-01

    Zoonoses have earned recognition as the source of serious problems for both public and animal health throughout the world. Emerging infectious diseases have been occurring at an unprecedented rate since the 1970s and a large proportion of these diseases are considered zoonotic. To aid in controlling zoonoses, countermeasures have been strengthened against these diseases and are maintained at both national and international levels. Atypical example of this international effort can be found in the revised International Health Regulations (2005), known as the IHR (2005), which were instituted by the World Health Organization and have been implemented since 2007. In Japan, the appropriate Ministries have established frameworks for controlling zoonoses that employ both administrative and scientific approaches to fulfill the demands of the IHR (2005). In this paper, the authors present the Japanese framework for controlling zoonoses, as a useful example for global public and animal health management in coming years.

  10. Regulatory compliance : a framework for South African banks / R.H. Mynhardt

    OpenAIRE

    Mynhardt, Ronald Henry

    2008-01-01

    In April 2005, after lengthy discussions and much debate with banks around the world, the Basel Committee issued its paper entitled "Compliance and the compliance function in banks". This paper provides detailed compliance principles to which banks should adhere. Regulation 47(1) of the Regulations relating to the Banks Act, Act 94 of 1990, states that: A bank shall establish an independent compliance function as part of its risk-management framework, in order to ensure that the bank continuo...

  11. The regulatory framework of accounting and accounting standard-setting bodies in the European Union member states

    Directory of Open Access Journals (Sweden)

    Ivana Mamić-Sačer

    2015-12-01

    Full Text Available One of the principal features of accounting in the 21st century is harmonisation and stanardisation. Regulation of the European Parliament and European Council No. 1606/2002 harmonizes financial reporting for certain companies in the EU. However, national accounting principles are of great importance for financial reporting. The main purpose of this research was to investigate the application of generally accepted accounting principles, the regulatory accounting framework and the standard-setting bodies of EU member states. The analysis of these accounting issues was conducted with respect to all 28 EU member states. The results indicate that EU member states regulate their principal accounting issues through separate accounting acts or implement those issues in companies acts. Some EU member states do not have national accounting standards, the national accounting principles being incorporated in companies acts and accounting acts. Nevertheless, national accounting standard-setting bodies are governmental organisations in almost half the member states.

  12. Using human rights for sexual and reproductive health: improving legal and regulatory frameworks

    Science.gov (United States)

    Kismodi, Eszter; Hilber, Adriane Martin; Lincetto, Ornella; Stahlhofer, Marcus; Gruskin, Sofia

    2010-01-01

    Abstract This paper describes the development of a tool that uses human rights concepts and methods to improve relevant laws, regulations and policies related to sexual and reproductive health. This tool aims to improve awareness and understanding of States’ human rights obligations. It includes a method for systematically examining the status of vulnerable groups, involving non-health sectors, fostering a genuine process of civil society participation and developing recommendations to address regulatory and policy barriers to sexual and reproductive health with a clear assignment of responsibility. Strong leadership from the ministry of health, with support from the World Health Organization or other international partners, and the serious engagement of all involved in this process can strengthen the links between human rights and sexual and reproductive health, and contribute to national achievement of the highest attainable standard of health. PMID:20616975

  13. Current Status and Regulatory Aspects of Pesticides Considered to be Persistent Organic Pollutants (POPs) in Taiwan

    Science.gov (United States)

    Tsai, Wen-Tien

    2010-01-01

    Organochlorine pesticides (OCPs) are capable of persisting in the environment, transporting between phase media and accumulating to high levels, implying that they could pose a risk of causing adverse effects to human health and the environment. Consequently, most OCPs are designated as persistent organic pollutants (POPs) and even as endocrine disrupting chemicals (EDCs). The objective of this paper was to review the current status of pesticide POPs in Taiwan, including aldrin, chlordane, chlordecone, DDT, dieldrin, endrin, heptachlor, hexachlorobenzene, α/β-hexachlorocyclohexanes, lindane, mirex, pentachloro-benzene, and toxaphene. The information about their environmental properties, banned use, carcinogenic toxicity and environmental levels, can be connected with the regulatory infrastructure, which has been established by the joint-venture of the central competent authorities (i.e., Environmental Protection Administration, Department of Health, Council of Agriculture, and Council of Labor Affairs). The significant progress to be reported is that the residual levels of these pesticide-POPs, ranging from trace amounts to a few ppb, have declined notably in recent years. PMID:21139852

  14. Drug interaction studies on new drug applications: current situations and regulatory views in Japan.

    Science.gov (United States)

    Nagai, Naomi

    2010-01-01

    Drug interaction studies on new drug applications (NDAs) for new molecular entities (NMEs) approved in Japan between 1997 and 2008 are examined in the Pharmaceuticals and Medical Devices Agency (PMDA). The situations of drug interaction studies in NDAs have changed over the past 12 years, especially in metabolizing enzyme and transporter-based drug interactions. Materials and approaches to study drug-metabolizing enzyme-based drug interactions have improved, and become more rational based on mechanistic theory and new technologies. On the basis of incremental evidence of transporter roles in human pharmacokinetics, transporter-based drug interactions have been increasingly studied during drug development and submitted in recent NDAs. Some recently approved NMEs include transporter-based drug interaction information in their package inserts (PIs). The regulatory document "Methods of Drug Interaction Studies," in addition to recent advances in science and technology, has also contributed to plan and evaluation of drug interaction studies in recent new drug development. This review summarizes current situations and further discussion points on drug interaction studies in NDAs in Japan.

  15. Current Status and Regulatory Aspects of Pesticides Considered to be Persistent Organic Pollutants (POPs in Taiwan

    Directory of Open Access Journals (Sweden)

    Wen-Tien Tsai

    2010-10-01

    Full Text Available Organochlorine pesticides (OCPs are capable of persisting in the environment, transporting between phase media and accumulating to high levels, implying that they could pose a risk of causing adverse effects to human health and the environment. Consequently, most OCPs are designated as persistent organic pollutants (POPs and even as endocrine disrupting chemicals (EDCs. The objective of this paper was to review the current status of pesticide POPs in Taiwan, including aldrin, chlordane, chlordecone, DDT, dieldrin, endrin, heptachlor, hexachlorobenzene, α/β-hexachlorocyclohexanes, lindane, mirex, pentachloro-benzene, and toxaphene. The information about their environmental properties, banned use, carcinogenic toxicity and environmental levels, can be connected with the regulatory infrastructure, which has been established by the joint-venture of the central competent authorities (i.e., Environmental Protection Administration, Department of Health, Council of Agriculture, and Council of Labor Affairs. The significant progress to be reported is that the residual levels of these pesticide-POPs, ranging from trace amounts to a few ppb, have declined notably in recent years.

  16. Regulatory Isolation and Prudential Insufficiency:the Problems and Reform of Chinese Financial Regulatory Framework%监管割据与审慎不足:中国金融监管体制的问题与改革

    Institute of Scientific and Technical Information of China (English)

    吴云; 史岩

    2016-01-01

    在详尽梳理世界主要国家金融监管模式与监管改革趋势的基础上,指出中国“一行三会”分立监管体制的根本问题是监管割据与审慎不足,这些缺陷在2015年的股灾中表现尤为突出。提出要改革中国的金融监管体系就必须按照双峰监管的模式同时整合监管权力与强化审慎监管。%Based on comparing the various financial regulatory frameworks and the recent financial regulation re-formsin the major countries, this paper reveals that the fundamental flaws of Chinese“one bank and three commit-tees” regulatory framework are regulatory isolation and prudential insufficiency, and these flaws are noticeably ex-posed in the 2015 stock market disaster. This paper further points out that the twin-peak model, to integrate and reorganize the regulatory powers and strengthen the prudential regulation concurrently, is the optimal way to reform the Chinese regulatory framework.

  17. A Semiquantitative Framework for Gene Regulatory Networks: Increasing the Time and Quantitative Resolution of Boolean Networks

    Science.gov (United States)

    Kerkhofs, Johan; Geris, Liesbet

    2015-01-01

    Boolean models have been instrumental in predicting general features of gene networks and more recently also as explorative tools in specific biological applications. In this study we introduce a basic quantitative and a limited time resolution to a discrete (Boolean) framework. Quantitative resolution is improved through the employ of normalized variables in unison with an additive approach. Increased time resolution stems from the introduction of two distinct priority classes. Through the implementation of a previously published chondrocyte network and T helper cell network, we show that this addition of quantitative and time resolution broadens the scope of biological behaviour that can be captured by the models. Specifically, the quantitative resolution readily allows models to discern qualitative differences in dosage response to growth factors. The limited time resolution, in turn, can influence the reachability of attractors, delineating the likely long term system behaviour. Importantly, the information required for implementation of these features, such as the nature of an interaction, is typically obtainable from the literature. Nonetheless, a trade-off is always present between additional computational cost of this approach and the likelihood of extending the model’s scope. Indeed, in some cases the inclusion of these features does not yield additional insight. This framework, incorporating increased and readily available time and semi-quantitative resolution, can help in substantiating the litmus test of dynamics for gene networks, firstly by excluding unlikely dynamics and secondly by refining falsifiable predictions on qualitative behaviour. PMID:26067297

  18. A regulatory framework for shoot stem cell control integrating metabolic, transcriptional, and phytohormone signals.

    Science.gov (United States)

    Schuster, Christoph; Gaillochet, Christophe; Medzihradszky, Anna; Busch, Wolfgang; Daum, Gabor; Krebs, Melanie; Kehle, Andreas; Lohmann, Jan U

    2014-02-24

    Plants continuously maintain pluripotent stem cells embedded in specialized tissues called meristems, which drive long-term growth and organogenesis. Stem cell fate in the shoot apical meristem (SAM) is controlled by the homeodomain transcription factor WUSCHEL (WUS) expressed in the niche adjacent to the stem cells. Here, we demonstrate that the bHLH transcription factor HECATE1 (HEC1) is a target of WUS and that it contributes to SAM function by promoting stem cell proliferation, while antagonizing niche cell activity. HEC1 represses the stem cell regulators WUS and CLAVATA3 (CLV3) and, like WUS, controls genes with functions in metabolism and hormone signaling. Among the targets shared by HEC1 and WUS are phytohormone response regulators, which we show to act as mobile signals in a universal feedback system. Thus, our work sheds light on the mechanisms guiding meristem function and suggests that the underlying regulatory system is far more complex than previously anticipated. Copyright © 2014 Elsevier Inc. All rights reserved.

  19. British Columbia's fish health regulatory framework's contribution to sustainability goals related to salmon aquaculture.

    Science.gov (United States)

    Stephen, Craig; Dicicco, Emiliano; Munk, Brandon

    2008-12-01

    Salmon farming is a significant contribution to the global seafood market to which the goal of sustainability is often applied. Diseases related to farms are perhaps the most contentious issues associated with sustainable salmon farming. We reviewed literature and policies in British Columbia, Canada, as well as interviewed key informants to examine how fish health regulations do or could support sustainability goals. We found four main obstacles to the development and application of a sustainability-based health management system. First, salmon farming faced the same challenges as other industries when trying to establish an operational definition of sustainability that captures all stakeholders' interests. Second, there was no program responsible for integrating the various regulations, responsible departments, and monitoring efforts to develop a comprehensive view of sustainability. Third, there was inadequate research base and social consensus on the criteria that should be used to track health outcomes for sustainability purposes. Fourth, the regulatory and management paradigm for salmon farming has been focused on diseases and pathogens as opposed to embracing a more inclusive health promotion model that includes biotic, abiotic, and social determinants of health. A transparent and inclusive participatory process that effectively links expert views with community and industry concerns should serve as the foundation for the next generation of health management regulations for salmon farming.

  20. New approaches to the electromagnetic monitoring for improving the regulatory framework “green” building

    Directory of Open Access Journals (Sweden)

    Grafkina Marina

    2016-01-01

    Full Text Available In the regulatory legal base of a “green” construction existing now in the Russian Federation for assessment of an ecological safety of rooms of residential and public buildings criteria of electromagnetic comfort aren’t used. Its completion with obligatory assessment of indicators of electromagnetic safety is reasonable. Suggestions for improvement of the existing documents regulating assessment of conformity of real estate objects to ecological requirements are given in article. For the purpose of further development of system of regulation of negative factors of the habitat and electromagnetic safety, authors offer new approach to environmental control of low-frequency electromagnetic fields – transition from measurement of amplitude characteristics to determination of energy parameters. Sanitary and hygienic assessment and regulation of low-frequency electromagnetic fields it is performed separately on intensity of electric and magnetic field that doesn’t give an idea of an overall picture of spatial distribution of energy. The energy approach offered by authors will allow to estimate total energy impact of electromagnetic fields per capita, and also to develop new system of regulation of low-frequency electromagnetic fields in energy parameters.

  1. The Current Legal Framework of the Use of Force against Terrorist Organizations

    OpenAIRE

    Petra PERISIC

    2013-01-01

    Events that took place on 9/11, when symbols of American nation were destroyed by hijacked civilian airplanes, raised the issue of the effectiveness of the currently existing legal framework which regulates terrorist activities. Prior to that event, dealing with terrorist activities was mostly regulated by conventions, many of which were ratified by no more than couple of states. However, it became questionable whether these instruments are sufficient to fight terrorists who are ...

  2. [Regulatory Program for Medical Devices in Cuba: experiences and current challenges].

    Science.gov (United States)

    Pereira, Dulce María Martínez; Rodríguez, Yadira Álvarez; Valdés, Yamila Cedeño; Ribas, Silvia Delgado

    2016-05-01

    Regulatory control of medical devices in Cuba is conducted through a system based on the Regulatory Program for Medical Devices as a way to ensure the safety, efficacy, and effectiveness of these technologies, which are in use by the National Health System. This program was launched in 1992, when the Regulations for State Evaluation and Registration of Medical Devices were approved. Its successive stages and the merging of regulatory activities for drugs and medical equipment have meant progress toward stronger, more transparent strategies and greater control of industry and the National Health System. Throughout its course the Cuban program has met with challenges and difficulties that it has addressed by drawing on its own experiences. During the new period, the greatest challenges revolve around ensuring that regulatory systems incorporate scientific evaluation, risk levels, maximum rigor through the use of technical standards, and the implementation of international recommendations, together with the application of the ISO 13485 certification scheme, enhanced market monitoring, and classification of medical devices in accordance with their relevance to the country's national health policies. From the regional standpoint, the greatest challenge lies in working toward regulatory convergence. The Collaborating Centre for the Regulation of Health Technologies will support the proposed regulatory strategy and established regional priorities, in particular in connection with the implementation of actions involving medical devices.

  3. European regulatory framework on the use and development of pharmaceuticals and radiopharmaceuticals for pediatrics.

    Science.gov (United States)

    Mensonides-Harsema, Marguérite; Otte, Andreas

    2011-01-01

    A survey in 2000 revealed that only about 30% of the prescriptions in the European pediatric population were on the basis of evidence-based medicine (EbM). Less for radiopharmaceuticals and principally for diagnostics, radiologists throughout Europe are referred to the pediatric guidelines of the European Association of Nuclear Medicine (EANM), as none of the frequently used tracers have been evaluated in clinical trials in the different pediatric subgroups. Following a resolution to address the lack of EbM in children, the European Commission published the Pediatric Regulation EC 1901/2006 and its amendment EC 1902/2006, effective from 2007. This regulation foresees the development of evidence-based medicine in the pediatric population. This is effected through a set of principles like the mandatory pediatric investigation plan (PIP) to be included with the market authorization application (MAA), and the pediatric use market authorization (PUMA) for off-patent pharmaceuticals, and to a very small part radiopharmaceuticals with funding possibilities for pediatric-specific research through the 7th Framework Programme (7FP) of the European Union.

  4. A proposed regulatory framework for road and rail freight transport in South Africa

    Directory of Open Access Journals (Sweden)

    Wessel Pienaar

    2007-09-01

    land freight transport activity in South Africa will be offered within the framework of a free-functioning freight transport market. 

  5. E-learning tools for education: regulatory aspects, current applications in radiology and future prospects.

    Science.gov (United States)

    Pinto, A; Selvaggi, S; Sicignano, G; Vollono, E; Iervolino, L; Amato, F; Molinari, A; Grassi, R

    2008-02-01

    E-learning, an abbreviation of electronic learning, indicates the provision of education and training on the Internet or the World Wide Web. The impact of networks and the Internet on radiology is undoubtedly important, as it is for medicine as a whole. The Internet offers numerous advantages compared with other mass media: it provides access to a large amount of information previously known only to individual specialists; it is flexible, permitting the use of images or video; and it allows linking to Web sites on a specific subject, thus contributing to further expand knowledge. Our purpose is to illustrate the regulatory aspects (including Internet copyright laws), current radiological applications and future prospects of e-learning. Our experience with the installation of an e-learning platform is also presented. We performed a PubMed search on the published literature (without time limits) dealing with e-learning tools and applications in the health sector with specific reference to radiology. The search included all study types in the English language with the following key words: e-learning, education, teaching, online exam, radiology and radiologists. The Fiaso study was referred to for the regulatory aspects of e-learning. The application of e-learning to radiology requires the development of a model that involves selecting and creating e-learning platforms, creating and technologically adapting multimedia teaching modules, creating and managing a unified catalogue of teaching modules, planning training actions, defining training pathways and Continuing Education in Medicine (CME) credits, identifying levels of teaching and technological complexity of support tools, sharing an organisational and methodological model, training the trainers, operators' participation and relational devices, providing training, monitoring progress of the activities, and measuring the effectiveness of training. Since 2004, a platform--LiveLearning--has been used at our

  6. White paper on the promotion of an integrated risk assessment concept in European regulatory frameworks for chemicals.

    Science.gov (United States)

    Wilks, M F; Roth, N; Aicher, L; Faust, M; Papadaki, P; Marchis, A; Calliera, M; Ginebreda, A; Andres, S; Kühne, R; Schüürmann, G

    2015-07-15

    The vision of a sustainable and safe use of chemicals to protect human health, preserve the environment and maintain the ecosystem requires innovative and more holistic approaches to risk assessment (RA) in order to better inform decision making. Integrated risk assessment (IRA) has been proposed as a solution to current scientific, societal and policy needs. It is defined as the mutual exploitation of environmental risk assessment (ERA) for human health risk assessment (HHRA) and vice versa in order to coherently and more efficiently characterize an overall risk to humans and the environment for better informing the risk analysis process. Extrapolating between species which are relevant for HHRA and ERA requires a detailed understanding of pathways of toxicity/modes of action (MoA) for the various toxicological endpoints. Significant scientific advances, changes in chemical legislation, and increasing environmental consciousness have created a favourable scientific and regulatory environment to develop and promote the concept and vision of IRA. An initial proof of concept is needed to foster the incorporation of IRA approaches into different chemical sectorial regulations and demonstrate their reliability for regulatory purposes. More familiarity and confidence with IRA will ultimately contribute to an overall reduction in in vivo toxicity testing requirements. However, significant progress will only be made if long-term support for MoA-related research is secured. In the short term, further exchange and harmonization of RA terminology, models and methodologies across chemical categories and regulatory agencies will support these efforts. Since societal values, public perceptions and cultural factors are of increasing importance for the acceptance of risk analysis and successful implementation of risk mitigation measures, the integration of socio-economic analysis and socio-behavioural considerations into the risk analysis process may help to produce a more

  7. Regulatory Impact Assessment: Its Current Status and Development Prospects in Russia

    Directory of Open Access Journals (Sweden)

    A V Minaev

    2011-12-01

    Full Text Available The article examines the procedure of Regulatory Impact Assessment (RIA, which is widely used in developed countries for elaborating and making state-level decisions and is new to Russia. The paper analyzes the origins and essential features of the RIA model applied abroad, reviews major methodological approaches to the preparation of statements on regulatory impact assessment. The study focuses on the Russian RIA model, describing its differences from the foreign analogues; the paper also analyzes the shortcomings of this model. A forecast for the development of RIA in Russia is made by the author.

  8. Implementing sustainable drainage systems for urban surface water management within the regulatory framework in England and Wales.

    Science.gov (United States)

    Ellis, J Bryan; Lundy, Lian

    2016-12-01

    The UK 2007 floods resulted in damages estimated to exceed over £4 billion. This triggered a national review of strategic flood risk management (Pitt, 2008) with its recommendations informing and implemented by the Flood and Water Management, Act (FWMA, 2010). Estimating that up to two-thirds of properties flooded in the 2007 event as a direct result of overloaded sewer systems, the FWMA set out an ambitious overhaul of flood risk management approaches including identifying bodies responsible for the management of local flood risk (local municipalities) and the development of over-arching Lead Local Flood Authorities (LLFAs) at a regional level. LLFAs duties include developing local flood risk management strategies and, aligned with this, many LLFAs and local municipalities produced sustainable drainage system (SUDS) guidance notes. In parallel, changes to the national planning policy framework (NPPF) in England give priority to the use of SUDS in new major developments, as does the related Town and Country Planning Order (2015). However, whilst all three pieces of legislation refer to the preferential use of SUDs, these requirements remain "economically proportionate" and thus the inclusion of SUDS within development controls remain desirable - but not mandatory - obligations. Within this dynamic policy context, reignited most recently by the December 2015 floods, this paper examines some of the challenges to the implementation of SUDS in England and Wales posed by the new regulatory frameworks. In particular, it examines how emerging organisational procedures and processes are likely to impact on future SUDS implementation, and highlights the need for further cross-sectoral working to ensure opportunities for cross-sectoral benefits- such as that accrued by reducing stormwater flows within combined sewer systems for water companies, property developers and environmental protection - are not lost.

  9. BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES – BRIEF REVIEW ON SOME DENTISTRY PRODUCTS.

    Directory of Open Access Journals (Sweden)

    Maya Lyapina

    2015-02-01

    Full Text Available Defining a given product as a medical device and interpretation of the application of the classification rules fall within the competence of the competent authorities of the Member States where the product is on the market. Different interpretations of Community legislation occur, and, can put public health at risk and distort the internal market. Borderline cases are considered to be those cases where it is not clear from the outset whether a given product is a medical device, an in vitro diagnostic medical device, an active implantable medical device or not. Classification cases can be described as those cases where there exists a difficulty in the uniform application of the classification rules as laid down in the Medical Devices Directive (MDD, or where for a given device, depending on interpretation of the rules, different classifications can occur. The aim of the present work is to make a brief review on discussion on classification in the community regulatory framework for medical devices of some dentistry products.

  10. Non-human primate regulatory T cells: Current biology and implications for transplantation

    NARCIS (Netherlands)

    E.M. Dons (Eefje); G. Raimondi (Giorgio); D.K.C. Cooper (David); A.W. Thomson (Angus)

    2010-01-01

    textabstractRegulatory T cells (Treg) offer potential for improving long-term outcomes in cell and organ transplantation. The non-human primate model is a valuable resource for addressing issues concerning the transfer of Treg therapy to the clinic. Herein, we discuss the properties of non-human pri

  11. A GPS-Based Control Framework for Accurate Current Sharing and Power Quality Improvement in Microgrids

    DEFF Research Database (Denmark)

    Golsorkhi, Mohammad; Savaghebi, Mehdi; Lu, Dylan;

    2016-01-01

    consensus protocol to ensure proportional sharing of average power. The voltage conditioning scheme produces compensation signals at fundamental and dominant harmonics to improve the voltage quality at a sensitive load bus. Experimental results are presented to validate the efficacy of the proposed method.......This paper proposes a novel hierarchical control strategy for improvement of load sharing and power quality in ac microgrids. This control framework is composed of a droop based controller at the primary level, and a combination of distributed power sharing and voltage conditioning schemes...... dynamic response. The droop coefficient, which acts as a virtual resistance is adaptively changed as a function of the peak current. This strategy not only simplifies the control design but also improves the current sharing accuracy at high loading conditions. The distributed power sharing scheme uses...

  12. The Current Legal Framework of the Use of Force against Terrorist Organizations

    Directory of Open Access Journals (Sweden)

    Petra PERISIC

    2013-11-01

    Full Text Available Events that took place on 9/11, when symbols of American nation were destroyed by hijacked civilian airplanes, raised the issue of the effectiveness of the currently existing legal framework which regulates terrorist activities. Prior to that event, dealing with terrorist activities was mostly regulated by conventions, many of which were ratified by no more than couple of states. However, it became questionable whether these instruments are sufficient to fight terrorists who are not only immune to a threat of sanctions, but are even ready to sacrifice their lives. After the attacks took place, the United States launched against Afghanistan an armed action, ending up in a more than a decade long occupation, holding Taliban regime responsible for the attacks undertaken by Al-Qaida. The United States response to the 9/11 raised an important question: what is the legal response to terrorist attacks? This article explores the current legal framework of the use of force in response to terrorist attacks, especially with regard to distinguishing terrorist acts which are attributable to a certain state, from those which are undertaken by a terrorist group, not associated with any particular state.

  13. 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.

  14. Clinical Potential of Regulatory T Cell Therapy in Liver Diseases: An Overview and Current Perspectives

    Science.gov (United States)

    Jeffery, Hannah C.; Braitch, Manjit Kaur; Brown, Solomon; Oo, Ye Htun

    2016-01-01

    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 facilities have paved the way to apply Treg cells as a potential therapy to restore peripheral self-tolerance in autoimmune liver diseases (AILD), chronic rejection, and posttransplantation. Past and on-going studies have applied Treg in type-1 diabetes mellitus, systemic lupus erythematosus, graft versus host diseases, and solid organ transplantations. There have not been any new therapies for the AILD 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. PMID:27656181

  15. 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.

  16. Increased susceptibility to the innovative energy-saving technologies in the oil and fat industry by improving regulatory and institutional framework

    OpenAIRE

    V.G. Dyuzhev; Popov, N A

    2014-01-01

    The aim of the article. The aim of the article is to increase the susceptibility to innovative energy saving technologies in oil and fat industry basing on the formation of organizational and economic section of the regulatory framework of energy efficiency programs. The results of the analysis. Angle susceptibility innovative energy conservation program in the oilseed industry is analyzed in this article. Stages of formation of the organizational and economic section sectoral energy savin...

  17. La col·laboració publicoprivada en la provisió d’infraestructures de servei públic. Revisió crítica i alternatives al marc regulador actual Public-private - Collaboration in the Provision of Public Service Infrastructure: a Critical Revision and some Alternatives to the Current Regulatory Framework - La colaboración público-privada en la provisión de infraestructuras de servicio público. Revisión crítica y alternativas al actual marco regulador

    Directory of Open Access Journals (Sweden)

    Joan Ridao Martin

    2012-12-01

    Full Text Available L’actual emergència de la col·laboració publicoprivada en la provisió d’infraestructures de servei públic és conseqüència de les tensions de tresoreria de les administracions públiques. Els avantatges d’aquesta tècnica es concreten en el diàleg entre el sector públic i el sector privat per consensuar el finançament i l’execució de projectes, la bona relació qualitat-preu i el tractament en termes de comptabilitat pública, que determina un nul impacte en el deute. Els inconvenients, tanmateix, se centren en el deficient marc regulador europeu i estatal, tant en matèria de contractació com d’incentius a la captació d’actius financers. Cal, doncs, un nou marc normatiu que afavoreixi l’estructuració adequada dels projectes, els contractes i l’esquema de distribució de riscos, com també que prevegi incentius a la participació, aclareixi els mecanismes de pagament i, en particular, millori la definició del nou contracte de col·laboració entre el sector públic i el sector privat i, en concret, de la fórmula del diàleg competitiu com a procediment d’adjudicació. The current emergence of public-private collaboration in the provision of public service infrastructure is plan, to provide for incentives to participation, and to clarify payment mechanisms. In particular, such a framework is necessary in order to improve the definition of the new private sector-public sector collaboration contract, and, concretely, the definition of the formula for competitive dialogue as a mechanism for awarding contracts.a consequence of the pressure on the liquid assets held by public authorities.  The advantages of this technique come to the fore through public-private sector dialogue aimed at reaching a consensus on the financing and execution of projects, a good quality-price ratio and a way of dealing with such projects in terms of public accounting, which has no impact on the debt.  The disadvantages, nonetheless, are

  18. Comparative analysis of nursing and midwifery regulatory and professional bodies' scope of practice and associated decision-making frameworks: a discussion paper.

    Science.gov (United States)

    Kennedy, Catriona; O'Reilly, Pauline; Fealy, Gerard; Casey, Mary; Brady, Anne-Marie; McNamara, Martin; Prizeman, Geraldine; Rohde, Daniela; Hegarty, Josephine

    2015-08-01

    To review, discuss and compare nursing and midwifery regulatory and professional bodies' scope of practice and associated decision-making frameworks. Scope of practice in professional nursing and midwifery is an evolving process which needs to be responsive to clinical, service, societal, demographic and fiscal changes. Codes and frameworks offer a system of rules and principles by which the nursing and midwifery professions are expected to regulate members and demonstrate responsibility to society. Discussion paper. Twelve scope of practice and associated decision-making frameworks (January 2000-March 2014). Two main approaches to the regulation of the scope of practice and associated decision-making frameworks exist internationally. The first approach is policy and regulation driven and behaviour oriented. The second approach is based on notions of autonomous decision-making, professionalism and accountability. The two approaches are not mutually exclusive, but have similar elements with a different emphasis. Both approaches lack explicit recognition of the aesthetic aspects of care and patient choice, which is a fundamental principle of evidence-based practice. Nursing organizations, regulatory authorities and nurses should recognize that scope of practice and the associated responsibility for decision-making provides a very public statement about the status of nursing in a given jurisdiction. © 2015 John Wiley & Sons Ltd.

  19. Structured Frameworks to Increase the Transparency of the Assessment of Benefits and Risks of Medicines : Current Status and Possible Future Directions

    NARCIS (Netherlands)

    Pignatti, F.; Ashby, D.; Brass, E. P.; Eichler, H-G; Frey, P.; Hillege, H. L.; Hori, A.; Levitan, B.; Liberti, L.; Loefstedt, R. E.; McAuslane, N.; Micaleff, A.; Noel, R. A.; Postmus, D.; Renn, O.; Sabourin, B. J.; Salmonson, T.; Walker, S.

    2015-01-01

    Structured frameworks for benefit-risk analysis in drug licensing decisions are being implemented across a number of regulatory agencies worldwide. The aim of these frameworks is to aid the analysis and communication of the benefit-risk assessment throughout the development, evaluation, and supervis

  20. Managing Carbon Regulatory Risk in Utility Resource Planning:Current Practices in the Western United States

    Energy Technology Data Exchange (ETDEWEB)

    Barbose, Galen; Wiser, Ryan; Phadke, Amol; Goldman, Charles

    2008-05-16

    Concerns about global climate change have substantially increased the likelihood that future policy will seek to minimize carbon dioxide emissions. Assuch, even today, electric utilities are making resource planning and investment decisions that consider the possible implications of these future carbon regulations. In this article, we examine the manner in which utilities assess the financial risks associated with future carbon regulations within their long-term resource plans. We base our analysis on a review of the most recent resource plans filed by fifteen electric utilities in the Western United States. Virtually all of these utilities made some effort to quantitatively evaluate the potential cost of future carbon regulations when analyzing alternate supply- and demand-side resource options for meeting customer load. Even without Federal climate regulation in the U.S., the prospect of that regulation is already having an impact on utility decision-making and resource choices. That said, the methods and assumptions used by utilities to analyze carbon regulatory risk, and the impact of that analysis on their choice of a particular resource strategy, vary considerably, revealing a number of opportunities for analytic improvement. Though our review focuses on a subset of U.S. electric utilities, this work holds implications for all electric utilities and energy policymakers who are seeking to minimize the compliance costs associated with future carbon regulations

  1. Managing Carbon Regulatory Risk in Utility Resource Planning: Current Practices in the Western United States

    Energy Technology Data Exchange (ETDEWEB)

    Barbose, Galen; Wiser, Ryan; Phadke, Amol; Goldman, Charles

    2008-07-11

    Concerns about global climate change have substantially increased the likelihood that future policy will seek to minimize carbon dioxide emissions. As such, even today, electric utilities are making resource planning and investment decisions that consider the possible implications of these future carbon regulations. In this article, we examine the manner in which utilities assess the financial risks associated with future carbon regulations within their long-term resource plans. We base our analysis on a review of the most recent resource plans filed by fifteen electric utilities in the Western United States. Virtually all of these utilities made some effort to quantitatively evaluate the potential cost of future carbon regulations when analyzing alternate supply- and demand-side resource options for meeting customer load. Even without Federal climate regulation in the U.S., the prospect of that regulation is already having an impact on utility decision-making and resource choices. That said, the methods and assumptions used by utilities to analyze carbon regulatory risk, and the impact of that analysis on their choice of a particular resource strategy, vary considerably, revealing a number of opportunities for analytic improvement. Though our review focuses on a subset of U.S. electric utilities, this work holds implications for all electric utilities and energy policymakers who are seeking to minimize the compliance costs associated with future carbon regulations.

  2. IPTV Market Development and Regulatory Aspects

    DEFF Research Database (Denmark)

    Tadayoni, Reza; Sigurdsson, Halldór Matthias

    2006-01-01

    The aim of this paper is to analyse the development of IPTV technology / market and to discuss major regulatory parameters. A general overview of architectures and the technologies deployed for establishing IPTV services is given and the main stake holder identified, along with, the current service...... architecture, the available content in IPTV platforms, and the current business models. Furthermore the regulatory framework of the TV broadcast and IPTV in Europe is analysed....

  3. Development of neuroleptic agents: pharmacogenetics and current safety issues of regulatory concern.

    Science.gov (United States)

    Shah, Rashmi

    2002-12-01

    The development of safe and effective new drug treatments for schizophrenia poses a challenging task. This class of drugs is known to be associated with a wide range of serious and troublesome safety problems that include neurological, cardiac, endocrine, and metabolic side effects. Many of these drugs have a narrow therapeutic index and generate metabolites that often have their own unique pharmacological profile different from the parent compound. These features make it imperative that the optimal dose schedules for neuroleptic drugs are carefully characterized. Many of these drugs are metabolized by cytochrome P450 enzymes, which show genetic polymorphism and a bi modal distribution within the population, A significant subset of the population cannot eliminate these drugs as effectively as the majority. This brings an added dimension of complexity in characterizing the dose and individualizing therapy. Many neuroleptic agents are proarrhythmic with an adverse effect on cardiac repolarization. They are prone to prolonging the QT interval and inducing torsade de pointes. Given the potentially fatal outcome of this ventricular tachyarrhythmia, drug development programs need to ensure that the proarrhythmic potential of any new neuroleptic agent is thoroughly explored and its proarrhythmic risk characterized. The clinical use of many of these drugs is further troubled by their high potential for drug-drug interactions. These too need to be adequately investigated during development The approval and the labeling of a new neuroleptic agent require a careful regulatory assessment of its risk/benefit ratio in comparison with the available alternatives. Their safe and effective use in routine clinical practice depends on careful attention to prescribing information, especially the contraindications, precautions, and patient-monitoring requirements.

  4. Relevance of animal studies in regulatory toxicology : current approaches and future opportunities

    NARCIS (Netherlands)

    Sandt, J.J.M. van de; Feron, V.J.

    1996-01-01

    With rapidly increasing knowledge of toxicological processes, the scientific value and relevance of toxicity studies for risk assessment must be re-evaluated. In this paper, it is proposed that the rigid risk evaluation currently required should be replaced by a more flexible, case-by-case approach,

  5. Increased susceptibility to the innovative energy-saving technologies in the oil and fat industry by improving regulatory and institutional framework

    Directory of Open Access Journals (Sweden)

    V.G. Dyuzhev

    2014-09-01

    Full Text Available The aim of the article. The aim of the article is to increase the susceptibility to innovative energy saving technologies in oil and fat industry basing on the formation of organizational and economic section of the regulatory framework of energy efficiency programs. The results of the analysis. Angle susceptibility innovative energy conservation program in the oilseed industry is analyzed in this article. Stages of formation of the organizational and economic section sectoral energy saving program to improve the level of susceptibility to specific innovative energy-saving technologies are developed. Step 1. To conduct classification measures in the oil and fat industry by: structural and institutional facilities; types of energy savings; the level of expenses; typical beneficial effects. Step 2. Analysis of information flows from various sources on the problems of energy saving based on the use of energy-saving measures in terms of enterprise in oil and fat industries. Step 3. This step is based on the analysis and systematization of information flows (step 2, and in accordance with the classification criteria (stage 1 were isolated most current energy-saving areas, grouped by objects oil and fat industry, marked specificity processes, respectively, each object has their «targeted» energy efficiency measures. Received results of the group of energy-saving measures after the «address» information flow is an important element in the formation of secondary innovation susceptibility to energy conservation. Step 4. Forming a typical list of possible effects of energy-saving measures for implementation at different sites. Step 5. Combination of typical beneficial effects of specific measures will show the potential effects that are possible as a result of energy conservation on specific sites for specific fuel and energy resources, in particular the level of capital expenditures. It is necessary to improve the innovative capabilities of

  6. Training in clinical forensic medicine in the UK--perceptions of current regulatory standards.

    Science.gov (United States)

    Stark, Margaret M; Norfolk, Guy A

    2011-08-01

    As clinical forensic medicine (CFM) is not currently recognised as a speciality in the UK there are no nationally agreed mandatory standards for training forensic physicians in either general forensic (GFM) or sexual offence medicine (SOM). The General Medical Council (GMC), the medical regulator in the UK, has issued clear standards for training in all specialities recommending that "trainees must be supported to acquire the necessary skills and experience through induction, effective educational supervision, an appropriate workload and time to learn". In order to evaluate the current situation in the field of clinical forensic medicine, doctors who have recently (within the last two years) started working in the field "trainees" (n = 38), and trainers (n = 61) with responsibility for clinical and educational supervision of new trainees, were surveyed by questionnaire to gather their perceptions of how the relevant GMC standards are being met in initial on-the-job training. Telephone interviews were performed with eleven doctors working as clinical or medical directors to determine their views. It is clear that currently the quality of training in CFM is sub-standard and inconsistent and that the published standards, as to the minimum requirement for training that must be met by post-graduate medical and training providers at all levels, are not being met. The Faculty of Forensic and Legal Medicine (FFLM) needs to set explicit minimum standards which will comply with the regulator and work to pilot credentialing for forensic physicians. A number of recommendations are made for urgent FFLM development.

  7. Use of Biosensors as Alternatives to Current Regulatory Methods for Marine Biotoxins

    Directory of Open Access Journals (Sweden)

    Luis M. Botana

    2009-11-01

    Full Text Available Marine toxins are currently monitored by means of a bioassay that requires the use of many mice, which poses a technical and ethical problem in many countries. With the exception of domoic acid, there is a legal requirement for the presence of other toxins (yessotoxin, saxitoxin and analogs, okadaic acid and analogs, pectenotoxins and azaspiracids in seafood to be controlled by bioassay, but other toxins, such as palytoxin, cyclic imines, ciguatera and tetrodotoxin are potentially present in European food and there are no legal requirements or technical approaches available to identify their presence. The need for alternative methods to the bioassay is clearly important, and biosensors have become in recent years a feasible alternative to animal sacrifice. This review will discuss the advantages and disadvantages of using biosensors as alternatives to animal assays for marine toxins, with particular focus on surface plasmon resonance (SPR technology.

  8. A Framework for the Evaluation of Biosecurity, Commercial, Regulatory, and Scientific Impacts of Plant Viruses and Viroids Identified by NGS Technologies

    Science.gov (United States)

    Massart, Sebastien; Candresse, Thierry; Gil, José; Lacomme, Christophe; Predajna, Lukas; Ravnikar, Maja; Reynard, Jean-Sébastien; Rumbou, Artemis; Saldarelli, Pasquale; Škorić, Dijana; Vainio, Eeva J.; Valkonen, Jari P. T.; Vanderschuren, Hervé; Varveri, Christina; Wetzel, Thierry

    2017-01-01

    Recent advances in high-throughput sequencing technologies and bioinformatics have generated huge new opportunities for discovering and diagnosing plant viruses and viroids. Plant virology has undoubtedly benefited from these new methodologies, but at the same time, faces now substantial bottlenecks, namely the biological characterization of the newly discovered viruses and the analysis of their impact at the biosecurity, commercial, regulatory, and scientific levels. This paper proposes a scaled and progressive scientific framework for efficient biological characterization and risk assessment when a previously known or a new plant virus is detected by next generation sequencing (NGS) technologies. Four case studies are also presented to illustrate the need for such a framework, and to discuss the scenarios. PMID:28174561

  9. A framework for current public mental health care practice in South Africa.

    Science.gov (United States)

    Janse Van Rensburg, A B

    2007-11-01

    One of the main aims of the new Mental Health Care Act, Act No. 17 of 2002 (MHCA) is to promote the human rights of people with mental disabilities in South Africa. However, the upholding of these rights seems to be subject to the availability of resources. Chapter 2 of the MHCA clarifies the responsibility of the State to provide infrastructure and systems. Chapters 5, 6 and 7 of the Act define and regulate the different categories of mental health care users, clarify the procedures around these categories and spell out mental health practitioners' roles and responsibilities in this regard. Also according to the National Health Act No. 61 of 2003, the State remains the key role player in mental health care provision, being responsible for adequate mental health infrastructure and resource allocation. Due to "limited resources" practitioners however often work in environments where staff ratios may be fractional of what should be expected and in units of which the physical structure and security is totally inadequate. The interface between professional responsibility of clinical workers versus the inadequacy of clinical interventions resulting from infrastructure and staffing constraints needs to be defined. This paper considered recent legislation currently relevant to mental health care practice in order to delineate the legal, ethical and labour framework in which public sector mental health practitioners operate as state employees. These included the Mental Health Care Act, No.17 of 2002; the National Health Act, No. 61 of 2003 and the proposed Traditional Health Practitioners Act, No. 35 of 2004. Formal legal review of and advice on this legislation as it pertains to public sector mental health practitioners as state employees, is necessary and should form the basis of the principles and standards for care endorsed by organized mental health care practitioner groups such as the South African Society of Psychiatrists (SASOP).

  10. Configuración actual del comercio exterior en Galicia = Current foreign trade framework in Galicia

    Directory of Open Access Journals (Sweden)

    José Luis Placer Galán

    2016-12-01

    Full Text Available La reciente crisis económica y la contracción de la demanda interna han impulsado un creciente interés por los mercados exteriores. Esta investigación pretende caracterizar la configuración actual del comercio exterior de la Comunidad Autónoma de Galicia, tanto en lo relativo a los productos como a los mercados geográficos de origen y destino. Para ello se emplean una serie de indicadores, ampliamente contrastados en la investigación económica, que permiten identificar: el grado de apertura de la economía provincial leonesa; la propensión exportadora y la dependencia importadora; el grado de concentración, por producto y mercados, de sus flujos comerciales exteriores; la especialización exportadora y la ventaja comparativa sectorial; la composición inter o intra-industrial del comercio exterior; y la distribución geográfica de los flujos comerciales de la economía gallega con los mercados exteriores. The recent economic crisis and internal demand contraction have encouraged the emerging interest in international markets. This study aims at featuring the current foreign trade framework of the Galicia, in regards to both import and export products and geographical markets. For that purpose, several indexes, widely verified in this study, have been utilized to identify the trade openness level of Leon economy, its export propensity, import dependence as well as the concentration level for products and internal trade flows. Leon export specialization, its comparative advantage by sector, the inter-intra-industry trade composition and geographical distribution of trade with international markets have been likewise included in this study.   Keywords: .

  11. Historical Development of NATO Stanag 6001 Language Standards and Common European Framework (CEF) and the Comparison of Their Current Status

    Science.gov (United States)

    Solak, Ekrem

    2011-01-01

    The aim of the article is to shed light on the historical development of language studies in military and social context and to compare the current status of NATO Stanag (Standard Agreement) 6001 language scale with Common European Framework (CEF). Language studies in military context date back to World War II and the emergence of Army Specialized…

  12. Moderating Effect of Self-Regulatory Efficacy on the Relationship between Organizational Formal Controls and Workplace Deviance: A Proposed Framework

    Directory of Open Access Journals (Sweden)

    Kabiru Maitama Kura

    2013-01-01

    Full Text Available Several studies in the field of industrial and organizational psychology (I/O have reported that workplace deviance is related to organization/work variables, such as organizational politics, perceived organizational support, job satisfaction, job stress, and organizational justice among others. However, relatively few studies have attempted to consider the relationship between organizational formal controls and workplace deviance. Even if any, they have reported mixed findings. Hence, a moderating variable is suggested. This paper proposes a moderating role of self-regulatory efficacy on the relationship between organizational formal controls and workplace deviance.

  13. Integrating process safety with molecular modeling-based risk assessment of chemicals within the REACH regulatory framework: benefits and future challenges.

    Science.gov (United States)

    Lewis, Amanda; Kazantzis, Nikolaos; Fishtik, Ilie; Wilcox, Jennifer

    2007-04-11

    Registration, evaluation and authorization of chemicals (REACH) represents a recent regulatory initiative by the European union commission to protect human health and the environment from potentially hazardous chemicals. Under REACH, all stakeholders must submit (thermo)physical, thermochemical, and toxicological data for certain chemicals. The commission's impact assessment studies estimate that the costs of REACH will be approximately 3-5 billion Euros. The present study advocates the systematic incorporation of computational chemistry and computer-assisted chemical risk assessment methods into REACH to reduce regulatory compliance costs. Currently powerful computer-aided ab initio techniques can be used to generate predictions of key properties of broad classes of chemicals, without resorting to costly experimentation and potentially hazardous testing. These data could be integrated into a centralized IT decision and compliance support system, and stored in a retrievable, easily communicable manner should new regulatory and/or production requirements necessitate the introduction of different uses of chemicals under different conditions. For illustration purposes, ab initio calculations are performed on heterocyclic nitrogen-containing compounds which currently serve as high energy density materials in the chemical industry. Since investigations of these compounds are still in their infancy, stability studies are imperative regarding their safe handling and storage, as well as registration under REACH.

  14. Artificial islands for cluster-siting of offshore energy facilities: an assessment of the legal and regulatory framework

    Energy Technology Data Exchange (ETDEWEB)

    Backstrom, T.D.; Baram, M.

    1976-06-01

    One of the ways in which offshore coastal regions can be used in energy development is examined, namely through the construction of offshore islands for the siting of energy-related facilities. The purpose of the study is to review and assess the significant sectors of this accumulation of legal and regulatory authority, in order that those proposing and supervising such offshore development can formulate suggestions for coordination and rational allocation of responsibility. The potential demands on offshore resources are considerably greater than many would expect. In addition to offshore drilling and other mineral exploitation, there is increasing interest in safety of navigation, harvest and aquaculture of living marine resources, recreation, and preservation of uniquely valuable marine landscapes and ecosystems. Within this dynamic context, the offshore implications of the energy needs of the United States must be fully evaluated. New energy installations might be appropriately sited offshore on artificial islands. This legal and regulatory assessment contains little case law, new Congressional enactments, or proposed regulations and is, in general, a first-order analysis of the legal context for a new concept--the multiple-facility artificial island--which has not yet been tested, but which merits serious study as an alternative for uses of the offshore regions to meet energy requirements. An extensive bibliography containing 254 citations is included.

  15. Statistical considerations associated with a comprehensive regulatory framework to address the unmet need for new antibacterial therapies.

    Science.gov (United States)

    Dane, Aaron; Wetherington, Jeffrey D

    2014-01-01

    At present, there are situations in antibiotic drug development where the low number of enrollable patients with key problem pathogens makes it impossible to conduct fully powered non-inferiority trials in the traditional way. Recent regulatory changes have begun to address this situation. In parallel, statistical issues regarding the application of alternative techniques, balancing the unmet need with the level of certainty in the approval process, and the use of additional sources of data are critical areas to increase development feasibility. Although such approaches increase uncertainty compared with a traditional development program, this will be necessary to allow new agents to be made available. Identification of these risks and explicit discussion around requirements in these areas should help clarify the situation, and hence, the feasibility of developing drugs to treat the most concerning pathogens before the unmet need becomes even more acute than at present.

  16. P2RP: a Web-based framework for the identification and analysis of regulatory proteins in prokaryotic genomes.

    Science.gov (United States)

    Barakat, Mohamed; Ortet, Philippe; Whitworth, David E

    2013-04-20

    Regulatory proteins (RPs) such as transcription factors (TFs) and two-component system (TCS) proteins control how prokaryotic cells respond to changes in their external and/or internal state. Identification and annotation of TFs and TCSs is non-trivial, and between-genome comparisons are often confounded by different standards in annotation. There is a need for user-friendly, fast and convenient tools to allow researchers to overcome the inherent variability in annotation between genome sequences. We have developed the web-server P2RP (Predicted Prokaryotic Regulatory Proteins), which enables users to identify and annotate TFs and TCS proteins within their sequences of interest. Users can input amino acid or genomic DNA sequences, and predicted proteins therein are scanned for the possession of DNA-binding domains and/or TCS domains. RPs identified in this manner are categorised into families, unambiguously annotated, and a detailed description of their features generated, using an integrated software pipeline. P2RP results can then be outputted in user-specified formats. Biologists have an increasing need for fast and intuitively usable tools, which is why P2RP has been developed as an interactive system. As well as assisting experimental biologists to interrogate novel sequence data, it is hoped that P2RP will be built into genome annotation pipelines and re-annotation processes, to increase the consistency of RP annotation in public genomic sequences. P2RP is the first publicly available tool for predicting and analysing RP proteins in users' sequences. The server is freely available and can be accessed along with documentation at http://www.p2rp.org.

  17. Aquifer Storage and Recovery as a Viable Climate Change Adaptation Technique: Sustainable Development under the Current Regulatory Framework

    Science.gov (United States)

    A holistic investigation of aquifer storage and recovery (ASR) technique and application in the U.S. is being conducted as a part of the USEPA Water Resources Adaptation Program (WRAP). The research focus is to evaluate the potential of ASR application as a practical climate chan...

  18. Development of a modelling framework in response to new European energy-efficiency regulatory obligations. The Irish experience

    Energy Technology Data Exchange (ETDEWEB)

    Hull, David [Arup Consulting Engineers, 15 Oliver Plunkett Street, Cork (Ireland); O Gallachoir, Brian P. [Department of Civil and Environmental Engineering, University College Cork, College Road, Cork (Ireland); Environmental Research Institute, University College Cork, Lee Road, Cork (Ireland); Walker, Neil [School of Geography, Planning and Environmental Policy, University College Dublin, Belfield, Dublin 4 (Ireland)

    2009-12-15

    Momentum has been building for an EU-wide approach to energy policy in which energy end-use efficiency is regarded as one of the main planks. Member States are already obliged to plan for the achievement of energy savings targets in respect of the period 2008-2016 and they now face additional economy-wide targets for 2020. Efficiency investments are widely regarded as capable of improving industrial competitiveness, security of energy supply and the abatement of greenhouse gas emissions. Nevertheless, the design of policy packages may involve trade-offs between these objectives. The challenge for energy modellers is to quantify future energy savings associated with combinations of efficiency measures. This paper draws on the international experience in energy modelling and tracks recent progress that has been made towards a harmonised European framework for verification of savings. It points to the significant development work that remains to be done, particularly to enable an increased reliance on bottom-up evaluation methods. One significant gap in our knowledge relates to the required adjustment of technical savings due to behavioural factors such as rebound effects. The paper uses one country (Ireland) as a case study to demonstrate how a framework is being developed to respond to these new requirements. (author)

  19. Development of a modelling framework in response to new European energy-efficiency regulatory obligations: The Irish experience

    Energy Technology Data Exchange (ETDEWEB)

    Hull, David [Arup Consulting Engineers, 15 Oliver Plunkett Street, Cork (Ireland); O Gallachoir, Brian P. [Department of Civil and Environmental Engineering, University College Cork, College Road, Cork (Ireland); Environmental Research Institute, University College Cork, Lee Road, Cork (Ireland); Walker, Neil, E-mail: neil.walker@ucd.i [School of Geography, Planning and Environmental Policy, University College Dublin, Belfield, Dublin 4 (Ireland)

    2009-12-15

    Momentum has been building for an EU-wide approach to energy policy in which energy end-use efficiency is regarded as one of the main planks. Member States are already obliged to plan for the achievement of energy savings targets in respect of the period 2008-2016 and they now face additional economy-wide targets for 2020. Efficiency investments are widely regarded as capable of improving industrial competitiveness, security of energy supply and the abatement of greenhouse gas emissions. Nevertheless, the design of policy packages may involve trade-offs between these objectives. The challenge for energy modellers is to quantify future energy savings associated with combinations of efficiency measures. This paper draws on the international experience in energy modelling and tracks recent progress that has been made towards a harmonised European framework for verification of savings. It points to the significant development work that remains to be done, particularly to enable an increased reliance on bottom-up evaluation methods. One significant gap in our knowledge relates to the required adjustment of technical savings due to behavioural factors such as rebound effects. The paper uses one country (Ireland) as a case study to demonstrate how a framework is being developed to respond to these new requirements.

  20. On the presence of electric currents in the solar atmosphere. I - A theoretical framework

    Science.gov (United States)

    Hagyard, M.; Low, B. C.; Tandberg-Hanssen, E.

    1981-01-01

    The general magnetic field above the solar photosphere is divided by an elementary analysis based on Ampere's law into two parts: a potential field due to electric currents below the photosphere and a field produced by electric currents above the photosphere combined with the induced mirror currents. The latter, by symmetry, has a set of field lines lying in the plane taken to be the photosphere which may be constructed from given vector magnetograph measurements. These field lines also represent all the information on the electric currents above the photosphere that a magnetograph can provide. Theoretical illustrations are given, and implications for data analysis are discussed.

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

    Energy Technology Data Exchange (ETDEWEB)

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

    1997-02-01

    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.

  2. A Human right to water while the well runs dry: analyzing the legal and regulatory framework of Yemen water law

    NARCIS (Netherlands)

    van Rijswick, H.F.M.W.; Misiedjan, D.J.E.; Tjen A Kwoei, Alberto

    2015-01-01

    Yemen is currently in the midst of great unrest. Amongst many different conflicts there is one that receives less attention than others, that of water. Yemen is expected to be the first country in the world to run out of water. By 2025 the estimated 4.2 million inhabitants of Yemen’s capital, Sana’a

  3. The Framework Convention on Tobacco Control, ten years later: the regulatory function of OMS to the rescue of global health?

    Directory of Open Access Journals (Sweden)

    KASTLER, Florian

    2016-06-01

    Full Text Available This article analyzes the implementation of the Framework Convention on Tobacco Control (FCTC ten years after its entry into force in 2005, when it was received as a binding legal healthy, innovative and international, instrument. Considered as a symptom of the strong normative function of the World Health Organization (WHO, in accordance with Article 19 of its Constitution, the FCTC could respond to the expectation to become an example to be followed in the creation of new legal instruments of global health. After analyzing the influence of the Convention in national legal systems and its impact on the health of individuals, this article examines the elements that contributed to its approval and the continuing difficulties for its implementation. The analysis shows that if the results in the fight against smoking are promising, based on the experience of the FCTC, some lessons were learned: first, to improve the monitoring and control system to implement the Convention; and second, to consider new ambitious instruments in other areas of health. It seems that these instruments should be adapted to the specific contexts of each health challenge. More generally, in the context of reform, this article demonstrates that the proper use of the normative function offers a response to the criticism being made to WHO, questioning its legitimacy and credibility as an institution focused on global health.

  4. European Framework for the Diffusion of Biogas Uses: Emerging Technologies, Acceptance, Incentive Strategies, and Institutional-Regulatory Support

    Directory of Open Access Journals (Sweden)

    Andrea G. Capodaglio

    2016-03-01

    Full Text Available Biogas will constitute a significant fraction of future power supply, since it is expected to contribute a large share of the EU renewable energy targets. Biogas, once produced, can be combusted in traditional boilers to provide heat, or to generate electricity. It can be used for the production of chemical compounds, or fed into a pipeline. This review paper will briefly analyze the current most promising emerging biogas technologies in the perspective of their potential uses, environmental benefits, and public acceptance; draw a picture of current conditions on the adoption of a biogas road map in the several EU Member States; analyze incentive and support policy implementation status and gaps; discuss non-technological barriers; and summarize proposed solutions to widen this energy’s use.

  5. Developing an Integrated Conceptual Framework of Pro-Environmental Behavior in the Workplace through Synthesis of the Current Literature

    Directory of Open Access Journals (Sweden)

    Faye V. McDonald

    2014-08-01

    Full Text Available Recent studies have begun to bridge the gap between general and workplace pro-environmental behavior by adapting specific existing behavioral models to the workplace environment. This conceptual article proposes a different approach by synthesizing the current general and workplace literature to develop a new model of the antecedents to pro-environmental behavior. Guided by this approach, this paper combines the insights of the current general and workplace models to develop an integrated framework of pro-environmental behavior in the workplace. In doing so, an overview of the current general and workplace literatures will be provided as well as their similarities and differences highlighted. The proposed framework will provide further insights into the antecedents of workplace pro-environmental behavior and identify common findings across the different existing workplace models. This theory can be the basis for further research in order to provide a comprehensive picture of the antecedents of pro-environmental behavior in the workplace. Lastly, implications for specific interventions to develop targeted Human Resource Management practices and work towards achieving environmental sustainability will be discussed.

  6. Clinical Development and Commercialization of Advanced Therapy Medicinal Products in the European Union: How Are the Product Pipeline and Regulatory Framework Evolving?

    Science.gov (United States)

    Boráň, Tomáš; Menezes-Ferreira, Margarida; Reischl, Ilona; Celis, Patrick; Ferry, Nicolas; Gänsbacher, Bernd; Krafft, Hartmut; Lipucci di Paola, Michele; Sladowski, Dariusz; Salmikangas, Paula

    2017-09-01

    The research and development of advanced therapy medicinal products (ATMPs) has been active in Europe and worldwide during recent years. Yet, the number of licensed products remains low. The main expected legal change in the near future in the European Union (EU) concerns the regulation on clinical trials (536/2014), which will come into force in 2018. With this new framework, a more harmonized and swift process for approval of clinical trials is anticipated, which is expected to support the entry of new innovations into the EU market. A survey on ATMPs in clinical trials during 2010-2015 in the EU was conducted in order to study the trends of ATMP development since the earlier survey published in 2012. According to the results, the number of clinical trials using ATMPs is slowly increasing in the EU. Yet, the focus is still in early development, and the projects are mainly carried out by small and medium-sized enterprises, academia, and hospitals. Oncology is the main area of clinical development. Yet, the balance between cell-based products and gene therapy medicinal products in this area may be changing in the future due to the new T-cell technologies. Many limitations and challenges are identified for ATMP development, requiring proportionate regulatory requirements. On the other hand, for such a novel field, the developers should be active in considering possible constraints and actively engage with authorities to look for solutions. This article provides up to-date information on forthcoming regulatory improvements and discusses the main challenges hampering the commercialization of ATMPs in the EU.

  7. Implementation of the Framework Convention on Tobacco Control in Africa: Current Status of Legislation

    Directory of Open Access Journals (Sweden)

    Jacqueline Tumwine

    2011-11-01

    Full Text Available Objective: To describe, as of July 2011, the status of tobacco control legislation in Africa in three key areas of the Framework Convention on Tobacco Control (FCTC—(1 Protection from exposure to tobacco smoke, (2 Packaging and labelling of tobacco products, and (3 Tobacco advertising, promotion and sponsorship. Methods: Review and analysis of tobacco control legislation in Africa, media reports, journal articles, tobacco industry documents and data published in the 2011 WHO Report on the Global Tobacco Epidemic. Results: Modest progress in FCTC implementation in Africa with many countries having legislation or policies on the protection from exposure to tobacco smoke, however, only a handful of countries meet the standards of the FCTC Article 8 and its Guidelines particularly with regards to designated smoking areas. Little progress on packaging and labelling of tobacco products, with few countries having legislation meeting the minimum standards of the FCTC Article 11 and its Guidelines. Mauritius is the only African country with graphic or pictorial health warnings in place and has the largest warning labels in Africa. Slightly better progress in banning tobacco advertising, promotion and sponsorship has been shown by African countries, although the majority of legislation falls short of the standards of the FCTC Article 13 and its Guidelines. Despite their efforts, African countries’ FCTC implementation at national level has not matched the strong regional commitment demonstrated during the FCTC treaty negotiations. Conclusion: This study highlights the need for Africa to step up efforts to adopt and implement effective tobacco control legislation that is fully compliant with the FCTC. In order to achieve this, countries should prioritise resources for capacity building for drafting strong FCTC compliant legislation, research to inform policy and boost political will, and countering the tobacco industry which is a major obstacle to FCTC

  8. The Indus basin in the framework of current and future water resources management

    Science.gov (United States)

    Laghari, A. N.; Vanham, D.; Rauch, W.

    2012-04-01

    The Indus basin is one of the regions in the world that is faced with major challenges for its water sector, due to population growth, rapid urbanisation and industrialisation, environmental degradation, unregulated utilization of the resources, inefficient water use and poverty, all aggravated by climate change. The Indus Basin is shared by 4 countries - Pakistan, India, Afghanistan and China. With a current population of 237 million people which is projected to increase to 319 million in 2025 and 383 million in 2050, already today water resources are abstracted almost entirely (more than 95% for irrigation). Climate change will result in increased water availability in the short term. However in the long term water availability will decrease. Some current aspects in the basin need to be re-evaluated. During the past decades water abstractions - and especially groundwater extractions - have augmented continuously to support a rice-wheat system where rice is grown during the kharif (wet, summer) season (as well as sugar cane, cotton, maize and other crops) and wheat during the rabi (dry, winter) season. However, the sustainability of this system in its current form is questionable. Additional water for domestic and industrial purposes is required for the future and should be made available by a reduction in irrigation requirements. This paper gives a comprehensive listing and description of available options for current and future sustainable water resources management (WRM) within the basin. Sustainable WRM practices include both water supply management and water demand management options. Water supply management options include: (1) reservoir management as the basin is characterised by a strong seasonal behaviour in water availability (monsoon and meltwater) and water demands; (2) water quality conservation and investment in wastewater infrastructure; (3) the use of alternative water resources like the recycling of wastewater and desalination; (4) land use

  9. The Indus basin in the framework of current and future water resources management

    Directory of Open Access Journals (Sweden)

    A. N. Laghari

    2012-04-01

    Full Text Available The Indus basin is one of the regions in the world that is faced with major challenges for its water sector, due to population growth, rapid urbanisation and industrialisation, environmental degradation, unregulated utilization of the resources, inefficient water use and poverty, all aggravated by climate change. The Indus Basin is shared by 4 countries – Pakistan, India, Afghanistan and China. With a current population of 237 million people which is projected to increase to 319 million in 2025 and 383 million in 2050, already today water resources are abstracted almost entirely (more than 95% for irrigation. Climate change will result in increased water availability in the short term. However in the long term water availability will decrease. Some current aspects in the basin need to be re-evaluated. During the past decades water abstractions – and especially groundwater extractions – have augmented continuously to support a rice-wheat system where rice is grown during the kharif (wet, summer season (as well as sugar cane, cotton, maize and other crops and wheat during the rabi (dry, winter season. However, the sustainability of this system in its current form is questionable. Additional water for domestic and industrial purposes is required for the future and should be made available by a reduction in irrigation requirements. This paper gives a comprehensive listing and description of available options for current and future sustainable water resources management (WRM within the basin. Sustainable WRM practices include both water supply management and water demand management options. Water supply management options include: (1 reservoir management as the basin is characterised by a strong seasonal behaviour in water availability (monsoon and meltwater and water demands; (2 water quality conservation and investment in wastewater infrastructure; (3 the use of alternative water resources like the recycling of wastewater and desalination; (4

  10. Implementation workshop of WHO guidelines on evaluation of malaria vaccines: Current regulatory concepts and issues related to vaccine quality, Pretoria, South Africa 07 Nov 2014.

    Science.gov (United States)

    Ho, Mei Mei; Baca-Estrada, Maria; Conrad, Christoph; Karikari-Boateng, Eric; Kang, Hye-Na

    2015-08-26

    The current World Health Organization (WHO) guidelines on the quality, safety and efficacy of recombinant malaria vaccines targeting the pre-erythrocytic and blood stages of Plasmodium falciparum were adopted by the WHO Expert Committee on Biological Standardization in 2012 to provide guidance on the quality, nonclinical and clinical aspects of recombinant malaria vaccines. A WHO workshop was organised to facilitate implementation into African (national/regional) regulatory practices, of the regulatory evaluation principles outlined in the guidelines regarding quality aspects. The workshop was used also to share knowledge and experience on regulatory topics of chemistry, manufacturing and control with a focus on vaccines through presentations and an interactive discussion using a case study approach. The basic principles and concepts of vaccine quality including consistency of production, quality control and manufacturing process were presented and discussed in the meeting. By reviewing and practicing a case study, better understanding on the relationship between consistency of production and batch release tests of an adjuvanted pre-erythrocytic recombinant malaria vaccine was reached. The case study exercise was considered very useful to understand regulatory evaluation principles of vaccines and a suggestion was made to WHO to provide such practices also through its Global Learning Opportunities for Vaccine Quality programme.

  11. An overview of the Hadoop/MapReduce/HBase framework and its current applications in bioinformatics.

    Science.gov (United States)

    Taylor, Ronald C

    2010-12-21

    Bioinformatics researchers are now confronted with analysis of ultra large-scale data sets, a problem that will only increase at an alarming rate in coming years. Recent developments in open source software, that is, the Hadoop project and associated software, provide a foundation for scaling to petabyte scale data warehouses on Linux clusters, providing fault-tolerant parallelized analysis on such data using a programming style named MapReduce. An overview is given of the current usage within the bioinformatics community of Hadoop, a top-level Apache Software Foundation project, and of associated open source software projects. The concepts behind Hadoop and the associated HBase project are defined, and current bioinformatics software that employ Hadoop is described. The focus is on next-generation sequencing, as the leading application area to date. Hadoop and the MapReduce programming paradigm already have a substantial base in the bioinformatics community, especially in the field of next-generation sequencing analysis, and such use is increasing. This is due to the cost-effectiveness of Hadoop-based analysis on commodity Linux clusters, and in the cloud via data upload to cloud vendors who have implemented Hadoop/HBase; and due to the effectiveness and ease-of-use of the MapReduce method in parallelization of many data analysis algorithms.

  12. Olive oil authentication: A comparative analysis of regulatory frameworks with especial emphasis on quality and authenticity indices, and recent analytical techniques developed for their assessment. A review.

    Science.gov (United States)

    Bajoub, Aadil; Bendini, Alessandra; Fernández-Gutiérrez, Alberto; Carrasco-Pancorbo, Alegría

    2016-09-22

    Over the last decades, olive oil quality and authenticity control has become an issue of great importance to consumers, suppliers, retailers, and regulators in both traditional and emerging olive oil producing countries, mainly due to the increasing worldwide popularity and the trade globalization of this product. Thus, in order to ensure olive oil authentication, various national and international laws and regulations have been adopted, although some of them are actually causing an enormous debate about the risk that they can represent for the harmonization of international olive oil trade standards. Within this context, this review was designed to provide a critical overview and comparative analysis of selected regulatory frameworks for olive oil authentication, with special emphasis on the quality and purity criteria considered by these regulation systems, their thresholds and the analytical methods employed for monitoring them. To complete the general overview, recent analytical advances to overcome drawbacks and limitations of the official methods to evaluate olive oil quality and to determine possible adulterations were reviewed. Furthermore, the latest trends on analytical approaches to assess the olive oil geographical and varietal origin traceability were also examined.

  13. Bitcoin: a regulatory nightmare to a libertarian dream

    Directory of Open Access Journals (Sweden)

    Primavera De Filippi

    2014-05-01

    Full Text Available This article provides an overview of national policies and current discussions on the regulation of bitcoin in Europe and beyond. After presenting the potential threat that cryptocurrencies pose to governmental and financial institutions worldwide, it discusses the regulatory challenges and the difficulty for national regulators to come up with a sound regulatory framework, which the author believes explains the current (lack of regulatory responses in this field. The article concludes that regulation is needed, but that in order not to excessively stifle innovation in this nascent ecosystem, some of these challenges might better be addressed through self-regulation.

  14. Genomics in the land of regulatory science.

    Science.gov (United States)

    Tong, Weida; Ostroff, Stephen; Blais, Burton; Silva, Primal; Dubuc, Martine; Healy, Marion; Slikker, William

    2015-06-01

    Genomics science has played a major role in the generation of new knowledge in the basic research arena, and currently question arises as to its potential to support regulatory processes. However, the integration of genomics in the regulatory decision-making process requires rigorous assessment and would benefit from consensus amongst international partners and research communities. To that end, the Global Coalition for Regulatory Science Research (GCRSR) hosted the fourth Global Summit on Regulatory Science (GSRS2014) to discuss the role of genomics in regulatory decision making, with a specific emphasis on applications in food safety and medical product development. Challenges and issues were discussed in the context of developing an international consensus for objective criteria in the analysis, interpretation and reporting of genomics data with an emphasis on transparency, traceability and "fitness for purpose" for the intended application. It was recognized that there is a need for a global path in the establishment of a regulatory bioinformatics framework for the development of transparent, reliable, reproducible and auditable processes in the management of food and medical product safety risks. It was also recognized that training is an important mechanism in achieving internationally consistent outcomes. GSRS2014 provided an effective venue for regulators andresearchers to meet, discuss common issues, and develop collaborations to address the challenges posed by the application of genomics to regulatory science, with the ultimate goal of wisely integrating novel technical innovations into regulatory decision-making.

  15. Regulatory frameworks for hydropower in Europe. Comparing the examples of Germany, France and the United Kingdom; Regulatorische Rahmenbedingungen fuer die Wasserkraftnutzung in Europa am Beispiel der Laender Deutschland, Frankreich und Grossbritannien

    Energy Technology Data Exchange (ETDEWEB)

    Krull, Devid; Schneider, Claus Till; Detering, Michael [innogy SE, Essen (Germany). Sparte Erneuerbare Energien; Logie, Andrew [innogy SE, Perth (United Kingdom). Hydro Development; Seyler, Juergen [Energies France S.A.S., Paris (France)

    2016-11-01

    The regulatory framework for hydro power in the European countries Germany, United Kingdom and France is compared. All have as a common target on the one hand an increase of the share of renewable energy production and to this means a support regime for hydro power among other renewable technologies. The respective support mechanisms in the three countries are summarised. As part of the implementation of the European Water Framework Directive the countries formulate stricter environmental requirements for water bodies leading to reduced electricity generation and necessary investments in technical adaptations.

  16. Establishment of the nuclear regulatory framework for the process of decommissioning of nuclear installations in Mexico; Establecimiento del marco regulador nuclear para el proceso de cierre de instalaciones nucleares en Mexico

    Energy Technology Data Exchange (ETDEWEB)

    Salmeron V, J. A.; Camargo C, R.; Nunez C, A., E-mail: juan.salmeron@cnsns.gob.mx [Comision Nacional de Seguridad Nuclear y Salvaguardias, Dr. Barragan 779, Col. Narvarte, 03020 Ciudad de Mexico (Mexico)

    2015-09-15

    Today has not managed any process of decommissioning of nuclear installations in the country; however because of the importance of the subject and the actions to be taken to long term, the Comision Nacional de Seguridad Nuclear y Salvaguardias (CNSNS) in Mexico, accordance with its objectives is developing a National Nuclear Regulatory Framework and defined requirements to ensure the implementation of appropriate safety standards when such activities are performed. In this regard, the national nuclear regulatory framework for nuclear installations and the particular case of nuclear power reactors is presented, as well as a proposed licensing process for the nuclear power plant of Laguna Verde based on international regulations and origin country regulations of the existing reactors in nuclear facilities in accordance with the license conditions of operation to allow to define and incorporate such regulation. (Author)

  17. Regulatory approaches to obesity prevention: A systematic overview of current laws addressing diet-related risk factors in the European Union and the United States.

    Science.gov (United States)

    Sisnowski, Jana; Handsley, Elizabeth; Street, Jackie M

    2015-06-01

    High prevalence of overweight and obesity remains a significant international public health problem. Law has been identified as a tool for obesity prevention and selected high-profile measures have been reported. However, the nature and extent of enacted legislation internationally are unclear. This research provides an overview of regulatory approaches enacted in the United States, the European Union, and EU Member States since 2004. To this end, relevant databases of primary and secondary legislation were systematically searched to identify and explore laws addressing dietary risk factors for obesity. Across jurisdictions, current regulatory approaches to obesity prevention are limited in reach and scope. Target groups are rarely the general population, but instead sub-populations in government-supported settings. Consumer information provision is preferred over taxation and marketing restrictions other than the regulation of health and nutrition claims. In the EU in particular, product reformulation with industry consent has also emerged as a popular small-scale measure. While consistent and widespread use of law is lacking, governments have employed a range of regulatory measures in the name of obesity prevention, indicating that there is, in principle, political will. Results from this study may serve as a starting point for future research and policy development. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  18. Examination of the regulatory frameworks applicable to biologic drugs (including stem cells and their progeny) in Europe, the U.S., and Australia: part I--a method of manual documentary analysis.

    Science.gov (United States)

    Ilic, Nina; Savic, Snezana; Siegel, Evan; Atkinson, Kerry; Tasic, Ljiljana

    2012-12-01

    Recent development of a wide range of regulatory standards applicable to production and use of tissues, cells, and other biologics (or biologicals), as advanced therapies, indicates considerable interest in the regulation of these products. The objective of this study was to analyze and compare high-tier documents within the Australian, European, and U.S. biologic drug regulatory environments using qualitative methodology. Cohort 1 of the selected 18 high-tier regulatory documents from the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and the Therapeutic Goods Administration (TGA) regulatory frameworks were subject to a manual documentary analysis. These documents were consistent with the legal requirements for manufacturing and use of biologic drugs in humans and fall into six different categories. Manual analysis included a terminology search. The occurrence, frequency, and interchangeable use of different terms and phrases were recorded in the manual documentary analysis. Despite obvious differences, manual documentary analysis revealed certain consistency in use of terminology across analyzed frameworks. Phrase search frequencies have shown less uniformity than the search of terms. Overall, the EMA framework's documents referred to "medicinal products" and "marketing authorization(s)," the FDA documents discussed "drug(s)" or "biologic(s)," and the TGA documents referred to "biological(s)." Although high-tier documents often use different terminology they share concepts and themes. Documents originating from the same source have more conjunction in their terminology although they belong to different frameworks (i.e., Good Clinical Practice requirements based on the Declaration of Helsinki, 1964). Automated (software-based) documentary analysis should be obtained for the conceptual and relational analysis.

  19. Regulatory T cells as a therapeutic tool to induce solid-organ transplant tolerance: current clinical experiences.

    Science.gov (United States)

    Nikoueinejad, Hassan; Sharif, Mohammad Reza; Amirzargar, Aliakbar; Mirshafiey, Abbas; Einollahi, Behzad

    2013-10-01

    Long-term tolerance is potentially an ideal in organ transplant. Achieving this leads us to eliminate immunosuppressive therapies and their associated side effects. Although most succession in this field belongs to mixed chimerism methods of tolerance induction, regulatory T cells and (T-reg)-based methods also have been demonstrated to prevent organ rejection and lead to transplant tolerance through different mechanisms. In contrast to chimeric protocols (which require bone marrow transplant), T-reg-mediated protocols do not aggressively manipulate blood and the immune system. Most treatment has been done for graft-versus-host disease after hematopoietic stem cell transplant. This review describes different types and mechanisms of action and clinical strategies using T-regs to induce transplant tolerance.

  20. Great expectations: using an analysis of current practices to propose a framework for the undergraduate inorganic curriculum.

    Science.gov (United States)

    Reisner, Barbara A; Smith, Sheila R; Stewart, Joanne L; Raker, Jeffrey R; Crane, Johanna L; Sobel, Sabrina G; Pesterfield, Lester L

    2015-09-21

    The undergraduate inorganic chemistry curriculum in the United States mirrors the broad diversity of the inorganic research community and poses a challenge for the development of a coherent curriculum that is thorough, rigorous, and engaging. A recent large survey of the inorganic community has provided information about the current organization and content of the inorganic curriculum from an institutional level. The data reveal shared "core" concepts that are broadly taught, with tremendous variation in content coverage beyond these central ideas. The data provide an opportunity for a community-driven discussion about how the American Chemical Society's Committee on Professional Training's vision of a foundation and in-depth course for each of the five subdisciplines maps onto an inorganic chemistry curriculum that is consistent in its coverage of the core inorganic concepts, yet reflects the diversity and creativity of the inorganic community. The goal of this Viewpoint is to present the current state of the diverse undergraduate curriculum and lay a framework for an effective and engaging curriculum that illustrates the essential role inorganic chemistry plays within the chemistry community.

  1. Perceived historical drinking norms and current drinking behavior: using the theory of normative social behavior as a framework for assessment.

    Science.gov (United States)

    Carcioppolo, Nick; Jensen, Jakob D

    2012-01-01

    Social norms are sustained and disseminated, both implicitly and explicitly, through the act of communication. As a result, communication researchers have sought to classify and target normative perceptions to enact social change. In line with this research, the current study investigated whether perceptions of past normative behavior, referred to here as historical norms, were significantly related to current behavior. Using the theory of normative behavior as a guiding framework, two studies were conducted to assess whether college student drinking behavior was related to one of two perceived historical drinking norms measures: historical consumption norms (i.e., the perceived percentage of students who drank over time) and historical tradition norms (i.e., the perception of drinking as a university tradition). Study 1 revealed that although historical consumption norms was not directly related to drinking behavior, it moderated the effect of descriptive norms on drinking behavior (p = .03). A full assessment of the theory of normative social behavior was conducted in study 2 to determine whether perceived historical drinking norms influenced behavior above and beyond both descriptive and injunctive norms. Findings demonstrated that historical tradition norms were significantly related to drinking behavior (p = .001), and marginally moderated the relationship between descriptive norms and drinking behavior (p = .09). These findings offer preliminary evidence in support of measuring perceived historical drinking norms in future campaigns and interventions designed to reduce drinking behavior.

  2. Ethanol: the importance of the new regulatory framework for the sugar-alcohol market in Brazil; Etanol: a importancia do novo marco regulatorio para o mercado sucroalcooleiro do Brasil

    Energy Technology Data Exchange (ETDEWEB)

    Batista, Jessica de Araujo; Alves, Rayana Lins [Agencia Nacional do Petroleo, Gas Natural e Biocombustiveis (ANP), Rio de Janeiro, RJ (Brazil). Programa de Recursos Humanos em Direito do Petroleo, Gas Natural e Biocombustiveis

    2010-07-01

    The present work intends to make an analysis concerning the panorama which it inserts the regulation of the industry of ethanol in Brazil, in detaining in the problematic that it is detached in the economic scene and present politics: the necessity of a new regulatory framework that could adapt on necessities and requirements of the sugarcane industry of Brazil. In the present time, the absence of regulation makes that the sugarcane sector is regulated by some actors, who act of determinant and diffuse form, in the creation of public politics that deal with ethanol fuel. Thus, with the divergence of interests and the absence of consensus, occurs an impediment to energy development of ethanol. In this work, it was used doctrinal research regarding the sugarcane sector, with the intention to analyze it historically, since the previous period the Constitution of 1988 until the energy planning 2030. It is had as resulted the necessity of the creation of a new regulatory framework for the sugarcane sector, which must contain clauses to develop the paper of the ANP in the sector; to diminish the technological specifications; to increase the advantages taxes etc. In this way, it was reached the conclusion that it is not any creation of regulatory framework that will go to benefit the development of the sector, but a legislation resultant of discussions concerning the present sugarcane industry. (author)

  3. A niche-based framework to assess current monitoring of European forest birds and guide indicator species' selection.

    Science.gov (United States)

    Wade, Amy S I; Barov, Boris; Burfield, Ian J; Gregory, Richard D; Norris, Ken; Vorisek, Petr; Wu, Taoyang; Butler, Simon J

    2014-01-01

    Concern that European forest biodiversity is depleted and declining has provoked widespread efforts to improve management practices. To gauge the success of these actions, appropriate monitoring of forest ecosystems is paramount. Multi-species indicators are frequently used to assess the state of biodiversity and its response to implemented management, but generally applicable and objective methodologies for species' selection are lacking. Here we use a niche-based approach, underpinned by coarse quantification of species' resource use, to objectively select species for inclusion in a pan-European forest bird indicator. We identify both the minimum number of species required to deliver full resource coverage and the most sensitive species' combination, and explore the trade-off between two key characteristics, sensitivity and redundancy, associated with indicators comprising different numbers of species. We compare our indicator to an existing forest bird indicator selected on the basis of expert opinion and show it is more representative of the wider community. We also present alternative indicators for regional and forest type specific monitoring and show that species' choice can have a significant impact on the indicator and consequent projections about the state of the biodiversity it represents. Furthermore, by comparing indicator sets drawn from currently monitored species and the full forest bird community, we identify gaps in the coverage of the current monitoring scheme. We believe that adopting this niche-based framework for species' selection supports the objective development of multi-species indicators and that it has good potential to be extended to a range of habitats and taxa.

  4. The use of Depletion Methods to assess Mediterranean cephalopod stocks under the current EU Data Collection Framework

    Directory of Open Access Journals (Sweden)

    S. KELLER

    2015-11-01

    Full Text Available Fuelled by the raising importance of cephalopod fisheries in Europe, there have been demands from scientists and stakeholders for their assessment and management. However, little has been done to improve the data collection in order to analyse cephalopod populations under the EU Data Collection Framework (DCF. While the DCF allows member states to design flexible national sampling programmes, it establishes the minimum data requirements (MDR each state is obliged to fulfil. In this study, it was investigated whether such MDR currently set by the DCF allow the application of depletion models (DMs to assess European cephalopod stocks. Squid and cuttlefish fisheries from the western Mediterranean were used as a case study. This exercise sheds doubt on the suitability of the MDR to properly assess and manage cephalopod stocks by means of DMs. Owing to the high plasticity of life-history traits in cephalopod populations, biological parameters should be estimated during the actual depletion period of the fished stocks, in contrast with the triennial sampling established by the DCF. In order to accurately track the depletion event, the rapid growth rates of cephalopods implies that their populations should be monitored at shorter time scales (ideally weekly or biweekly instead of quarterly as required by the DCF. These measures would not demand additional resources of the ongoing DCF, but a redistribution of sampling efforts during the depletion period. Such changes in the sampling scheme could be designed and undertaken by the member states or directly integrated as requirements.

  5. Assessing Land Degradation and Desertification Using Vegetation Index Data: Current Frameworks and Future Directions

    Directory of Open Access Journals (Sweden)

    Thomas P. Higginbottom

    2014-10-01

    Full Text Available Land degradation and desertification has been ranked as a major environmental and social issue for the coming decades. Thus, the observation and early detection of degradation is a primary objective for a number of scientific and policy organisations, with remote sensing methods being a candidate choice for the development of monitoring systems. This paper reviews the statistical and ecological frameworks of assessing land degradation and desertification using vegetation index data. The development of multi-temporal analysis as a desertification assessment technique is reviewed, with a focus on how current practice has been shaped by controversy and dispute within the literature. The statistical techniques commonly employed are examined from both a statistical as well as ecological point of view, and recommendations are made for future research directions. The scientific requirements for degradation and desertification monitoring systems identified here are: (I the validation of methodologies in a robust and comparable manner; and (II the detection of degradation at minor intensities and magnitudes. It is also established that the multi-temporal analysis of vegetation index data can provide a sophisticated measure of ecosystem health and variation, and that, over the last 30 years, considerable progress has been made in the respective research.

  6. The use of Depletion Methods to assess Mediterranean cephalopod stocks under the current EU Data Collection Framework

    Directory of Open Access Journals (Sweden)

    S. KELLER

    2015-09-01

    Full Text Available Fuelled by the raising importance of cephalopod fisheries in Europe, there have been demands from scientists and stakeholders for their assessment and management. However, little has been done to improve the data collection in order to analyse cephalopod populations under the EU Data Collection Framework (DCF. While the DCF allows member states to design flexible national sampling programmes, it establishes the minimum data requirements (MDR each state is obliged to fulfil. In this study, it was investigated whether such MDR currently set by the DCF allow the application of depletion models (DMs to assess European cephalopod stocks. Squid and cuttlefish fisheries from the western Mediterranean were used as a case study. This exercise sheds doubt on the suitability of the MDR to properly assess and manage cephalopod stocks by means of DMs. Owing to the high plasticity of life-history traits in cephalopod populations, biological parameters should be estimated during the actual depletion period of the fished stocks, in contrast with the triennial sampling established by the DCF. In order to accurately track the depletion event, the rapid growth rates of cephalopods implies that their populations should be monitored at shorter time scales (ideally weekly or biweekly instead of quarterly as required by the DCF. These measures would not demand additional resources of the ongoing DCF, but a redistribution of sampling efforts during the depletion period. Such changes in the sampling scheme could be designed and undertaken by the member states or directly integrated as requirements.

  7. Adipose-Derived Stem Cells in Aesthetic Surgery: A Mixed Methods Evaluation of the Current Clinical Trial, Intellectual Property, and Regulatory Landscape.

    Science.gov (United States)

    Arshad, Zeeshaan; Halioua-Haubold, Celine-Lea; Roberts, Mackenna; Urso-Baiarda, Fulvio; Branford, Oliver A; Brindley, David A; Davies, Benjamin M; Pettitt, David

    2017-06-07

    Adipose tissue, which can be readily harvested via a number of liposuction techniques, offers an easily accessible and abundant source of adipose-derived stem cells (ASCs). Consequently, ASCs have become an increasingly popular reconstructive option and a novel means of aesthetic soft tissue augmentation. This paper examines recent advances in the aesthetic surgery field, extending beyond traditional review formats to incorporate a comprehensive analysis of current clinical trials, adoption status, and the commercialization pathway. Keyword searches were carried out on clinical trial databases to search for trials using ASCs for aesthetic indications. An intellectual property landscape was created using commercial software (Thomson Reuters Thomson Innovation, New York, NY). Analysis of who is claiming what in respect of ASC use in aesthetic surgery for commercial purposes was analyzed by reviewing the patent landscape in relation to these techniques. Key international regulatory guidelines were also summarized. Completed clinical trials lacked robust controls, employed small sample sizes, and lacked long-term follow-up data. Ongoing clinical trials still do not address such issues. In recent years, claims to intellectual property ownership have increased in the "aesthetic stem cell" domain, reflecting commercial interest in the area. However, significant translational barriers remain including regulatory challenges and ethical considerations. Further rigorous randomized controlled trials are required to delineate long-term clinical efficacy and safety. Providers should consider the introduction of patient reported outcome metrics to facilitate clinical adoption. Robust regulatory and ethical policies concerning stem cells and aesthetic surgery should be devised to discourage further growth of "stem cell tourism."

  8. First update of the International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes--Chapter 1: update on national regulatory frameworks pertinent to clinical islet xenotransplantation.

    Science.gov (United States)

    Cozzi, Emanuele; Tönjes, Ralf R; Gianello, Pierre; Bühler, Léo H; Rayat, Gina R; Matsumoto, Shinichi; Park, Chung-Gyu; Kwon, Ivo; Wang, Wei; O'Connell, Philip; Jessamine, Stewart; Elliott, Robert B; Kobayashi, Takaaki; Hering, Bernhard J

    2016-01-01

    Islet xenotransplantation represents an attractive solution to overcome the shortage of human islets for use in type 1 diabetes. The wide-scale application of clinical islet xenotransplantation, however, requires that such a procedure takes place in a specifically and tightly regulated environment. With a view to promoting the safe application of clinical islet xenotransplantation, a few years ago the International Xenotransplantation Association (IXA) published a Consensus Statement that outlined the key ethical and regulatory requirements to be satisfied before the initiation of xenotransplantation studies in diabetic patients. This earlier IXA Statement also documented a disparate regulatory landscape among different geographical areas. This situation clearly fell short of the 2004 World Health Assembly Resolution WHA57.18 that urged Member States "to cooperate in the formulation of recommendations and guidelines to harmonize global practices" to ensure the highest ethical and regulatory standards on a global scale. In this new IXA report, IXA members who are active in xenotransplantation research in their respective geographic areas herewith briefly describe changes in the regulatory frameworks that have taken place in the intervening period in the various geographic areas or countries. The key reassuring take-home message of the present report is that many countries have embraced the encouragement of the WHO to harmonize the procedures in a more global scale. Indeed, important regulatory changes have taken place or are in progress in several geographic areas that include Europe, Korea, Japan, and China. Such significant regulatory changes encompass the most diverse facets of the clinical application of xenotransplantation and comprise ethical aspects, source animals and product specifications, study supervision, sample archiving, patient follow-up and even insurance coverage in some legislations. All these measures are expected to provide a better care and

  9. Regulatory Considerations for the Clinical and Research Use of Transcranial Direct Current Stimulation (tDCS): review and recommendations from an expert panel

    Science.gov (United States)

    Fregni, F; Nitsche, MA; Loo, C.K.; Brunoni, AR; Marangolo, P; Leite, J; Carvalho, S; Bolognini, N; Caumo, W; Paik, NJ; Simis, M; Ueda, K; Ekhitari, H; Luu, P; Tucker, DM; Tyler, WJ; Brunelin, J; Datta, A; Juan, CH; Venkatasubramanian, G; Boggio, PS; Bikson, M

    2014-01-01

    The field of transcranial electrical stimulation (tES) has experienced significant growth in the past 15 years. One of the tES techniques leading this increased interest is transcranial direct current stimulation (tDCS). Significant research efforts have been devoted to determining the clinical potential of tDCS in humans. Despite the promising results obtained with tDCS in basic and clinical neuroscience, further progress has been impeded by a lack of clarity on international regulatory pathways. We therefore convened a group of research and clinician experts on tDCS to review the research and clinical use of tDCS. In this report, we review the regulatory status of tDCS, and we summarize the results according to research, off-label and compassionate use of tDCS in the following countries: Australia, Brazil, France, Germany, India, Iran, Italy, Portugal, South Korea, Taiwan and United States. Research use, off label treatment and compassionate use of tDCS are employed in most of the countries reviewed in this study. It is critical that a global or local effort is organized to pursue definite evidence to either approve and regulate or restrict the use of tDCS in clinical practice on the basis of adequate randomized controlled treatment trials. PMID:25983531

  10. 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.

  11. Regulatory agencies and regulatory risk

    OpenAIRE

    Knieps, Günter; Weiß, Hans-Jörg

    2007-01-01

    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...

  12. Single-Session Transcranial Direct Current Stimulation Temporarily Improves Symptoms, Mood, and Self-Regulatory Control in Bulimia Nervosa: A Randomised Controlled Trial.

    Science.gov (United States)

    Kekic, Maria; McClelland, Jessica; Bartholdy, Savani; Boysen, Elena; Musiat, Peter; Dalton, Bethan; Tiza, Meyzi; David, Anthony S; Campbell, Iain C; Schmidt, Ulrike

    2017-01-01

    Evidence suggests that pathological eating behaviours in bulimia nervosa (BN) are underpinned by alterations in reward processing and self-regulatory control, and by functional changes in neurocircuitry encompassing the dorsolateral prefrontal cortex (DLPFC). Manipulation of this region with transcranial direct current stimulation (tDCS) may therefore alleviate symptoms of the disorder. This double-blind sham-controlled proof-of-principle trial investigated the effects of bilateral tDCS over the DLPFC in adults with BN. Thirty-nine participants (two males) received three sessions of tDCS in a randomised and counterbalanced order: anode right/cathode left (AR/CL), anode left/cathode right (AL/CR), and sham. A battery of psychological/neurocognitive measures was completed before and after each session and the frequency of bulimic behaviours during the following 24-hours was recorded. AR/CL tDCS reduced eating disorder cognitions (indexed by the Mizes Eating Disorder Cognitions Questionnaire-Revised) when compared to AL/CR and sham tDCS. Both active conditions suppressed the self-reported urge to binge-eat and increased self-regulatory control during a temporal discounting task. Compared to sham stimulation, mood (assessed with the Profile of Mood States) improved after AR/CL but not AL/CR tDCS. Lastly, the three tDCS sessions had comparable effects on the wanting/liking of food and on bulimic behaviours during the 24 hours post-stimulation. These data suggest that single-session tDCS transiently improves symptoms of BN. They also help to elucidate possible mechanisms of action and highlight the importance of selecting the optimal electrode montage. Multi-session trials are needed to determine whether tDCS has potential for development as a treatment for adult BN.

  13. A framework for a European network for a systematic environmental impact assessment of genetically modified organisms (GMO)

    DEFF Research Database (Denmark)

    Graaf, F; Römbke, J; Binimelis, R

    2012-01-01

    (ERA). The current regulatory system is hampered by insufficiently developed methods for GM crop safety testing and introduction studies. Improvement to the regulatory system needs to address the lack of well designed GM crop monitoring frameworks, professional and financial conflicts of interest...

  14. Security issues of new innovative payments and their regulatory challenges

    NARCIS (Netherlands)

    Kasiyanto, Safari; Gabriella, Gimigliano

    2016-01-01

    Kasiyanto discusses how the security issues of M-payments and Bitcoin as new forms of innovative payments challenge the existing EU regulatory frameworks, and whether the proposed regulatory frameworks suffice to address such challenges. The regulatory frameworks Kasiyanto discusses mainly focus on

  15. Security issues of new innovative payments and their regulatory challenges

    NARCIS (Netherlands)

    Kasiyanto, Safari; Gabriella, Gimigliano

    2016-01-01

    Kasiyanto discusses how the security issues of M-payments and Bitcoin as new forms of innovative payments challenge the existing EU regulatory frameworks, and whether the proposed regulatory frameworks suffice to address such challenges. The regulatory frameworks Kasiyanto discusses mainly focus on

  16. Metabolic constraint-based refinement of transcriptional regulatory networks.

    Science.gov (United States)

    Chandrasekaran, Sriram; Price, Nathan D

    2013-01-01

    There is a strong need for computational frameworks that integrate different biological processes and data-types to unravel cellular regulation. Current efforts to reconstruct transcriptional regulatory networks (TRNs) focus primarily on proximal data such as gene co-expression and transcription factor (TF) binding. While such approaches enable rapid reconstruction of TRNs, the overwhelming combinatorics of possible networks limits identification of mechanistic regulatory interactions. Utilizing growth phenotypes and systems-level constraints to inform regulatory network reconstruction is an unmet challenge. We present our approach Gene Expression and Metabolism Integrated for Network Inference (GEMINI) that links a compendium of candidate regulatory interactions with the metabolic network to predict their systems-level effect on growth phenotypes. We then compare predictions with experimental phenotype data to select phenotype-consistent regulatory interactions. GEMINI makes use of the observation that only a small fraction of regulatory network states are compatible with a viable metabolic network, and outputs a regulatory network that is simultaneously consistent with the input genome-scale metabolic network model, gene expression data, and TF knockout phenotypes. GEMINI preferentially recalls gold-standard interactions (p-value = 10(-172)), significantly better than using gene expression alone. We applied GEMINI to create an integrated metabolic-regulatory network model for Saccharomyces cerevisiae involving 25,000 regulatory interactions controlling 1597 metabolic reactions. The model quantitatively predicts TF knockout phenotypes in new conditions (p-value = 10(-14)) and revealed potential condition-specific regulatory mechanisms. Our results suggest that a metabolic constraint-based approach can be successfully used to help reconstruct TRNs from high-throughput data, and highlights the potential of using a biochemically-detailed mechanistic framework to

  17. A Review and Framework for Categorizing Current Research and Development in Health Related Geographical Information Systems (GIS) Studies.

    Science.gov (United States)

    Lyseen, A K; Nøhr, C; Sørensen, E M; Gudes, O; Geraghty, E M; Shaw, N T; Bivona-Tellez, C

    2014-08-15

    The application of GIS in health science has increased over the last decade and new innovative application areas have emerged. This study reviews the literature and builds a framework to provide a conceptual overview of the domain, and to promote strategic planning for further research of GIS in health. The framework is based on literature from the library databases Scopus and Web of Science. The articles were identified based on keywords and initially selected for further study based on titles and abstracts. A grounded theory-inspired method was applied to categorize the selected articles in main focus areas. Subsequent frequency analysis was performed on the identified articles in areas of infectious and non-infectious diseases and continent of origin. A total of 865 articles were included. Four conceptual domains within GIS in health sciences comprise the framework: spatial analysis of disease, spatial analysis of health service planning, public health, health technologies and tools. Frequency analysis by disease status and location show that malaria and schistosomiasis are the most commonly analyzed infectious diseases where cancer and asthma are the most frequently analyzed non-infectious diseases. Across categories, articles from North America predominate, and in the category of spatial analysis of diseases an equal number of studies concern Asia. Spatial analysis of diseases and health service planning are well-established research areas. The development of future technologies and new application areas for GIS and data-gathering technologies such as GPS, smartphones, remote sensing etc. will be nudging the research in GIS and health.

  18. Applications of the MapReduce programming framework to clinical big data analysis: current landscape and future trends.

    Science.gov (United States)

    Mohammed, Emad A; Far, Behrouz H; Naugler, Christopher

    2014-01-01

    The emergence of massive datasets in a clinical setting presents both challenges and opportunities in data storage and analysis. This so called "big data" challenges traditional analytic tools and will increasingly require novel solutions adapted from other fields. Advances in information and communication technology present the most viable solutions to big data analysis in terms of efficiency and scalability. It is vital those big data solutions are multithreaded and that data access approaches be precisely tailored to large volumes of semi-structured/unstructured data. THE MAPREDUCE PROGRAMMING FRAMEWORK USES TWO TASKS COMMON IN FUNCTIONAL PROGRAMMING: Map and Reduce. MapReduce is a new parallel processing framework and Hadoop is its open-source implementation on a single computing node or on clusters. Compared with existing parallel processing paradigms (e.g. grid computing and graphical processing unit (GPU)), MapReduce and Hadoop have two advantages: 1) fault-tolerant storage resulting in reliable data processing by replicating the computing tasks, and cloning the data chunks on different computing nodes across the computing cluster; 2) high-throughput data processing via a batch processing framework and the Hadoop distributed file system (HDFS). Data are stored in the HDFS and made available to the slave nodes for computation. In this paper, we review the existing applications of the MapReduce programming framework and its implementation platform Hadoop in clinical big data and related medical health informatics fields. The usage of MapReduce and Hadoop on a distributed system represents a significant advance in clinical big data processing and utilization, and opens up new opportunities in the emerging era of big data analytics. The objective of this paper is to summarize the state-of-the-art efforts in clinical big data analytics and highlight what might be needed to enhance the outcomes of clinical big data analytics tools. This paper is concluded by

  19. Current insights into the molecular systems pharmacology of lncRNA-miRNA regulatory interactions and implications in cancer translational medicine

    Directory of Open Access Journals (Sweden)

    Sujit Nair

    2016-04-01

    Full Text Available In recent times, the role(s of microRNAs (miRNAs and long noncoding RNAs (lncRNAs in the pathogenesis of various cancers has received great attention. Indeed, there is also a growing recognition of regulatory RNA cross-talk, i.e., lncRNA-miRNA interactions, that may modulate various events in carcinogenesis and progression to metastasis. This review summarizes current evidence in the literature of lncRNA-miRNA interactions in various cancers such as breast, liver, stomach, lung, prostate, bladder, colorectal, blood, brain, skin, kidney, cervical, laryngeal, gall bladder, and bone. Further, the potential prognostic and theragnostic clinical applications of lncRNA-miRNA interactions in cancer are discussed along with an overview of noncoding RNA (ncRNA-based studies that were presented at the American Society of Clinical Oncology (ASCO 2015. Interestingly, the last decade has seen tremendous innovation, as well as increase in complexity, of the cancer biological network(s from mRNA- to miRNA- and lncRNA-based networks. Thus, biological networks devoted to understanding regulatory interactions between these ncRNAs would be the next frontier in better elucidating the contributions of lncRNA-miRNA interactions in cancer. Herein, a cancer biological network of lncRNA-miRNA interactions is presented wherein “edges” connect interacting lncRNA-miRNA pairs, with each ncRNA serving as a discrete “node” of the network. In conclusion, the untapped potential of lncRNA-miRNA interactions in terms of its diagnostic, prognostic and therapeutic potential as targets for clinically actionable intervention as well as biomarker validation in discovery pipelines remains to be explored. Future research will likely harness this potential so as to take us closer to the goal of “precision” and “personalized medicine” which is tailor-made to the unique needs of each cancer patient, and is clearly the way forward going into the future.

  20. NanoCRED: A transparent framework to assess the regulatory adequacy of ecotoxicity data for nanomaterials – relevance and reliability revisited

    DEFF Research Database (Denmark)

    Hartmann, Nanna B.; Ågerstrand, Malene; Lützhøft, Hans-Christian Holten

    2017-01-01

    and labelling can be based and Predicted No-Effect Concentration (PNEC) values can be estimated. In a regulatory context ecotoxicological data is often recommended to be generated according to accepted and validated test guidelines, preferably also following Good Laboratory Practice. However, engineered...... guidance, were developed to be used in combination with those developed through the ‘Criteria for Reporting and Evaluating Ecotoxicity Data (CRED)’ project. This approach can accommodate all types of nanomaterials, all types of aquatic ecotoxicity studies, and qualitative as well as quantitative data...

  1. The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes--chapter 1: Key ethical requirements and progress toward the definition of an international regulatory framework.

    Science.gov (United States)

    Cozzi, Emanuele; Tallacchini, Mariachiara; Flanagan, Enda B; Pierson, Richard N; Sykes, Megan; Vanderpool, Harold Y

    2009-01-01

    The outstanding results recently obtained in islet xenotransplantation suggest that porcine islet clinical trials may soon be scientifically appropriate. Before the initiation of such clinical studies, however, it is essential that a series of key ethical and regulatory conditions are satisfied. As far as ethics is concerned, the fundamental requirements have been previously reported in a position paper of the Ethics Committee of the International Xenotransplantation Association. These include aspects related to the selection of adequately informed, appropriate recipients; animal breeding and welfare; safety issues and the need for a favorable risk/benefit assessment based on strong efficacy data in relevant xenotransplantation studies in the primate. As most diabetic patients are not at risk of short-term mortality without islet transplantation, only a small subset of patients could currently be considered for any type of islet transplant. However, there are potential advantages to xenotransplantation that could result in a favorable benefit-over-harm determination for islet xenotransplantation in this subpopulation and ultimately in a broader population of diabetic patients. With regard to regulatory aspects, the key concepts underlying the development of the regulatory models in existence in the United States, Europe and New Zealand are discussed. Each of these models provides an example of a well-defined regulatory approach to ensure the initiation of well-regulated and ethically acceptable clinical islet xenotransplantation trials. At this stage, it becomes apparent that only a well-coordinated international effort such as that initiated by the World Health Organization, aimed at harmonizing xenotransplantation procedures according to the highest ethical and regulatory standards on a global scale, will enable the initiation of clinical xenotransplantation trials under the best auspices for its success and minimize any risk of failure.

  2. Integrating resource efficiency and EU State aid. An evaluation of resource efficiency considerations in the current EU State aid framework

    Energy Technology Data Exchange (ETDEWEB)

    Bennink, D.; Faber, J.; Smit, M. [CE Delft, Delft (Netherlands); Goba, V. [SIA Estonian, Latvian and Lithuanian Environment ELLE, Tallinn (Estonia); Miller, K.; Williams, E. [AEA Technology plc, London (United Kingdom)

    2012-10-15

    This study, for the European Commission, analyses the issues that need to be addressed in the revision of the EU State aid framework to ensure that they do not hinder environmental, resource efficiency and sustainable development goals. In some cases, State aid can be considered an environmentally harmful subsidy (EHS). The study analyses (1) the extent to which the Environmental Aid Guidelines (EAG) need to be changed to take into account recent European environmental policy developments; (2) existing and potential resource efficiency considerations in a) the Regional Aid Guidelines; b) the Research, Development and Innovation (RDI) Guidelines and c) the Agriculture and Forestry Guidelines; assesses cases and schemes using these guidelines to identify whether resource efficiency considerations are taken into account. The study also considers the social, environmental and economic impacts of these cases and schemes. It develops recommendations for the review of the EAG and a number of horizontal guidelines. One of the conclusions of the analysis is that the way in which multiple objectives and impacts are balanced, when deciding to approve state aid, is unclear. Also, EU member states are not required to provide information on certain types of (estimated) impacts. To guarantee that multiple objectives and impacts are sufficiently balanced, it is recommended that the State aid framework prescribes that applicants identify social, economic and environmental objectives and impacts and describe how these are taken into account in the procedure of balancing multiple (conflicting) objectives. Objectives and impacts should be quantified as much as possible, for example by making use of the method of external cost calculation laid down in 'the Handbook on estimation of external costs in the transport Sector'. The results of the study are used by the European Commission as an input for evaluating and improving the EU State aid framework.

  3. Current medical research funding and frameworks are insufficient to address the health risks of global environmental change.

    Science.gov (United States)

    Ebi, Kristie L; Semenza, Jan C; Rocklöv, Joacim

    2016-11-11

    Three major international agreements signed in 2015 are key milestones for transitioning to more sustainable and resilient societies: the UN 2030 Agenda for Sustainable Development; the Sendai Framework for Disaster Risk Reduction; and the Paris Agreement under the United Nations Framework Convention on Climate Change. Together, these agreements underscore the critical importance of understanding and managing the health risks of global changes, to ensure continued population health improvements in the face of significant social and environmental change over this century. BODY: Funding priorities of major health institutions and organizations in the U.S. and Europe do not match research investments with needs to inform implementation of these international agreements. In the U.S., the National Institutes of Health commit 0.025 % of their annual research budget to climate change and health. The European Union Seventh Framework Programme committed 0.08 % of the total budget to climate change and health; the amount committed under Horizon 2020 was 0.04 % of the budget. Two issues apparently contributing to this mismatch are viewing climate change primarily as an environmental problem, and therefore the responsibility of other research streams; and narrowly framing research into managing the health risks of climate variability and change from the perspective of medicine and traditional public health. This reductionist, top-down perspective focuses on proximate, individual level risk factors. While highly successful in reducing disease burdens, this framing is insufficient to protect health and well-being over a century that will be characterized by profound social and environmental changes. International commitments in 2015 underscored the significant challenges societies will face this century from climate change and other global changes. However, the low priority placed on understanding and managing the associated health risks by national and international research

  4. Elements to evaluate the intention in the non-compliance s or violations to the regulatory framework in the national nuclear facilities; Elementos para evaluar la intencionalidad en los incumplimientos o violaciones al marco regulador en las instalaciones nucleares nacionales

    Energy Technology Data Exchange (ETDEWEB)

    Espinosa V, J. M.; Gonzalez V, J. A., E-mail: jmespinosa@cnsns.gob.mx [Comision Nacional de Seguridad Nuclear y Salvaguardias, Dr. Jose Ma. Barragan No. 779, Col. Narvarte, 03020 Mexico D. F. (Mexico)

    2013-10-15

    Inside the impact evaluation process to the safety of non-compliance s or violations, developed and implanted by the Comision Nacional de Seguridad Nuclear y Salvaguardias (CNSNS), the Guide for the Impact Evaluation to the Safety in the National Nuclear Facilities by Non-compliance s or Violations to the Regulatory Framework was developed, which indicates that in the determination of the severity (graveness level) of a non-compliance or violation, four factors are evaluated: real and potential consequences to the safety, the impact to the regulator process and the intention. The non-compliance s or intentional violations are of particular interest, since the development of the regulatory activities of the CNSNS considers that the personnel of the licensees, as well as their contractors, will act and will communicate with integrity and honesty. The CNSNS cannot tolerate intentional non-compliance s, for what this violations type can be considered of a level of more graveness that the subjacent non-compliance. To determine the severity of a violation that involves intention, the CNSNS also took in consideration factors as the position and the personnel's responsibilities involved in the violation, the graveness level of the non-compliance in itself, the offender's intention and the possible gain that would produce the non-compliance, if exists, either economic or of another nature. The CNSNS hopes the licensees take significant corrective actions in response to non-compliance s or intentional violations, these corrective actions should correspond to the violation graveness with the purpose of generating a dissuasive effect in the organizations of the licensees. The present article involves the legal framework that confers the CNSNS the attributions to impose administrative sanctions to its licensees, establishes the definition of the CNSNS about what constitutes a non-compliance or intentional violation and finally indicates the intention types (deliberate

  5. CluGene: A Bioinformatics Framework for the Identification of Co-Localized, Co-Expressed and Co-Regulated Genes Aimed at the Investigation of Transcriptional Regulatory Networks from High-Throughput Expression Data.

    Directory of Open Access Journals (Sweden)

    Tania Dottorini

    Full Text Available The full understanding of the mechanisms underlying transcriptional regulatory networks requires unravelling of complex causal relationships. Genome high-throughput technologies produce a huge amount of information pertaining gene expression and regulation; however, the complexity of the available data is often overwhelming and tools are needed to extract and organize the relevant information. This work starts from the assumption that the observation of co-occurrent events (in particular co-localization, co-expression and co-regulation may provide a powerful starting point to begin unravelling transcriptional regulatory networks. Co-expressed genes often imply shared functional pathways; co-expressed and functionally related genes are often co-localized, too; moreover, co-expressed and co-localized genes are also potential targets for co-regulation; finally, co-regulation seems more frequent for genes mapped to proximal chromosome regions. Despite the recognized importance of analysing co-occurrent events, no bioinformatics solution allowing the simultaneous analysis of co-expression, co-localization and co-regulation is currently available. Our work resulted in developing and valuating CluGene, a software providing tools to analyze multiple types of co-occurrences within a single interactive environment allowing the interactive investigation of combined co-expression, co-localization and co-regulation of genes. The use of CluGene will enhance the power of testing hypothesis and experimental approaches aimed at unravelling transcriptional regulatory networks. The software is freely available at http://bioinfolab.unipg.it/.

  6. A framework to analyze emissions implications of manufacturing shifts in the industry through integrating bottom-up energy models and economic input-output environmental life cycle assessment models

    Science.gov (United States)

    Future year emissions depend highly on the evolution of the economy, technology and current and future regulatory drivers. A scenario framework was adopted to analyze various technology development pathways and societal change while considering existing regulations and future unc...

  7. Regulatory focus and work-related outcomes: a review and meta-analysis.

    Science.gov (United States)

    Lanaj, Klodiana; Chang, Chu-Hsiang Daisy; Johnson, Russell E

    2012-09-01

    Regulatory focus theory (Higgins, 1997) has received growing attention in organizational psychology, necessitating a quantitative review that synthesizes its effects on important criteria. In addition, there is need for theoretical integration of regulatory focus theory with personality research. Theoretical integration is particularly relevant, since personality traits and dispositions are distal factors that are unlikely to have direct effects on work behaviors, yet they may have indirect effects via regulatory focus. The current meta-analysis introduces an integrative framework in which the effects of personality on work behaviors are best understood when considered in conjunction with more proximal motivational processes such as regulatory focus. Using a distal-proximal approach, we identify personality antecedents and work-related consequences of regulatory foci in a framework that considers both general and work-specific regulatory foci as proximal motivational processes. We present meta-analytic results for relations of regulatory focus with its antecedents (approach and avoid temperaments, conscientiousness, openness to experience, agreeableness, self-esteem, and self-efficacy) and its consequences (work behaviors and attitudes). In addition to estimates of bivariate relationships, we support a meta-analytic path model in which distal personality traits relate to work behaviors via the mediating effects of general and work-specific regulatory focus. Results from tests of incremental and relative validity indicated that regulatory foci predict unique variance in work behaviors after controlling for established personality, motivation, and attitudinal predictors. Consistent with regulatory focus theory and our integrative theoretical framework, regulatory focus has meaningful relations with work outcomes and is not redundant with other individual difference variables.

  8. A suggestion to improve a day keeps your depletion away: Examining promotive and prohibitive voice behaviors within a regulatory focus and ego depletion framework.

    Science.gov (United States)

    Lin, Szu-Han Joanna; Johnson, Russell E

    2015-09-01

    One way that employees contribute to organizational effectiveness is by expressing voice. They may offer suggestions for how to improve the organization (promotive voice behavior), or express concerns to prevent harmful events from occurring (prohibitive voice behavior). Although promotive and prohibitive voices are thought to be distinct types of behavior, very little is known about their unique antecedents and consequences. In this study we draw on regulatory focus and ego depletion theories to derive a theoretical model that outlines a dynamic process of the antecedents and consequences of voice behavior. Results from 2 multiwave field studies revealed that promotion and prevention foci have unique ties to promotive and prohibitive voice, respectively. Promotive and prohibitive voice, in turn, were associated with decreases and increases, respectively, in depletion. Consistent with the dynamic nature of self-control, depletion was associated with reductions in employees' subsequent voice behavior, regardless of the type of voice (promotive or prohibitive). Results were consistent across 2 studies and remained even after controlling for other established antecedents of voice and alternative mediating mechanisms beside depletion.

  9. Benchmarking of electron cyclotron heating and current drive codes on ITER scenarios within the European Integrated Tokamak Modelling framework

    Directory of Open Access Journals (Sweden)

    Peysson Y.

    2012-09-01

    Full Text Available Electron cyclotron resonance heating (ECRH and electron cyclotron current drive (ECCD are used to heat the plasma, to tailor the current profiles and to achieve different operating regimes of tokamak plasmas. Plasmas with ECRH/ECCD are characterized by non-thermal electrons, which cannot be described by a Maxwellian distribution. Non-thermal electrons are also generated during MHD activity, like sawteeth crashes. Quantifying the non-thermal electron distribution is therefore a key for understanding EC heated fusion plasmas. For this purpose a vertical electron cyclotron emission (V-ECE diagnostic is being installed at TCV. The diagnostic layout, the calibration, the analysis technique for data interpretation, the physics potentials and limitations are discussed.

  10. Impact of regulatory science on global public health.

    Science.gov (United States)

    Patel, Meghal; Miller, Margaret Ann

    2012-07-01

    Regulatory science plays a vital role in protecting and promoting global public health by providing the scientific basis for ensuring that food and medical products are safe, properly labeled, and effective. Regulatory science research was first developed for the determination of product safety in the early part of the 20th Century, and continues to support innovation of the processes needed for regulatory policy decisions. Historically, public health laws and regulations were enacted following public health tragedies, and often the research tools and techniques required to execute these laws lagged behind the public health needs. Throughout history, similar public health problems relating to food and pharmaceutical products have occurred in countries around the world, and have usually led to the development of equivalent solutions. For example, most countries require a demonstration of pharmaceutical safety and efficacy prior to marketing these products using approaches that are similar to those initiated in the United States. The globalization of food and medical products has created a shift in regulatory compliance such that gaps in food and medical product safety can generate international problems. Improvements in regulatory research can advance the regulatory paradigm toward a more preventative, proactive framework. These improvements will advance at a greater pace with international collaboration by providing additional resources and new perspectives for approaching and anticipating public health problems. The following is a review of how past public health disasters have shaped the current regulatory landscape, and where innovation can facilitate the shift from reactive policies to proactive policies.

  11. NRC regulatory initiatives

    Energy Technology Data Exchange (ETDEWEB)

    Johnson, T.C. [Nuclear Regulatory Commission (United States)

    1989-11-01

    The US Nuclear Regulatory Commission (NRC) is addressing several low-level waste disposal issues that will be important to waste generators and to States and Compacts developing new disposal capacity. These issues include Greater-Than-Class C (GTCC) waste, mixed waste, below regulatory concern (BRC) waste, and the low-level waste data base. This paper discusses these issues and their current status.

  12. Current practices and reform proposals for the regulation of advanced medicinal products in Canada.

    Science.gov (United States)

    Viswanathan, Sowmya; Bubela, Tania

    2015-01-01

    We describe the Canadian regulatory framework for evaluating advanced medicinal products based on current policies, guidance documents and regulations and analyze proposed reforms. Our analysis is based on a documentary review supplemented by discussions with Health Canada officials. We present an overview of the Canadian regulatory framework for cell and gene therapy, medical devices and manufacturing facilities. We use the approval of Prochymal™ to highlight Canada's conditional marketing approval system. Finally, we discuss proposed changes to the regulatory framework in response to identified gaps, stakeholder consultations and international harmonization initiatives. Based on our analyses, we suggest that Canadian regulators have taken a reasonable approach in applying their regulatory framework without compromising on product safety.

  13. Addressing the challenge of high-priced prescription drugs in the era of precision medicine: A systematic review of drug life cycles, therapeutic drug markets and regulatory frameworks.

    Science.gov (United States)

    Gronde, Toon van der; Uyl-de Groot, Carin A; Pieters, Toine

    2017-01-01

    Recent public outcry has highlighted the rising cost of prescription drugs worldwide, which in several disease areas outpaces other health care expenditures and results in a suboptimal global availability of essential medicines. A systematic review of Pubmed, the Financial Times, the New York Times, the Wall Street Journal and the Guardian was performed to identify articles related to the pricing of medicines. Changes in drug life cycles have dramatically affected patent medicine markets, which have long been considered a self-evident and self-sustainable source of income for highly profitable drug companies. Market failure in combination with high merger and acquisition activity in the sector have allowed price increases for even off-patent drugs. With market interventions and the introduction of QALY measures in health care, governments have tried to influence drug prices, but often encounter unintended consequences. Patent reform legislation, reference pricing, outcome-based pricing and incentivizing physicians and pharmacists to prescribe low-cost drugs are among the most promising short-term policy options. Due to the lack of systematic research on the effectiveness of policy measures, an increasing number of ad hoc decisions have been made with counterproductive effects on the availability of essential drugs. Future challenges demand new policies, for which recommendations are offered. A fertile ground for high-priced drugs has been created by changes in drug life-cycle dynamics, the unintended effects of patent legislation, government policy measures and orphan drug programs. There is an urgent need for regulatory reform to curtail prices and safeguard equitable access to innovative medicines.

  14. The current status of the debate on socio-economic regulatory assessments: positions and policies in Canada, the USA, the EU and developing countries

    NARCIS (Netherlands)

    Falck-Zepeda, J.; Wesseler, J.H.H.; Smyth, S.

    2013-01-01

    Article 26.1 of the Cartagena Protocol on Biosafety has the option of considering socio-economic issues in biosafety regulatory approval processes related to genetically engineered organisms. National laws and regulations in some countries have already defined positions and may have enacted policies

  15. Impact of boundary regions on the interior circulation of the California Current System in a regional modeling framework

    Science.gov (United States)

    Veneziani, M.; Edwards, C.; Moore, A.

    2008-12-01

    We use the Regional Ocean Modeling System (ROMS) to model the circulation of the California Current System (CCS) using ECCO-GODAE products to force the model at the open boundaries of the domain. We investigate the impact that lateral boundary forcing (and the boundary region in general) has on particular metrics of the interior circulation by adopting both an adjoint model and a traditional sensitivity approach. Adjoint methods are naturally suited to sensitivity studies as they provide the direct dependencies of circulation metrics on uncertainties of the model initial conditions, surface and lateral external forcing, and model parameters, but their results are only valid within the time scale during which the linearity assumption underlying adjoint models can be considered to hold. More traditional sensitivity studies must be conducted to investigate longer time scales. We describe the adjoint model results for two metrics that represent the upwelling processes of the Central California region and the mean sea level field of the coastal circulation, respectively. The spatial distribution of the adjoint sensitivity fields allows us to quantify the contribution of the boundary regions over a biweekly time scale. We investigate longer time scales by adopting two methods: 1) apply different ECCO products at the open boundaries and evaluate mean stratification changes in the CalCOFI coastal region; 2) release passive tracers at the boundaries and calculate ventilation time scales and pathways from the boundary areas to the CCS interior.

  16. Assessment on regulatory framework for safety of radioactive waste management as preparation for future NPP in Indonesia; a comparison study with South Korea

    Energy Technology Data Exchange (ETDEWEB)

    Setianingsih, Lilis Susanti [KAIST, Daejeon (Korea, Republic of); Jeong, Seung Young [KINS, Daejeon (Korea, Republic of)

    2012-10-15

    information regarding natural radioactive sources downhole in oil and gas exploration and exploitation. Tracer is another type of nuclear energy utilization in industrial facilities. Tracer is operated by utilizing radioactive source attached to the system to follow the behavior pathway of one or more components of the particular system. It is used to detect easily and clearly on low concentration radioactive level of the system, as well as to detect and take samples without destroying the active system. Number of total radioactive and/or nuclear facilities for industrial purposes in Indonesia tends to be increasing as the implementation is getting wider. One of the nuclear authorities in Indonesia is the Nuclear Regulatory Agency (BAPETEN) which on behalf of the government grants the licenses to the respective facilities and monitors the regulation implementation on the facilities to ensure the safety, security and safeguard for the purpose providing protection to the people, property and environment. Considering the wide use of nuclear energy application and implementation in industrial purposes facilities, qualified human resources for controlling the law enforcement to ensure the proper standards of safety and security including the management of the waste generated by various nuclear energy utilization. Wide progressive demands of electricity for the future give challenges to the government to meet the projected needs of energy to be fulfilled. One of the options which can be considered reasonable in answering such problem to provide the high request of energy is by building nuclear power plant. Understanding the much wider use of nuclear energy implementation within the country, nuclear and radioactive waste facilities need to be developed in meeting the capacity required for prospective requirements.

  17. Biofuels and regulatory framework: recent developments and key technological routes; Biocombustiveis e marco regulatorio: evolucao recente e as principais rotas tecnologicas

    Energy Technology Data Exchange (ETDEWEB)

    Berni, Mauro Donizeti [Universidade Estadual de Campinas (NIPE/UNICAMP), SP (Brazil). Nucleo Interdisciplinar de Planejamento Energetico], e-mail: mauro_berni@yahoo.com.br; Guerra, Sinclair M. Guy [Universidade Federal do ABC (CECS/UFABC), Santo Andre, SP (Brazil). Centro de Engenharia, Modelagem e Ciencias Sociais Aplicadas], e-mail: sguerra@ufabc.edu.br

    2008-07-01

    The excessive dependence of energy of the current societies, and the growing concern with the potentials associated climate change motivate the implementation of energy systems with base in resources of renewable energy. Climate change is the greatest environmental challenge the world is facing today. Rising global temperatures will bring changes in weather patterns, rising sea levels and increased frequency and intensity of extreme weather events. The effects will be felt here in Brazil; internationally there may be severe problems for people in regions that are particularly vulnerable. Brazil with experience in the bio fuels production can participate as a supplier of new technology for his production, at world level. This work, shows the recent evolution of the regulation for the bio fuels in Brazil, as well as their main ones routes technology, and it indicates the possible alternatives to guarantee the sustainability for the production and use. (author)

  18. Role of the North Sea power transmission in realising the 2020 renewable energy targets. Planning and permitting challenges: a deliverable from WP 4 regulatory framework

    Energy Technology Data Exchange (ETDEWEB)

    Kielland, Jens Jacob; Ruud, Audun

    2012-07-01

    This study explores and assesses challenges for the European permitting and planning system with regard to grid development in the North Sea. The following question is discussed: What planning and permitting challenges can influence the realization of an offshore grid in the North Sea? This is answered by referring to the political context of the North Sea and the development of an offshore grid therein. We present the main features of the proposed regulation by the European Commission (COM(2011)658) that will, if it is adapted, impact current grid permitting procedures. Further, key supranational planning tools for offshore grid development are accounted for and the proposed EU measures are discussed with reference to relevant studies on planning and permitting procedures of realizing electricity grids. Finally, the report provides the general findings and conclusions. (Author)

  19. Legal Relations and Regulatory Framework of Investment for Fundamental Pension Fund in Personal Accounts%基本养老保险个人账户基金投资的法律关系架构及监管

    Institute of Scientific and Technical Information of China (English)

    刘军霞

    2014-01-01

    This paper is about the problem of investment for the fundamental pension insurance fund in personal accounts, from a legal point of view demonstrates the legitimacy of the Fund’ s investments, and in accordance with China’ s national conditions designed to fund investment objective system of legal relations and regulatory framework, principles and specific system.Legal obstacles to exclude personal account fund investments, provide reference for legislation.%本文针对基本养老保险个人账户基金投资问题,从法律角度论证了基金投资的正当性,并根据我国国情设计了基金投资的法律关系架构和监管的目标体系、原则和具体制度,以期排除个人账户基金投资的法律障碍,对立法提供借鉴。

  20. The Chinese health care regulatory institutions in an era of transition.

    Science.gov (United States)

    Fang, Jing

    2008-02-01

    The purpose of this paper is to contribute to a better understanding of Chinese health care regulation in an era of transition. It describes the major health care regulatory institutions operating currently in China and analyzes the underlying factors. The paper argues that in the transition from a planned to a market economy, the Chinese government has been employing a hybrid approach where both old and new institutions have a role in the management of emerging markets, including the health care market. This approach is consistent with the incremental reform strategy adopted by the Party-state. Although a health care regulatory framework has gradually taken shape, the framework is incomplete, with a particular lack of emphasis on professional self-regulation. In addition, its effectiveness is limited despite the existence of many regulatory institutions. In poor rural areas, the effectiveness of the regulatory framework is further undermined or distorted by the extremely difficult financial position that local governments find themselves in. The interpretations of the principle of 'rule of law' by policy makers and officials at different levels and the widespread informal network of relations between known individuals (Guanxi) play an important role in the operation of the regulatory framework. The findings of this paper reveal the complex nature of regulating health care in transitional China.

  1. Current Scientific and Regulatory Approaches for Development of Orally Inhaled and Nasal Drug Products: Overview of the IPAC-RS/University of Florida Orlando Inhalation Conference.

    Science.gov (United States)

    Hochhaus, Guenther; Davis-Cutting, Craig; Oliver, Martin; Lee, Sau L; Lyapustina, Svetlana

    2015-09-01

    This article summarizes discussions at the March 2014 conference organized by the University of Florida (UF) and International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS), entitled "Orlando Inhalation Conference: Approaches in International Regulation." The special focus of the conference was on global scientific and regulatory issues associated with the testing and demonstration of equivalence for the registration of orally inhaled drug products (OIDPs) in the United States, Europe, Brazil, China, and India. The scope included all types of OIDPs throughout their lifecycle, e.g., innovator/brand-name products, generics, modifications due to lifecycle management, device changes, etc. Details were presented for the U.S. "weight of evidence approach" for registration of generic products (which includes demonstration of in vitro and in vivo equivalence, as well as quantitative and qualitative sameness, and device similarity). The European "stepwise" approach was elucidated, and the thinking of regulatory agencies in the major emerging markets was clarified. The conference also highlighted a number of areas that would benefit from further research and discussion, especially around patient/device interface and human factor studies, statistical methods and criteria for demonstrating equivalence, the relative roles of in vivo and in vitro tests, and appropriate designs and metrics for in vivo studies of inhaled drugs.

  2. 1D Current Source Density (CSD) Estimation in Inverse Theory: A Unified Framework for Higher-Order Spectral Regularization of Quadrature and Expansion-Type CSD Methods.

    Science.gov (United States)

    Kropf, Pascal; Shmuel, Amir

    2016-07-01

    Estimation of current source density (CSD) from the low-frequency part of extracellular electric potential recordings is an unstable linear inverse problem. To make the estimation possible in an experimental setting where recordings are contaminated with noise, it is necessary to stabilize the inversion. Here we present a unified framework for zero- and higher-order singular-value-decomposition (SVD)-based spectral regularization of 1D (linear) CSD estimation from local field potentials. The framework is based on two general approaches commonly employed for solving inverse problems: quadrature and basis function expansion. We first show that both inverse CSD (iCSD) and kernel CSD (kCSD) fall into the category of basis function expansion methods. We then use these general categories to introduce two new estimation methods, quadrature CSD (qCSD), based on discretizing the CSD integral equation with a chosen quadrature rule, and representer CSD (rCSD), an even-determined basis function expansion method that uses the problem's data kernels (representers) as basis functions. To determine the best candidate methods to use in the analysis of experimental data, we compared the different methods on simulations under three regularization schemes (Tikhonov, tSVD, and dSVD), three regularization parameter selection methods (NCP, L-curve, and GCV), and seven different a priori spatial smoothness constraints on the CSD distribution. This resulted in a comparison of 531 estimation schemes. We evaluated the estimation schemes according to their source reconstruction accuracy by testing them using different simulated noise levels, lateral source diameters, and CSD depth profiles. We found that ranking schemes according to the average error over all tested conditions results in a reproducible ranking, where the top schemes are found to perform well in the majority of tested conditions. However, there is no single best estimation scheme that outperforms all others under all tested

  3. Academic Standards and Regulatory Frameworks: Necessary Compromises?

    Science.gov (United States)

    Stowell, Marie; Falahee, Marie; Woolf, Harvey

    2016-01-01

    Assessment regulations in higher education, which are important for assuring threshold academic standards, reflect institutional cultures and histories, and are shaped by pragmatic concerns about quality indicators such as retention and progression rates, as well as principles of equity. This paper articulates some of the tensions that confront…

  4. Carbon Capture and Storage: Model Regulatory Framework

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2010-07-01

    Energy-related carbon dioxide (CO2) emissions are set to double by 2050 unless decisive action is taken. International Energy Agency (IEA) analysis demonstrates, however, that it is possible -- in the same timeframe to 2050 -- to reduce projected greenhouse-gas emissions to half 2005 levels, but this will require an energy technology revolution, involving the aggressive deployment of a portfolio of low-carbon energy technologies.

  5. Developing legal regulatory frameworks for modern biotechnology ...

    African Journals Online (AJOL)

    analytical; the challenges that are posed by GMO technology are analysed from public ... the pressing issues that are raised by biotechnology generally and GMOs in particular. Full Text: EMAIL FREE FULL TEXT EMAIL FREE FULL TEXT

  6. The SAFE FOODS Risk Analysis Framework suitable for GMOs? A case study

    NARCIS (Netherlands)

    Kuiper, H.A.; Davies, H.V.

    2010-01-01

    This paper describes the current EU regulatory framework for risk analysis of genetically modified (GM) crop cultivation and market introduction of derived food/feed. Furthermore the risk assessment strategies for GM crops and derived food/feed as designed by the European Food Safety Authority (EFSA

  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. Danish Technology Framework

    DEFF Research Database (Denmark)

    Bonke, Sten; Jørgensen, Tom Rydahl

    This report investigates the occurrence of foundation failures within the context of the Danish construction technology framework. The report comprises a definition/typology section on the basis of which Danish regulatory and administrative procedures in relation to foundation failures are reviewed....

  9. Regulatory Risk under Optimal Incentive Regulation

    OpenAIRE

    Strausz, Roland

    2009-01-01

    The paper provides a tractable, analytical framework to study regulatory risk under optimal incentive regulation. Regulatory risk is captured by uncertainty about the policy variables in the regulator’s objective function: weights attached to profits and costs of public funds. Results are as follows: 1) The regulator’s reaction to regulatory risk depends on the curvature of the aggregate demand function. 2) It yields a positive information rent effect exactly when demand is convex. 3) Firms b...

  10. Small regulatory RNA and Legionella pneumophila

    Directory of Open Access Journals (Sweden)

    Sebastien P Faucher

    2011-05-01

    Full Text Available Legionella pneumophila is a gram-negative bacterial species that is ubiquitous in almost any aqueous environment. It is the agent of Legionnaires’ disease, an acute and often under-reported form of pneumonia. In mammals, L. pneumophila replicates inside macrophages within a modified vacuole. Many protein regulators have been identified that control virulence-related properties, including RpoS, LetA/LetS and PmrA/PmrB. In the past few years, the importance of regulation of virulence factors by small regulatory RNA has been increasingly appreciated. This is also the case in L. pneumophila where three sRNAs (RsmY, RsmZ and 6S RNA were recently shown to be important determinants of virulence regulation and 79 actively transcribed sRNAs were identified. In this review we describe current knowledge about sRNAs and their regulatory properties and how this relates to the known regulatory systems of L. pneumophila. We also provide a model for sRNA-mediated control of gene expression that serves as a framework for understanding the regulation of virulence-related properties of L. pneumophila.

  11. PROACTIVE REGULATORY INTERVENTION IN EU COMMUNICATIONS SECTOR AND ITS FORESEEABLE FUTURE

    Directory of Open Access Journals (Sweden)

    Mantas Barčys

    2013-06-01

    Full Text Available Purpose – to review and provide insights on the issues concerning ex ante regulatory approach in EU telecommunications (hereinafter – electronic communications industry, identify and emphasise benefits, main challenges and further regulatory prospective. Design/methodology/approach – based on current regulatory framework and analysis of academic literature, author discusses problematic issues related to the needs and further perspectives of proactive regulatory regime in EU electronic communications sector. Findings – the author reviews special qualities for different regulatory regimes (ex ante, ex post and examines them in the context of sharp developments of the industry and EU regulatory policy. Research limitations/implications –the analysis aims to convey the main understanding on the regulatory specifics of the communications industry, the main features, distinguishing communications industry from the others and foreseeable regulatory perspectives Practical implications – the core aspect of the paper is to evaluate current regulatory approach of the EU electronic communications sector and assess potential regulatory approaches in the context of making self-sustaining pro-competitive market structure, technological development. Originality/Value – the paper highlights some significant changes between two regulatory approaches in the light of specific features in EU electronic communications. Author provides his insights on the status and perspectives on application for both regulatory methods. Apparently, these issues have so far been subjected too little academic analysis. As shown in this paper, regulatory policy can have the essential impact on the activities taken by other players. The decision to give an even bigger role to competition rules, do not mean to eliminate sector specifics itself. With this in mind, EU legislators are not able to eliminate proactive regulatory control, thus reducing ex ante rules progressively

  12. Reforming Financial Regulatory System in China after the Stock Market Turbulence:Problems and the Responses

    Institute of Scientific and Technical Information of China (English)

    Chen Zhenyun

    2016-01-01

    In an age when modern financial companies have become more and more complex,and if not adequately supervised,they can cause lethal harm to the stability of one’ s financial system. In post-financial crisis era,major developed economies have apparently rein-forced the function of the central bank in a country’ s financial regulatory system. Over the past several years,China has witnessed the huge changes in the financial sector but the financial regulatory framework remains the same as before. The Chinese stock market crash that began on June 12 2015 has urged the domestic regulators to restructure its financial regulatory sys-tem. The issue that which modal China should follow has perplexed Chinese policymakers. The governor of People’ s Bank of China,Zhou Xiaochuan,clearly responded to the problem concerning the current financial regulatory system, and indicated that Chinese regulators and policymakers had still studied the regulatory approach China would adopt during the press of People’s Congress of 2016. This paper reviews the development of China’s banking regulato-ry system,points out the deficiencies in its original system and analyzes the recent trends of fi-nancial regulatory reform in UK to learn the international experience for further reform re-garding financial regulatory system in China.

  13. Measuring Progress in Conflict Environments (MPICE): A Metrics Framework

    Science.gov (United States)

    2010-06-04

    Infrastructure Strengthened B. fiscal Integrity Strengthened C. regulatory and Corporate Governance framework Strengthened D. financial Institutions...generation? Integrity of government revenue generation (by department and/or function). EK + C. Regulatory and Corporate Governance Framework Strengthened...regulatory and corporate governance systems effectively constrain black-market activities from adversely affecting the economy? Conviction rates

  14. An Ethical Framework for Evaluating Experimental Technology.

    Science.gov (United States)

    van de Poel, Ibo

    2016-06-01

    How are we to appraise new technological developments that may bring revolutionary social changes? Currently this is often done by trying to predict or anticipate social consequences and to use these as a basis for moral and regulatory appraisal. Such an approach can, however, not deal with the uncertainties and unknowns that are inherent in social changes induced by technological development. An alternative approach is proposed that conceives of the introduction of new technologies into society as a social experiment. An ethical framework for the acceptability of such experiments is developed based on the bioethical principles for experiments with human subjects: non-maleficence, beneficence, respect for autonomy, and justice. This provides a handle for the moral and regulatory assessment of new technologies and their impact on society.

  15. A review of the UK methodology used for monitoring cigarette smoke yields, aspects of analytical data variability and their impact on current and future regulatory compliance.

    Science.gov (United States)

    Purkis, Stephen W; Drake, Linda; Meger, Michael; Mariner, Derek C

    2010-04-01

    The European Union (EU) requires that tobacco products are regulated by Directive 2001/37/EC through testing and verification of results on the basis of standards developed by the International Organization for Standardization (ISO). In 2007, the European Commission provided guidance to EU Member States by issuing criteria for competent laboratories which includes accreditation to ISO 17025:2005. Another criterion requires regular laboratory participation in collaborative studies that predict the measurement tolerance that must be observed to conclude that test results on any particular product are different. However, differences will always occur when comparing overall data across products between different laboratories. A forum for technical discussion between laboratories testing products as they are manufactured and a Government appointed verification laboratory gives transparency, ensures consistency and reduces apparent compliance issues to the benefit of all parties. More than 30years ago, such a forum was set up in the UK that continued until 2007 and will be described in this document. Anticipating further testing requirements in future product regulation as proposed by the Framework Convention on Tobacco Control, cooperation between accredited laboratories, whether for testing or verification, should be established to share know-how, to ensure a standardised level of quality and to offer competent technical dialogue in the best interest of regulators and manufacturers alike.

  16. An Emergent Research and Policy Framework for Telehealth.

    Science.gov (United States)

    Edmunds, Margo; Tuckson, Reed; Lewis, Joy; Atchinson, Brian; Rheuban, Karen; Fanberg, Hank; Olinger, Lois; Rosati, Robert; Austein-Casnoff, Cheryl; Capistrant, Gary; Thomas, Latoya

    2017-01-01

    Telehealth is a fast-growing sector in health care, using a variety of technologies to exchange information across locations and to improve access, quality, and outcomes across the continuum of care. Thousands of studies and hundreds of systematic reviews have been done, but their variability leaves many questions about telehealth's effectiveness, implementation priorities, and return on investment. There is an urgent need for a systematic, policy-relevant framework to integrate regulatory, operational, and clinical factors and to guide future investments in telehealth research and practice. An invited multidisciplinary group of 21 experts from AcademyHealth, the American Telemedicine Association (ATA), Kaiser Permanente Institute for Health Policy (KP), and the Physician Insurers Association of America (PIAA) met to review and discuss the components of a draft framework for policy-relevant telehealth research. The framework was revised and presented in a challenge workshop at Concordium 2016, and some additional refinements were made. The current framework encompasses the regulatory and payment policy context for telehealth, delivery system factors, and outcomes of telehealth interventions. Based on the feedback at Concordium 2016, the framework seems to have potential to help educate policymakers, payers, and health systems about the value of telehealth and to frame discussions about implementation barriers, including risk management concerns, technology costs, and organizational culture. However, questions remain about how to disseminate and use the framework to help coordinate policy, research, and implementation efforts in the delivery system.

  17. An Update of the Brazilian Regulatory Bioequivalence Recommendations for Approval of Generic Topical Dermatological Drug Products.

    Science.gov (United States)

    Soares, Kelen Carine Costa; Santos, Gustavo Mendes Lima; Gelfuso, Guilherme M; Gratieri, Tais

    2015-11-01

    This note aims to clarify the Brazilian regulatory bioequivalence recommendations for approval of generic topical dermatological drug products, since the legal framework of the "Brazilian Health Surveillance Agency" (ANVISA) is only available in Portuguese. According to Resolutions RE n. 1170 (December 19th 2006) and RDC n. 37 (August 3rd 2011) in Brazil, only in vitro studies are required for registration of generic topical dermatological drug products. Current Regulatory Agenda of ANVISA, which contains possible future resolutions to be revised over 2015-2016, includes a discussion on biowaiver requirements and on possible in vitro and in vivo comparability tests for these products.

  18. 基于新监管框架的中国股权众筹的“热发展”与“冷思考”%The"Rapid Development"and"Deep Thinking"on China's Equity-Based Crowdfunding under the New Regulatory Framework

    Institute of Scientific and Technical Information of China (English)

    彭红枫; 赵海燕

    2016-01-01

    Based on the development characteristics and the current situation of China's equity-based crowdfund-ing, this article not only verifies the development feasibilities of equity-based crowdfunding in China from four per-spectives including the policy environment, economic environment, social environment and technological environ-ment, with the help of PEST analysis, but also explores the breakthroughs for the development of China's equity-based crowdfunding under the new regulatory framework through learning from the experience of the development of foreign crowdfunding in UK and US. It suggests that we should make clear the market orientation,simplify the financ-ing procedure, reduce the financing restraints, improve the after-financing management mechanism and focus on the mode innovation.%本文立足于股权众筹在中国的发展特征、现状的基础上,运用PEST分析法从政策环境、经济环境、社会环境和技术环境四个角度证实了中国具备股权众筹发展的可行性,而且通过研究英美股权众筹的发展经验来寻找新监管框架下中国股权众筹的发展突破口,提出明确市场定位、简化融资流程且减少融资约束、完善融后管理机制、注重模式创新等建议。

  19. Análise comparativa do desenho normativo de instituições reguladoras do presente e do passado Comparative analysis of the normative design of former and current regulatory institutions

    Directory of Open Access Journals (Sweden)

    Antonio Gelis Filho

    2006-08-01

    Full Text Available Este artigo desenvolve um modelo matricial para avaliação do desenho normativo de instituições reguladoras do presente e do passado (autarquias econômicas da república "populista". Desenho normativo é definido como o conjunto de possibilidades de estruturação e de atuação de uma instituição que é delimitado pelas normas jurídicas que a criaram. O modelo é estruturado a partir de dois parâmetros principais: independência em relação ao poder central e transparência em relação à sociedade. Foram testadas cinco hipóteses, concluindo-se que as instituições reguladoras do presente apresentam desenhos normativos heterogêneos e que se distinguem de instituições do passado tanto por maior independência quanto por maior transparência, sendo a diferença mais acentuada em relação ao segundo parâmetro.This article develops a matrix model to assess the normative design of past and current regulatory institutions (economic autarchies of the 'populist' republic. Normative design is defined as a set of possibilities for an institution's structure and actions which is limited by the legal norms that created it. The model is structured based on two main parameters: independence in relation to the central power and transparency in relation to society. Five hypothesis were tested, and the conclusion was that current regulatory institutions have heterogeneous designs and they differ from the former ones for being both more independent and more transparent, and the largest difference is in the second parameter.

  20. Regulatory Consequences of "Brexit" for the Development of Medicinal Products.

    Science.gov (United States)

    Jackson, E L; Feldschreiber, P; Breckenridge, A

    2017-08-01

    The United Kingdom voted in a referendum in June 2016 to leave the European Union (EU) after 45 years of membership. Among the many political, social, and scientific consequences are those for the regulation of health care products. No longer will the efficacy, safety, and quality of medicines in the United Kingdom be subject to an EU regulatory framework. The European Medicines Agency (EMA), which is currently located in London, will move elsewhere in Europe. The pharmaceutical industry will reassess its commitment to the UK health scene. © 2017, ASCPT.

  1. Healthcare regulatory concepts in Brazil.

    Science.gov (United States)

    Oliveira, Robson Rocha de; Elias, Paulo Eduardo Mangeon

    2012-06-01

    The healthcare regulatory concepts used in Brazilian scientific publications on healthcare management were reviewed. A typo-logical classification for regulatory concepts was developed from the most current ideas in five disciplines: life sciences, law, economics, sociology and political science. Four ideas stood out: control, balance, adaptation and direction, with greatest emphasis on the technical nature of regulation. The political nature of regulation was secondary. It was considered that dis-cussion of healthcare regulatory concepts was connected with comprehension of the role that the state plays in this sector. De-finition of the forms of state intervention is the key convergence point between the different ways of conceptualizing healthcare regulation.

  2. A system-wide analysis using a senior-friendly hospital framework identifies current practices and opportunities for improvement in the care of hospitalized older adults.

    Science.gov (United States)

    Wong, Ken S; Ryan, David P; Liu, Barbara A

    2014-11-01

    Older adults are vulnerable to hospital-associated complications such as falls, pressure ulcers, functional decline, and delirium, which can contribute to prolonged hospital stay, readmission, and nursing home placement. These vulnerabilities are exacerbated when the hospital's practices, services, and physical environment are not sufficiently mindful of the complex, multidimensional needs of frail individuals. Several frameworks have emerged to help hospitals examine how organization-wide processes can be customized to avoid these complications. This article describes the application of one such framework-the Senior-Friendly Hospital (SFH) framework adopted in Ontario, Canada-which comprises five interrelated domains: organizational support, processes of care, emotional and behavioral environment, ethics in clinical care and research, and physical environment. This framework provided the blueprint for a self-assessment of all 155 adult hospitals across the province of Ontario. The system-wide analysis identified practice gaps and promising practices within each domain of the SFH framework. Taken together, these results informed 12 recommendations to support hospitals at all stages of development in becoming friendly to older adults. Priorities for system-wide action were identified, encouraging hospitals to implement or further develop their processes to better address hospital-acquired delirium and functional decline. These recommendations led to collaborative action across the province, including the development of an online toolkit and the identification of accountability indicators to support hospitals in quality improvement focusing on senior-friendly care.

  3. Towards an integrated global framework to assess the impacts of land use and management change on soil carbon: current capability and future vision

    NARCIS (Netherlands)

    Smith, P.; Davies, C.A.; Ogle, S.; Zanchi, G.; Bellarby, J.; Bird, N.; Boddey, R.M.; McNamara, N.P.; Powlson, D.; Cowie, A.; Noordwijk, van M.; Davis, S.C.; Richter, de D.B.; Kryzanowski, L.; Wijk, van M.T.; Stuart, J.; Kirton, A.; Eggar, D.; Newton_Cross, G.; Adhya, T.K.; Braimoh, A.K.

    2012-01-01

    Intergovernmental Panel on Climate Change (IPCC) Tier 1 methodologies commonly underpin project-scale carbon accounting for changes in land use and management and are used in frameworks for Life Cycle Assessment and carbon footprinting of food and energy crops. These methodologies were intended for

  4. REQUIREMENTS FOR STORAGE AND TRANSPORT OF BIOTECHNOLOGICAL MEDICAL PRODUCTS IN ACCORDANCE WITH THE REGULATORY FRAMEWORK OF MINISTRY OF PUBLIC HEALTH OF UKRAINE AND DETECTION OF VIOLATIONS IN THE MEDICAL AND PHARMACEUTICAL INSTITUTIONS

    Directory of Open Access Journals (Sweden)

    Shukaeva O.

    2015-05-01

    Full Text Available Introduction. The rapid development of the pharmaceutical industry and the expansion of the range of biotech drugs require special conditions to ensure the quality, storage and transport through out the entire chain: manufacturer - distributor - pharmacy - hospital - the patient.We analyzed the current legislative frame work of Ministry of Public Health of Ukraine and conducted a study to identify and analyze of typical violations in the medical and pharmaceutical institutions. The aim of the investigation was to investigate and analyze inspection acts under storage and transport of biological medical products and identify major violations during the performance requirements for storage and transportation of drugs, level of awareness about medical products which are requiring special storage requirement. Methods: systemic, logistical, structural, marketing, regulatory. Results & discussion. According to the data presented in the report «Assessing biosimilar uptake and competition in European markets» of «IMS Health», sales of medical products with biological nature - biological medicinal products and biosymilyars is about 27% of total sales of drugs in the EU. This segment of the pharmaceutical market is characterized by faster growth compared to the pharmaceutical marketas a whole. Thus, in 2012-2013 years sales of biological medical products in the EU countries increased by 5.5% compared to 1.5% increase in total sales of drugs. It is important that in Europe, according to the 2013 preparations, the market share in value terms, with eight to prepare biological products, the term of patent protection that are either already expired or will expireby 2020, and therefore they can be competitors with biosymilars. In creasing the number of medications on the market requires a careful approach of storing and preserving the quality of distribution during throughout the life of the medical products in the chain: manufacturer - distributor

  5. ATMPs for Cancer Immunotherapy: A Regulatory Overview.

    Science.gov (United States)

    Galli, Maria Cristina

    2016-01-01

    This chapter discusses European regulatory requirements for development of advanced therapy medicinal products (ATMP) for cancer immunotherapy approaches, describing the framework for clinical trials and for marketing authorization.Regulatory critical issues and challenges for developing ATMP are also discussed, with focus on potency determination, long-term follow-up, comparability, and insertional mutagenesis issues. Some of the most critical features of GMP application to ATMP are also described.

  6. CMIP: a software package capable of reconstructing genome-wide regulatory networks using gene expression data.

    Science.gov (United States)

    Zheng, Guangyong; Xu, Yaochen; Zhang, Xiujun; Liu, Zhi-Ping; Wang, Zhuo; Chen, Luonan; Zhu, Xin-Guang

    2016-12-23

    A gene regulatory network (GRN) represents interactions of genes inside a cell or tissue, in which vertexes and edges stand for genes and their regulatory interactions respectively. Reconstruction of gene regulatory networks, in particular, genome-scale networks, is essential for comparative exploration of different species and mechanistic investigation of biological processes. Currently, most of network inference methods are computationally intensive, which are usually effective for small-scale tasks (e.g., networks with a few hundred genes), but are difficult to construct GRNs at genome-scale. Here, we present a software package for gene regulatory network reconstruction at a genomic level, in which gene interaction is measured by the conditional mutual information measurement using a parallel computing framework (so the package is named CMIP). The package is a greatly improved implementation of our previous PCA-CMI algorithm. In CMIP, we provide not only an automatic threshold determination method but also an effective parallel computing framework for network inference. Performance tests on benchmark datasets show that the accuracy of CMIP is comparable to most current network inference methods. Moreover, running tests on synthetic datasets demonstrate that CMIP can handle large datasets especially genome-wide datasets within an acceptable time period. In addition, successful application on a real genomic dataset confirms its practical applicability of the package. This new software package provides a powerful tool for genomic network reconstruction to biological community. The software can be accessed at http://www.picb.ac.cn/CMIP/ .

  7. Call for a dedicated European legal framework for bacteriophage therapy.

    Science.gov (United States)

    Verbeken, Gilbert; Pirnay, Jean-Paul; Lavigne, Rob; Jennes, Serge; De Vos, Daniel; Casteels, Minne; Huys, Isabelle

    2014-04-01

    The worldwide emergence of antibiotic resistances and the drying up of the antibiotic pipeline have spurred a search for alternative or complementary antibacterial therapies. Bacteriophages are bacterial viruses that have been used for almost a century to combat bacterial infections, particularly in Poland and the former Soviet Union. The antibiotic crisis has triggered a renewed clinical and agricultural interest in bacteriophages. This, combined with new scientific insights, has pushed bacteriophages to the forefront of the search for new approaches to fighting bacterial infections. But before bacteriophage therapy can be introduced into clinical practice in the European Union, several challenges must be overcome. One of these is the conceptualization and classification of bacteriophage therapy itself and the extent to which it constitutes a human medicinal product regulated under the European Human Code for Medicines (Directive 2001/83/EC). Can therapeutic products containing natural bacteriophages be categorized under the current European regulatory framework, or should this framework be adapted? Various actors in the field have discussed the need for an adapted (or entirely new) regulatory framework for the reintroduction of bacteriophage therapy in Europe. This led to the identification of several characteristics specific to natural bacteriophages that should be taken into consideration by regulators when evaluating bacteriophage therapy. One important consideration is whether bacteriophage therapy development occurs on an industrial scale or a hospital-based, patient-specific scale. More suitable regulatory standards may create opportunities to improve insights into this promising therapeutic approach. In light of this, we argue for the creation of a new, dedicated European regulatory framework for bacteriophage therapy.

  8. Regulatory ozone modeling: Status, directions, and research needs

    Energy Technology Data Exchange (ETDEWEB)

    Georgopoulos, P.G. [Environmental and Occupational Health Sciences Institute, Piscataway, NJ (United States)

    1995-03-01

    The Clean Air Act Amendments (CAAA) of 1990 have established selected comprehensive, three-dimensional, Photochemical Air Quality Simulation Models (PAQSMs) as the required regulatory tools for analyzing the urban and regional problem of high ambient ozone levels across the United States. These models are currently applied to study and establish strategies for meeting the National Ambient Air Quality Standard (NAAQS) for ozone in nonattainment areas; State Implementation Plans (SIPs) resulting from these efforts must be submitted to the U.S. Environmental Protection Agency (U.S. EPA) in November 1994. The following presentation provides an overview and discussion of the regulatory ozone modeling process and its implications. First, the PAQSM-based ozone attainment demonstration process is summarized in the framework of the 1994 SIPs. Then, following a brief overview of the representation of physical and chemical processes in PAOSMs, the essential attributes of standard modeling systems currently in regulatory use are presented in a nonmathematical, self-contained format, intended to provide a basic understanding of both model capabilities and limitations. The types of air quality, emission, and meteorological data needed for applying and evaluating PAOSMs are discussed, as well as the sources, availability, and limitations of existing databases. The issue of evaluating a model`s performance in order to accept it as a tool for policy making is discussed, and various methodologies for implementing this objective are summarized. 43 refs., 9 figs.

  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. Regulatory barriers for activating flexibility in the Nordic-Baltic electricity market

    DEFF Research Database (Denmark)

    Bergaentzlé, Claire; Skytte, Klaus; Soysal, Emilie Rosenlund

    2017-01-01

    The rapid growth of variable renewable energy (VRE) and the expected decrease of conventional generation capacities will generate more flexibility needs in power systems and require flexibility resources to be activated. Flexibility potentials do exist, whether they refer to installed generation......, load adjustment or to a greater coupling to other energy sectors. In this paper, we identify the framework conditions that influence the provision of VRE-friendly flexibility in the Nordic and Baltic electricity sector, i.e., the market and regulatory settings that act as drivers or barriers...... to flexibility. We find that the most restrictive barriers against flexibility are emitted by public authorities as part of broader policy strategies. Overall, we find that current regulatory and market framework conditions do not hinder flexibility. However, despite that, flexibility remains limited due...

  11. Regulatory Snapshots: integrative mining of regulatory modules from expression time series and regulatory networks.

    Directory of Open Access Journals (Sweden)

    Joana P Gonçalves

    Full Text Available Explaining regulatory mechanisms is crucial to understand complex cellular responses leading to system perturbations. Some strategies reverse engineer regulatory interactions from experimental data, while others identify functional regulatory units (modules under the assumption that biological systems yield a modular organization. Most modular studies focus on network structure and static properties, ignoring that gene regulation is largely driven by stimulus-response behavior. Expression time series are key to gain insight into dynamics, but have been insufficiently explored by current methods, which often (1 apply generic algorithms unsuited for expression analysis over time, due to inability to maintain the chronology of events or incorporate time dependency; (2 ignore local patterns, abundant in most interesting cases of transcriptional activity; (3 neglect physical binding or lack automatic association of regulators, focusing mainly on expression patterns; or (4 limit the discovery to a predefined number of modules. We propose Regulatory Snapshots, an integrative mining approach to identify regulatory modules over time by combining transcriptional control with response, while overcoming the above challenges. Temporal biclustering is first used to reveal transcriptional modules composed of genes showing coherent expression profiles over time. Personalized ranking is then applied to prioritize prominent regulators targeting the modules at each time point using a network of documented regulatory associations and the expression data. Custom graphics are finally depicted to expose the regulatory activity in a module at consecutive time points (snapshots. Regulatory Snapshots successfully unraveled modules underlying yeast response to heat shock and human epithelial-to-mesenchymal transition, based on regulations documented in the YEASTRACT and JASPAR databases, respectively, and available expression data. Regulatory players involved in

  12. Regulatory research / Pesquisa regulatória

    Directory of Open Access Journals (Sweden)

    Altair Souza de Assis

    2013-05-01

    Full Text Available We present in this paper the concept, importance, and scope of research into the regulatory framework of regulation and legislation, with a particular focus on legislation related to legal metrology. This study also describes a comparative analysis of the various forms of regulation and the associated regulatory research, with the ultimate goal of better defi ning the concept and to validate the need to have research groups within a country’s regulatory bodies. Based on this work, we conclude that regulatory research is a key factor in the success of any regulatory body’s activities. Such research helps to avoid the creation of absurd or impractical regulatory barriers to a country’s technological development, or worse, to permit “orphans,” that is, technologies that are outside regulatory control, as is currently the case. Indeed, for a country to have a robust technological infrastructure, especially if it is still a developing country, strong and competent regulatory control is essential. However, this must be balanced by an atmosphere that fosters continuous and consistent technological innovation, and such development must also be self-sustainable from economic, social, and environmental viewpoints. ------------------------------------------------ Apresenta-se neste trabalho o conceito, a importância e a abrangência da pesquisa regulatória no âmbito da regulação e da regulamentação, com foco particular na regulamentação relacionada à metrologia legal. Faz-se também uma análise comparativa entre as várias formas de regular e regulamentar, e as suas pesquisas regulatórias afi ns, tendo como meta principal situar melhor o conceito e validar a necessidade de se fazer pesquisa nos órgãos e agências regulatórias do país. Com base neste trabalho, concluímos que a pesquisa regulatória é um fator chave para o sucesso de qualquer plano de ação de regulação para os agentes regulatórios do país. Ela ajuda a

  13. Regulatory and law framework of agricultural methanization and composting activities. User's guide; Le cadre reglementaire et juridique des activites agricoles de methanisation et de compostage. Guide Pratique

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2008-08-15

    After a presentation of the general context of organic waste management (its techniques, materials, legal and regulatory sources, i.e. European and French laws), this guide indicates the main regulatory and law aspects to those wishing to implement a project of methanization or composting of organic by-products in the agricultural sector. Several aspects are therefore discussed and presented in practical sheets. They concern the health and environment regulation, but not the professional risk prevention (explosion, fire, and so on). These aspects are the project setting up, input materials (animal by-products, organic materials coming from agricultural production or from out of it), waste collection and transport, process steps, organic product valorization, biogas valorization, solid and liquid release management

  14. Current limitations and recommendations to improve testing for the environmental assessment of endocrine active substances

    Science.gov (United States)

    In this paper existing regulatory frameworks and test systems for assessing potential endocrine-active chemicals are described, and associated challenges discussed, along with proposed approaches to address these challenges. Regulatory frameworks vary somewhat across organizatio...

  15. Regulatory system reform of occupational health and safety in China.

    Science.gov (United States)

    Wu, Fenghong; Chi, Yan

    2015-01-01

    With the explosive economic growth and social development, China's regulatory system of occupational health and safety now faces more and more challenges. This article reviews the history of regulatory system of occupational health and safety in China, as well as the current reform of this regulatory system in the country. Comprehensive, a range of laws, regulations and standards that promulgated by Chinese government, duties and responsibilities of the regulatory departments are described. Problems of current regulatory system, the ongoing adjustments and changes for modifying and improving regulatory system are discussed. The aim of reform and the incentives to drive forward more health and safety conditions in workplaces are also outlined.

  16. Considerations on a regulatory framework for environmental management of produced water resulting from the extraction of petroleum in the state of Bahia; Consideracoes acerca de um modelo regulatorio pra o gerenciamento ambiental da agua produzida resultante da extracao de petroleo do estado da Bahia

    Energy Technology Data Exchange (ETDEWEB)

    Fraser, Roberta Tourinho Dantas [Instituto do Meio Ambiente e Recursos Hidricos (INEMA), Salvador, BA (Brazil); Vieira, Victor Menezes [Geo Innova Ltda., Lauro de Freitas, BA (Brazil); Ferreira, Doneivan Fernandes [Universidade Federal da Bahia (UFBA), Salvador, BA (Brazil)

    2012-07-01

    Produced water is the main byproduct associated to oil and gas extraction process. This water, considered by regulation as a residue, has the potential to cause adverse impact on environment. As extraction progresses and reservoirs mature increasing volumes of water are produced and need to be wisely managed. Due to Reconcavo Basin advanced stage of maturity, the state of Bahia has become a very large producer of water in the country. Remarkably, no state environmental regulation is in place to provide management guidelines and proper disposal rules for this waste. The present study intends to argue the need for a regulatory framework involving the management of water produced in state onshore sedimentary basins, identifying and discussing critical variables involved in this process. The following methodological instruments were used in the study: literature and normative survey, interaction with key stakeholders and field work. Environmental regulation has, as its main purpose, protection and preservation of the environment against potential polluting activities, while recognizing the importance of socioeconomic development. In this sense, implementing specific rules for management of produced water not only serves to harmonize productive activities such as oil and gas extraction with protective policies, but also brings institutional benefits that could represent a significant reduction in operating costs associated with inadequate management of this waste. It also tends to improve industry image as perceived by society. However, success of regulatory compliance is dependent of a number of variables, which, in the case of produced water management includes: physicochemical characterization; establishment of benchmark studies to guide application of proper techniques for injection and disposal; the choice of efficient regulatory instruments; expertise and experienced human resources within regulatory agencies responsible for monitoring activities and enforcing

  17. Improvements to the DOE low-level waste regulatory structure and process under recommendation 94-2 - progress to date

    Energy Technology Data Exchange (ETDEWEB)

    Regnier, E.

    1995-12-31

    Among the concerns expressed by the Defense Nuclear Facility Safety Board (DNFSB) in its Recommendation 94-2 was the lack of a clearly defined and effective internal Department of Energy (DOE) regulatory oversight and enforcement process for ensuring that low-level radioactive waste management health, safety, and environmental requirements are met. Therefore, part of the response to the DNFSB concern is a task to clarify and strengthen the low-level waste management regulatory structure. This task is being conducted in two steps. First, consistent with the requirements of the current DOE waste management order and within the framework of the current organizational structure, interim clarification of a review process and the associated organizational responsibilities has been issued. Second, in coordination with the revision of the waste management order and consistent with the organizational responsibilities resulting from the strategic alignment of DOE, a rigorous, more independent regulatory oversight structure will be developed.

  18. Current trends in outcome studies for children with hearing loss and the need to establish a comprehensive framework of measuring outcomes in children with hearing loss in China

    Institute of Scientific and Technical Information of China (English)

    Xueman Liu

    2016-01-01

    Since the 1970s, outcome studies for children with hearing loss expanded from focusing on assessing auditory awareness and speech perception skills to evaluating language and speech development. Since the early 2000s, the multi-center large scale research systematically studied outcomes in the areas of auditory awareness, speech-perception, language development, speech development, educational achievements, cognitive development, and psychosocial development. These studies advocated the establishment of baseline and regular follow-up evaluations with a comprehensive framework centered on language development. Recent research interests also include understanding the vast differences in outcomes for children with hearing loss, understanding the relationships between neurocognitive development and language acquisition in children with hearing loss, and using outcome studies to guide evidence-based clinical practice. After the establishment of standardized Mandarin language assessments, outcomes research in Mainland China has the potential to expand beyond auditory awareness and speech perception studies.

  19. Current trends in outcome studies for children with hearing loss and the need to establish a comprehensive framework of measuring outcomes in children with hearing loss in China

    Directory of Open Access Journals (Sweden)

    Xueman Liu

    2016-06-01

    Full Text Available Since the 1970s, outcome studies for children with hearing loss expanded from focusing on assessing auditory awareness and speech perception skills to evaluating language and speech development. Since the early 2000s, the multi-center large scale research systematically studied outcomes in the areas of auditory awareness, speech-perception, language development, speech development, educational achievements, cognitive development, and psychosocial development. These studies advocated the establishment of baseline and regular follow-up evaluations with a comprehensive framework centered on language development. Recent research interests also include understanding the vast differences in outcomes for children with hearing loss, understanding the relationships between neurocognitive development and language acquisition in children with hearing loss, and using outcome studies to guide evidence-based clinical practice. After the establishment of standardized Mandarin language assessments, outcomes research in Mainland China has the potential to expand beyond auditory awareness and speech perception studies.

  20. Legal principles of regulatory administration and nuclear safety regulation

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Kyeong Hui; Cheong, Sang Kee [Hannam Univ., Taejon (Korea, Republic of)

    2000-12-15

    This research presents a critical analysis and evaluation of principles of administrative laws in order to provide framework of structural reform on the nuclear safety regulation system. The focus of this analysis and evaluation is centered around the area of origin of regulatory administrative laws; authorities of regulation; procedures of regulatory actions; regulatory enforcement; and administrative relief system. In chapter 2 the concept of regulatory administration is analysed. Chapter 3 identifies the origin of regulatory administration and the principles of administration laws. It also examines legal nature of the nuclear safety standard. In relation to regulatory authorities. Chapter 4 identifies role and responsibility of administration authorities and institutions. It also examines fundamental principles of delegation of power. Then the chapter discusses the nuclear safety regulation authorities and their roles and responsibilities. Chapter 5 classifies and examines regulatory administration actions. Chapter 6 evaluates enforcement measure for effectiveness of regulation. Finally, chapter 7 discusses the administrative relief system for reviewing unreasonable regulatory acts.

  1. Regulatory T Cells and Parasites

    Directory of Open Access Journals (Sweden)

    TP. Velavan

    2011-01-01

    Full Text Available Human host encounters a wide array of parasites; however, the crucial aspect is the failure of the host immune system to clear these parasites despite antigen recognition. In the recent past, a new immunological concept has emerged, which provides a framework to better understand several aspects of host susceptibility to parasitic infection. It is widely believed that parasites are able to modulate the magnitude of effector responses by inducing regulatory T cell (Tregs population and several studies have investigated whether this cell population plays a role in balancing protective immunity and pathogenesis during parasite infection. This review discusses the several mechanism of Treg-mediated immunosuppression in the human host and focuses on the functional role of Tregs and regulatory gene polymorphisms in infectious diseases.

  2. Strengthening the Canadian alcohol advertising regulatory system.

    Science.gov (United States)

    Heung, Carly M; Rempel, Benjamin; Krank, Marvin

    2012-05-24

    Research evidence points to harmful effects from alcohol advertising among children and youth. In particular, exposure to alcohol advertising has been associated with adolescents drinking both earlier and heavier. Although current federal and provincial guidelines have addressed advertising practices to prevent underage drinking, practice has not been supported by existing policy. While protective measures such as social marketing campaigns have the potential for counteracting the effects from alcohol advertising, the effectiveness of such measures can be easily drowned out with increasing advertising activities from the alcohol industry, especially without effective regulation. Research reviewed by the European Focus on Alcohol Safe Environment (FASE) Project has identified a set of key elements that are necessary to make alcohol advertising policy measures effective at protecting children and youth from the harmful effects of alcohol marketing. Using these key elements as an evaluation framework, there are critical components in the Canadian alcohol advertising regulatory system that clearly require strengthening. To protect impressionable children and youth against the harmful effects of alcohol advertising, 13 recommendations to strengthen current alcohol advertising regulations in Canada are provided for Canadian policy-makers, advertising standard agencies, and public health groups.

  3. Roadmapping as a Tool for Renewing Regulatory Practices

    DEFF Research Database (Denmark)

    Borch, Kristian; Norus, Jesper

    2004-01-01

    The aim of this paper is to explore technological roadmaps to identify key issuesconcerning the development and utilization of stem cells. From a review of the politicaldecision making processes in three countries, Denmark, the Netherlands, and Germanywe suggest that technological roadmapping...... in this emerging and discontinuedtechnology can provide critical policy information. This type of policy intelligence canbe used to rethink the regulatory practices away from today's framework basedregulation of the emerging technologies towards a regulatory policy based on how todevelop regulatory practices based...

  4. 21 CFR 26.74 - Preservation of regulatory authority.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Preservation of regulatory authority. 26.74 Section 26.74 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL... COMMUNITY âFrameworkâ Provisions § 26.74 Preservation of regulatory authority. (a) Nothing in this...

  5. Toxicogenomics in regulatory ecotoxicology

    Science.gov (United States)

    Ankley, Gerald T.; Daston, George P.; Degitz, Sigmund J.; Denslow, Nancy D.; Hoke, Robert A.; Kennedy, Sean W.; Miracle, Ann L.; Perkins, Edward J.; Snape, Jason; Tillitt, Donald E.; Tyler, Charles R.; Versteeg, Donald

    2006-01-01

    Recently, we have witnessed an explosion of different genomic approaches that, through a combination of advanced biological, instrumental, and bioinformatic techniques, can yield a previously unparalleled amount of data concerning the molecular and biochemical status of organisms. Fueled partially by large, well-publicized efforts such as the Human Genome Project, genomic research has become a rapidly growing topical area in multiple biological disciplines. Since 1999, when the term “toxicogenomics” was coined to describe the application of genomics to toxicology (1), a rapid increase in publications on the topic has occurred (Figure 1). The potential utility of toxicogenomics in toxicological research and regulatory activities has been the subject of scientific discussions and, as with any new technology, has evoked a wide range of opinion (2–6). VIEWPOINT © 2006 american chemical Society july 1, 2006 / EnvironmEntal SciEncE & tEchnology n 4055 The purpose of this feature article is to consider the roles of toxicogenomics in the field of regulatory ecotoxicology, explore current limitations in the science and practice of genomics, and propose possible avenues to approach and resolve some of the major challenges. A significant amount of input to our analysis came from a workshop sponsored by the Society of Environmental Toxicology and Chemistry (SETAC) in Pellston, Mich., in September 2005. A complete list of names and affiliations of the experts participating in that workshop is provided online in Table 1 of the Supporting Information for this paper.

  6. Current Challenges in Bioequivalence, Quality, and Novel Assessment Technologies for Topical Products

    DEFF Research Database (Denmark)

    Yacobi, Avraham; Shah, Vinod P; Bashaw, Edward D;

    2014-01-01

    topical products. The methods currently available for assessment of BE were reviewed as well as alternatives and the advantages and disadvantages of each method were considered. Guidance on quality and performance of topical products was reviewed and a framework to categorise existing and alternative......This paper summarises the proceedings of a recent workshop which brought together pharmaceutical scientists and dermatologists from academia, industry and regulatory agencies to discuss current regulatory issues and industry practices for establishing therapeutic bioequivalence (BE) of dermatologic...... of topical bioavailability. The discussion on the BE and clinical equivalence of topical products revealed considerable concerns about the variability present in the current methodologies utilized by the industry and regulatory agencies. It was proposed that academicians, researchers, the pharmaceutical...

  7. Genomic research in Zambia: confronting the ethics, policy and regulatory frontiers in the 21st Century.

    Science.gov (United States)

    Chanda-Kapata, Pascalina; Kapata, Nathan; Moraes, Albertina Ngomah; Chongwe, Gershom; Munthali, James

    2015-10-29

    Genomic research has the potential to increase knowledge in health sciences, but the process has to ensure the safety, integrity and well-being of research participants. A legal framework for the conduct of health research in Zambia is available. However, the ethical, policy and regulatory framework to operationalise genomic research requires a paradigm shift. This paper outlines the current legal and policy framework as well as the ethics environment, and suggests recommendations for Zambia to fully benefit from the opportunity that genomic research presents. This will entail creating national research interest, improving knowledge levels, and building community trust among researchers, policymakers, donors, regulators and, most importantly, patients and research participants. A real balancing act of the risk and benefits will need to be objectively undertaken.

  8. 信息框架、调节匹配和自我建构对冲动性购买行为的影响%The Influence of Information Framework,Regulatory Fit and Self-construction on Impulsive Buying Behavior

    Institute of Scientific and Technical Information of China (English)

    梁承磊; 李秀荣

    2012-01-01

    The study utilizes the concept of regulatory fit and self-construction to analyze the influence of two types of consumers' goal orientation on the impulsive buying behavior faced with the information framework of two difference reference groups' proposal.By conducting theoretical research and empirical analysis,it has found that when regulatory fit appears,consumers have more positive purchase intentions and impulse buying on products and self-construction will affect the relationship between purchase intention and impulse buying.%本文引入调节匹配和自我建构的概念,探讨两种不同目标导向——促进与预防的消费者在面对两种不同的参照群体建议的信息框架(正面/负面)时对冲动购买行为的影响。并采用SPSS对数据进行处理,结果发现:在调节匹配的情况下,消费者冲动性购买的意图和行为程度更高,自我建构会干扰冲动性购买意图对购买行为的影响效果。

  9. An ecotoxicological analysis of the sediment quality in a European Atlantic harbor emphasizes the current limitations of the Water Framework Directive.

    Science.gov (United States)

    Gonçalves, Sandra F; Calado, Ricardo; Gomes, Newton C M; Soares, Amadeu M V M; Loureiro, Susana

    2013-07-15

    The "PortoNovo" project was developed to standardize the methodologies for water quality management in the port areas of coastal Atlantic regions to improve the Water Frame Directive (WFD) for these specific water bodies. Under this scope, water and sediment samples were collected from five sites within the Port of Aveiro, Portugal. According to the physical and chemical parameters that were analyzed (i.e., metals, total organic carbon, polychlorinated biphenyls and polycyclic aromatic hydrocarbons), the sediments were not considered at risk based on European sediment quality laws. However, the bioassays that were performed on the sediment samples (Microtox®) and the standardized acute toxicity test using the marine rotifer, Brachionus plicatilis, on sediment elutriates revealed higher toxicity levels. The use of bioassays to assess sediment quality clearly complements more conservative approaches and highlights current gaps within the WFD. The approach presented here can be easily transferred to other port areas for more reliable water quality management.

  10. The welfare state within the framework of the capialist system. Does it have a future or is it non-viable in the current globalized system?

    Directory of Open Access Journals (Sweden)

    Manuel Fernando Cabrera Jiménez

    2014-07-01

    Full Text Available The important role played by the State in the economic, political, and social field during the 20th Century has engendered some reactions in favor or against from the point of view of several ideological thinkers within capitalism. Regardless of the point of view from where it is observed, it can be said that it has had an influence on individual freedom, in the relationships generated around the development conception and, in general, in current social-economic growth. The aim of this article is to review the study of the welfare State role in the capitalist society in the 20th Century, analyzing different contributions from the point of view of those who defend this theory, as well as those who are opposed to it. It recognizes that every State must confront the complex process that generates the interaction of different social structures interaction and their outcome that affects the people.

  11. The NRC's SPAR Models: Current Status, Future Development, and Modeling Issues

    Energy Technology Data Exchange (ETDEWEB)

    Robert F. Buell

    2008-09-01

    Probabilistic risk assessments (PRAs) play an increasingly important role in the regulatory framework of the U.S. nuclear power industry. The Nuclear Regulatory Commission (NRC) relies on a set of plant-specific Standardized Plant Analysis Risk (SPAR) models to provide critical risk-based input to the regulatory process. The Significance Determination Process (SDP), Management Directive 8.3 - NRC Incident Investigation Program, Accident Sequence Precursor (ASP) and Mitigating Systems Performance Index (MSPI) programs are among the regulatory initiatives that receive significant input from the SPAR models. Other uses of the SPAR models include: Screening & Resolution of Generic Safety Issues, License Amendment reviews and Notice of Enforcement Discretion (NOEDs). This paper presents the current status of SPAR model development activities, future development objectives, and issues related to the development, verification and maintenance of the SPAR models.

  12. Regulatory considerations for biosimilars

    Directory of Open Access Journals (Sweden)

    Ranjani Nellore

    2010-01-01

    Full Text Available Currently there is considerable interest in the legislative debate around generic biological drugs or "biosimilars" in the EU and US due to the large, lucrative market that it offers to the industry. While some countries have issued a few regulatory guidelines as well as product specific requirements, there is no general consensus as to a single, simple mechanism similar to the bioequivalence determination that leads to approval of generic small molecules all over the world. The inherent complex nature of the molecules, along with complicated manufacturing and analytical techniques to characterize them make it difficult to rely on a single human pharmacokinetic study for assurance of safety and efficacy. In general, the concept of comparability has been used for evaluation of the currently approved "similar" biological where a step by step assessment on the quality, preclinical and clinical aspects is made. In India, the focus is primarily on the availability and affordability of life-saving drugs. In this context every product needs to be evaluated on its own merit irrespective of the innovator brand. The formation of the National Biotechnology Regulatory Authority may provide a step in the right direction for regulation of these complex molecules. However, in order to have an efficient machinery for initial approval and ongoing oversight with a country-specific focus, cooperation with international authorities for granting approvals and continuous risk-benefit review is essential. Several steps are still needed for India to be perceived as a country that leads the world in providing quality biological products.

  13. 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.

  14. Modeling of hysteresis in gene regulatory networks.

    Science.gov (United States)

    Hu, J; Qin, K R; Xiang, C; Lee, T H

    2012-08-01

    Hysteresis, observed in many gene regulatory networks, has a pivotal impact on biological systems, which enhances the robustness of cell functions. In this paper, a general model is proposed to describe the hysteretic gene regulatory network by combining the hysteresis component and the transient dynamics. The Bouc-Wen hysteresis model is modified to describe the hysteresis component in the mammalian gene regulatory networks. Rigorous mathematical analysis on the dynamical properties of the model is presented to ensure the bounded-input-bounded-output (BIBO) stability and demonstrates that the original Bouc-Wen model can only generate a clockwise hysteresis loop while the modified model can describe both clockwise and counter clockwise hysteresis loops. Simulation studies have shown that the hysteresis loops from our model are consistent with the experimental observations in three mammalian gene regulatory networks and two E.coli gene regulatory networks, which demonstrate the ability and accuracy of the mathematical model to emulate natural gene expression behavior with hysteresis. A comparison study has also been conducted to show that this model fits the experiment data significantly better than previous ones in the literature. The successful modeling of the hysteresis in all the five hysteretic gene regulatory networks suggests that the new model has the potential to be a unified framework for modeling hysteresis in gene regulatory networks and provide better understanding of the general mechanism that drives the hysteretic function.

  15. Critical assessment of the current understanding/ knowledge of the framework of the Ecosystem Approach to Fisheries in the Mediterranean and Black Seas

    Directory of Open Access Journals (Sweden)

    Paolo Sartor

    2014-03-01

    Full Text Available A critical review was carried out involving experts from 17 countries, to identify, summarize and evaluate the current understanding related to the Ecosystem Approach to Fisheries management (EAF in the Mediterranean and Black Seas. The existing information available at country level, coming from research and monitoring projects and other types of activities, was explored. The evaluation was done following a standardized protocol and using simple semi-quantitative methods. The results highlighted an overall low-medium degree of fulfilment of the requirements of the EAF, with some differences related to the different issues considered. The highest scores were reported for the knowledge related to fleet structure/ behaviour and species/habitat distribution, whereas the lowest scores were reported for modelling, and socio-economic and management issues. Although only semi-quantitative, these results provided an initial picture at a broad regional level on the state of knowledge with a view to a proper implementation of the EAF in the Mediterranean and Black Seas, and identified gaps in scientific knowledge that should be covered.

  16. Regulatory Issues Surrounding Merchant Interconnection

    Energy Technology Data Exchange (ETDEWEB)

    Kuijlaars, Kees-Jan; Zwart, Gijsbert [Office for Energy Regulation (DTe), The Hague (Netherlands)

    2003-11-01

    We discussed various issues concerning the regulatory perspective on private investment in interconnectors. One might claim that leaving investment in transmission infrastructure to competing market parties is more efficient than relying on regulated investment only (especially in the case of long (DC) lines connecting previously unconnected parts of the grids, so that externalities from e.g. loop flows do not play a significant role). We considered that some aspects of interconnection might reduce these market benefits. In particular, the large fixed costs of interconnection construction may lead to significant under investment (due to both first mover monopoly power and the fact that part of generation cost efficiencies realised by interconnection are not captured by the investor itself, and remain external to the investment decision). Second, merchant ownership restricts future opportunities for adaptation of regulation, as would be required e.g. for introduction of potentially more sophisticated methods of congestion management or market splitting. Some of the disadvantages of merchant investment may be mitigated however by a suitable regulatory framework, and we discussed some views in this direction. The issues we discussed are not intended to give a complete framework, and detailed regulation will certainly involve many more specific requirements. Areas we did not touch upon include e.g. the treatment of deep connection costs, rules for operation and maintenance of the line, and impact on availability of capacity on other interconnections.

  17. Perspective Reforms for Approximation of the Ukrainian Legal Framework for Telecommunications

    DEFF Research Database (Denmark)

    Batura, Olga; Kretova, Olga A.

    2016-01-01

    This article studies Ukrainian legal and regulatory rules for telecommunications services markets against the backdrop of Ukrainian commitments under the GATS and especially the Association Agreement with the EU. The study elucidates to what extent the Ukrainian telecoms regulatory framework...

  18. Policy and Regulatory Issues for Underground Coal Gasification in India

    Science.gov (United States)

    Singh, Sunil K.

    2017-07-01

    Underground coal gasification (UCG) is in its nascent stage of development. Most of the projects are in the nature of pilot projects. UCG technology requires acceptance in general commercial framework as it matures with the progress of time. Policy and regulatory framework, therefore, is considered here only in the expectation that UCG technology may finally be rolled out sooner than later. India is actively pursuing consultations with major countries which have recorded successes in implementing UCG technology in varying measures. In this background, the discussion on policy and regulatory framework is essentially an effort to capture the broad outline of the understanding of the UCG process in a regulatory construct as compared with other regulatory regimes of similar nature.

  19. Regulatory bioinformatics for food and drug safety.

    Science.gov (United States)

    Healy, Marion J; Tong, Weida; Ostroff, Stephen; Eichler, Hans-Georg; Patak, Alex; Neuspiel, Margaret; Deluyker, Hubert; Slikker, William

    2016-10-01

    "Regulatory Bioinformatics" strives to develop and implement a standardized and transparent bioinformatic framework to support the implementation of existing and emerging technologies in regulatory decision-making. It has great potential to improve public health through the development and use of clinically important medical products and tools to manage the safety of the food supply. However, the application of regulatory bioinformatics also poses new challenges and requires new knowledge and skill sets. In the latest Global Coalition on Regulatory Science Research (GCRSR) governed conference, Global Summit on Regulatory Science (GSRS2015), regulatory bioinformatics principles were presented with respect to global trends, initiatives and case studies. The discussion revealed that datasets, analytical tools, skills and expertise are rapidly developing, in many cases via large international collaborative consortia. It also revealed that significant research is still required to realize the potential applications of regulatory bioinformatics. While there is significant excitement in the possibilities offered by precision medicine to enhance treatments of serious and/or complex diseases, there is a clear need for further development of mechanisms to securely store, curate and share data, integrate databases, and standardized quality control and data analysis procedures. A greater understanding of the biological significance of the data is also required to fully exploit vast datasets that are becoming available. The application of bioinformatics in the microbiological risk analysis paradigm is delivering clear benefits both for the investigation of food borne pathogens and for decision making on clinically important treatments. It is recognized that regulatory bioinformatics will have many beneficial applications by ensuring high quality data, validated tools and standardized processes, which will help inform the regulatory science community of the requirements

  20. Dynamic simulation of regulatory networks using SQUAD

    Directory of Open Access Journals (Sweden)

    Xenarios Ioannis

    2007-11-01

    Full Text Available Abstract Background The ambition of most molecular biologists is the understanding of the intricate network of molecular interactions that control biological systems. As scientists uncover the components and the connectivity of these networks, it becomes possible to study their dynamical behavior as a whole and discover what is the specific role of each of their components. Since the behavior of a network is by no means intuitive, it becomes necessary to use computational models to understand its behavior and to be able to make predictions about it. Unfortunately, most current computational models describe small networks due to the scarcity of kinetic data available. To overcome this problem, we previously published a methodology to convert a signaling network into a dynamical system, even in the total absence of kinetic information. In this paper we present a software implementation of such methodology. Results We developed SQUAD, a software for the dynamic simulation of signaling networks using the standardized qualitative dynamical systems approach. SQUAD converts the network into a discrete dynamical system, and it uses a binary decision diagram algorithm to identify all the steady states of the system. Then, the software creates a continuous dynamical system and localizes its steady states which are located near the steady states of the discrete system. The software permits to make simulations on the continuous system, allowing for the modification of several parameters. Importantly, SQUAD includes a framework for perturbing networks in a manner similar to what is performed in experimental laboratory protocols, for example by activating receptors or knocking out molecular components. Using this software we have been able to successfully reproduce the behavior of the regulatory network implicated in T-helper cell differentiation. Conclusion The simulation of regulatory networks aims at predicting the behavior of a whole system when subject

  1. Theory of Regulatory Compliance for Requirements Engineering

    CERN Document Server

    Jureta, Ivan; Mylopoulos, John; Perini, Anna; Susi, Angelo

    2010-01-01

    Regulatory compliance is increasingly being addressed in the practice of requirements engineering as a main stream concern. This paper points out a gap in the theoretical foundations of regulatory compliance, and presents a theory that states (i) what it means for requirements to be compliant, (ii) the compliance problem, i.e., the problem that the engineer should resolve in order to verify whether requirements are compliant, and (iii) testable hypotheses (predictions) about how compliance of requirements is verified. The theory is instantiated by presenting a requirements engineering framework that implements its principles, and is exemplified on a real-world case study.

  2. Reviewing the regulatory barriers for nanomedicine: global questions and challenges.

    Science.gov (United States)

    Bowman, Diana M; Gatof, Jake

    2015-01-01

    Nanomedicine will play an increasing role in prevention and treatment across the entire healthcare spectrum. However, their precise market size, economic value and areas of application remain unclear. This opacity, including the question of what constitutes nanomedicine matters, especially when considered alongside the key regulatory questions and concerns. This article begins by placing these key questions into context in relation to the current scientific state of the art, focusing particular attention on the human health and safety context. In exploring these central questions surrounding the regulation of nanomedicine, this perspective also explores existing and suggested frameworks that aim to deal with emerging technologies more generally. It then outlines priority areas for action and general conclusions specific to nanomedicine.

  3. Regulatory Reform in Mexico's Gas Industry Regulatory Reform in Mexico's Gas Industry

    Directory of Open Access Journals (Sweden)

    Juan Rosellón

    1995-03-01

    Full Text Available This paper addresses the economic considerations behind the regulatory policies that are being considered after the recent reforms to the gas legal framework in Mexico. These reforms let Pemex maintain its over production but allow private investment in transportarion and distribution. The main challenge for gas regulation is Mexico is to develop a competitive structure when i the initial condition is an upstream monopoly and ii there is a dominant competitor in transportation. The paper discusses the solutions that are being designed during the elaboration of the gas regulatory framework. The main purpose is to describe how economic policy is responding to a fast evolving phenomena and to suggest topics for future research. This paper addresses the economic considerations behind the regulatory policies that are being considered after the recent reforms to the gas legal framework in Mexico. These reforms let Pemex maintain its over production but allow private investment in transportarion and distribution. The main challenge for gas regulation is Mexico is to develop a competitive structure when i the initial condition is an upstream monopoly and ii there is a dominant competitor in transportation. The paper discusses the solutions that are being designed during the elaboration of the gas regulatory framework. The main purpose is to describe how economic policy is responding to a fast evolving phenomena and to suggest topics for future research.

  4. Regulatory approaches to worker protection in nanotechnology industry in the USA and European union.

    Science.gov (United States)

    Murashov, Vladimir; Schulte, Paul; Geraci, Charles; Howard, John

    2011-01-01

    A number of reports have been published regarding the applicability of existing regulatory frameworks to protect consumers and the environment from potentially adverse effects related to introduction of nanomaterials into commerce in the United States and the European Union. However, a detailed comparison of the regulatory approaches to worker safety and health in the USA and in the EU is lacking. This report aims to fill this gap by reviewing regulatory frameworks designed to protect workers and their possible application to nanotechnology.

  5. The economic opportunity of energy efficiency. An overview of the legal and regulatory framework, programs and energy services evaluation in Europe and in Portugal and of the possible implementation of the present proposal on the energy services directive

    Energy Technology Data Exchange (ETDEWEB)

    Vasconcelos, F

    2004-11-01

    The economic development requires a bigger access to energy sources, which amplifies energy demand. In Portugal, the increase energy demand allied to an economic development and scarce endogenous energy sources allows us to conclude that this will be a critical issue in a near future. While effective market forces and good information can accelerate energy efficiency improvements, market failures and barriers can inhibit efficiency gains. In such cases, certain government interventions may be useful in focusing market interest on energy efficiency. These include codes, standards, voluntary agreements, special financing arrangements and clustering small projects into investment portfolios. Although much attention has been given to the potential strategic role of renewable energy, increased end-use efficiency offers comparable if not greater near-term potential. Furthermore, it also generally less expensive per unit of energy saved than is an incremental unit of new energy supply (whether it is renewable or fossil-based). Thus, increased end-use efficiency investment is consistent with sound business practices. The implementation of the IEM and IGM was the way found to reduce efficiency barriers in the supply side but the demand side remained forgotten. However, full economic and environmental efficiency can only be achieved by including the demand-side into the competition and developing an Internal Market for energy services and programmes. The analysis of the energy policy, a strategy and economics of DSM activities is one of the actual subjects in the sector and that interest to all actors at the market. In this report we analyse the evolution and the consumption energy trends in some European countries, establishing when possible the link with Portugal. We also describe 'driving forces' of the energy consumption in the Europe and identify the legal and regulatory frame of this problem. Furthermore, we also identify policies that have improved the

  6. Modular Semantic Tagging of Medline Abstracts and its Use in Inferring Regulatory Networks

    Energy Technology Data Exchange (ETDEWEB)

    Verhagen, Marc; Pustejovsky, James; Taylor, Ronald C.; Sanfilippo, Antonio P.

    2011-09-19

    We describe MedstractPlus, a resource for mining relations from the Medline bibliographic database that is currently under construction. It was built on the remains of Medstract, a previously created resource that included a biorelation server and an acronym database. MedstractPlus uses simple and scalable natural language processing modules to structure text, is designed with reusability and extendibility in mind, and adheres to the philosophy of the Linguistic Annotation Framework. We show how MedstractPlus has been used to provide seeds for a novel approach to inferring transcriptional regulatory networks from gene expression data.

  7. Cis-regulatory mutations in human disease.

    Science.gov (United States)

    Epstein, Douglas J

    2009-07-01

    Cis-acting regulatory sequences are required for the proper temporal and spatial control of gene expression. Variation in gene expression is highly heritable and a significant determinant of human disease susceptibility. The diversity of human genetic diseases attributed, in whole or in part, to mutations in non-coding regulatory sequences is on the rise. Improvements in genome-wide methods of associating genetic variation with human disease and predicting DNA with cis-regulatory potential are two of the major reasons for these recent advances. This review will highlight select examples from the literature that have successfully integrated genetic and genomic approaches to uncover the molecular basis by which cis-regulatory mutations alter gene expression and contribute to human disease. The fine mapping of disease-causing variants has led to the discovery of novel cis-acting regulatory elements that, in some instances, are located as far away as 1.5 Mb from the target gene. In other cases, the prior knowledge of the regulatory landscape surrounding the gene of interest aided in the selection of enhancers for mutation screening. The success of these studies should provide a framework for following up on the large number of genome-wide association studies that have identified common variants in non-coding regions of the genome that associate with increased risk of human diseases including, diabetes, autism, Crohn's, colorectal cancer, and asthma, to name a few.

  8. CURRENT FRAMEWORK OF EDUCATIONAL DIGITAL BOOKS

    Directory of Open Access Journals (Sweden)

    Almeida, P.S

    2015-12-01

    Full Text Available The constant changes in society and the expansion of information and communication technologies present new challenges for all sectors, mainly in educational areas, where new forms of work are The constant changes in society and the expansion of information and communication technologies present new challenges for all sectors, mainly in educational areas, where new forms of work are

  9. Improving the Current DHS Capabilities Framework

    Science.gov (United States)

    2008-09-01

    Laboratories ( PNL ) to establish the standards for the NIMS initiative. This entire situation creates another set of inconsistencies in criteria for...www.hsaj.org/?fullarticle=1.2.2, (accessed June 12, 2007), 8. 24 setting agencies: NFPA, PNL , American National Standards Institute (ANSI), and...with Pacific Northwest Laboratory ( PNL ) to develop the NIC standards. The Incident Management Standards Working Group (IMSWG) was established

  10. The emergence and popularisation of autologous somatic cellular therapies in Australia: therapeutic innovation or regulatory failure?

    Science.gov (United States)

    McLean, Alison K; Stewart, Cameron; Kerridge, Ian

    2014-09-01

    Private stem cell clinics throughout Australia are providing autologous stem cell therapies for a range of chronic and debilitating illnesses despite the lack of published literature to support the clinical application of these therapies. The Therapeutic Goods Administration has excluded autologous stem cell therapies from its regulatory domain leaving such therapies to be regulated by the same mechanisms that regulate research, such as the National Health and Medical Research Council Research Ethics Guidelines, and clinical practice, such as the Australian Health Practitioner Regulation Agency. However, the provision of these stem cell therapies does not follow the established pathways for legitimate medical advance--therapeutic innovation or research. The current regulatory framework is failing to achieve its aims of protecting vulnerable patients and ensuring the proper conduct of medical practitioners in the private stem cell industry.

  11. The dynamics of the transnational food chain regulatory governance

    DEFF Research Database (Denmark)

    Chatzopoulou, Sevasti

    2015-01-01

    Purpose: The need for food safety and food quality standards is acknowledged by public regulators, private actors, and the society. The purpose of this paper is to identify the types of actors in the multilevel transnational food chain regulatory governance and how their interlinking affects...... regulatory outcomes over time. Design/methodology/approach – Food chain regulatory standards emerge within a complex process beyond the state. Based on interdisciplinary theoretical perspectives, namely regulatory governance and political economy, this paper provides a integrative framework of analysis...... by identifying the types of actors and their interactions in the food chain regulatory governance. Findings – Food chain regulatory standards setting have been mainly studied either from the public regulator or the firm self-regulating point of view. This paper demonstrates how the political and economics...

  12. A critical appraisal of the process of regulatory implementation of novel in vivo and in vitro methods for chemical hazard and risk assessment.

    Science.gov (United States)

    Piersma, Aldert H; Ezendam, Janine; Luijten, Mirjam; Muller, J J Andre; Rorije, Emiel; van der Ven, Leo T M; van Benthem, Jan

    2014-11-01

    Regulatory toxicology urgently needs applicable alternative test systems that reduce animal use, testing time, and cost. European regulation on cosmetic ingredients has already banned animal experimentation for hazard identification, and public awareness drives toward additional restrictions in other regulatory frameworks as well. In addition, scientific progress stimulates a more mechanistic approach of hazard identification. Nevertheless, the implementation of alternative methods is lagging far behind their development. In search for general bottlenecks for the implementation of alternative methods, this manuscript reviews the state of the art as to the development and implementation of 10 diverse test systems in various areas of toxicological hazard assessment. They vary widely in complexity and regulatory acceptance status. The assays are reviewed as to parameters assessed, biological system involved, standardization, interpretation of results, extrapolation to human hazard, position in testing strategies, and current regulatory acceptance status. Given the diversity of alternative methods in many aspects, no common bottlenecks could be identified that hamper implementation of individual alternative assays in general. However, specific issues for the regulatory acceptance and application were identified for each assay. Acceptance of one-in-one replacement of complex in vivo tests by relatively simple in vitro assays is not feasible. Rather, innovative approaches using test batteries are required together with metabolic information and in vitro to in vivo dose extrapolation to convincingly provide the same level of information of current in vivo tests. A mechanistically based alternative approach using the Adverse Outcome Pathway concept could stimulate further (regulatory) acceptance of non-animal tests.

  13. The residential electricity sector in Denmark: A description of current conditions

    DEFF Research Database (Denmark)

    Kitzing, Lena; Katz, Jonas; Schröder, Sascha Thorsten

    We provide an overview of the current conditions and framework for residential electricity consumption in Denmark. This includes a general overview of the sector, the retail market and the regulatory framework. We describe the regulations currently in place and changes which have been decided for...... in the area, which are listed in the Glossary towards the end of the report. We also attach a list and description of the major sources of information and data that can be obtained and downloaded for analysis of the Danish residential electricity sector.......We provide an overview of the current conditions and framework for residential electricity consumption in Denmark. This includes a general overview of the sector, the retail market and the regulatory framework. We describe the regulations currently in place and changes which have been decided...... for the coming years. The information and data described are all publicly available, though much of it only in Danish language. This description is to our knowledge one of the first comprehensive overviews of the Danish residential sector in English language. We have translated a number of terms commonly used...

  14. Integrated Regulatory and Metabolic Networks of the Marine Diatom Phaeodactylum tricornutum Predict the Response to Rising CO2 Levels.

    Science.gov (United States)

    Levering, Jennifer; Dupont, Christopher L; Allen, Andrew E; Palsson, Bernhard O; Zengler, Karsten

    2017-01-01

    Diatoms are eukaryotic microalgae that are responsible for up to 40% of the ocean's primary productivity. How diatoms respond to environmental perturbations such as elevated carbon concentrations in the atmosphere is currently poorly understood. We developed a transcriptional regulatory network based on various transcriptome sequencing expression libraries for different environmental responses to gain insight into the marine diatom's metabolic and regulatory interactions and provide a comprehensive framework of responses to increasing atmospheric carbon levels. This transcriptional regulatory network was integrated with a recently published genome-scale metabolic model of Phaeodactylum tricornutum to explore the connectivity of the regulatory network and shared metabolites. The integrated regulatory and metabolic model revealed highly connected modules within carbon and nitrogen metabolism. P. tricornutum's response to rising carbon levels was analyzed by using the recent genome-scale metabolic model with cross comparison to experimental manipulations of carbon dioxide. IMPORTANCE Using a systems biology approach, we studied the response of the marine diatom Phaeodactylum tricornutum to changing atmospheric carbon concentrations on an ocean-wide scale. By integrating an available genome-scale metabolic model and a newly developed transcriptional regulatory network inferred from transcriptome sequencing expression data, we demonstrate that carbon metabolism and nitrogen metabolism are strongly connected and the genes involved are coregulated in this model diatom. These tight regulatory constraints could play a major role during the adaptation of P. tricornutum to increasing carbon levels. The transcriptional regulatory network developed can be further used to study the effects of different environmental perturbations on P. tricornutum's metabolism.

  15. Development of regulatory policy for SMART-P

    Energy Technology Data Exchange (ETDEWEB)

    Lee, S. H.; Lee, Y. H.; Moo, Philip; Koh, B. J.; Son, M. K.; Han, G. H.; Kim, D. H. [Korea Association for Nuclear Technology, Daejeon (Korea, Republic of)

    2004-06-15

    KAERI promoted the construction of a research reactor, SMART-P, the reduced scale of SMART, with intent to demonstrate the safety and performance of SMART. According to this progress, the development of regulatory process for SMART-P became necessary. The establishment of regulatory policy, based on the current regulatory guidelines as well as technical aspect, became essential matters. Considering the on-going small and medium size reactors in near future, the selection of the appropriate measure in the existing regulatory process to SMART-P is very important. Thus the schematic study for the applicable licensing procedure and regulatory requirements suitable for SMART-P is required.

  16. Development of regulatory policy for SMART-P

    Energy Technology Data Exchange (ETDEWEB)

    Lee, S. H.; Moon, S. H.; Lee, Y. H.; Son, M. K.; Han, K. H.; Kim, D. H. [Korea Association for Nuclear Technology, Taejon (Korea, Republic of)

    2003-06-15

    KAERI promoted the construction of a research reactor, SMART-P, the reduced scale of SMART, with intent to demonstrate the safety and performance of SMART. According to this progress, the development of regulatory process for SMART-P became necessary. The establishment of regulatory policy, based on the current regulatory guidelines as well as technical aspect, became essential matters. Considering the on-going small and medium size reactors m near future, the selection of the appropriate measure in the existing regulatory process to SMART-P is very important. Thus the schematic study for the applicable licensing procedure and regulatory requirements suitable for SMART-P is required.

  17. Voting Power : A Generalised Framework

    CERN Document Server

    Das, Sreejith

    2012-01-01

    This paper examines an area of Game Theory called Voting Power Theory. With the adoption of a measure theoretic framework it argues that the many different indices and tools currently used for measuring voting power can be replaced by just three simple probabilities. The framework is sufficiently general to be applicable to every conceivable type of voting game, and every possible decision rule.

  18. Regulating regulatory T cells.

    Science.gov (United States)

    Le, N T; Chao, N

    2007-01-01

    Regulatory T cells (Tregs) are a specialized subpopulation of T cells that act to suppress activation of other immune cells and thereby maintain immune system homeostasis, self-tolerance as well as control excessive response to foreign antigens. The mere concept of Tregs was the subject of significant controversy among immunologists for many years owing to the paucity of reliable markers for defining these cells and the ambiguity of the nature and molecular basis of suppressive phenomena. However, recent advances in the molecular characterization of this cell population have firmly established their existence and their vital role in the vertebrate immune system. Of interest, accumulating evidence from both humans and experimental animal models has implicated the involvement of Tregs in the development of graft-versus-host disease (GVHD). The demonstration that Tregs could separate GVHD from graft-versus-tumor (GVT) activity suggests that their immunosuppressive potential could be manipulated to reduce GVHD without detrimental consequence on GVT effect. Although a variety of T lymphocytes with suppressive capabilities have been reported, the two best-characterized subsets are the naturally arising, intrathymic-generated Tregs (natural Tregs) and the peripherally generated, inducible Tregs (inducible Tregs). This review summarizes our current knowledge of the generation, function and regulation of these two populations of Tregs during an immune response. Their role in the development of GVHD and their therapeutic potential for the prevention and treatment of GVHD will also be described.

  19. Regulatory guidelines for biosimilars in Malaysia.

    Science.gov (United States)

    Abas, Arpah

    2011-09-01

    The biosimilars sector continues to attract huge interest and controversy. Biosimilars are new biopharmaceuticals that are "similar" but not identical to the innovator product. Characteristics of biopharmaceuticals are closely related to the manufacturing process, which implies that the products cannot be exactly duplicated. Minuscule differences in the product's structure and manufacturing process can result in different clinical outcome. This raises concerns over the safety, efficacy and even pharmacovigilance of biosimilars. Thus, biosimilars are unique - they are not a true chemical generic and are regulated via a distinct regulatory framework. This report discusses the features of Malaysian regulatory oversight of biosimilars and experience acquired in the evaluation of some products from various countries. Ensuring regulatory position adequately reflects scientific advancement, expertise/resources is key. The regulatory situation is an evolving process. Various guidance documents are being prepared with the aim of developing a uniform global framework towards assuring the dual goal of lower costs and patient safety while expediting the availability of important biosimilar products.

  20. Measuring Progress in Conflict Environments (MPICE) - A Metrics Framework for Assessing Conflict Transformation and Stabilization. Version 1.0

    Science.gov (United States)

    2008-08-01

    Regulatory and Corporate Governance Framework Strengthened D. Financial Institutions Strengthened E. Employment Strengthened F. Private Sector...Regulatory and Corporate Governance Strengthened How effectively regulated are commercial and financial transactions? o Strength of regulatory...of commercial and financial regulations. (EK)`+ Do regulatory and corporate governance systems effectively constrain black market activities

  1. Ethical and regulatory challenges posed by synthetic biology.

    Science.gov (United States)

    Rager-Zisman, Bracha

    2012-01-01

    Synthetic biology is a relatively new science with tremendous potential to change how we view and know the life sciences, but like many developing technologies, it has provoked ethical concerns from the scientific community and the public and confronts demands for new regulatory measures. The concerns raised involve the danger of "dual use," in which results for improving human well-being and the environment may be misappropriated for bioterror. To counteract these dangers, many governments, but the United States and Israel in particular, have introduced new laws and redoubled measures for biosafety and biosecurity. In the United States, the recent H5N1 results achieved by two groups of NIH-funded investigators highlighted the dilemma of balancing the risk of dual-use research and the freedom of science. In Israel, concern for unconventional terrorism is long-standing, and the country is constantly engaged in improving biosecurity and biodefense measures. In 2008, the Israeli parliament passed the Regulation of Research into Biological Disease Agents Law, a legislative framework for safeguarding research into biological disease agents. This article summarizes and analyzes the current state of affairs in the United States and Israel, ethical attitudes, and regulatory responses to synthetic biology.

  2. A drinking water quality framework for South Africa

    African Journals Online (AJOL)

    Quality Framework for South Africa to enable effective management of drinking water quality and the protection of public health. ... to monitor, manage, communicate and regulate drinking water quality. ... Inadequate WSA institutional capacity (staffing, funding, .... Although demonstrating compliance with regulatory limits.

  3. Regulatory guidance document

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1994-05-01

    The Office of Civilian Radioactive Waste Management (OCRWM) Program Management System Manual requires preparation of the OCRWM Regulatory Guidance Document (RGD) that addresses licensing, environmental compliance, and safety and health compliance. The document provides: regulatory compliance policy; guidance to OCRWM organizational elements to ensure a consistent approach when complying with regulatory requirements; strategies to achieve policy objectives; organizational responsibilities for regulatory compliance; guidance with regard to Program compliance oversight; and guidance on the contents of a project-level Regulatory Compliance Plan. The scope of the RGD includes site suitability evaluation, licensing, environmental compliance, and safety and health compliance, in accordance with the direction provided by Section 4.6.3 of the PMS Manual. Site suitability evaluation and regulatory compliance during site characterization are significant activities, particularly with regard to the YW MSA. OCRWM`s evaluation of whether the Yucca Mountain site is suitable for repository development must precede its submittal of a license application to the Nuclear Regulatory Commission (NRC). Accordingly, site suitability evaluation is discussed in Chapter 4, and the general statements of policy regarding site suitability evaluation are discussed in Section 2.1. Although much of the data and analyses may initially be similar, the licensing process is discussed separately in Chapter 5. Environmental compliance is discussed in Chapter 6. Safety and Health compliance is discussed in Chapter 7.

  4. An expanded conceptual framework for solution-focused management of chemical pollution in European waters.

    Science.gov (United States)

    Munthe, John; Brorström-Lundén, Eva; Rahmberg, Magnus; Posthuma, Leo; Altenburger, Rolf; Brack, Werner; Bunke, Dirk; Engelen, Guy; Gawlik, Bernd Manfred; van Gils, Jos; Herráez, David López; Rydberg, Tomas; Slobodnik, Jaroslav; van Wezel, Annemarie

    2017-01-01

    This paper describes a conceptual framework for solutions-focused management of chemical contaminants built on novel and systematic approaches for identifying, quantifying and reducing risks of these substances. The conceptual framework was developed in interaction with stakeholders representing relevant authorities and organisations responsible for managing environmental quality of water bodies. Stakeholder needs were compiled via a survey and dialogue. The content of the conceptual framework was thereafter developed with inputs from relevant scientific disciplines. The conceptual framework consists of four access points: Chemicals, Environment, Abatement and Society, representing different aspects and approaches to engaging in the issue of chemical contamination of surface waters. It widens the scope for assessment and management of chemicals in comparison to a traditional (mostly) perchemical risk assessment approaches by including abatement- and societal approaches as optional solutions. The solution-focused approach implies an identification of abatement- and policy options upfront in the risk assessment process. The conceptual framework was designed for use in current and future chemical pollution assessments for the aquatic environment, including the specific challenges encountered in prioritising individual chemicals and mixtures, and is applicable for the development of approaches for safe chemical management in a broader sense. The four access points of the conceptual framework are interlinked by four key topics representing the main scientific challenges that need to be addressed, i.e.: identifying and prioritising hazardous chemicals at different scales; selecting relevant and efficient abatement options; providing regulatory support for chemicals management; predicting and prioritising future chemical risks. The conceptual framework aligns current challenges in the safe production and use of chemicals. The current state of knowledge and implementation

  5. 现代残疾康复理念、政策与社区康复体系研究%Current Conceptual Framework and Policies of Disability and Rehabilitation and Approach of Community-based Rehabilitation

    Institute of Scientific and Technical Information of China (English)

    邱卓英; 李多

    2011-01-01

    This paper explored the current conceptual framework of disability and rehabilitation, and constructed theorctical structure with three layers of international convention, resolutions and policies, and domestic laws and operational lools. The characteristics of community-based rehabilitation (CBR) had been discussed with inclusive development approach. Some recommendations had been proposed for the development of rehabilitation and work programs of rehabilitation for all in China.%本研究分析了当代残疾康复的理念和理论架构,构建了以国际公约、决议和政策、国内法律和政策以及操作性工具3个层次的康复理论体系;运用包容性发展,分析探讨了当代社区康复的体系和特点;就发展康复事业、为残疾人提供全面系统的康复服务提出相关的政策建议。

  6. Regulatory hurdles for genome editing: process- vs. product-based approaches in different regulatory contexts.

    Science.gov (United States)

    Sprink, Thorben; Eriksson, Dennis; Schiemann, Joachim; Hartung, Frank

    2016-07-01

    Novel plant genome editing techniques call for an updated legislation regulating the use of plants produced by genetic engineering or genome editing, especially in the European Union. Established more than 25 years ago and based on a clear distinction between transgenic and conventionally bred plants, the current EU Directives fail to accommodate the new continuum between genetic engineering and conventional breeding. Despite the fact that the Directive 2001/18/EC contains both process- and product-related terms, it is commonly interpreted as a strictly process-based legislation. In view of several new emerging techniques which are closer to the conventional breeding than common genetic engineering, we argue that it should be actually interpreted more in relation to the resulting product. A legal guidance on how to define plants produced by exploring novel genome editing techniques in relation to the decade-old legislation is urgently needed, as private companies and public researchers are waiting impatiently with products and projects in the pipeline. We here outline the process in the EU to develop a legislation that properly matches the scientific progress. As the process is facing several hurdles, we also compare with existing frameworks in other countries and discuss ideas for an alternative regulatory system.

  7. Safeguards inventory and process monitoring regulatory comparison

    Energy Technology Data Exchange (ETDEWEB)

    Cavaluzzi, Jack M. [Texas A & M Univ., College Station, TX (United States); Gibbs, Philip W. [Brookhaven National Lab. (BNL), Upton, NY (United States)

    2013-06-27

    Detecting the theft or diversion of the relatively small amount of fissile material needed to make a nuclear weapon given the normal operating capacity of many of today’s running nuclear production facilities is a difficult task. As throughput increases, the ability of the Material Control and Accountability (MC&A) Program to detect the material loss decreases because the statistical measurement uncertainty also increases. The challenge faced is the ability of current accounting, measurement, and material control programs to detect small yet significant losses under some regulatory approaches can decrease to the point where it is extremely low if not practically non-existent at normal operating capacities. Adding concern to this topic is that there are variations among regulatory bodies as far as what is considered a Significant Quantity (SQ). Some research suggests that thresholds should be lower than those found in any current regulation which if adopted would make meeting detection goals even more difficult. This paper reviews and compares the current regulatory requirements for the MA elements related to physical inventory, uncertainty of the Inventory Difference (ID), and Process Monitoring (PM) in the United States Department of Energy (DOE) and Nuclear Regulatory Commission (NRC), Rosatom of the Russian Federation and the Chinese Atomic Energy Agency (CAEA) of China. The comparison looks at how the regulatory requirements for the implementation of various MA elements perform across a range of operating capacities in example facilities.

  8. Regulatory T cell memory

    Science.gov (United States)

    Rosenblum, Michael D.; Way, Sing Sing; Abbas, Abul K.

    2016-01-01

    Memory for antigen is a defining feature of adaptive immunity. Antigen-specific lymphocyte populations show an increase in number and function after antigen encounter and more rapidly re-expand upon subsequent antigen exposure. Studies of immune memory have primarily focused on effector B cells and T cells with microbial specificity, using prime challenge models of infection. However, recent work has also identified persistently expanded populations of antigen-specific regulatory T cells that protect against aberrant immune responses. In this Review, we consider the parallels between memory effector T cells and memory regulatory T cells, along with the functional implications of regulatory memory in autoimmunity, antimicrobial host defence and maternal fetal tolerance. In addition, we discuss emerging evidence for regulatory T cell memory in humans and key unanswered questions in this rapidly evolving field. PMID:26688349

  9. Regulatory Models and the Environment: Practice, Pitfalls, and Prospects

    Energy Technology Data Exchange (ETDEWEB)

    Holmes, K. John; Graham, Judith A.; McKone, Thomas; Whipple, Chris

    2008-06-01

    Computational models support environmental regulatory activities by providing the regulator an ability to evaluate available knowledge, assess alternative regulations, and provide a framework to assess compliance. But all models face inherent uncertainties, because human and natural systems are always more complex and heterogeneous than can be captured in a model. Here we provide a summary discussion of the activities, findings, and recommendations of the National Research Council's Committee on Regulatory Environmental Models, a committee funded by the US Environmental Protection Agency to provide guidance on the use of computational models in the regulatory process. Modeling is a difficult enterprise even outside of the potentially adversarial regulatory environment. The demands grow when the regulatory requirements for accountability, transparency, public accessibility, and technical rigor are added to the challenges. Moreover, models cannot be validated (declared true) but instead should be evaluated with regard to their suitability as tools to address a specific question. The committee concluded that these characteristics make evaluation of a regulatory model more complex than simply comparing measurement data with model results. Evaluation also must balance the need for a model to be accurate with the need for a model to be reproducible, transparent, and useful for the regulatory decision at hand. Meeting these needs requires model evaluation to be applied over the"life cycle" of a regulatory model with an approach that includes different forms of peer review, uncertainty analysis, and extrapolation methods than for non-regulatory models.

  10. 4th IEA International CCS Regulatory Network Meeting

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2012-07-01

    On 9 and 10 May 2012, the IEA International CCS Regulatory Network (Network), launched in Paris in May 2008 to provide a neutral forum for CCS regulators, policy makers and stakeholders to share updates and views on CCS regulatory developments, held its fourth meeting at the International Energy Agency (IEA) offices in Paris, France. The aim of the meeting was to: provide an update on government efforts to develop and implement carbon capture and storage (CCS) legal and regulatory frameworks; and consider ways in which governments are dealing with some of the more difficult or complex aspects of CCS regulation. This report summarises the proceedings of the meeting.

  11. Phased array ultrasonic inspection of feeder welds - regulatory perspective

    Energy Technology Data Exchange (ETDEWEB)

    Carroll, B.; Kirkhope, K.; Colligan, L.; Valpy, B.; Stevenson, J. [Canadian Nuclear Safety Commission, Ottawa, Ontario (Canada)

    2011-07-01

    The Canadian Nuclear Safety Commission has accepted the application of Phased Array Ultrasonic Testing (PAUT) in lieu of Radiographic Testing for feeder piping replacement at the Point Lepreau and Bruce A Units 1 and 2 refurbishment projects. Background information regarding the principles and elements of the CNSC regulatory approach for the acceptance of PAUT for feeder installation will be discussed, addressing quality management and regulatory oversight activities focused on inspection reliability and dose reduction. CNSC staff's views for future direction on the application of PAUT in lieu of RT in regulatory framework and codes and standards are also discussed. (author)

  12. The OECD Fish Testing Framework Project

    Science.gov (United States)

    OECD Project 2.30 on a Fish Testing Framework was initiated in mid-2009, with the United States as the lead country. The objectives of the project are to review the regulatory needs and data requirements for fish testing and review the currency of existing OECD Test Guidelines. ...

  13. Factors influencing quality decision-making: regulatory and pharmaceutical industry perspectives.

    Science.gov (United States)

    Donelan, Ronan; Walker, Stuart; Salek, Sam

    2015-03-01

    Currently, there is no qualified understanding of the influences, behaviours and other factors that impact the decision-making of individuals and organisations involved in the development of new medicines. The aim of this qualitative study was to investigate and identify the important issues that influence quality decision-making. Semi-structured interviews were carried out with 29 senior decision-makers from the pharmaceutical industry and regulatory authorities. The study participants were invited to discuss and review their perception of decision-making within their organisation, its role in drug development and the regulatory review and their awareness and use of decision-making techniques and the impact and monitoring of decisions. The analyses (using NVivo 8(©) software) resulted in the identification of 32 major and 97 sub-themes that were consolidated into 19 overarching themes. These included items such as quality and validity of data, time considerations, organisational and cultural influences, analytical and logical approach, qualification and experience, subjective and personal considerations, political influences, precedents for similar previous decisions, understanding of the decision in question, impact analyses, audit trail, education and awareness, individual versus corporate decision-making and frameworks. Relationships between themes were identified. The 19 overarching decision-making themes were integrated into a framework for quality decision-making. This study has achieved its aim of exploring decision-making from the perspective of the individual and the organisation working in drug development and the regulatory review and has identified issues and considerations relating to making good quality decisions and allowed for the generation of a framework to aid quality decision-making. Copyright © 2015 John Wiley & Sons, Ltd.

  14. From molecule to market access: drug regulatory science as an upcoming discipline.

    Science.gov (United States)

    Gispen-de Wied, Christine C; Leufkens, Hubertus G M

    2013-11-05

    Regulatory science as a discipline has evolved over the past years with the object to boost and promote scientific rationale behind benefit/risk and decision making by regulatory authorities. The European Medicines Agency, EMA, the Food and Drug Administration, FDA, and the Japanese Pharmaceutical and Medical Devices Agency, PMDA, highlighted in their distinct ways the importance of regulatory science as a basis of good quality assessment in their strategic plans. The Medicines Evaluation Board, MEB, states: 'regulatory science is the science of developing and validating new standards and tools to evaluate and assess the benefit/risk of medicinal products, facilitating sound and transparent regulatory decision making'. Through analysis of regulatory frameworks itself and their effectiveness, however, regulatory science can also advance knowledge of these systems in general. The comprehensive guidance that is issued to complete an application dossier for regulatory product approval has seldomly been scrutinized for its efficiency. Since it is the task of regulatory authorities to protect and promote public health, it is understood that they take a cautious approach in regulating drugs prior to market access. In general, the authorities are among the first to be blamed if dangerous or useless drugs were allowed to the market. Yet, building a regulatory framework that is not challenged continuously in terms of deliverables for public health and cost-effectiveness, might be counterproductive in the end. Regulatory science and research can help understand how and why regulatory decisions are made, and where renewed discussions may be warranted. The MEB supports regulatory science as an R&D activity to fuel primary regulatory processes on product evaluation and vigilance, but also invests in a 'looking into the mirror' approach. Along the line of the drug life-cycle, publicly available data are reviewed and their regulatory impact highlighted. If made explicit

  15. Review of Policy, Regulatory, and Organizational Frameworks of ...

    African Journals Online (AJOL)

    kim

    report in 2010 as part of the global endeavor to characterize and underscore the importance of connecting health .... harnessing hydro, geothermal, and solar energy. None of these produces ... Implementation of the policy needs strategic research plans or policy .... them, heightens our hope for living in a pollution-free.

  16. Assessment of the Institutional Regulatory Framework of Auditor ...

    African Journals Online (AJOL)

    Nneka Umera-Okeke

    proliferation of Accounting Professional Bodies and decline in Ethics. The study, ... its statutory duties and responsibilities. At least one board ... auditor; and performance of the company's internal audit function as well as that of external ...

  17. law of the dance: legal and regulatory framework for promoting ...

    African Journals Online (AJOL)

    RAYAN_

    easily highlight the strategic power of dance and melody in inspiring societal development in .... which involves the development and exercise of their capacities for rationality ..... 33 Amy Morin, “Can Music Be a Bad Influence on Kids & Teens?” (27 January ... of money, ostentatious goods, and the ratification of the excess.

  18. Review of Policy, Regulatory, and Organizational Frameworks of ...

    African Journals Online (AJOL)

    Background: Ethiopia produced its Environmental Health Situational ... 2010 as part of the global endeavor to characterize and underscore the importance of ... with a focus on air pollution, occupational safety and health, and climate change.

  19. LEGAL ASPECTS OF THE REGULATORY FRAMEWORK FOR CREDIT RATING AGENCIES

    Directory of Open Access Journals (Sweden)

    Oana Mihaela MARIOARA (ORHEIAN

    2014-06-01

    Full Text Available This article makes an analysis of the main regulations used by the credit rating agencies on the financial market. The article describes the main specific legislation on credit rating agencies existing on the market. Credit rating agencies are issuing independent opinions on the reliability of an entity, of a debt, of financial obligations, or of a certain financial instrument. The credit ratings issued by the credit rating agencies established in the European Union are analysed by investors, debtors, issuers and governments, helping all these entities in making any decisions on investments and financing. These ratings may also serve as reference for determining their own funds, necessary to ensure the solvency or reference helping the investors in assessing any risks related to their investment activities. Rating agencies and the products they offer on the international capital market are subject of various researches, which mainly refer to market structure and organization, to the architecture of agencies` s rating systems, to the rating functions, to the controversies concerning rating activity, the role of rating agencies and rating quality.

  20. Towards an adequate regulatory framework for bacteriophage therapy

    OpenAIRE

    Verbeken, Gilbert

    2015-01-01

    Summary The worldwide emergence of antibiotic resistant bacteria and constraints to investment in potential solutions may eventually lead to a return to the pre-antibiotic era. As industries’ antibiotic pipeline is virtually dry and infectious diseases are steadily on the increase, the use of bacteriophages (bacteriophages are bacterio-specific viruses) to kill bacteria can be considered as a valuable option. Bacteriophages (meaning “bacteria-eaters”) are the bacteria’s natural enemie...

  1. Better understanding of the EU regulatory frameworks for cosmetic products.

    Science.gov (United States)

    Rasmussen, Kirsten; Mech, Agnieszka

    2014-05-01

    This letter to the editor corrects some misunderstandings regarding the EU regulations covering cosmetic products stated in a recent publication by A. Sobek et al. "In the shadow of the cosmetics directive - Inconsistencies in EU environmental hazard classification requirements for UV-filters" published in Science of the Total Environment 461-462 (2013) 706-711.

  2. Oceans and the regulatory framework: A techno-legal perspective

    Digital Repository Service at National Institute of Oceanography (India)

    VijayKumar, B.

    organizations are to be held responsible for damage caused by their own research activities or for action they take against the research conducted by others when such action contravenes the Convention. In the event of certain disputes the researching state... over maritime areas adjacent to their coasts, navigation and marine transport, overflight of aircraft, marine pollution, marine scientific research and technology, conservation and exploitation of marine living resources, and the development...

  3. Department of Agriculture Semiannual Regulatory Agenda

    Science.gov (United States)

    2010-04-26

    ... members of the public have advocated for amending the regulations for sourcing dairy replacement animals. They have asserted that the current regulatory language on sourcing dairy replacement animals lacks... Order for dairy product promotion, research, and nutrition education as part of a comprehensive strategy...

  4. IS Audit Considerations in Respect of Current Economic Environment

    Directory of Open Access Journals (Sweden)

    Vlasta Svata

    2011-01-01

    Full Text Available Accountancy organizations, regulatory bodies, standard setters, and other international organizations have developed guidance, articles, frameworks and resources on issues related to the global financial crisis. Now there is a clear and widely accepted need for more rigorous governance over companies´ systems of internal control. Historically there exist many different activities aiming to support effective enterprise governance (legislative acts, best practices, standards, frameworks. But all these activities may have reinforced the already-existing focus on enterprise governance, but they did not necessarily bring clarity to the topic. Therefore we can currently notice some changes aiming to improve the adoption and adaptation of best practices and standards within the area of enterprise governance. The paper discusses the changes in the Enterprise Governance of IT/IS, audit/assurance evolution, and intended Cobit improvements.

  5. Carbon Capture and Storage Legal and Regulatory Review. Edition 3

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2012-07-01

    The International Energy Agency (IEA) considers carbon capture and storage (CCS) a crucial part of worldwide efforts to limit global warming by reducing greenhouse-gas emissions. The IEA estimates that emissions can be reduced to a level consistent with a 2°C global temperature increase through the broad deployment of low-carbon energy technologies – and that CCS would contribute about one-fifth of emission reductions in this scenario. Achieving this level of deployment will require that regulatory frameworks – or rather a lack thereof – do not unnecessarily impede environmentally safe demonstration and deployment of CCS, so in October 2010 the IEA launched the IEA Carbon Capture and Storage Legal and Regulatory Review. The CCS Review is a regular review of CCS regulatory progress worldwide. Produced annually, it collates contributions by national and regional governments, as well as leading organisations engaged in CCS regulatory activities, to provide a knowledge-sharing forum to support CCS framework development. Each two page contribution provides a short summary of recent and anticipated CCS regulatory developments and highlights a particular, pre-nominated regulatory theme. To introduce each edition, the IEA provides a brief analysis of key advances and trends, based on the contributions submitted. The theme for this third edition is stakeholder engagement in the development of CO2 storage projects. Other issues addressed include: regulating CO2-EOR, CCS and CO2-EOR for storage; CCS incentive policy; key, substantive issues being addressed by jurisdictions taking steps to finalise CCS regulatory framework development; and CCS legal and regulatory developments in the context of the Clean Energy Ministerial Carbon Capture, Use and Storage Action Group.

  6. Revised analyses of decommissioning for the reference pressurized Water Reactor Power Station. Volume 2, Effects of current regulatory and other considerations on the financial assurance requirements of the decommissioning rule and on estimates of occupational radiation exposure: Appendices, Final report

    Energy Technology Data Exchange (ETDEWEB)

    Konzek, G.J.; Smith, R.I.; Bierschbach, M.C.; McDuffie, P.N.

    1995-11-01

    With the issuance of the final Decommissioning Rule (July 27, 1998), owners and operators of licensed nuclear power plants are required to prepare, and submit to the US Nuclear Regulatory Commission (NRC) for review, decommissioning plans and cost estimates. The NRC staff is in need of bases documentation that will assist them in assessing the adequacy of the licensee submittals, from the viewpoint of both the planned actions, including occupational radiation exposure, and the probable costs. The purpose of this reevaluation study is to provide some of the needed bases documentation. This report contains the results of a review and reevaluation of the 1978 PNL decommissioning study of the Trojan nuclear power plant (NUREG/CR-0130), including all identifiable factors and cost assumptions which contribute significantly to the total cost of decommissioning the nuclear power plant for the DECON, SAFSTOR, and ENTOMB decommissioning alternatives. These alternatives now include an initial 5--7 year period during which time the spent fuel is stored in the spent fuel pool, prior to beginning major disassembly or extended safe storage of the plant. Included for information (but not presently part of the license termination cost) is an estimate of the cost to demolish the decontaminated and clean structures on the site and to restore the site to a ``green field`` condition. This report also includes consideration of the NRC requirement that decontamination and decommissioning activities leading to termination of the nuclear license be completed within 60 years of final reactor shutdown, consideration of packaging and disposal requirements for materials whose radionuclide concentrations exceed the limits for Class C low-level waste (i.e., Greater-Than-Class C), and reflects 1993 costs for labor, materials, transport, and disposal activities.

  7. Revised analyses of decommissioning for the reference pressurized Water Reactor Power Station. Effects of current regulatory and other considerations on the financial assurance requirements of the decommissioning rule and on estimates of occupational radiation exposure, Volume 1, Final report

    Energy Technology Data Exchange (ETDEWEB)

    Konzek, G.J.; Smith, R.I.; Bierschbach, M.C.; McDuffie, P.N. [Pacific Northwest Lab., Richland, WA (United States)

    1995-11-01

    With the issuance of the final Decommissioning Rule (July 27, 1988), owners and operators of licensed nuclear power plants are required to prepare, and submit to the US Nuclear Regulatory Commission (NRC) for review, decommissioning plans and cost estimates. The NRC staff is in need of bases documentation that will assist them in assessing the adequacy of the licensee submittals, from the viewpoint of both the planned actions, including occupational radiation exposure, and the probable costs. The purpose of this reevaluation study is to provide some of the needed bases documentation. This report contains the results of a review and reevaluation of the {prime}978 PNL decommissioning study of the Trojan nuclear power plant (NUREG/CR-0130), including all identifiable factors and cost assumptions which contribute significantly to the total cost of decommissioning the nuclear power plant for the DECON, SAFSTOR, and ENTOMB decommissioning alternatives. These alternatives now include an initial 5--7 year period during which time the spent fuel is stored in the spent fuel pool, prior to beginning major disassembly or extended safe storage of the plant. Included for information (but not presently part of the license termination cost) is an estimate of the cost to demolish the decontaminated and clean structures on the site and to restore the site to a ``green field`` condition. This report also includes consideration of the NRC requirement that decontamination and decommissioning activities leading to termination of the nuclear license be completed within 60 years of final reactor shutdown, consideration of packaging and disposal requirements for materials whose radionuclide concentrations exceed the limits for Class C low-level waste (i.e., Greater-Than-Class C), and reflects 1993 costs for labor, materials, transport, and disposal activities.

  8. Rationales for regulatory activity

    Energy Technology Data Exchange (ETDEWEB)

    Perhac, R.M. [Univ. of Tennessee, Knoxville, TN (United States)

    1997-02-01

    The author provides an outline which touches on the types of concerns about risk evaluation which are addressed in the process of establishing regulatory guides. Broadly he says regulatory activity serves three broad constituents: (1) Paternalism (private risk); (2) Promotion of social welfare (public risks); (3) Protection of individual rights (public risks). He then discusses some of the major issues encountered in reaching a decision on what is an acceptable level of risk within each of these areas, and how one establishes such a level.

  9. Measuring and Modeling the U.S. Regulatory Ecosystem

    Science.gov (United States)

    Bommarito, Michael J., II; Katz, Daniel Martin

    2017-07-01

    Over the last 23 years, the U.S. Securities and Exchange Commission has required over 34,000 companies to file over 165,000 annual reports. These reports, the so-called "Form 10-Ks," contain a characterization of a company's financial performance and its risks, including the regulatory environment in which a company operates. In this paper, we analyze over 4.5 million references to U.S. Federal Acts and Agencies contained within these reports to measure the regulatory ecosystem, in which companies are organisms inhabiting a regulatory environment. While individuals across the political, economic, and academic world frequently refer to trends in this regulatory ecosystem, far less attention has been paid to supporting such claims with large-scale, longitudinal data. In this paper, in addition to positing a model of regulatory ecosystems, we document an increase in the regulatory energy per filing, i.e., a warming "temperature." We also find that the diversity of the regulatory ecosystem has been increasing over the past two decades. These findings support the claim that regulatory activity and complexity are increasing, and this framework contributes an important step towards improving academic and policy discussions around legal complexity and regulation.

  10. Measuring and Modeling the U.S. Regulatory Ecosystem

    Science.gov (United States)

    Bommarito, Michael J., II; Katz, Daniel Martin

    2017-09-01

    Over the last 23 years, the U.S. Securities and Exchange Commission has required over 34,000 companies to file over 165,000 annual reports. These reports, the so-called "Form 10-Ks," contain a characterization of a company's financial performance and its risks, including the regulatory environment in which a company operates. In this paper, we analyze over 4.5 million references to U.S. Federal Acts and Agencies contained within these reports to measure the regulatory ecosystem, in which companies are organisms inhabiting a regulatory environment. While individuals across the political, economic, and academic world frequently refer to trends in this regulatory ecosystem, far less attention has been paid to supporting such claims with large-scale, longitudinal data. In this paper, in addition to positing a model of regulatory ecosystems, we document an increase in the regulatory energy per filing, i.e., a warming "temperature." We also find that the diversity of the regulatory ecosystem has been increasing over the past two decades. These findings support the claim that regulatory activity and complexity are increasing, and this framework contributes an important step towards improving academic and policy discussions around legal complexity and regulation.

  11. Framework for continuous performance improvement in small drinking water systems.

    Science.gov (United States)

    Bereskie, Ty; Haider, Husnain; Rodriguez, Manuel J; Sadiq, Rehan

    2017-01-01

    Continuous performance improvement (CPI) can be a useful approach to overcome water quality problems impacting small communities. Small drinking water systems (SDWSs) struggle to meet regulatory requirements and often lack the economic and human resource flexibility for immediate improvement. A CPI framework is developed to provide SDWS managers and operators an approach to gauge their current performance against similar systems and to track performance improvement from the implementation of the new technologies or innovations into the future. The proposed CPI framework incorporates the use of a water quality index (WQI) and functional performance benchmarking to evaluate and compare drinking water quality performance of an individual water utility against that of a representative benchmark. The results are then used to identify and prioritize the most vulnerable water quality indicators and subsequently identify and prioritize performance improvement strategies. The proposed CPI framework has been demonstrated using data collected from SDWSs in the province of Newfoundland and Labrador (NL), Canada and using the Canadian Council of Ministers of the Environment (CCME) WQI.

  12. ROMANIAN AERONAUTICAL METEOROLOGY APPLICABLE LEGAL FRAMEWORK –BRIEFING

    Directory of Open Access Journals (Sweden)

    CATALIN POPA

    2012-05-01

    Full Text Available The purpose of this briefing is toprovide an overview of the aeronautical meteorology legal framework in Romania. In this context, the role and importance of aeronautical meteorology in international air traffic management will be underlined, with focus on the civil aviation activity in Romania. The international legal framework and modalities of implementing these rules at national level will constitute a significant part of the present study., Specific accent will be put on the national regulatory framework and structure, means of updating it, and how it responds to changing regulatory requirements.

  13. Sci-Vis Framework

    Energy Technology Data Exchange (ETDEWEB)

    2015-03-11

    SVF is a full featured OpenGL 3d framework that allows for rapid creation of complex visualizations. The SVF framework handles much of the lifecycle and complex tasks required for a 3d visualization. Unlike a game framework SVF was designed to use fewer resources, work well in a windowed environment, and only render when necessary. The scene also takes advantage of multiple threads to free up the UI thread as much as possible. Shapes (actors) in the scene are created by adding or removing functionality (through support objects) during runtime. This allows a highly flexible and dynamic means of creating highly complex actors without the code complexity (it also helps overcome the lack of multiple inheritance in Java.) All classes are highly customizable and there are abstract classes which are intended to be subclassed to allow a developer to create more complex and highly performant actors. There are multiple demos included in the framework to help the developer get started and shows off nearly all of the functionality. Some simple shapes (actors) are already created for you such as text, bordered text, radial text, text area, complex paths, NURBS paths, cube, disk, grid, plane, geometric shapes, and volumetric area. It also comes with various camera types for viewing that can be dragged, zoomed, and rotated. Picking or selecting items in the scene can be accomplished in various ways depending on your needs (raycasting or color picking.) The framework currently has functionality for tooltips, animation, actor pools, color gradients, 2d physics, text, 1d/2d/3d textures, children, blending, clipping planes, view frustum culling, custom shaders, and custom actor states

  14. Self-Regulatory Climate: A Positive Attribute of Public Schools

    Science.gov (United States)

    Adams, Curt M.; Ware, Jordan K.; Miskell, Ryan C.; Forsyth, Patrick B.

    2016-01-01

    This study contributes to the development of a positive framework for effective public schools in 2 ways. First, it advances the construct self-regulatory climate as consisting of 3 generative school norms--collective faculty trust in students, collective student trust in teachers, and student-perceived academic emphasis. The authors argue these…

  15. REGULATORY AND PRACTICAL MATTERS REGARDING CHILD PROTECTION IN ROMANIA

    Directory of Open Access Journals (Sweden)

    Mihaela Tofan

    2013-11-01

    Full Text Available Social protection of children as prerequisite of social economy is a topic of theoretical and practical analysis over Romanian law system. Addressing the regulatory framework in force and following the practical impact of the effects that legal rules may generate, the article leads to conclusions on improving and developing institutions and mechanisms that support the coherent functioning of the social economy.

  16. Regulatory uncertainty and opportunity seeking: The case of clean development

    NARCIS (Netherlands)

    A. Kolk; G. Mulder

    2011-01-01

    Regulatory uncertainty has been inherent to climate change in the absence of a successor to the Kyoto Protocol and with ongoing policy discussions on how to proceed. To facilitate steps to help address the issue, many companies have called for more certainty and a stable policy framework. What has r

  17. Prediction of regulatory elements

    DEFF Research Database (Denmark)

    Sandelin, Albin

    2008-01-01

    Finding the regulatory mechanisms responsible for gene expression remains one of the most important challenges for biomedical research. A major focus in cellular biology is to find functional transcription factor binding sites (TFBS) responsible for the regulation of a downstream gene. As wet-lab...

  18. The Effectiveness of the Regulatory Regime for Black Carbon Mitigation in the Arctic

    Directory of Open Access Journals (Sweden)

    Daria Shapovalova

    2016-11-01

    Full Text Available In addition to being a hazardous air pollutant, Black Carbon is the second-largest contributor to Arctic warming. Its mitigation is being addressed at the international regulatory level by the Arctic Council and the Convention on Long-Range Transboundary Air Pollution (CLRTAP. Whilst the Convention and its protocols are binding documents, the Black Carbon regulation under their framework appears to have ‘soft law’ characteristics. At the same time, the voluntary Black Carbon and Methane Framework, adopted by the Arctic Council, demonstrates positive compliance and follow-up dynamics compared to earlier norm-creating attempts. This paper argues that the nature of the norm (binding or non-binding is not the decisive factor regarding effective implementation in the Arctic region. Current efforts to mitigate Black Carbon by means of a non-binding Arctic Council Black Carbon and Methane Framework represent an improvement in the Council's normative function and may have more effect on the behaviour of Arctic States than relevant provisions under the Gothenburg Protocol to the CLRTAP. To support this argument, the first section presents an overview of the Arctic Council as an actor in Arctic policy-making. It then provides an assessment of current efforts to combat Black Carbon carried out by the Arctic Council and the CLRTAP.

  19. Regulatory approval pathways for anticancer drugs in Japan, the EU and the US.

    Science.gov (United States)

    Nagai, Sumimasa; Ozawa, Keiya

    2016-07-01

    The Pharmaceuticals and Medical Devices Agency and the Ministry of Health, Labour and Welfare in Japan and the US Food and Drug Administration are responsible for reviewing applications and approving drugs, medical devices, and regenerative medicines. In the EU, the European Medicines Agency is responsible for the centralized authorization procedure of medicines including oncologic drugs. In this review, we discuss general pathways for the marketing authorization of oncologic drugs and other drugs in Japan, the EU, and the US. There are still unmet medical needs in oncology, whereas scientific innovation and clinical development in oncology are rapid and active, suggesting a reasonable scope for new regulatory schemes for expedited review. Because regulatory schemes are also evolving rapidly, clinicians and academic researchers may have difficulty following the updated regulations in other regions as well as those in their own countries. However, keeping current with new regulations is important for the conduct of translational research and clinical development of new therapeutic products efficiently. This review is intended to help an international audience better understand the essence of the regulatory frameworks for the marketing authorization of oncologic drugs in Japan, the EU, and the US.

  20. Motif Discovery in Tissue-Specific Regulatory Sequences Using Directed Information

    Directory of Open Access Journals (Sweden)

    States David

    2007-01-01

    Full Text Available Motif discovery for the identification of functional regulatory elements underlying gene expression is a challenging problem. Sequence inspection often leads to discovery of novel motifs (including transcription factor sites with previously uncharacterized function in gene expression. Coupled with the complexity underlying tissue-specific gene expression, there are several motifs that are putatively responsible for expression in a certain cell type. This has important implications in understanding fundamental biological processes such as development and disease progression. In this work, we present an approach to the identification of motifs (not necessarily transcription factor sites and examine its application to some questions in current bioinformatics research. These motifs are seen to discriminate tissue-specific gene promoter or regulatory regions from those that are not tissue-specific. There are two main contributions of this work. Firstly, we propose the use of directed information for such classification constrained motif discovery, and then use the selected features with a support vector machine (SVM classifier to find the tissue specificity of any sequence of interest. Such analysis yields several novel interesting motifs that merit further experimental characterization. Furthermore, this approach leads to a principled framework for the prospective examination of any chosen motif to be discriminatory motif for a group of coexpressed/coregulated genes, thereby integrating sequence and expression perspectives. We hypothesize that the discovery of these motifs would enable the large-scale investigation for the tissue-specific regulatory role of any conserved sequence element identified from genome-wide studies.

  1. Linking the Regulatory and Reimbursement Processes for Medical Devices: The Need for Integrated Assessments.

    Science.gov (United States)

    Ciani, Oriana; Wilcher, Britni; van Giessen, Anoukh; Taylor, Rod S

    2017-02-01

    Much criticism has been directed at the licencing requirements for medical devices (MDs) as they often result in a lack of robust evidence to inform health technology assessment (HTA) decisions. To better understand the current international decisional framework on MD technologies, we undertook three linked research studies: a review of the device regulatory procedures, a survey of current HTA practices and an empirical comparison of HTA reports of drugs versus MDs. Our review confirms that current device regulatory processes across the globe are substantially less stringent than drugs. As a result, international HTA agencies report that they face a number of challenges when assessing MDs, including reliance on suboptimal data to make clinical and cost-effectiveness decisions. Whilst many HTA agencies have adapted their processes and procedures to handle MD technology submissions, in our comparison of HTA reports we found little evidence of the application of methodologies that take account of device-specific issues, such as incremental development. Overall, our research reinforces the need for better linkage between licencing and HTA and the development and application of innovative HTA methodologies with the objective of securing faster patient access for those technologies that can be shown to represent good value for money. © 2017 The Authors. Health Economics Published by John Wiley & Sons, Ltd.

  2. Regulatory approval of cancer risk-reducing (chemopreventive) drugs: moving what we have learned into the clinic.

    Science.gov (United States)

    Meyskens, Frank L; Curt, Gregory A; Brenner, Dean E; Gordon, Gary; Herberman, Ronald B; Finn, Olivera; Kelloff, Gary J; Khleif, Samir N; Sigman, Caroline C; Szabo, Eva

    2011-03-01

    This article endeavors to clarify the current requirements and status of regulatory approval for chemoprevention (risk reduction) drugs and discusses possible improvements to the regulatory pathway for chemoprevention. Covering a wide range of topics in as much depth as space allows, this report is written in a style to facilitate the understanding of nonscientists and to serve as a framework for informing the directions of experts engaged more deeply with this issue. Key topics we cover here are as follows: a history of definitive cancer chemoprevention trials and their influence on the evolution of regulatory assessments; a brief review of the long-standing success of pharmacologic risk reduction of cardiovascular diseases and its relevance to approval for cancer risk reduction drugs; the use and limitations of biomarkers for developing and the approval of cancer risk reduction drugs; the identification of individuals at a high(er) risk for cancer and who are appropriate candidates for risk reduction drugs; business models that should incentivize pharmaceutical industry investment in cancer risk reduction; a summary of scientific and institutional barriers to development of cancer risk reduction drugs; and a summary of major recommendations that should help facilitate the pathway to regulatory approval for pharmacologic cancer risk reduction drugs.

  3. REGULATORY AGENCIES, CONSUMER AND ENVIROMENT

    Directory of Open Access Journals (Sweden)

    Giseli Valezi Raymundo

    2011-03-01

    Full Text Available The aim of this paper is to present the analysis on the insertion of the consumer in the current model of State in Brazil, considering the nowaday legal system. It is wished to be shown, moreover, the already existing reality on the theme, even if modest, so to in a way to question the responsibility of the consumer, according to its consuming habits and its inertia, takes in today’s technological society. To such proposal, the most effective research method, and, for this reason had been used in this paper, is the extensive bibliography research and legislation consultation. Through it, it had been found that the State model has changed over the past decades in order to delegate the execution of various activities of State ownership to private enterprise, in view of the existence of a minimal State and governor. In this sense, there were created the Regulatory Agencies, which are indirect public administration entities, with the ultimate objective of regulating and supervising the execution of those legal activities, performed by the private sector. The consumer, inserted in this reality, is the direct recipient of the action of the mentioned entities, questioning the legislative and sanction legitimacy of the regulatory entities as well as the possibility of judicial review on the merits of administrative actions of these entities and the applicability of the Brazilian Code of Defense of the Consumer (CDC to the execution of public services, a discipline that affects the administrative law rights. Notwithstanding the above analysis in context, all these social workers, consumers and regulatory agencies are immersed in changing habits, due to the optimization of actions, aimed at preserving the environment, the prospect of achieving sustainable development. Based on this perspective, the results brought by the survey showed that the application of the Brazilian Code of Defense of the Consumer in relations between consumers does not preclude

  4. Gene regulatory networks governing pancreas development.

    Science.gov (United States)

    Arda, H Efsun; Benitez, Cecil M; Kim, Seung K

    2013-04-15

    Elucidation of cellular and gene regulatory networks (GRNs) governing organ development will accelerate progress toward tissue replacement. Here, we have compiled reference GRNs underlying pancreas development from data mining that integrates multiple approaches, including mutant analysis, lineage tracing, cell purification, gene expression and enhancer analysis, and biochemical studies of gene regulation. Using established computational tools, we integrated and represented these networks in frameworks that should enhance understanding of the surging output of genomic-scale genetic and epigenetic studies of pancreas development and diseases such as diabetes and pancreatic cancer. We envision similar approaches would be useful for understanding the development of other organs.

  5. Competency frameworks: which format for which target?

    Science.gov (United States)

    Vandeweerd, Jean-Michel; Cambier, Carole; Romainville, Marc; Perrenoud, Philippe; Desbrosse, Francis; Dugdale, Alexandra; Gustin, Pascal

    2014-01-01

    In veterinary medical education, it is now necessary to design competency frameworks (CFs) that list expected competencies at graduation. Three different CFs with different formats and contents have been published in Europe, such as the Day One Skills (DOS), the recommendations of the World Organization for Animal Health(OIE), and the Veterinary Professional (VetPro). In the current study, on the basis of a survey among Belgian veterinarians, a fourth document was designed that lists the necessary knowledge, skills, and attitudes grouped into families according to professional situations. The objectives of this study were to assess the perception of CFs by various categories of stakeholders, identify the possible uses of CFs, and determine whether one format should be preferred to another. We used a qualitative approach based on semi-structured face-to-face interviews with different stakeholders after they had reviewed the four different documents (CFs). This study showed that an obligation to design CFs was clearly perceived by academic and professional authorities. Teachers and veterinarians may be either enthusiastic or apprehensive about CFs, while students perceive the usefulness of the documents to plan and assess their learning objectives. Three main roles of CFs were identified: they can be used as communication tools, regulatory tools, or educational tools. However, not one of the documents used in this study was perceived to fulfill all roles. It is therefore likely that no one ideal document yet exists and a combination of formats is necessary.

  6. Watershed Planning within a Quantitative Scenario Analysis Framework.

    Science.gov (United States)

    Merriam, Eric R; Petty, J Todd; Strager, Michael P

    2016-07-24

    There is a critical need for tools and methodologies capable of managing aquatic systems within heavily impacted watersheds. Current efforts often fall short as a result of an inability to quantify and predict complex cumulative effects of current and future land use scenarios at relevant spatial scales. The goal of this manuscript is to provide methods for conducting a targeted watershed assessment that enables resource managers to produce landscape-based cumulative effects models for use within a scenario analysis management framework. Sites are first selected for inclusion within the watershed assessment by identifying sites that fall along independent gradients and combinations of known stressors. Field and laboratory techniques are then used to obtain data on the physical, chemical, and biological effects of multiple land use activities. Multiple linear regression analysis is then used to produce landscape-based cumulative effects models for predicting aquatic conditions. Lastly, methods for incorporating cumulative effects models within a scenario analysis framework for guiding management and regulatory decisions (e.g., permitting and mitigation) within actively developing watersheds are discussed and demonstrated for 2 sub-watersheds within the mountaintop mining region of central Appalachia. The watershed assessment and management approach provided herein enables resource managers to facilitate economic and development activity while protecting aquatic resources and producing opportunity for net ecological benefits through targeted remediation.

  7. The governance of hydro power in Norway and Sweden: How to manage the European current?

    Energy Technology Data Exchange (ETDEWEB)

    Ruud, Audun; Jacobsen, Gerd; Knudsen, Joergen; Nilsson, Maans; Rudberg, Peter

    2010-07-01

    Objectives of the paper: The proposed paper will be based on studies of renewable electricity production within two different national contexts. Experiences clearly demonstrate that variations in political settings provide energy companies with disparate opportunities, constraints and motivations (Lafferty et Ruud, 2008). This is also the case with two countries as similar as Norway and Sweden. Both countries are, however, committed by EU-based legislation, not least former and current Directives on renewable electricity and energy as well as the Water Framework Management Directive. By comparing current governance of hydropower and how environmental concerns are taken into account, the paper aims at discussing differences in regulatory practice, and thereby assess to what extent EU legislation modify and/or reinforce the existing regulatory framework in Norway and Sweden. Organisation and methodology: The paper is related to the ongoing research project Governance for Renewable Electricity Production (GOVREP), which is part of the Centre for Environmental Design of Renewable Energy (CEDREN) one of the eight newly established Centres for Environment-friendly Energy research. GOVREP aims at contributing to a better integration of environmental- and energy policy concerns in renewable electricity production. The authors of the proposed paper are working within the project. The proposed paper will present a comparative case study of specific hydro power projects. The research method is based on document analysis as well as interviews with relevant stakeholders. The primary data to be presented in the paper will thus represent original findings. The research will employ analytical approaches related to policy analysis and europeanization of national policies. Outline of results: The paper will assess the importance of national differences in regulatory practice vis-a-vis specific hydropower projects. Furthermore, the paper will provide an assessment as to what extent

  8. Orphan drugs: the regulatory environment.

    Science.gov (United States)

    Franco, Pedro

    2013-02-01

    The definition of a rare disease is not universal and depends on the legislation and policies adopted by each region or country. The main objective of this article is to describe and discuss the legal framework and the regulatory environment of orphan drugs worldwide. Some reflections and discussions on the need for specific orphan drug legislation or policies are described at length. Furthermore, some aspects of the history of each region in respect of the orphan drug legislation evolution are outlined. This article describes and compares the orphan drug legislation or policies of the following countries or regions: United Sates of America (US), European Union (EU), Japan, Australia, Singapore, Taiwan and Canada. The incentives described in the orphan drug legislations or policies, the criteria for designation of orphan status and the authorisation process of an orphan drug are also described and compared. The legislations and policies are to some extent similar but not the same. It is important to understand the main differences among all available legislative systems to improve the international collaboration in the field of orphan drugs and rare diseases.

  9. ZEND FRAMEWORK

    Directory of Open Access Journals (Sweden)

    Lupasc Adrian

    2013-12-01

    Full Text Available In this paper we present Zend Architecture, which is an open source technology for developing web applications and services, based on object-oriented components, and the Model-View-Controller architectural pattern, also known as MVC, which is the fundament of this architecture. The MVC presentation emphasises its main characteristics, such as facilitating the components reuse by dividing the application into distinct interconnected modules, tasks distribution in the process of developing an application, the MVC life cycle and also the essential features of the components in which it separates the application: model, view, controller. The controller coordinates the models and views and it’s responsible with manipulating the user events through the corresponding actions. The model contains application rules, respectively the scripts that implement the database manipulation. The third component, the view represents the controllers interface with the user or the way it displays the response to the event triggered by the user. Another aspect treated in this paper consists in highlighting the Zend architecture advantages and disadvantages. Among the framework advantages, we can enumerate good code organization, due to its delimitation into three sections, presentation, logic and data access, and dividing the code into components, which facilitates the code reuse and testing. Other advantages are the open-source license and the support for multiple database systems. The main disadvantages are represented by its size and complexity, that makes it hard to understand for a beginner programmer, the resources it needs etc. The last section of the paper presents a comparison between Zend and other PHP architectures, like Symphony, CakePHP and CodeIgniter, which includes their essential features and points out their similarities and differences, based on the unique functions that set them apart from others. The main thing that distinguishes ZF from the

  10. Like or dislike : Intrapersonal regulatory fit affects the intensity of interpersonal evaluation

    NARCIS (Netherlands)

    Hamstra, Melvyn R. W.; Van Yperen, Nico W.; Wisse, Barbara; Sassenberg, Kai

    2013-01-01

    Regulatory fit is an experience of motivational force that makes individuals feel 'right'. Prior work has almost exclusively focused on how regulatory fit affects individuals' experience of tasks, activities, and products and has primarily focused on the bright side of regulatory fit. The current re

  11. Like or dislike : Intrapersonal regulatory fit affects the intensity of interpersonal evaluation

    NARCIS (Netherlands)

    Hamstra, Melvyn R. W.; Van Yperen, Nico W.; Wisse, Barbara; Sassenberg, Kai

    Regulatory fit is an experience of motivational force that makes individuals feel 'right'. Prior work has almost exclusively focused on how regulatory fit affects individuals' experience of tasks, activities, and products and has primarily focused on the bright side of regulatory fit. The current

  12. Like or dislike : Intrapersonal regulatory fit affects the intensity of interpersonal evaluation

    NARCIS (Netherlands)

    Hamstra, Melvyn R. W.; Van Yperen, Nico W.; Wisse, Barbara; Sassenberg, Kai

    2013-01-01

    Regulatory fit is an experience of motivational force that makes individuals feel 'right'. Prior work has almost exclusively focused on how regulatory fit affects individuals' experience of tasks, activities, and products and has primarily focused on the bright side of regulatory fit. The current re

  13. Nuclear Regulatory Commission information digest

    Energy Technology Data Exchange (ETDEWEB)

    None,

    1990-03-01

    The Nuclear Regulatory Commission information digest provides summary information regarding the US Nuclear Regulatory Commission, its regulatory responsibilities, and areas licensed by the commission. This is an annual publication for the general use of the NRC Staff and is available to the public. The digest is divided into two parts: the first presents an overview of the US Nuclear Regulatory Commission and the second provides data on NRC commercial nuclear reactor licensees and commercial nuclear power reactors worldwide.

  14. Assessment of three approaches for regulatory decision making on pesticides with endocrine disrupting properties.

    Science.gov (United States)

    Marx-Stoelting, P; Niemann, L; Ritz, V; Ulbrich, B; Gall, A; Hirsch-Ernst, K I; Pfeil, R; Solecki, R

    2014-12-01

    Recent EU legislation has introduced endocrine disrupting properties as a hazard-based "cut-off" criterion for the approval of active substances as pesticides and biocides. Currently, no specific science-based approach for the assessment of substances with endocrine disrupting properties has been agreed upon, although this new legislation provides interim criteria based on classification and labelling. Different proposals for decision making on potential endocrine disrupting properties in human health risk assessment have been developed by the German Federal Institute for Risk Assessment (BfR) and other regulatory bodies. All these frameworks, although differing with regard to hazard characterisation, include a toxicological assessment of adversity of the effects, the evaluation of underlying modes/mechanisms of action in animals and considerations concerning the relevance of effects to humans. Three options for regulatory decision making were tested upon 39 pesticides for their applicability and to analyze their potential impact on the regulatory status of active substances that are currently approved for use in Europe: Option 1, based purely on hazard identification (adversity, mode of action, and the plausibility that both are related); Option 2, based on hazard identification and additional elements of hazard characterisation (severity and potency); Option 3, based on the interim criteria laid down in the recent EU pesticides legislation. Additionally, the data analysed in this study were used to address the questions, which parts of the endocrine system were affected, which studies were the most sensitive and whether no observed adverse effect levels were observed for substance with ED properties. The results of this exercise represent preliminary categorisations and must not be used as a basis for definitive regulatory decisions. They demonstrate that a combination of criteria for hazard identification with additional criteria of hazard characterisation

  15. SND Off—Line Framework

    Institute of Scientific and Technical Information of China (English)

    D.A.Bukin; V.N.Ivanchenko; 等

    2001-01-01

    SND is a spherical non-magnetic detector operating since 1996 at VEPP-2M electron-positron collider in Novosibirsk,SND is performing an upgrade of its subsystems,electronics,and software for the next run at VEPP-2000,Present Fortran-based offline programs will be replaced with the object-oriented framework,which supports simulation,reconstruction and analysis activities,New framework exploits the experience obtained in the work with the current offline and supports or extends its essential features.The main framework concept is a module,which is a basic processing unit consuming some data and producing new data.Every module can be parameterized during run time.Formalized description of the modules is used by the framework sequencer for the selection and ordering of minimal subset of modules for any given task.Data persistency services are made sufficiently abstract to allow implementation for different persistency technologies.Prsently there is an implementation for the sequential files with packed data.The framework provides an interface for scripting languages.Together with a custom expression parser this gives a support for extensible run-time histogramming.The functional prototype of the framework was implemented in Python language and proved the concepts of the project.Currently this prototype is being reimplemented in C++.

  16. Validation of Gene Regulatory Network Inference Based on Controllability

    Directory of Open Access Journals (Sweden)

    Edward eDougherty

    2013-12-01

    Full Text Available There are two distinct issues regarding network validation: (1 Does an inferred network provide good predictions relative to experimental data? (2 Does a network inference algorithm applied within a certain network model framework yield networks that are accurate relative to some criterion of goodness? The first issue concerns scientific validation and the second concerns algorithm validation. In this paper we consider inferential validation relative to controllability; that is, if an inference procedure is applied to synthetic data generated from a gene regulatory network and an intervention procedure is designed on the inferred network, how well does it perform on the true network? The reasoning behind such a criterion is that, if our purpose is to use gene regulatory networks to design therapeutic intervention strategies, then we are not concerned with network fidelity, per se, but only with our ability to design effective interventions based on the inferred network. We will consider the problem from the perspectives of stationary control, which involves designing a control policy to be applied over time based on the current state of the network, with the decision procedure itself being time independent. {The objective of a control policy is to optimally reduce the total steady-state probability mass of the undesirable states (phenotypes, which is equivalent to optimally increasing the total steady-state mass of the desirable states. Based on this criterion we compare several proposed network inference procedures. We will see that inference procedure psi may perform poorer than inference procedure xi relative to inferring the full network structure but perform better than xi relative to controllability. Hence, when one is aiming at a specific application, it may be wise to use an objective-based measure of inference validity.

  17. Hastening the regulatory process

    Energy Technology Data Exchange (ETDEWEB)

    Stringham, G. [Canadian Association of Petroleum Producers, Calgary, AB (Canada)

    2001-07-01

    The state of the Canadian oil industry was discussed during this power point presentation with particular emphasis on its production, exports, drilling, industry revenues and capital investment levels. The proposed projects in each of northern Alberta's oil sands deposits, the Athabasca, Peace River and Cold Lake were were announced, along with the inventory of major Alberta projects and the projection of oil sands capital investment. Since 1998, $9 billion has been invested and a further $33 billion has been announced for new or expanded oil sands projects. The year 2000 estimates for Canadian crude oil and natural gas production are 2.3 million barrels per day and 6.3 trillion cubic feet per year respectively. This represented a record year for production of both crude oil and natural gas. In 2000, more than 15,500 wells were drilled in Canada. A graph depicting Canadian crude oil supply forecasted a steady increase in supply from year 2000 to 2010. The Canadian Association of Petroleum Producers (CAPP) completed a review of the Alberta Energy and Utilities Board regulatory and enforcement processes. Both industry and government efforts are focusing on eliminating regulatory overlap and duplication. Some of the main areas of interest for exploration, drilling, production and pipeline facilities include the examination of regulatory processes for environmentally sensitive areas, rural municipalities with planning bylaws, aboriginal lands and additional fees. 8 figs.

  18. The Change Idea of Virtual Learning Tools Standards Development:Current Situation and System Framework%变革理念下虚拟学具标准研制现状梳理与体系框架*

    Institute of Scientific and Technical Information of China (English)

    郁晓华; 雷云鹤; 祝智庭; 吴永和

    2013-01-01

    As a new term in the new round of e-Schoolbags development, virtual learning tools merge the concepts of learning toolkits and learning instruments. The standards of virtual learning tools are important technical support and security guidance for its industrial development and educational practice. Current developments of virtual learning tools follows the models and ideas of traditional teaching, so learners still do not enjoy sufficient autonomy and freedom during the interaction with the learning tools. New learning forms and technologies require to change the development concept and concentrate on user experience, which are more intelligent, open and personalized, and establish an active service mechanism of being process-oriented, activity-sensitive even content-sensitive. Guided by the changing idea, an analysis is made among the needs and problems of the standards stakeholders. The entire standard framework of virtual learning tools is proposed, including classification standard, description standard, configuration specification, polymerization specification and evaluation standard.%  虚拟学具是电子书包新一轮发展所引入的一个全新概念,是学具和学习工具二者发展的集合体,其标准的研制是指导虚拟学具领域产业发展和教育实践的重要技术支持和保障。目前虚拟学具的发展表现的都是一种传统教学模式和观念的延续,学习者在与虚拟学具互动的过程中并没有获得足够的自主权和自由度。学习形态和新技术的发展要求虚拟学具变革发展理念,以用户体验为中心,趋于更加智能、开放、个性化,建立一种过程导向、活动敏感甚至内容敏感的主动服务机制。在这种变革理念指导下分析虚拟学具标准各利益相关人员的需求与问题,得出虚拟学具标准的内容体系包括虚拟学具分类标准、虚拟学具描述标准、虚拟学具配置规范、虚拟学具聚合规范和虚

  19. 移动医疗APP运行现状及其法律监管问题初探%Discussion on the Current Running Status of Mobile Medical APP and Relevant Legal Regulatory Issues

    Institute of Scientific and Technical Information of China (English)

    邓勇; 刘威; 李桐萱

    2015-01-01

    In recent years, the mobile medical market is increasingly becoming a trans-boundary focus. The operation of "medical + IT" mode has constructed a complete mobile medical industry chain. However, the development of emerging health industry represented by mobile medical APP (Application) is facing a lot of trouble. What's more, its benign operation also needs legal regulation. This paper ifrstly interpreted the formation, development and function of mobile medical APP, and then analyzed the current dilemma that mobile medical APP suffered from, ifnally put forward the concrete measures to solve the problems in running of the mobile medical APP.%近年来,移动医疗市场正日益成为跨界焦点,"医疗+IT"模式的运行,构建了一条完整的移动医疗产业链.然而,以移动医疗APP为代表的新兴医疗产业正面临诸多发展困境,其良性运行亦亟待法律监管.本文首先解读了移动医疗APP的产生、发展及功能,然后剖析了当前移动医疗APP遇到的种种困境,最后针对性地提出了破解移动医疗APP运行困境的具体对策.

  20. Regulatory overview of digital I and C system in Taiwan Lungmen Project

    Energy Technology Data Exchange (ETDEWEB)

    Chuang, C.F. [Department of Engineering and System Science, National Tsing Hua University, Taipei, Taiwan (China); Nuclear Regulatory Division, Atomic Energy Council, Taiwan (China)], E-mail: chuang@aec.gov.tw; Chou, H.P. [Department of Engineering and System Science, National Tsing Hua University, Taipei, Taiwan (China)], E-mail: hpc@mx.nthu.edu.tw; Chen, Y.B. [Nuclear Regulatory Division, Atomic Energy Council, Taiwan (China)], E-mail: ybchen@aec.gov.tw; Shiao, H. [Nuclear Regulatory Division, Atomic Energy Council, Taiwan (China)], E-mail: shiao@aec.gov.tw

    2008-05-15

    The Lungmen Nuclear Power Plant (LMNPP) is currently under construction in Taiwan, which consists of two Advanced Boiling Water Reactor (ABWR) units. The instrumentation and control (I and C) systems of the Lungmen NPS are based on the state-of-the-art modernized fully integrated digital design. The design and architecture of digital systems are inherently different from those of analog systems. We face challenges in areas where there is limited technical guidance and regulatory precedent. This paper presents regulatory overviews, regulatory requirements, current major regulatory issues, as well as the areas of regulatory concerns and the lessons learned on the digital I and C systems in the Lungmen Project.

  1. Regulatory Impact Analysis: a new tool for better regulation at ANVISA.

    Science.gov (United States)

    Alves, Flávia Neves Rocha; Peci, Alketa

    2011-08-01

    Regulatory Impact Analysis, which is recommended to regulatory departments, aims to improve regulatory quality by providing information about the costs and benefits of regulation as well as solutions to current issues to enhance the decision-making process. This article discusses the importance of Regulatory Impact Analysis in the context of the National Agency for Sanitary Surveillance performance as well as the agency's current phase of regulation improvement and strengthening. Also, the main definitions related to the regulatory field as well as some international case experiences are presented.

  2. Adapting the IDEAL Framework and Recommendations for medical device evaluation: A modified Delphi survey.

    Science.gov (United States)

    Pennell, Christopher P; Hirst, Allison; Sedrakyan, Art; McCulloch, Peter G

    2016-04-01

    Current regulatory systems for medical device marketing approval lack adequate requirements for evidence of safety and efficacy. The Total Product Life Cycle (TPLC) concept, with clinical use and marketing expanding as evidence develops, has won support, but lacks a template to define evidence requirements at different stages. The IDEAL Framework & Recommendations, originally developed for new surgical procedures, might provide such a template, but may require modification. We conducted a Delphi expert consensus exercise to determine how IDEAL might be modified to accommodate the needs of device regulation. 34 experts were invited to participate in 3 rounds of questioning, with feedback of the results of each round to participants before the next. 27 of 34 experts responded in at least one survey round. Experts agreed that, after appropriate modifications, IDEAL could form an evidence template for a TPLC-based regulatory system. Necessary modifications include a new Stage 0 should guide reporting of pre-clinical studies, expansion of registries to all stages, and omission of IDEAL stages 2 and 3 for "successor" devices under certain conditions. A standard approach to TPLC evaluation of medical devices does not currently exist. The IDEAL Framework, if modified appropriately, could fill such a void and improve the safety of new medical devices. Copyright © 2016 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.

  3. A regulatory theory of cortical organization and its applications to robotics

    Science.gov (United States)

    Thangavelautham, Jekanthan

    2009-11-01

    Fundamental aspects of biologically-inspired regulatory mechanisms are considered in a robotics context, using artificial neural-network control systems. Regulatory mechanisms are used to control expression of genes, adaptation of form and behavior in organisms. Traditional neural network control architectures assume networks of neurons are fixed and are interconnected by wires. However, these architectures tend to be specified by a designer and are faced with several limitations that reduce scalability and tractability for tasks with larger search spaces. Traditional methods used to overcome these limitations with fixed network topologies are to provide more supervision by a designer. More supervision as shown does not guarantee improvement during training particularly when making incorrect assumptions for little known task domains. Biological organisms often do not require such external intervention (more supervision) and have self-organized through adaptation. Artificial neural tissues (ANT) addresses limitations with current neural-network architectures by modeling both wired interactions between neurons and wireless interactions through use of chemical diffusion fields. An evolutionary (Darwinian) selection process is used to 'breed' ANT controllers for a task at hand and the framework facilitates emergence of creative solutions since only a system goal function and a generic set of basis behaviours need be defined. Regulatory mechanisms are formed dynamically within ANT through superpositioning of chemical diffusion fields from multiple sources and are used to select neuronal groups. Regulation drives competition and cooperation among neuronal groups and results in areas of specialization forming within the tissue. These regulatory mechanisms are also shown to increase tractability without requiring more supervision using a new statistical theory developed to predict performance characteristics of fixed network topologies. Simulations also confirm the

  4. Current directions in screening-level ecological risk assessments

    Energy Technology Data Exchange (ETDEWEB)

    Carlsen, T M; Efroymson, R A

    2000-12-11

    Ecological risk assessment (ERA) is a tool used by many regulatory agencies to evaluate the impact to ecological receptors from changes in environmental conditions. Widespread use of ERAs began with the United States Environmental Protection Agency's Superfund program to assess the ecological impact from hazardous chemicals released to the environment. Many state hazardous chemical regulatory agencies have adopted the use of ERAs, and several state regulatory agencies are evaluating the use of ERAs to assess ecological impacts from releases of petroleum and gas-related products. Typical ERAs are toxicologically-based, use conservative assumptions with respect to ecological receptor exposure duration and frequency, often require complex modeling of transport and exposure and are very labor intensive. In an effort to streamline the ERA process, efforts are currently underway to develop default soil screening levels, to identify ecological screening criteria for excluding sites from formal risk assessment, and to create risk-based corrective action worksheets. This should help reduce the time spent on ERAs, at least for some sites. Work is also underway to incorporate bioavailability and spatial considerations into ERAs. By evaluating the spatial nature of contaminant releases with respect to the spatial context of the ecosystem under consideration, more realistic ERAs with respect to the actual impact to ecological receptors at the population, community or ecosystem scale should be possible. In addition, by considering the spatial context, it should be possible to develop mitigation and monitoring efforts to more appropriately address such sites within the context of an ecological framework.

  5. Estado actual del marco legal argentino para la caza, producción y comercialización del Lagarto overo (Tupinambis spp. Current state of the Argentine legal framework for the hunting, production and commercialization of the Tegu lizard (Tupinambis spp

    Directory of Open Access Journals (Sweden)

    C.P Basso

    2005-12-01

    framework and the documentation to be carried out by exporters. Tupinambis Project, from the National Program for the Management and Sustainable Use of Wild Species is a fundamental tool for the rational use of this species. The existence of numerous guidelines and regulations, the overlapping of most of them, together with the overlapping of the authorities in charge of their application, determine the convenience of creating unified global guidelines, more complete, simple and clear which would allow the development of a technologically and economically efficient production, sustainable in the ecological environment. This makes necessary a review and a proposal for the creation of new regulations which would fit current needs.

  6. Codes and standards and other guidance cited in regulatory documents

    Energy Technology Data Exchange (ETDEWEB)

    Nickolaus, J.R.; Bohlander, K.L.

    1996-08-01

    As part of the U.S. Nuclear Regulatory Commission (NRC) Standard Review Plan Update and Development Program (SRP-UDP), Pacific Northwest National Laboratory developed a listing of industry consensus codes and standards and other government and industry guidance referred to in regulatory documents. The SRP-UDP has been completed and the SRP-Maintenance Program (SRP-MP) is now maintaining this listing. Besides updating previous information, Revision 3 adds approximately 80 citations. This listing identifies the version of the code or standard cited in the regulatory document, the regulatory document, and the current version of the code or standard. It also provides a summary characterization of the nature of the citation. This listing was developed from electronic searches of the Code of Federal Regulations and the NRC`s Bulletins, Information Notices, Circulars, Enforcement Manual, Generic Letters, Inspection Manual, Policy Statements, Regulatory Guides, Standard Technical Specifications and the Standard Review Plan (NUREG-0800).

  7. Print Me an Organ? Ethical and Regulatory Issues Emerging from 3D Bioprinting in Medicine.

    Science.gov (United States)

    Gilbert, Frederic; O'Connell, Cathal D; Mladenovska, Tajanka; Dodds, Susan

    2017-02-09

    Recent developments of three-dimensional printing of biomaterials (3D bioprinting) in medicine have been portrayed as demonstrating the potential to transform some medical treatments, including providing new responses to organ damage or organ failure. However, beyond the hype and before 3D bioprinted organs are ready to be transplanted into humans, several important ethical concerns and regulatory questions need to be addressed. This article starts by raising general ethical concerns associated with the use of bioprinting in medicine, then it focuses on more particular ethical issues related to experimental testing on humans, and the lack of current international regulatory directives to guide these experiments. Accordingly, this article (1) considers whether there is a limit as to what should be bioprinted in medicine; (2) examines key risks of significant harm associated with testing 3D bioprinting for humans; (3) investigates the clinical trial paradigm used to test 3D bioprinting; (4) analyses ethical questions of irreversibility, loss of treatment opportunity and replicability; (5) explores the current lack of a specific framework for the regulation and testing of 3D bioprinting treatments.

  8. Central bank operating frameworks and collateral markets

    OpenAIRE

    Bank for International Settlements

    2015-01-01

    Collateral markets have become increasingly important as demand for collateral assets has increased in recent years, driven by changing market practices and an evolving regulatory landscape. This report explores whether and how the design of central banks' operational frameworks influences private collateral markets, including collateral availability, pricing, related market practices, and market performance under stress. It studies these issues by reviewing available information from a range...

  9. 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.

  10. Frameworks and tools for risk assessment of manufactured nanomaterials.

    Science.gov (United States)

    Hristozov, Danail; Gottardo, Stefania; Semenzin, Elena; Oomen, Agnes; Bos, Peter; Peijnenburg, Willie; van Tongeren, Martie; Nowack, Bernd; Hunt, Neil; Brunelli, Andrea; Scott-Fordsmand, Janeck J; Tran, Lang; Marcomini, Antonio

    2016-10-01

    Commercialization of nanotechnologies entails a regulatory requirement for understanding their environmental, health and safety (EHS) risks. Today we face challenges to assess these risks, which emerge from uncertainties around the interactions of manufactured nanomaterials (MNs) with humans and the environment. In order to reduce these uncertainties, it is necessary to generate sound scientific data on hazard and exposure by means of relevant frameworks and tools. The development of such approaches to facilitate the risk assessment (RA) of MNs has become a dynamic area of research. The aim of this paper was to review and critically analyse these approaches against a set of relevant criteria. The analysis concluded that none of the reviewed frameworks were able to fulfill all evaluation criteria. Many of the existing modelling tools are designed to provide screening-level assessments rather than to support regulatory RA and risk management. Nevertheless, there is a tendency towards developing more quantitative, higher-tier models, capable of incorporating uncertainty into their analyses. There is also a trend towards developing validated experimental protocols for material identification and hazard testing, reproducible across laboratories. These tools could enable a shift from a costly case-by-case RA of MNs towards a targeted, flexible and efficient process, based on grouping and read-across strategies and compliant with the 3R (Replacement, Reduction, Refinement) principles. In order to facilitate this process, it is important to transform the current efforts on developing databases and computational models into creating an integrated data and tools infrastructure to support the risk assessment and management of MNs.

  11. A feasibility study on regulatory analysis in the nuclear regulatory decision making process in Korea

    Energy Technology Data Exchange (ETDEWEB)

    Lee, K. J.; Lee, B. W.; Lee, D. K.; Lim, C. Y.; Choi, Y. S.; Kim, K. K. [Korea Advanced Institute of Science and Technology, Taejon (Korea, Republic of)

    1996-12-15

    Nuclear safety regulation has different implications from economic regulation. In recent survey, it was found that Korea people want more regulatory effort than current one. This indicates that scientific method is necessary to improve the efficiency of regulation with limited resources of regulators. The main reason to conduct the regulatory analysis like cost-benefit analysis is obtaining the rationality of regulation to be implemented and persuading the licensees to comply under the quantified condition. That is, the ultimate goal is to verify the necessity and justice of regulation and to achieve the safety goal with minimum impacts. Guidelines and procedures developed in this study should help regulators to reach that goal.

  12. Establishing a regulatory value chain model: An innovative approach to strengthening medicines regulatory systems in resource-constrained settings.

    Science.gov (United States)

    Chahal, Harinder Singh; Kashfipour, Farrah; Susko, Matt; Feachem, Neelam Sekhri; Boyle, Colin

    2016-05-01

    Medicines Regulatory Authorities (MRAs) are an essential part of national health systems and are charged with protecting and promoting public health through regulation of medicines. However, MRAs in resource-constrained settings often struggle to provide effective oversight of market entry and use of health commodities. This paper proposes a regulatory value chain model (RVCM) that policymakers and regulators can use as a conceptual framework to guide investments aimed at strengthening regulatory systems. The RVCM incorporates nine core functions of MRAs into five modules: (i) clear guidelines and requirements; (ii) control of clinical trials; (iii) market authorization of medical products; (iv) pre-market quality control; and (v) post-market activities. Application of the RVCM allows national stakeholders to identify and prioritize investments according to where they can add the most value to the regulatory process. Depending on the economy, capacity, and needs of a country, some functions can be elevated to a regional or supranational level, while others can be maintained at the national level. In contrast to a "one size fits all" approach to regulation in which each country manages the full regulatory process at the national level, the RVCM encourages leveraging the expertise and capabilities of other MRAs where shared processes strengthen regulation. This value chain approach provides a framework for policymakers to maximize investment impact while striving to reach the goal of safe, affordable, and rapidly accessible medicines for all.

  13. Improving gene regulatory network inference using network topology information.

    Science.gov (United States)

    Nair, Ajay; Chetty, Madhu; Wangikar, Pramod P

    2015-09-01

    Inferring the gene regulatory network (GRN) structure from data is an important problem in computational biology. However, it is a computationally complex problem and approximate methods such as heuristic search techniques, restriction of the maximum-number-of-parents (maxP) for a gene, or an optimal search under special conditions are required. The limitations of a heuristic search are well known but literature on the detailed analysis of the widely used maxP technique is lacking. The optimal search methods require large computational time. We report the theoretical analysis and experimental results of the strengths and limitations of the maxP technique. Further, using an optimal search method, we combine the strengths of the maxP technique and the known GRN topology to propose two novel algorithms. These algorithms are implemented in a Bayesian network framework and tested on biological, realistic, and in silico networks of different sizes and topologies. They overcome the limitations of the maxP technique and show superior computational speed when compared to the current optimal search algorithms.

  14. Politically Induced Regulatory Risk and Independent Regulatory Agencies

    OpenAIRE

    Strausz, Roland

    2015-01-01

    Uncertainty in election outcomes generates politically induced regulatory risk. Political parties' risk attitudes towards such risk depend on a fluctuation effect that hurts both parties and an output--expansion effect that benefits at least one party. Notwithstanding the parties' risk attitudes, political parties have incentives to negotiate away all regulatory risk by pre-electoral bargaining. Efficient pre-electoral bargaining outcomes fully eliminate politically induced regulatory risk. P...

  15. Regulatory Review Committee update

    Energy Technology Data Exchange (ETDEWEB)

    Steele, T. [Polishuk, Camman and Steele, London ON (Canada)

    2001-07-01

    The Committee's objectives, current membership and current issues are reviewed. Each current issue, notably the consultation process with the Ministry of Natural Resources, appeal of Ministry actions, orphan wells/security deposits, oilfield fluid disposal and labour code practices review are discussed in some detail. Dissatisfaction with the current appeals process to the Ministry is highlighted, along with a search for an all encompassing solution. The orphan well problem also received considerable attention, with similar demands for a comprehensive solution.

  16. Regulatory reform of Finnish environmental policy

    Energy Technology Data Exchange (ETDEWEB)

    Sairinen, R.

    2000-07-01

    The main question of this study concerns the regulatory reform i.e. formation and design of new policy instruments in the Finnish environmental policy. The research question is divided into two parts: (1) How have the new policy instruments evolved and been designed (2) What are the political, administrative, historical and ideological factors underlying the processes of policy instrument formation and design? Three main approaches for analysis are introduced: the model of policy instrument choice by Linder and Peters, the model of policy explanation by Jaenicke, and the concept of governmentality developed by Foucault. Within the developed theoretical framework, the general societal background of regulatory reform is composed of the various features of 'environmental governmentality'. The research questions are divided into two empirical research tasks. (1) Analysis of the historical development of Finnish environmental governing and policy style provides background information about the national institutional settings and policy cultures in order to understand the role of the new policy instruments in the Finnish environmental policy during last two decades. Here, Finnish environmental policy divides into consensual pollution policies and adversial nature conservation. Four main periods of environmental governmentality in Finland is presented: the early nature conservation initiatives (1800-1939), the neglect of environmental issues (1945-1969), the environmental institutionalisation (1970-1986), and the regulatory reform (1987-). (2) The contextual case studies concerns: the drafting of the EIA Act in 1982-1994; the formation of the carbon tax policy in 1989-1996; and the implementation of voluntary environmental agreements in 1987-99. The study shows that regulatory reform has not been an easy policy process in Finland. There has been no common environmental governmentality behind the on-going regulatory reform. The new policy instruments have been

  17. Regulatory Challenges for Cartilage Repair Technologies.

    Science.gov (United States)

    McGowan, Kevin B; Stiegman, Glenn

    2013-01-01

    In the United States, few Food and Drug Administration (FDA)-approved options exist for the treatment of focal cartilage and osteochondral lesions. Developers of products for cartilage repair face many challenges to obtain marketing approval from the FDA. The objective of this review is to discuss the necessary steps for FDA application and approval for a new cartilage repair product. FDA Guidance Documents, FDA Panel Meetings, scientific organization recommendations, and clinicaltrials.gov were reviewed to demonstrate the current thinking of FDA and the scientific community on the regulatory process for cartilage repair therapies. Cartilage repair therapies can receive market approval from FDA as medical devices, drugs, or biologics, and the specific classification of product can affect the nonclinical, clinical, and regulatory strategy to bring the product to market. Recent FDA guidance gives an outline of the required elements to bring a cartilage repair product to market, although these standards are often very general. As a result, companies have to carefully craft their study patient population, comparator group, and clinical endpoint to best showcase their product's attributes. In addition, regulatory strategy and manufacturing process validation need to be considered early in the clinical study process to allow for timely product approval following the completion of clinical study. Although the path to regulatory approval for a cartilage repair therapy is challenging and time-consuming, proper clinical trial planning and attention to the details can eventually save companies time and money by bringing a product to the market in the most expeditious process possible.

  18. Promise of new translational safety biomarkers in drug development and challenges to regulatory qualification.

    Science.gov (United States)

    Sistare, Frank D; DeGeorge, Joseph J

    2011-08-01

    One promise of new translational safety biomarkers (TSBs) is their ability to demonstrate that toxicities in animal studies are monitorable at an early stage, such that human relevance of potential adverse effects of drugs can be safely and definitively evaluated in clinical trials. Another is that they would provide an earlier, more definitive and deeper insight to patient prognosis compared with conventional biomarkers. Recent experience with regulatory authorities indicates that resource demands for new TSB qualifications under the current framework are daunting and the rate of their expansion will be slow, particularly in light of mounting financial pressures on the pharmaceutical industry. Sponsors face a dilemma over engaging in safety biomarker qualification consortia. While it is clear new TSBs could be considered catalysts to drug development and that patient health, business and scientific benefits, described here using examples, should outweigh qualification costs, concerns exist that early ambiguities in biomarker interpretations at the introduction of such new TSBs might hinder drug development.

  19. Clinical research: regulatory issues.

    Science.gov (United States)

    Wermeling, D P

    1999-02-01

    The regulatory issues faced by institutions performing clinical research are described. Many institutions do not have on staff an expert who understands the regulatory issues involved in managing investigational new drug research and who knows the institution's obligations under the federal rules. Because pharmacists understand the FDA regulations that apply to the management of drugs in clinical research, institutions are asking pharmacists to expand their role and manage clinical research offices. Many authorities govern various aspects of investigational drug research. FDA has published regulations for good clinical practice (GCP), and the International Conference on Harmonisation is developing an international standard for the proper management of clinical trials. The guidelines published by the Joint Commission on Accreditation of Healthcare Organizations aim to protect patients who are in the institution to receive health care and also participate in clinical trials. The Social Security Administration Acts specifically state that only items and services that are reasonable and necessary for the diagnosis and treatment of injury or disease can be billed to the government; research-related billings are excluded from coverage. Proper management of drug research is crucial to the success of a research program that is integrated with patient care.

  20. Methods for Characterizing the Epigenetic Attractors Landscape Associated with Boolean Gene Regulatory Networks

    OpenAIRE

    Davila-Velderrain, Jose; Juarez-Ramiro, Luis; Martinez-Garcia, Juan C.; Alvarez-Buylla, Elena R

    2015-01-01

    Gene regulatory network (GRN) modeling is a well-established theoretical framework for the study of cell-fate specification during developmental processes. Recently, dynamical models of GRNs have been taken as a basis for formalizing the metaphorical model of Waddington's epigenetic landscape, providing a natural extension for the general protocol of GRN modeling. In this contribution we present in a coherent framework a novel implementation of two previously proposed general frameworks for m...

  1. Conceptual frameworks of individual work performance: A systematic review

    NARCIS (Netherlands)

    Koopmans, L.; Bernaards, C.M.; Hildebrandt, V.H.; Schaufeli, W.B.; Vet, H.C.W. de; Beek, A.J. van der

    2011-01-01

    Objective: Individual work performance is differently conceptualized and operationalized in different disciplines. The aim of the current review was twofold: (1) identifying conceptual frameworks of individual work performance and (2) integrating these to reach a heuristic conceptual framework. Meth

  2. Odontologia e Saúde Suplementar: marco regulatório, políticas de promoção da saúde e qualidade da atenção Dentistry and supplementary health: regulatory framework, health promotion policies and quality of care

    Directory of Open Access Journals (Sweden)

    Daniela Garbin

    2013-02-01

    Full Text Available A partir do marco regulatório e de um panorama da odontologia na saúde suplementar, este artigo discute as especificidades do setor odontológico no que se refere às políticas de promoção da saúde e qualidade da atenção à saúde propostas pela Agência Nacional de Saúde Suplementar (ANS. A atuação do Estado na saúde suplementar se dá a partir das leis 9.656/98, que define relações entre operadoras, produtos e seus beneficiários e 9.961/2000, que cria a ANS. Concomitantemente, houve elevado crescimento da odontologia no setor, por conta de mudanças no exercício liberal da profissão, trazendo a necessidade de conhecer a lógica de organização dos serviços quanto à assistência prestada e ao modelo de atenção praticado. A ANS desenvolve ações para estimular as operadoras na implantação de programas de promoção da saúde, na busca por um modelo de atenção integral. Ao mesmo tempo, promove a Política de Qualificação na saúde suplementar, com ênfase na dimensão assistencial, porém na odontologia o enfoque da avaliação ainda é o atendimento individual e fragmentado. Por fim, o grande desafio da odontologia passa pelo seu fortalecimento enquanto política de saúde pública, acessível a toda a população, e pela qualificação da atenção odontológica na saúde suplementar.Based on the regulatory framework and an overview of dentistry in supplementary health, this paper discusses the specifics of the dental sector with respect to health promotion policies and quality of health care services proposed by the National Supplementary Health Agency (ANS. The State's activities in supplementary health are based on law 9.656/98, which defines the relations between operators, products and their beneficiaries, and law 9.961/2000, which created the ANS. Concomitantly there was a great increase in dentistry in the private health plan market, because of changes in the practices of the profession. This required the

  3. Ethical Awareness for the Classroom: A Framework.

    Science.gov (United States)

    Fraedrich, John P.; Guerts, Michael D.

    1990-01-01

    Prescribes a cognitive framework for sensitizing students in ethical decision making. Reviews the current status of ethics in business education, presents methods of teaching ethics, discusses problems encountered in teaching ethics, and provides a teaching framework enhancing effectiveness in the ethics area. (Author/JOW)

  4. Engineering governance: introducing a governance meta framework.

    NARCIS (Netherlands)

    Brand, N.; Beens, B.; Vuuregge, E.; Batenburg, R.

    2011-01-01

    There is a need for a framework that depicts strategic choices within an organisation with regard to potential governance structures. The governance meta framework provides the necessary structure in the current developments of governance. Performance as well as conformance are embedded in this fram

  5. Framework agreements in public procurement

    DEFF Research Database (Denmark)

    Andrecka, Marta; Telles, Pedro

    2015-01-01

    Interview with Dr. Marta Andrecka, Postdoctoral Fellow at the Department of Law at the University of Aarhus, where she is currently working on a project called "Dealing with legal loopholes and uncertainties within EU public procurement law regarding framework agreements" sponsored by the Carlsberg...... Foundation. Before taking up her present position she carried out her doctoral research in Denmark and Australia and worked at law offices in both Poland and the UK. The topic for today’s talk is framework agreements, a relatively popular way of undertaking public procurement...

  6. Volume 8, Issue2 (April/June 2005)Articles in the Current Issue:Research ArticleBeyond NIMBYism: towards an integrated framework for understanding public perceptions of wind energy

    Science.gov (United States)

    Devine-Wright, Patrick

    2005-04-01

    It is widely recognised that public acceptability often poses a barrier towards renewable energy development. This article reviews existing research on public perceptions of wind energy, where opposition is typically characterized by the NIMBY (not in my back yard) concept. The objectives of the article are to provide a critical assessment of past research and an integrated, multidimensional framework to guide future work. Six distinct strands of research are identified, summarized and critiqued: public support for switching from conventional energy sources to wind energy; aspects of turbines associated with negative perceptions; the impact of physical proximity to turbines; acceptance over time of wind farms; NIMBYism as an explanation for negative perceptions; and, finally, the impact of local involvement on perceptions. Research across these strands is characterized by opinion poll studies of general beliefs and case studies of perceptions of specific developments. In both cases, research is fragmented and has failed to adequately explain, rather than merely describe, perceptual processes. The article argues for more theoretically informed empirical research, grounded in social science concepts and methods. A multidimensional framework is proposed that goes beyond the NIMBY label and integrates previous findings with social and environmental psychological theory. Copyright

  7. Challenges in orphan drug development and regulatory policy in China

    OpenAIRE

    Cheng, Alice; Xie, Zhi

    2017-01-01

    While regulatory policy is well defined for orphan drug development in the United States and Europe, rare disease policy in China is still evolving. Many Chinese patients currently pay out of pocket for international treatments that are not yet approved in China. The lack of a clear definition and therefore regulatory approval process for rare diseases has, until now, de-incentivized pharmaceutical companies to pursue rare disease drug development in China. In turn, many grassroots movements ...

  8. Beyond the Crisis: Financial Regulatory Reform in Emerging Asia

    OpenAIRE

    Lee, Chee Sung; Park, Cyn-Young

    2009-01-01

    The main objective of this paper is to suggest reform measures to address the gaps and weaknesses in emerging Asia's financial regulatory and supervisory systems, on the basis of lessons drawn from the global crisis. For emerging Asia, the direct impact of the global financial crisis has been limited, thus generating substantially less pressure for financial restructuring and regulatory reform than is the case in developed economies. However, the underlying causes of the current turmoil—such ...

  9. (Q)SAR modeling and safety assessment in regulatory review.

    Science.gov (United States)

    Kruhlak, N L; Benz, R D; Zhou, H; Colatsky, T J

    2012-03-01

    The ability to predict clinical safety based on chemical structures is becoming an increasingly important part of regulatory decision making. (Quantitative) structure-activity relationship ((Q)SAR) models are currently used to evaluate late-arising safety concerns and possible nonclinical effects of a drug and its related compounds when adequate safety data are absent or equivocal. Regulatory use will likely increase with the standardization of analytical approaches, more complete and reliable data collection methods, and a better understanding of toxicity mechanisms.

  10. The role of learning environment on high school chemistry students' motivation and self-regulatory processes

    Science.gov (United States)

    Judd, Jeffrey S.

    Changes to the global workforce and technological advancements require graduating high school students to be more autonomous, self-directed, and critical in their thinking. To reflect societal changes, current educational reform has focused on developing more problem-based, collaborative, and student-centered classrooms to promote effective self-regulatory learning strategies, with the goal of helping students adapt to future learning situations and become life-long learners. This study identifies key features that may characterize these "powerful learning environments", which I term "high self-regulating learning environments" for ease of discussion, and examine the environment's role on students' motivation and self-regulatory processes. Using direct observation, surveys, and formal and informal interviews, I identified perceptions, motivations, and self-regulatory strategies of 67 students in my high school chemistry classes as they completed academic tasks in both high and low self-regulating learning environments. With social cognitive theory as a theoretical framework, I then examined how students' beliefs and processes changed after they moved from low to a high self-regulating learning environment. Analyses revealed that key features such as task meaning, utility, complexity, and control appeared to play a role in promoting positive changes in students' motivation and self-regulation. As embedded cases, I also included four students identified as high self-regulating, and four students identified as low self-regulating to examine whether the key features of high and low self-regulating learning environments played a similar role in both groups. Analysis of findings indicates that key features did play a significant role in promoting positive changes in both groups, with high self-regulating students' motivation and self-regulatory strategies generally remaining higher than the low self-regulating students; this was the case in both environments. Findings

  11. Unmanned aircraft systems in wildlife research: Current and future applications of a transformative technology

    Science.gov (United States)

    Christie, Katherine S.; Gilbert, Sophie L.; Brown, Casey L.; Hatfield, Michael; Hanson, Leanne

    2016-01-01

    Unmanned aircraft systems (UAS) – also called unmanned aerial vehicles (UAVs) or drones – are an emerging tool that may provide a safer, more cost-effective, and quieter alternative to traditional research methods. We review examples where UAS have been used to document wildlife abundance, behavior, and habitat, and illustrate the strengths and weaknesses of this technology with two case studies. We summarize research on behavioral responses of wildlife to UAS, and discuss the need to understand how recreational and commercial applications of this technology could disturb certain species. Currently, the widespread implementation of UAS by scientists is limited by flight range, regulatory frameworks, and a lack of validation. UAS are most effective when used to examine smaller areas close to their launch sites, whereas manned aircraft are recommended for surveying greater distances. The growing demand for UAS in research and industry is driving rapid regulatory and technological progress, which in turn will make them more accessible and effective as analytical tools.

  12. Tobacco regulatory science: research to inform regulatory action at the Food and Drug Administration's Center for Tobacco Products.

    Science.gov (United States)

    Ashley, David L; Backinger, Cathy L; van Bemmel, Dana M; Neveleff, Deborah J

    2014-08-01

    The U.S. Food and Drug Administration (FDA) promotes the development of regulatory science to ensure that a strong evidence base informs all of its regulatory activities related to the manufacture, marketing, and distribution of tobacco products as well as public education about tobacco product constituents and effects. Toward that end, the FDA's Center for Tobacco Products (CTP) provides funding for research studies with scientific aims that fall within its defined regulatory authority. However, given their traditional biomedical focus on basic and applied research, some researchers may not understand the principles of regulatory science or the types of studies CTP funds. The purpose of this paper is (1) to clarify the definition of regulatory science as a distinct scientific discipline, (2) to explore the role of tobacco regulatory science in order to help researchers understand the parameters and types of research that can be funded by CTP, and (3) to describe the types of research efforts that will inform the FDA's public health framework for tobacco product regulation. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco 2014. This work is written by (a) US Government employee(s) and is in the public domain in the US.

  13. 重新界定商业银行分类监管的标准%Study on Redefining Regulatory Classification Standard of Commercial Banks

    Institute of Scientific and Technical Information of China (English)

    张惠

    2016-01-01

    现行的商业银行分类监管“唯身份论”,惯有的历史问题与现实监管缺陷存在明显的时代不适性与监管负效应,问题的根本就在于并没有形成一种有效的分类标准。从现行的分类监管框架出发,变革分类监管思路,坚持可行性原则设立分类标的,按照动态性原则定期调整等级,遵循差异性原则制定监管政策,依照导向性原则保证监管有效,进而重新界定分类监管标准体系,形成纵横交汇的网状监管构架,推动金融监管体制创新改革。从而推动金融业健康有序发展,更好地服务于经济建设。%The current regulatory classification of commercial banks “only identity theory”, Usual historical issues and reality regulatory defect obvious discomfort of the times and the negative effect of regulation , the fundamental problem is that not form an effective classification criteria .Starting from the classification of the current regulatory framework , change the Classification regula-tion ideas, adhere to the principle of the feasibility of setting up the subject of classification , in accordance with the principle of pe-riodic adjustment of the dynamic level , following the principle of the development of regulatory policy differences , in accordance with the guiding principle to ensure effective supervision , thus redefining the classification system of regulatory standards , form the vertical and horizontal intersection reticular regulatory framework , promote financial innovation and regulatory reform .

  14. Regulatory mark; Marco regulatorio

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2009-10-15

    This chapter is based on a work performed in distinct phases. The first phase consisted in of the analysis regulatory legislation existent in Brazil for the sugar-alcohol sector since the beginning of the X X century. This analysis allowed the identification of non existent points and legal devices related to the studied aspects, and that were considered as problematic for the sector expansion. In the second phase, related treaties and international agreements was studied and possible obstacles for the brazilian bio ethanol exportation for the international market. Initiatives were examined at European Union, United States of America, Caribbean and countries of the sub-Saharan Africa. In this phase, policies were identified related to the incentives and adoption of use of bio fuels added to the gasoline in countries or group of countries considered as key for the consolidation of bio ethanol as a world commodity.

  15. 75 FR 54210 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

    Science.gov (United States)

    2010-09-03

    ...-2010-032] Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of... Transactions August 30, 2010. On June 17, 2010, the Financial Industry Regulatory Authority, Inc....

  16. Scientific and Regulatory Policy Committee (SRPC) Review: Interpretation and Use of Cell Proliferation Data in Cancer Risk Assessment.

    Science.gov (United States)

    Wood, Charles E; Hukkanen, Renee R; Sura, Radhakrishna; Jacobson-Kram, David; Nolte, Thomas; Odin, Marielle; Cohen, Samuel M

    2015-08-01

    Increased cell proliferation is a central key event in the mode of action for many non-genotoxic carcinogens, and quantitative cell proliferation data play an important role in the cancer risk assessment of many pharmaceutical and environmental compounds. Currently, there is limited unified information on assay standards, reference values, targeted applications, study design issues, and quality control considerations for proliferation data. Here, we review issues in measuring cell proliferation indices, considerations for targeted studies, and applications within current risk assessment frameworks. As the regulatory environment moves toward more prospective evaluations based on quantitative pathway-based models, standardization of proliferation assays will become an increasingly important part of cancer risk assessment. To help address this development, we also discuss the potential role for proliferation data as a component of alternative carcinogenicity testing models. This information should improve consistency of cell proliferation methods and increase efficiency of targeted testing strategies.

  17. The Bregman Variational Dual-Tree Framework

    DEFF Research Database (Denmark)

    Amizadeh, Saeed; Thiesson, Bo; Hauskrecht, Milos

    2013-01-01

    . A significant effort to find more efficient solutions to the problem has been made in the literature. One of the state-of-the-art methods that has been recently introduced is the Variational Dual-Tree (VDT) framework. Despite some of its unique features, VDT is currently restricted only to Euclidean spaces...... framework can maintain all the pivotal features of the VDT framework and yet significantly improve its performance in non-Euclidean domains. We apply the proposed framework to different text categorization problems and demonstrate its benefits over the original VDT....

  18. The current status of diabetes professional educational standards and competencies in the UK--a position statement from the Diabetes UK Healthcare Professional Education Competency Framework Task and Finish Group.

    Science.gov (United States)

    Walsh, N; George, S; Priest, L; Deakin, T; Vanterpool, G; Karet, B; Simmons, D

    2011-12-01

    Diabetes is a significant health concern, both in the UK and globally. Management can be complex, often requiring high levels of knowledge and skills in order to provide high-quality and safe care. The provision of good, safe, quality care lies within the foundations of healthcare education, continuing professional development and evidence-based practice, which are inseparable and part of a continuum during the career of any health professional. Sound education provides the launch pad for effective clinical management and positive patient experiences. This position paper reviews and discusses work undertaken by a Working Group under the auspices of Diabetes UK with the remit of considering all health professional educational issues for people delivering care to people with diabetes. This work has scoped the availability of education for those within the healthcare system who may directly or indirectly encounter people with diabetes and reviews alignment to existing competency frameworks within the UK's National Health Service.

  19. An extended framework for science.

    Science.gov (United States)

    Cazalis, Roland

    2017-09-01

    We may be at the cusp of a next generation framework for science which can be facilitated by understanding current limitations in the context of a divergence of 'scientific' tradition from the Axial Age (800-200 BCE) to the present. A powerful advance may come from fusing certain elements from Western and Eastern traditions, synthesizing the framework with an apt understanding of the divergence. Key traits will include the ethopoetic nature of the scientist with attention to his/her experience of self. The framework will also 'access' knowledge through a state of mind less encumbered with paradoxes, duality, incompatibility and other aporias. Case studies in biology and physics illustrate possibilities. Copyright © 2017. Published by Elsevier Ltd.

  20. Animation framework using volume visualization

    Science.gov (United States)

    Fang, Wenxuan; Wang, Hongli

    2004-03-01

    As the development of computer graphics, scientific visualization and advanced imaging scanner and sensor technology, high quality animation making of volume data set has been a challenging in industries. A simple animation framework by using current volume visualization techniques is proposed in this paper. The framework consists of two pipelines: one is surface based method by using marching cubes algorithm, the other is volume rendering method by using shear-warp method. The volume visualization results can not only be used as key frame sources in the animation making, but also can be directly used as animation when the volume visualization is in stereoscopic mode. The proposed framework can be applied into fields such as medical education, film-making and archaeology.

  1. Demonstrating Value for Biosimilars: A Conceptual Framework

    Science.gov (United States)

    Rompas, Sotiris; Goss, Thomas; Amanuel, Sally; Coutinho, Victoria; Lai, Zhihong; Antonini, Paola; Murphy, Michael F.

    2015-01-01

    Background The value proposition for biosimilars can be characterized as a concept that moves beyond the argument of cost reduction relative to the innovator biologic drug and into a framework that incorporates the diverse needs of key healthcare stakeholders during the transition from clinical development to commercialization in the marketplace. Objectives To identify factors that facilitate and inhibit the development, commercialization, and adoption of biosimilars, and to recommend modifications in program design that are likely to support the demonstration of the value of biosimilars for payers, providers, and patients. Methods The primary data sources for this article include surveys conducted by Boston Healthcare Associates with payers and clinicians in the United States and the European Union 5 markets and blinded international protocol feasibility assessments completed by Worldwide Clinical Trials. Survey methodology used either convenience or purposeful sampling as appropriate, with participants extracted from diverse audiences, representative of those who generate or evaluate clinical data shaping the economic exchange and preferential status influencing physician adoption and patient access to biosimilars. Patient characteristics and psychosocial issues influencing patients' perception of small-molecule generics were extracted from the available literature to inform exploratory hypotheses, given the relative absence of such information for biosimilars. Discussion This article reviews the current evidence and summarizes results of surveys conducted with payers, providers, and drug investigation sites in the United States. Based on a review of published literature, as well as these survey results, conflicting and convergent demands exist for gathering data related to biosimilars. The motivations and data needs for these new agents are diverse, requiring adjudication of regulatory, economic, and clinical incentives beginning at program inception and

  2. Emerging regulatory paradigms in glutathione metabolism

    Science.gov (United States)

    Liu, Yilin; Hyde, Annastasia S.; Simpson, Melanie A.; Barycki, Joseph J.

    2015-01-01

    One of the hallmarks of cancer is the ability to generate and withstand unusual levels of oxidative stress. In part, this property of tumor cells is conferred by elevation of the cellular redox buffer glutathione. Though enzymes of the glutathione synthesis and salvage pathways have been characterized for several decades, we still lack a comprehensive understanding of their independent and coordinate regulatory mechanisms. Recent studies have further revealed that overall central metabolic pathways are frequently altered in various tumor types, resulting in significant increases in biosynthetic capacity, and feeding into glutathione synthesis. In this review, we will discuss the enzymes and pathways affecting glutathione flux in cancer, and summarize current models for regulating cellular glutathione through both de novo synthesis and efficient salvage. In addition, we examine the integration of glutathione metabolism with other altered fates of intermediary metabolites, and highlight remaining questions about molecular details of the accepted regulatory modes. PMID:24974179

  3. Regulatory mechanisms link phenotypic plasticity to evolvability.

    Science.gov (United States)

    van Gestel, Jordi; Weissing, Franz J

    2016-04-18

    Organisms have a remarkable capacity to respond to environmental change. They can either respond directly, by means of phenotypic plasticity, or they can slowly adapt through evolution. Yet, how phenotypic plasticity links to evolutionary adaptability is largely unknown. Current studies of plasticity tend to adopt a phenomenological reaction norm (RN) approach, which neglects the mechanisms underlying plasticity. Focusing on a concrete question - the optimal timing of bacterial sporulation - we here also consider a mechanistic approach, the evolution of a gene regulatory network (GRN) underlying plasticity. Using individual-based simulations, we compare the RN and GRN approach and find a number of striking differences. Most importantly, the GRN model results in a much higher diversity of responsive strategies than the RN model. We show that each of the evolved strategies is pre-adapted to a unique set of unseen environmental conditions. The regulatory mechanisms that control plasticity therefore critically link phenotypic plasticity to the adaptive potential of biological populations.

  4. Legal and regulatory concerns about transgenic plants in Brazil.

    Science.gov (United States)

    Fontes, Eliana M G

    2003-06-01

    Brazil has a biosafety law that was approved in 1995. This law provides for a horizontal type of regulation that coordinates other existing regulatory frameworks in the areas of agriculture, health and environment. Various federal government departments are responsible for implementing the law. The National Technical Biosafety Commission is the national competent authority on biosafety with overall responsibility. In the case of Bt plants or any insecticidal organism, the Agrochemical Law also applies and authorization for laboratory, greenhouse and field studies must be obtained from the Plant Protection Secretariat, the Brazilian Institute of Environment and the National Agency of Health. Furthermore, the National Environmental Council must issue a license for commercialization of any GMO. There is pressure needed for capacity building and to harmonize the regulatory and administrative frameworks among the different federal departments involved. Some perspectives and challenges for the commercial registration of transgenic crops are discussed.

  5. Regulatory focus in groupt contexts

    NARCIS (Netherlands)

    Faddegon, Krispijn Johannes

    2009-01-01

    The thesis examines the influence of group processes on the regulatory focus of individual group members. It is demonstrated that the group situation can affect group members' regulatory focus both in a top-down fashion (via the identitiy of the group) and in a bottom-up fashion (emerging from the g

  6. Reconsidering Styles of Regulatory Enforcement

    DEFF Research Database (Denmark)

    May, Peter J.; Winter, Søren

    2000-01-01

    This study addresses enforcement styles of regulatory inspectors, based on an examination of the municipal enforcement of agro-environmental policies in Denmark. Our findings make three contributions to the regulatory literature. One contribution is to add empirical support for theorizing about i...

  7. Reconsidering Styles of Regulatory Enforcement

    DEFF Research Database (Denmark)

    J. May, Peter; Winter, Søren

    2007-01-01

    This study addresses enforcement styles of regulatory inspectors based on an examination of the municipal enforcement of agro-environmental policies in Denmark. Our findings make three contributions to the regulatory literature. One contribution is to add empirical support for theorizing about in...

  8. Regulatory Foci and Organizational Commitment

    Science.gov (United States)

    Markovits, Yannis; Ullrich, Johannes; van Dick, Rolf; Davis, Ann J.

    2008-01-01

    We use regulatory focus theory to derive specific predictions regarding the differential relationships between regulatory focus and commitment. We estimated a structural equation model using a sample of 520 private and public sector employees and found in line with our hypotheses that (a) promotion focus related more strongly to affective…

  9. Disclosure as a regulatory tool

    DEFF Research Database (Denmark)

    2006-01-01

    The chapter analyses how disclure can be used as a regulatory tool and analyses how it has been applied so far in the area of financial market law and consumer law.......The chapter analyses how disclure can be used as a regulatory tool and analyses how it has been applied so far in the area of financial market law and consumer law....

  10. Programming Entity Framework

    CERN Document Server

    Lerman, Julia

    2010-01-01

    Get a thorough introduction to ADO.NET Entity Framework 4 -- Microsoft's core framework for modeling and interacting with data in .NET applications. The second edition of this acclaimed guide provides a hands-on tour of the framework latest version in Visual Studio 2010 and .NET Framework 4. Not only will you learn how to use EF4 in a variety of applications, you'll also gain a deep understanding of its architecture and APIs. Written by Julia Lerman, the leading independent authority on the framework, Programming Entity Framework covers it all -- from the Entity Data Model and Object Service

  11. Overcoming language barriers in the informed consent process: regulatory and compliance issues with the use of the "short form".

    Science.gov (United States)

    Lad, Pramod M; Dahl, Rebecca

    2014-01-01

    Language barriers in the informed consent process can be a significant impediment when recruiting non-English speaking subjects into clinical research studies. Regulatory guidelines indicate that the short form procedure be utilized in such circumstances. In this paper, we examine some of the ambiguities in the regulatory framework, the resulting need for institutional policy guidelines, and compliance issues with the short form process.

  12. Perspective Reforms for Approximation of the Ukrainian Legal Framework for Telecommunications

    DEFF Research Database (Denmark)

    Batura, Olga; Kretova, Olga A.

    2016-01-01

    This article studies Ukrainian legal and regulatory rules for telecommunications services markets against the backdrop of Ukrainian commitments under the GATS and especially the Association Agreement with the EU. The study elucidates to what extent the Ukrainian telecoms regulatory framework comp...

  13. ATLAS Future Framework Requirements Group Report

    CERN Document Server

    The ATLAS collaboration

    2016-01-01

    The Future Frameworks Requirements Group was constituted in Summer 2013 to consider and summarise the framework requirements from trigger and offline for configuring, scheduling and monitoring the data processing software needed by the ATLAS experiment. The principal motivation for such a re-examination arises from the current and anticipated evolution of CPUs, where multiple cores, hyper-threading and wide vector registers require a shift to a concurrent programming model. Such a model requires extensive changes in the current Gaudi/Athena frameworks and offers the opportunity to consider how HLT and offline processing can be better accommodated within the ATLAS framework. This note contains the report of the Future Frameworks Requirements Group.

  14. Anti-regulatory T cells

    DEFF Research Database (Denmark)

    Andersen, Mads Hald

    2017-01-01

    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...... 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...

  15. A UML profile for framework modeling

    Institute of Scientific and Technical Information of China (English)

    XU Xiao-liang(徐小良); WANG Le-yu(汪乐宇); ZHOU Hong(周泓)

    2004-01-01

    The current standard Unified Modeling Language(UML) could not model framework flexibility and extendibility adequately due to lack of appropriate constructs to distinguish framework hot-spots from kernel elements. A new UML profile that may customize UML for framework modeling was presented using the extension mechanisms of UML, providing a group of UML extensions to meet the needs of framework modeling. In this profile, the extended class diagrams and sequence diagrams were defined to straightforwardly identify the hot-spots and describe their instantiation restrictions. A transformation model based on design patterns was also put forward, such that the profile based framework design diagrams could be automatically mapped to the corresponding implementation diagrams. It was proved that the presented profile makes framework modeling more straightforwardly and therefore easier to understand and instantiate.

  16. A UML profile for framework modeling.

    Science.gov (United States)

    Xu, Xiao-liang; Wang, Le-yu; Zhou, Hong

    2004-01-01

    The current standard Unified Modeling Language(UML) could not model framework flexibility and extendability adequately due to lack of appropriate constructs to distinguish framework hot-spots from kernel elements. A new UML profile that may customize UML for framework modeling was presented using the extension mechanisms of UML, providing a group of UML extensions to meet the needs of framework modeling. In this profile, the extended class diagrams and sequence diagrams were defined to straightforwardly identify the hot-spots and describe their instantiation restrictions. A transformation model based on design patterns was also put forward, such that the profile based framework design diagrams could be automatically mapped to the corresponding implementation diagrams. It was proved that the presented profile makes framework modeling more straightforwardly and therefore easier to understand and instantiate.

  17. Enhancing Tissue Engineering and Regenerative Medicine Product Commercialization: The Role of Science in Regulatory Decision-Making for the TE/RM Product Development.

    Science.gov (United States)

    Bertram, Timothy A; Johnson, Peter C; Tawil, Bill J; Van Dyke, Mark; Hellman, Kiki B

    2015-10-01

    TERMIS-AM Industry Committee (TERMIS-AM/IC), in collaboration with the TERMIS-Europe (EU)/IC, conducted a symposium involving the European Medicines Agency and the U.S. Food and Drug Administration (FDA) toward building an understanding of the rational basis for regulatory decision-making and providing a framework for decisions made during the evaluation of safety and efficacy of TE/RM technologies. This symposium was held in August 2012 during the TERMIS-WC in Vienna, Austria. Emerging from this international initiative by the European Union and the United States, representatives from the respective agencies demonstrated that there are ongoing interagency efforts for developing common national practices toward harmonization of regulatory requirements for the TE/RM products. To extend a broad-based understanding of the role of science in regulatory decision-making, TERMIS-AM/IC, in cooperation with the FDA, organized a symposium at the 2014 TERMIS-AM Annual Meeting, which was held in Washington, DC. This event provided insights from leaders in the FDA and TERMIS on the current status of regulatory approaches for the approved TE/RM products, the use of science in making regulatory decisions, and TE/RM technologies that are in the development pipeline to address unmet medical needs. A far-ranging discussion with FDA representatives, industrialists, physicians, regenerative medicine biologists, and tissue engineers considered the gaps in today's scientific and regulatory understanding of TE/RM technologies. The identified gaps represent significant opportunities to advance TE/RM technologies toward commercialization.

  18. Comparative Human Health Impact Assessment of Engineered Nanomaterials in the Framework of Life Cycle Assessment.

    Science.gov (United States)

    Fransman, Wouter; Buist, Harrie; Kuijpers, Eelco; Walser, Tobias; Meyer, David; Zondervan-van den Beuken, Esther; Westerhout, Joost; Klein Entink, Rinke H; Brouwer, Derk H

    2017-07-01

    For safe innovation, knowledge on potential human health impacts is essential. Ideally, these impacts are considered within a larger life-cycle-based context to support sustainable development of new applications and products. A methodological framework that accounts for human health impacts caused by inhalation of engineered nanomaterials (ENMs) in an indoor air environment has been previously developed. The objectives of this study are as follows: (i) evaluate the feasibility of applying the CF framework for NP exposure in the workplace based on currently available data; and (ii) supplement any resulting knowledge gaps with methods and data from the life cycle approach and human risk assessment (LICARA) project to develop a modified case-specific version of the framework that will enable near-term inclusion of NP human health impacts in life cycle assessment (LCA) using a case study involving nanoscale titanium dioxide (nanoTiO2 ). The intent is to enhance typical LCA with elements of regulatory risk assessment, including its more detailed measure of uncertainty. The proof-of-principle demonstration of the framework highlighted the lack of available data for both the workplace emissions and human health effects of ENMs that is needed to calculate generalizable characterization factors using common human health impact assessment practices in LCA. The alternative approach of using intake fractions derived from workplace air concentration measurements and effect factors based on best-available toxicity data supported the current case-by-case approach for assessing the human health life cycle impacts of ENMs. Ultimately, the proposed framework and calculations demonstrate the potential utility of integrating elements of risk assessment with LCA for ENMs once the data are available. © 2016 Society for Risk Analysis.

  19. Regulatory Streamlining and Improvement

    Energy Technology Data Exchange (ETDEWEB)

    Mark A. Carl

    2006-07-11

    The Interstate Oil and Gas Compact Commission (IOGCC) engaged in numerous projects outlined under the scope of work discussed in the United States Department of Energy (DOE) grant number DE-FC26-04NT15456 awarded to the IOGCC. Numerous projects were completed that were extremely valuable to state oil and gas agencies as a result of work performed utilizing resources provided by the grant. There are numerous areas in which state agencies still need assistance. This additional assistance will need to be addressed under future scopes of work submitted annually to DOE's Project Officer for this grant. This report discusses the progress of the projects outlined under the grant scope of work for the 2005-2006 areas of interest, which are as follows: Area of Interest No. 1--Regulatory Streamlining and Improvement: This area of interest continues to support IOGCC's regulatory streamlining efforts that include the identification and elimination of unnecessary duplications of efforts between and among state and federal programs dealing with exploration and production on public lands. Area of Interest No. 2--Technology: This area of interest seeks to improve efficiency in states through the identification of technologies that can reduce costs. Area of Interest No. 3--Training and Education: This area of interest is vital to upgrading the skills of regulators and industry alike. Within the National Energy Policy, there are many appropriate training and education opportunities. Education was strongly endorsed by the President's National Energy Policy Development group. Acting through the governors offices, states are very effective conduits for the dissemination of energy education information. While the IOGCC favors the development of a comprehensive, long-term energy education plan, states are also supportive of immediate action on important concerns, such as energy prices, availability and conservation. Area of Interest No. 4--Resource Assessment and

  20. Ethical and regulatory aspects of genome editing.

    Science.gov (United States)

    Kohn, Donald B; Porteus, Matthew H; Scharenberg, Andrew M

    2016-05-26

    Gene editing is a rapidly developing area of biotechnology in which the nucleotide sequence of the genome of living cells is precisely changed. The use of genome-editing technologies to modify various types of blood cells, including hematopoietic stem cells, has emerged as an important field of therapeutic development for hematopoietic disease. Although these technologies offer the potential for generation of transformative therapies for patients suffering from myriad disorders of hematopoiesis, their application for therapeutic modification of primary human cells is still in its infancy. Consequently, development of ethical and regulatory frameworks that ensure their safe and effective use is an increasingly important consideration. Here, we review a number of issues that have the potential to impact the clinical implementation of genome-editing technologies, and suggest paths forward for resolving them such that new therapies can be safely and rapidly translated to the clinic. © 2016 by The American Society of Hematology.

  1. Current regulations and state investment in the wind power projects

    Directory of Open Access Journals (Sweden)

    Danijela Simeunović

    2015-09-01

    Full Text Available It is the objective of this paper to present the path which the wind farm projects have undergone in Croatia from their introduction and expansion since the year 2007 up to the today's date when their development is temporarily stayed. The paper first describes the political and legal framework for renewable energy sources in Croatia, and specifically for wind power plants, as well as the current status of investment in building of wind farms in Croatia. The paper further analyses why the Croatian system of promotion of eligible producers has proven to attract investment, albeit unsustainable for a longer period of time, and which regulatory measures have later contributed to the suspension of wind farm investment in 2014. Legal and factual consequences of such suspension are discussed at the end of the paper, as well as some potential new business models for further exploitation of wind energy in Croatia.

  2. 75 FR 30453 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-06-01

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving..., Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a National Association of Securities Dealers... National Association of Securities Dealers, Inc., the Financial Industry Regulatory Authority, Inc., or...

  3. 75 FR 40000 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-07-13

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change Relating to the Restated Certificate of Incorporation of Financial Industry Regulatory Authority, Inc. July 2, 2010. On May 21, 2010, Financial Industry Regulatory Authority, Inc....

  4. Regulatory considerations in production of a cell therapy medicinal product in Europe to clinical research.

    Science.gov (United States)

    Martín, Patricia Gálvez; Martinez, Adolfina Ruiz; Lara, Visitación Gallardo; Naveros, Beatriz Clares

    2014-02-01

    The development of new drugs using stem cells has become a clinic alternative for the treatment of different diseases such as Alzheimer's, diabetes and myocardial infarction. Similar to conventional medicines, stem cells as new medicinal products for cell therapy are subjected to current legislation concerning their manufacture process. Besides, their legality is determined by the Regulatory Agencies belonging to the Member State of the European Union in which they are being registered. With the evolution of therapy that uses cells as medicines, there is a need to develop the appropriate legislative and regulatory framework capable of ensuring their safety and effectiveness. However, few works have been published regarding the regulations that these products must comply through production and commercialization processes. The present work is focused on the description of key events during clinical development and cell production of stem cells as drugs. Such as the regulations, requirements and directives involved in the production of cell therapy medicinal products, from the clinical design stage to its commercialization in Europe.

  5. Mesenchymal Stem Cells as Therapeutics Agents: Quality and Environmental Regulatory Aspects

    Science.gov (United States)

    Sabata, Roger; Verges, Josep; Zugaza, José L.; Ruiz, Adolfina; Clares, Beatriz

    2016-01-01

    Mesenchymal stem cells (MSCs) are one of the main stem cells that have been used for advanced therapies and regenerative medicine. To carry out the translational clinical application of MSCs, their manufacturing and administration in human must be controlled; therefore they should be considered as medicine: stem cell-based medicinal products (SCMPs). The development of MSCs as SCMPs represents complicated therapeutics due to their extreme complex nature and rigorous regulatory oversights. The manufacturing process of MSCs needs to be addressed in clean environments in compliance with requirements of Good Manufacturing Practice (GMP). Facilities should maintain these GMP conditions according to international and national medicinal regulatory frameworks that introduce a number of specifications in order to produce MSCs as safe SCMPs. One of these important and complex requirements is the environmental monitoring. Although a number of environmental requirements are clearly defined, some others are provided as recommendations. In this review we aim to outline the current issues with regard to international guidelines which impact environmental monitoring in cleanrooms and clean areas for the manufacturing of MSCs. PMID:27999600

  6. Mesenchymal Stem Cells as Therapeutics Agents: Quality and Environmental Regulatory Aspects

    Directory of Open Access Journals (Sweden)

    Patricia Galvez-Martin

    2016-01-01

    Full Text Available Mesenchymal stem cells (MSCs are one of the main stem cells that have been used for advanced therapies and regenerative medicine. To carry out the translational clinical application of MSCs, their manufacturing and administration in human must be controlled; therefore they should be considered as medicine: stem cell-based medicinal products (SCMPs. The development of MSCs as SCMPs represents complicated therapeutics due to their extreme complex nature and rigorous regulatory oversights. The manufacturing process of MSCs needs to be addressed in clean environments in compliance with requirements of Good Manufacturing Practice (GMP. Facilities should maintain these GMP conditions according to international and national medicinal regulatory frameworks that introduce a number of specifications in order to produce MSCs as safe SCMPs. One of these important and complex requirements is the environmental monitoring. Although a number of environmental requirements are clearly defined, some others are provided as recommendations. In this review we aim to outline the current issues with regard to international guidelines which impact environmental monitoring in cleanrooms and clean areas for the manufacturing of MSCs.

  7. Deformations of crystal frameworks

    CERN Document Server

    Borcea, Ciprian S

    2011-01-01

    We apply our deformation theory of periodic bar-and-joint frameworks to tetrahedral crystal structures. The deformation space is investigated in detail for frameworks modelled on quartz, cristobalite and tridymite.

  8. Internationalization of regulatory requirements.

    Science.gov (United States)

    Juillet, Y

    2003-02-01

    The aim of harmonisation of medicines regulatory requirements is to allow the patient quicker access to new drugs and to avoid animal and human duplications. Harmonisation in the European Union (EU) is now completed, and has led to the submission of one dossier in one language study leading to European marketing authorizations, thanks in particular to efficacy guidelines published at the European level. With the benefit of the European experience since 1989, more than 40 guidelines have been harmonised amongst the EU, Japan and the USA through the International Conference on Harmonisation (ICH). ICH is a unique process gathering regulators and industry experts from the three regions. Its activity is built on expertise and trust. The Common Technical Document (CTD), an agreed common format for application in the three regions, is a logical follow-up to the ICH first phase harmonising the content of the dossier. The CTD final implementation in July 2003 will have considerable influence on the review process and on the exchange of information in the three regions.

  9. An Ethical Framework for Evaluating Experimental Technology

    NARCIS (Netherlands)

    Van de Poel, I.R.

    2015-01-01

    How are we to appraise new technological developments that may bring revolutionary social changes? Currently this is often done by trying to predict or anticipate social consequences and to use these as a basis for moral and regulatory appraisal. Such an approach can, however, not deal with the unce

  10. NGNP Project Regulatory Gap Analysis for Modular HTGRs

    Energy Technology Data Exchange (ETDEWEB)

    Wayne Moe

    2011-09-01

    The Next Generation Nuclear Plant (NGNP) Project Regulatory Gap Analysis (RGA) for High Temperature Gas-Cooled Reactors (HTGR) was conducted to evaluate existing regulatory requirements and guidance against the design characteristics specific to a generic modular HTGR. This final report presents results and identifies regulatory gaps concerning current Nuclear Regulatory Commission (NRC) licensing requirements that apply to the modular HTGR design concept. This report contains appendices that highlight important HTGR licensing issues that were found during the RGA study. The information contained in this report will be used to further efforts in reconciling HTGR-related gaps in the NRC licensing structure, which has to date largely focused on light water reactor technology.

  11. Experience in implementing regulatory requirements to protect against industrial sabotage

    Energy Technology Data Exchange (ETDEWEB)

    Knuth, D.F.

    1978-01-01

    Some of the problems and concerns in implementing the current regulatory requirements in physical protection of nuclear power plants are discussed. Until 1973, the Nuclear Regulatory Commission (NRC) was of the opinion that a determined group of professional saboteurs was beyond the scope of protection required. Since then regulatory changes have altered that concept; each successive regulatory change envisions a higher level of threat, and, hence, requires more provisions to protect the facilities. The author contends that, in some areas, NRC's decisions were hastily conceived with unrealistic implementation schedules. These decisions and regulations, if fully implemented, could be counterproductive to maintaining good security in a nuclear power plant, and are counterproductive to safety and operability of the plants.

  12. The OECD Fish Testing Framework Project: Summary of Workshop Recommendations

    Science.gov (United States)

    An integrated Fish Testing Framework was initiated in mid-2009 as OECD Project 2.30 with the United States as the lead country. The objectives of the project were to review the regulatory needs and data requirements for fish testing and review the currency of existing OECD Test ...

  13. Public–private partnership conceptual framework and models for the ...

    African Journals Online (AJOL)

    This paper presents public–private partnership (PPP) framework models for funding and financing of water services ... capital markets to finance water infrastructure, particularly local bond markets ...... for the provision of water services infrastructure assets to be ... of water use charges and/or tariffs (pricing), regulatory impact.

  14. Application of Regulatory Focus Theory to Search Advertising

    Science.gov (United States)

    Mowle, Elyse N.; Georgia, Emily J.; Doss, Brian D.; Updegraff, John A.

    2015-01-01

    Purpose The purpose of this paper is to test the utility of regulatory focus theory principles in a real-world setting; specifically, Internet hosted text advertisements. Effect of compatibility of the ad text with the regulatory focus of the consumer was examined. Design/methodology/approach Advertisements were created using Google AdWords. Data were collected for the number of views and clicks each ad received. Effect of regulatory fit was measured using logistic regression. Findings Logistic regression analyses demonstrated that there was a strong main effect for keyword, such that users were almost six times as likely to click on a promotion advertisement as a prevention advertisement, as well as a main effect for compatibility, such that users were twice as likely to click on an advertisement with content that was consistent with their keyword. Finally, there was a strong interaction of these two variables, such that the effect of consistent advertisements was stronger for promotion searches than for prevention searches. Research limitations/implications The effect of ad compatibility had medium to large effect sizes, suggesting that individuals’ state may have more influence on advertising response than do individuals’ traits (e.g. personality traits). Measurement of regulatory fit was limited by the constraints of Google AdWords. Practical implications The results of this study provide a possible framework for ad creation for Internet advertisers. Originality/value This paper is the first study to demonstrate the utility of regulatory focus theory in online advertising. PMID:26430293

  15. Application of Regulatory Focus Theory to Search Advertising.

    Science.gov (United States)

    Mowle, Elyse N; Georgia, Emily J; Doss, Brian D; Updegraff, John A

    The purpose of this paper is to test the utility of regulatory focus theory principles in a real-world setting; specifically, Internet hosted text advertisements. Effect of compatibility of the ad text with the regulatory focus of the consumer was examined. Advertisements were created using Google AdWords. Data were collected for the number of views and clicks each ad received. Effect of regulatory fit was measured using logistic regression. Logistic regression analyses demonstrated that there was a strong main effect for keyword, such that users were almost six times as likely to click on a promotion advertisement as a prevention advertisement, as well as a main effect for compatibility, such that users were twice as likely to click on an advertisement with content that was consistent with their keyword. Finally, there was a strong interaction of these two variables, such that the effect of consistent advertisements was stronger for promotion searches than for prevention searches. The effect of ad compatibility had medium to large effect sizes, suggesting that individuals' state may have more influence on advertising response than do individuals' traits (e.g. personality traits). Measurement of regulatory fit was limited by the constraints of Google AdWords. The results of this study provide a possible framework for ad creation for Internet advertisers. This paper is the first study to demonstrate the utility of regulatory focus theory in online advertising.

  16. Global regulatory landscape of biosimilars: emerging and established market perspectives

    Directory of Open Access Journals (Sweden)

    Krishnan A

    2015-02-01

    Full Text Available Anita Krishnan,1 Rustom Mody,1 Hemant Malhotra21Lupin Limited, Biotech Division, Maharashtra, India; 2Division of Medical Oncology, RK Birla Cancer Center, SMS Medical College Hospital, Jaipur, India Abstract: Biological product development for launch in multiple geographies with varied regulatory expectations would require a planned and focused strategy, involving the selection of the appropriate reference product, defining the extent of process and product characterization and design of nonclinical and clinical studies. The development for established markets like the European Union and the United States, which have precedence in regulatory pathways, may face very different challenges compared to emerging markets, many of which are still in the nascent stages of regulatory guidelines. A clear and concise understanding of the regulatory framework of each region and awareness of the limitations of health care policies, with an added knowledge of the local factors that influence the biosimilar market, would be desirable for a good business strategy. Herein it is attempted to outline the stages of regional guideline implementation in the various global locations and compare the variability in regulatory requirement between them. The factors that could potentially impact biosimilars business in these regions are also outlined. Finally, the prevailing competition between manufacturers of innovative and biosimilar drugs, which could influence the availability of lifesaving off-patent drugs for critical diseases and the advent of more effective, alternate, or next-generation molecules, is also briefly described. Keywords: guidelines, India, comparability, EMA, US FDA, WHO

  17. Bioattractors: dynamical systems theory and the evolution of regulatory processes.

    Science.gov (United States)

    Jaeger, Johannes; Monk, Nick

    2014-06-01

    In this paper, we illustrate how dynamical systems theory can provide a unifying conceptual framework for evolution of biological regulatory systems. Our argument is that the genotype-phenotype map can be characterized by the phase portrait of the underlying regulatory process. The features of this portrait--such as attractors with associated basins and their bifurcations--define the regulatory and evolutionary potential of a system. We show how the geometric analysis of phase space connects Waddington's epigenetic landscape to recent computational approaches for the study of robustness and evolvability in network evolution. We discuss how the geometry of phase space determines the probability of possible phenotypic transitions. Finally, we demonstrate how the active, self-organizing role of the environment in phenotypic evolution can be understood in terms of dynamical systems concepts. This approach yields mechanistic explanations that go beyond insights based on the simulation of evolving regulatory networks alone. Its predictions can now be tested by studying specific, experimentally tractable regulatory systems using the tools of modern systems biology. A systematic exploration of such systems will enable us to understand better the nature and origin of the phenotypic variability, which provides the substrate for evolution by natural selection.

  18. Regulatory Accessibility and Social Influences on State Self-Control

    OpenAIRE

    vanDellen, Michelle R.; Hoyle, Rick H.

    2009-01-01

    The current work examined how social factors influence self-control. Current conceptions of state self-control treat it largely as a function of regulatory capacity. The authors propose that state self-control might also be influenced by social factors because of regulatory accessibility. Studies 1 through 4 provide evidence that individuals’ state self-control is influenced by the trait and state self-control of salient others such that thinking of others with good trait or state self-contro...

  19. 78 FR 4307 - Current Good Manufacturing Practice Requirements for Combination Products

    Science.gov (United States)

    2013-01-22

    ... streamlined regulatory framework for firms to use when demonstrating compliance with CGMP requirements for... framework that takes account of the fact that combination products are made up of drug, device, and biological product constituent parts. At the same time, commenters wanted to ensure that the framework...

  20. Programming Entity Framework

    CERN Document Server

    Lerman, Julia

    2009-01-01

    Programming Entity Framework is a thorough introduction to Microsoft's new core framework for modeling and interacting with data in .NET applications. This highly-acclaimed book not only gives experienced developers a hands-on tour of the Entity Framework and explains its use in a variety of applications, it also provides a deep understanding of its architecture and APIs -- knowledge that will be extremely valuable as you shift to the Entity Framework version in .NET Framework 4.0 and Visual Studio 2010. From the Entity Data Model (EDM) and Object Services to EntityClient and the Metadata Work

  1. Food safety regulatory systems in Europe and China:A study of how co-regulation can improve regulatory effectiveness

    Institute of Scientific and Technical Information of China (English)

    Kevin Chen; WANG Xin-xin; SONG Hai-ying

    2015-01-01

    Food safety has received a great deal of attention in both developed and developing countries in recent years. In China, the numerous food scandals and scares that have struck over the past decade have spurred signiifcant food safety regulatory reform, which has been increasingly oriented towards the public-private partnership model adopted by the Europe Union’s (EU) food safety regulatory system. This paper analyzes the development of both the EU’s and China’s food safety regu-latory systems, identiifes the current chalenges for China and additionaly considers the role of public-private partnership. The success of co-regulation in the food regulatory system would bring signiifcant beneifts and opportunities for China. Finaly, this paper recommends additional measures like training and grants to improve the private’s sector effectiveness in co-regulating China’s food safety issues.

  2. The Danish Regulatory Reform of Telecommunications

    DEFF Research Database (Denmark)

    Skouby, Knud Erik

    1998-01-01

    An overview of the liberalisation process and regulatory reform of telecommunications in Denmark......An overview of the liberalisation process and regulatory reform of telecommunications in Denmark...

  3. XcisClique: analysis of regulatory bicliques

    Directory of Open Access Journals (Sweden)

    Grene Ruth

    2006-04-01

    Full Text Available Abstract Background Modeling of cis-elements or regulatory motifs in promoter (upstream regions of genes is a challenging computational problem. In this work, set of regulatory motifs simultaneously present in the promoters of a set of genes is modeled as a biclique in a suitably defined bipartite graph. A biologically meaningful co-occurrence of multiple cis-elements in a gene promoter is assessed by the combined analysis of genomic and gene expression data. Greater statistical significance is associated with a set of genes that shares a common set of regulatory motifs, while simultaneously exhibiting highly correlated gene expression under given experimental conditions. Methods XcisClique, the system developed in this work, is a comprehensive infrastructure that associates annotated genome and gene expression data, models known cis-elements as regular expressions, identifies maximal bicliques in a bipartite gene-motif graph; and ranks bicliques based on their computed statistical significance. Significance is a function of the probability of occurrence of those motifs in a biclique (a hypergeometric distribution, and on the new sum of absolute values statistic (SAV that uses Spearman correlations of gene expression vectors. SAV is a statistic well-suited for this purpose as described in the discussion. Results XcisClique identifies new motif and gene combinations that might indicate as yet unidentified involvement of sets of genes in biological functions and processes. It currently supports Arabidopsis thaliana and can be adapted to other organisms, assuming the existence of annotated genomic sequences, suitable gene expression data, and identified regulatory motifs. A subset of Xcis Clique functionalities, including the motif visualization component MotifSee, source code, and supplementary material are available at https://bioinformatics.cs.vt.edu/xcisclique/.

  4. Regulatory cross-cutting topics for fuel cycle facilities.

    Energy Technology Data Exchange (ETDEWEB)

    Denman, Matthew R.; Brown, Jason; Goldmann, Andrew Scott; Louie, David

    2013-10-01

    This report overviews crosscutting regulatory topics for nuclear fuel cycle facilities for use in the Fuel Cycle Research & Development Nuclear Fuel Cycle Evaluation and Screening study. In particular, the regulatory infrastructure and analysis capability is assessed for the following topical areas: Fire Regulations (i.e., how applicable are current Nuclear Regulatory Commission (NRC) and/or International Atomic Energy Agency (IAEA) fire regulations to advance fuel cycle facilities) Consequence Assessment (i.e., how applicable are current radionuclide transportation tools to support risk-informed regulations and Level 2 and/or 3 PRA) While not addressed in detail, the following regulatory topic is also discussed: Integrated Security, Safeguard and Safety Requirement (i.e., how applicable are current Nuclear Regulatory Commission (NRC) regulations to future fuel cycle facilities which will likely be required to balance the sometimes conflicting Material Accountability, Security, and Safety requirements.)

  5. The African Health Profession Regulatory Collaborative for Nurses and Midwives

    Directory of Open Access Journals (Sweden)

    McCarthy Carey F

    2012-08-01

    Full Text Available Abstract Background More than thirty-five sub-Saharan African countries have severe health workforce shortages. Many also struggle with a mismatch between the knowledge and competencies of health professionals and the needs of the populations they serve. Addressing these workforce challenges requires collaboration among health and education stakeholders and reform of health worker regulations. Health professional regulatory bodies, such as nursing and midwifery councils, have the mandate to reform regulations yet often do not have the resources or expertise to do so. In 2011, the United States of America Centers for Disease Control and Prevention began a four-year initiative to increase the collaboration among national stakeholders and help strengthen the capacity of health professional regulatory bodies to reform national regulatory frameworks. The initiative is called the African Health Regulatory Collaborative for Nurses and Midwives. This article describes the African Health Regulatory Collaborative for Nurses and Midwives and discusses its importance in implementing and sustaining national, regional, and global workforce initiatives. Discussion The African Health Profession Regulatory Collaborative for Nurses and Midwives convenes leaders responsible for regulation from 14 countries in East, Central and Southern Africa. It provides a high profile, south-to-south collaboration to assist countries in implementing joint approaches to problems affecting the health workforce. Implemented in partnership with Emory University, the Commonwealth Secretariat, and the East, Central and Southern African College of Nursing, this initiative also supports four to five countries per year in implementing locally-designed regulation improvement projects. Over time, the African Health Regulatory Collaborative for Nurses and Midwives will help to increase the regulatory capacity of health professional organizations and ultimately improve regulation and

  6. Advanced Reactor Technology -- Regulatory Technology Development Plan (RTDP)

    Energy Technology Data Exchange (ETDEWEB)

    Moe, Wayne Leland [Idaho National Lab. (INL), Idaho Falls, ID (United States)

    2015-05-01

    importance of key DOE reactor research initiatives should be assessed early in the technology development process. Quality assurance requirements supportive of later licensing activities must also be attached to important research activities to ensure resulting data is usable in that context. Early regulatory analysis and licensing approach planning thus provides a significant benefit to the formulation of research plans and also enables the planning and development of a compatible AdvSMR licensing framework, should significant modification be required.

  7. Advanced Reactor Technologies - Regulatory Technology Development Plan (RTDP)

    Energy Technology Data Exchange (ETDEWEB)

    Moe, Wayne L.

    2017-08-23

    importance of key DOE reactor research initiatives should be assessed early in the technology development process. Quality assurance requirements supportive of later licensing activities must also be attached to important research activities to ensure resulting data is usable in that context. Early regulatory analysis and licensing approach planning thus provides a significant benefit to the formulation of research plans and also enables the planning and development of a compatible AdvSMR licensing framework, should significant modification be required.

  8. Taking Stock of Regulatory Variation.

    Science.gov (United States)

    Maurano, Matthew T; Stamatoyannopoulos, John A

    2015-07-29

    Three recent studies measure individual variation in regulatory DNA accessibility. What do they tell us about the prospects of assessing variation in single cells and across populations? Copyright © 2015 Elsevier Inc. All rights reserved.

  9. Regulatory facility guide for Ohio

    Energy Technology Data Exchange (ETDEWEB)

    Anderson, S.S.; Bock, R.E.; Francis, M.W.; Gove, R.M.; Johnson, P.E.; Kovac, F.M.; Mynatt, J.O. [Oak Ridge National Lab., TN (United States); Rymer, A.C. [Transportation Consulting Services, Knoxville, TN (United States)

    1994-02-28

    The Regulatory Facility Guide (RFG) has been developed for the DOE and contractor facilities located in the state of Ohio. It provides detailed compilations of international, federal, and state transportation-related regulations applicable to shipments originating at destined to Ohio facilities. This RFG was developed as an additional resource tool for use both by traffic managers who must ensure that transportation operations are in full compliance with all applicable regulatory requirements and by oversight personnel who must verify compliance activities.

  10. Electronic Commerce Removing Regulatory Impediments

    Science.gov (United States)

    1992-05-01

    AD-A252 691 ELECTRONIC COMMERCE Removing Regulatory Impediments ~DuiG A% ELECTE I JUL1 8 1992 0 C D Daniel J. Drake John A. Ciucci ... - ""N ST AT KE...Management Institute 6400 Goldsboro Road Bethesda, Maryland 20817-5886 92 LMI Executive Summary ELECTRONIC COMMERCE : REMOVING REGULATORY IMPEDIMENTS... Electronic Commerce techniques, such as electronic mail and electronic data interchange (EDI), enable Government agencies to conduct business without the

  11. A review of the current nomenclature for psychotropic agents and an introduction to the Neuroscience-based Nomenclature.

    Science.gov (United States)

    Zohar, Joseph; Stahl, Stephen; Moller, Hans-Jurgen; Blier, Pierre; Kupfer, David; Yamawaki, Shigeto; Uchida, Hiroyuki; Spedding, Michael; Goodwin, Guy M; Nutt, David

    2015-12-01

    Neuroscience based Nomenclature (NbN) is a new system of classifying psychotropic drugs by their pharmacological profile. The NbN was developed to replace the current indication-based nomenclature and to provide an up-to-date and more useful framework to better inform pharmacological decisions. NbN provides updated relevant and specific scientific, regulatory and clinical information, aiming to support rational and lucid prescribing. This pharmacologically driven nomenclature, which highlights pharmacological domains and modes of action, may also increase drug adherence as it clarifies the rationale for selecting a specific psychotropic agent.

  12. A Conceptual Framework for Assessing Motivation and Self-Regulated Learning in College Students

    Science.gov (United States)

    Pintrich, Paul R.

    2004-01-01

    A conceptual framework for assessing student motivation and self-regulated learning in the college classroom is presented. The framework is based on a self-regulatory (SRL) perspective on student motivation and learning in contrast to a student approaches to learning (SAL) perspective. The differences between SRL and SAL approaches are discussed,…

  13. On the use of mixture toxicity assessment in REACH and the water framework directive

    DEFF Research Database (Denmark)

    Syberg, Kristian; Jensen, T.S.; Cedergreen, Nina;

    2009-01-01

      This review seeks to connect the scientific theory of mixture toxicity to its implementation within different regulatory frameworks. The aim is to demonstrate how mixture toxicity assessment can be more thoroughly integrated into the European chemical regulations, REACH and the Water Framework ...

  14. Protection of people and environment from radiation risk through good regulatory practice

    Science.gov (United States)

    Jais, Azlina Mohammad; Hassan, Najwa

    2017-01-01

    The term "good regulatory practice" has seen growing frequency of usage worldwide, especially since the 2011 Fukushima nuclear incident. However, the term appears quite ambiguous as it may mean differently to different people. This leads us to the first important question: what does "good regulatory practice" actually mean? When used in conjunction with the Fukushima incident, do we imply that there is an absence of "good regulatory practice" in the Japanese' Nuclear and Industry Safety Agency (NISA)? This is quite troubling. It is clear that the term should be defined formally so that our understanding of "good regulatory practice" can be standardized. There is still another important question beyond agreeing on what "good regulatory practice" is: is "good regulatory practice" specific to a region, or is it global? And is it applicable only to nuclear regulators, or to all types of regulators per se? This paper aims to deliberate on the above mentioned questions. Specifically, we hope to discuss the "good regulatory practice" for atomic energy activities in order to protect the people and the environment from radiation risk of such activities. By understanding what "good regulatory practice" truly means, a newcomer country such as Malaysia can quickly learn and adopt these practices so as to assure a competent national nuclear regulatory authority who will be responsible in ensuring the safety, security and safeguards of peaceful atomic energy activities in the country including nuclear liability. In understanding this concept, a holistic approach will be taken by looking into example of advanced and newcomer countries of various nuclear regulatory authorities all around the world. Then the paper will focus on the challenges that the current nuclear regulatory authority in Malaysia which is Atomic Energy Licensing Board has, its challenges to follow the concept of "good regulatory practice" and its ways to overcome it. This study explore the initiatives could be

  15. Regulatory issues related to functional foods and natural health products in Canada: possible implications for manufacturers of conjugated linoleic acid.

    Science.gov (United States)

    Fitzpatrick, Kelley C

    2004-06-01

    The Canadian Food and Drugs Act and Regulations, through its definitions of food and drug, currently restricts health-related claims for foods, food ingredients, and natural health products (NHPs). Over the past few decades, scientific research has led to a large body of information that demonstrates the benefits for health of many food and NHP ingredients. Health Canada recognized the constraints of the current regulatory environment and started to develop regulations related to the allowance of health claims for functional foods and NHPs, including those foods and NHPs that would contain conjugated linoleic acid isomers. Health Canada has 3 initiatives under way in the area of health claims for foods: 1) to adopt the generic health claims of the United States within a Canadian context, 2) to develop scientific standards of evidence and a guidance document for supporting the validity of product-specific claims, and 3) to develop an overall regulatory framework for functional foods. In 2000, Health Canada announced approval for the use of 5 generic diet-related health claims: sodium and hypertension, calcium and osteoporosis, saturated and trans fat and cholesterol and coronary artery disease, fruits and vegetables and cancer, and sugar alcohols and dental caries. Under a separate initiative, Natural Health Products Regulations were published in the Canada Gazette Part II on June 18, 2003. The NHP Regulations came into force on January 1, 2004, with a transition period ranging from 2 y (for site licensing) to 6 y (for product licensing, for products already issued a drug identification number).

  16. Institutional and legal arrangements in the Nile river basin: suggestions to improve the current situation toward adaptive integrated water resources management.

    Science.gov (United States)

    Abdalla, Khalid Mohamed El Hassan

    2008-01-01

    A comparative study was conducted in this work in order to investigate the current situation in the Nile river basin (NRB) regarding the institutional and legal arrangements needed to support the adaptive integrated water resources management (AIWRM) strategy. Two similar river basins were selected to achieve this comparison and to introduce suggestions to reform the current situation in the basin. Before that, the ideal situation is investigated to be as a yardstick for the desired situation. The study indicated that the necessary AIWRM criteria may include regulatory as well as implementation organizations that support shared-vision reaching with its all necessary features (cooperation, stakeholders' participation, subsidiarity, and information and knowledge exchange). Thus the main features of the desired situations regarding AIWRM in river basins are stakeholders' participation, learning-driven ability, quick response to risks and uncertainties, and finally a legal framework that could support these criteria. Although the AIWRM criteria seem to be satisfied in NRB, the basin lacks the necessary regulatory institutions as well as the legal framework. According to this, this study recommends to reform the current situation in NRB by creating regulator institutions (policy and decision making level) as well a legal framework to legitimate them.

  17. Regulatory Risk Reduction for Advanced Reactor Technologies – FY2016 Status and Work Plan Summary

    Energy Technology Data Exchange (ETDEWEB)

    Moe, Wayne Leland [Idaho National Lab. (INL), Idaho Falls, ID (United States)

    2016-08-01

    Millions of public and private sector dollars have been invested over recent decades to realize greater efficiency, reliability, and the inherent and passive safety offered by advanced nuclear reactor technologies. However, a major challenge in experiencing those benefits resides in the existing U.S. regulatory framework. This framework governs all commercial nuclear plant construction, operations, and safety issues and is highly large light water reactor (LWR) technology centric. The framework must be modernized to effectively deal with non-LWR advanced designs if those designs are to become part of the U.S energy supply. The U.S. Department of Energy’s (DOE) Advanced Reactor Technologies (ART) Regulatory Risk Reduction (RRR) initiative, managed by the Regulatory Affairs Department at the Idaho National Laboratory (INL), is establishing a capability that can systematically retire extraneous licensing risks associated with regulatory framework incompatibilities. This capability proposes to rely heavily on the perspectives of the affected regulated community (i.e., commercial advanced reactor designers/vendors and prospective owner/operators) yet remain tuned to assuring public safety and acceptability by regulators responsible for license issuance. The extent to which broad industry perspectives are being incorporated into the proposed framework makes this initiative unique and of potential benefit to all future domestic non-LWR applicants

  18. The politics of surveillance policy: UK regulatory dynamics after Snowden

    Directory of Open Access Journals (Sweden)

    Arne Hintz

    2016-09-01

    Full Text Available The revelations by NSA whistleblower Edward Snowden have illustrated the scale and extent of digital surveillance carried out by different security and intelligence agencies. The publications have led to a variety of concerns, public debate, and some diplomatic fallout regarding the legality of the surveillance, the extent of state interference in civic life, and the protection of civil rights in the context of security. Debates about the policy environment of surveillance emerged quickly after the leaks began, but actual policy change is only starting. In the UK, a draft law (Investigatory Powers Bill has been proposed and is currently discussed. In this paper, we will trace the forces and dynamics that have shaped this particular policy response. Addressing surveillance policy as a site of struggle between different social forces and drawing on different fields across communication policy research, we suggest eight dynamics that, often in conflicting ways, have shaped the regulatory framework of surveillance policy in the UK since the Snowden leaks. These include the governmental context; national and international norms; court rulings; civil society advocacy; technical standards; private sector interventions; media coverage; and public opinion. We investigate how state surveillance has been met with criticism by parts of the technology industry and civil society, and that policy change was required as a result of legal challenges, review commissions and normative interventions. However a combination of specific government compositions, the strong role of security agendas and discourses, media justification and a muted reaction by the public have hindered a more fundamental review of surveillance practices so far and have moved policy debate towards the expansion, rather than the restriction, of surveillance in the aftermath of Snowden.

  19. Spin current

    CERN Document Server

    Valenzuela, Sergio O; Saitoh, Eiji; Kimura, Takashi

    2012-01-01

    In a new branch of physics and technology called spin-electronics or spintronics, the flow of electrical charge (usual current) as well as the flow of electron spin, the so-called 'spin current', are manipulated and controlled together. This book provides an introduction and guide to the new physics and application of spin current.

  20. Current situation of wind energy in the world and Turkey

    Energy Technology Data Exchange (ETDEWEB)

    Alper Kaplan, Yusuf; San, Ismail [Department of Electrical and Electronics Engineering, Anadolu University (Turkey)], email: yakaplan@anadolu.edu.tr, email: isan@anadolu.edu.tr

    2011-07-01

    This paper gives an overview of the current situation of wind power in Turkey and in the world by evaluating installed wind power using current data. It also looks at the political conditions of Turkey in relation to the current installed wind energy power in Turkey compared with that of certain developed countries. The problems encountered are also illustrated as a basis for proposing solutions. Turkey's wind energy potential is 48,000 MW but installed wind power was only 1,329 MW as of 2011. Wind energy is at present one of the most cost-competitive renewable energy technologies in the world when technical, geographical and social issues are taken into consideration. Economic sources should be researched. The development of current potential and the market entry of renewable energy resources requires a legal and regulatory framework that support suitable mechanisms. Local support is recommended together with tax exemptions. Long-term fixed-price guarantees should also be considered by government.

  1. DYVIPAC: an integrated analysis and visualisation framework to probe multi-dimensional biological networks.

    Science.gov (United States)

    Nguyen, Lan K; Degasperi, Andrea; Cotter, Philip; Kholodenko, Boris N

    2015-07-29

    Biochemical networks are dynamic and multi-dimensional systems, consisting of tens or hundreds of molecular components. Diseases such as cancer commonly arise due to changes in the dynamics of signalling and gene regulatory networks caused by genetic alternations. Elucidating the network dynamics in health and disease is crucial to better understand the disease mechanisms and derive effective therapeutic strategies. However, current approaches to analyse and visualise systems dynamics can often provide only low-dimensional projections of the network dynamics, which often does not present the multi-dimensional picture of the system behaviour. More efficient and reliable methods for multi-dimensional systems analysis and visualisation are thus required. To address this issue, we here present an integrated analysis and visualisation framework for high-dimensional network behaviour which exploits the advantages provided by parallel coordinates graphs. We demonstrate the applicability of the framework, named "Dynamics Visualisation based on Parallel Coordinates" (DYVIPAC), to a variety of signalling networks ranging in topological wirings and dynamic properties. The framework was proved useful in acquiring an integrated understanding of systems behaviour.

  2. Frameworks in CS1

    DEFF Research Database (Denmark)

    Christensen, Henrik Bærbak; Caspersen, Michael Edelgaard

    2002-01-01

    point for introducing graphical user interface frameworks such as Java Swing and AWT as the students are not overwhelmed by all the details of such frameworks right away but given a conceptual road-map and practical experience that allow them to cope with the complexity.......In this paper we argue that introducing object-oriented frameworks as subject already in the CS1 curriculum is important if we are to train the programmers of tomorrow to become just as much software reusers as software producers. We present a simple, graphical, framework that we have successfully...

  3. Performance measuring framework for grid market middleware

    OpenAIRE

    Freitag, Fèlix; Chacín Martínez, Pablo; Chao, Isaac; Brunner, René; Navarro Moldes, Leandro; Ardáiz Villanueva, Óscar

    2007-01-01

    Current implementations of Grid infrastructures provide frameworks which aim at achieve on-demand computing. In such a scenario, contribution and use of resources will be governed by business models. The challenge is to provide multi-level performance information which enables the participation of the different actors in such a system. In this paper we describe the performance measuring framework developed for Grid Market Middleware, a middleware which supports economic-model based selection ...

  4. Regulatory and Permitting Issues

    Energy Technology Data Exchange (ETDEWEB)

    Larry Myer

    2005-12-01

    As part of the West Coast Regional Carbon Sequestration Partnership (WESTCARB), Terralog Technologies USA, Inc., reviewed current state and federal regulations related to carbon dioxide capture and storage within geologic formations and enhanced carbon uptake in terrestrial ecosystems. We have evaluated and summarized the current and possible future permitting requirements for the six states that comprise the West Coast Regional Partnership. Four options exist for CO{sub 2} injection into appropriate geologic formations, including storage in: (1) oil and gas reservoirs, (2) saline formations, (3) unmineable coal beds, and (4) salt caverns. Terrestrial CO{sub 2} sequestration involves improved carbon conservation management (e.g. reduction of deforestation), carbon substitution (e.g., substitution for fossil fuel-based products, energy conservation through urban forestry, biomass for energy generation), and improved carbon storage management (e.g., expanding the storage of carbon in forest ecosystems). The primary terrestrial options for the West Coast Region include: (1) reforestation of under-producing lands (including streamside forest restoration), (2) improved forest management, (3) forest protection and conservation, and (4) fuel treatments for the reduction of risk of uncharacteristically severe fires (potentially with associated biomass energy generation). The permits and/or contracts required for any land-use changes/disturbances and biomass energy generation that may occur as part of WESTCARB's activities have been summarized for each state.

  5. Conceptual Framework for Analyzing the MTS within the Intermodal System

    Science.gov (United States)

    2012-06-01

    BUILDING STRONG® US Army Corps of Engineers BUILDING STRONG® Conceptual Framework for Analyzing the MTS within the Intermodal System Dr. Mike...2012 2. REPORT TYPE 3. DATES COVERED 00-00-2012 to 00-00-2012 4. TITLE AND SUBTITLE Conceptual Framework for Analyzing the MTS within the... Conceptual Framework c CURRENT MTS CURRENT INTERMODAL SYSTEM c MTS INVESTMENTS INTERMODAL INVESTMENTS FUTURE FREIGHT TRANSPORTATION DEMAND c

  6. Conceptual framework for environmental protection

    Energy Technology Data Exchange (ETDEWEB)

    Gilliland, M.W.

    1984-11-01

    The environmental and economic components of a region or a nation are inextricably linked. Moreover, environmental protection technology must deal specifically with the linkages between the economy and the environment, that is, with by-products of the economy as they move from the economy to the environment or with natural resources as they move from the environment to the economy. Yet, environmental policy analyses are rarely able to focus on these linkages. The author develops conceptual framework aimed at mitigating that inadequacy. The framework is tied to its theoretical basis in thermodynamics and is utilized to identify generic categories of environmental protection strategies, to identify some disadvantages of current strategies, and to suggest alternatives. 14 references, 4 figures.

  7. Modeling genomic regulatory networks with big data.

    Science.gov (United States)

    Bolouri, Hamid

    2014-05-01

    High-throughput sequencing, large-scale data generation projects, and web-based cloud computing are changing how computational biology is performed, who performs it, and what biological insights it can deliver. I review here the latest developments in available data, methods, and software, focusing on the modeling and analysis of the gene regulatory interactions in cells. Three key findings are: (i) although sophisticated computational resources are increasingly available to bench biologists, tailored ongoing education is necessary to avoid the erroneous use of these resources. (ii) Current models of the regulation of gene expression are far too simplistic and need updating. (iii) Integrative computational analysis of large-scale datasets is becoming a fundamental component of molecular biology. I discuss current and near-term opportunities and challenges related to these three points.

  8. 77 FR 46339 - Chrysanthemum White Rust Regulatory Status and Restrictions

    Science.gov (United States)

    2012-08-03

    ..., destruction, treatment, or other sanitation measures called for in our National Management Plan. The... reevaluating our current regulatory strategy in order to improve the effectiveness and economic efficiency of...-Goldner, National Program Manager, Emergency and Domestic Programs, PPQ, APHIS, 4700 River Road Unit 160...

  9. Perspectives on an alternative career path in regulatory science

    OpenAIRE

    Fields, F. Owen

    2013-01-01

    Perspectives are provided on an alternative career path in regulatory science for those currently involved in basic biology research. This path is compared and contrasted with basic research, and factors to be examined if one is considering such a path are discussed.

  10. Perspectives on an alternative career path in regulatory science.

    Science.gov (United States)

    Fields, F Owen

    2013-07-01

    Perspectives are provided on an alternative career path in regulatory science for those currently involved in basic biology research. This path is compared and contrasted with basic research, and factors to be examined if one is considering such a path are discussed.

  11. Determinants of Effective Information Transfer in International Regulatory Standards Adoption

    Science.gov (United States)

    Popescu, Denisa

    2010-01-01

    The role of international regulatory standards within the current global environment has become of the most importance. The age of the global system and free market capitalism carried us into the unprecedented age of regulations, and standard setting. Regulations are now becoming the emerging mode of global governance. This study focuses on…

  12. Policy and Regulatory Challenges in the Tourism Collaborative Economy

    DEFF Research Database (Denmark)

    Dredge, Dianne

    2017-01-01

    The choice of policy approach and regulatory framework in dealing with the collaborative economy rests on two fundamental factors—that government decisions should be based on good sound knowledge and that this knowledge should be above politics. In the newly emerging and rapidly growing collabora......The choice of policy approach and regulatory framework in dealing with the collaborative economy rests on two fundamental factors—that government decisions should be based on good sound knowledge and that this knowledge should be above politics. In the newly emerging and rapidly growing...... collaborative economy, these conditions are difficult to meet. The dynamic restructuring of power relations, new stakeholders and information asymmetries can obscure what is really going on. Some authors offer valuable meso-level explorations of policy and regulatory issues in different sub......-sectors of the collaborative economy. However, these solutions are often based on assumptions about government sovereignty and power relations that do not necessarily apply in the slippery global world of platform capitalism. This chapter seeks to undertake a critical exploration of the factors and values that permeate...

  13. General trends in the evolution of prokaryotic transcriptional regulatory networks.

    Science.gov (United States)

    Madan Babu, M; Balaji, S; Aravind, L

    2007-01-01

    Gene expression in organisms is controlled by regulatory proteins termed transcription factors, which recognize and bind to specific nucleotide sequences. Over the years, considerable information has accumulated on the regulatory interactions between transcription factors and their target genes in various model prokaryotes, such as Escherichia coli and Bacillus subtilis. This has allowed the representation of this information in the form of a directed graph, which is commonly referred to as the transcriptional regulatory network. The network representation provides us with an excellent conceptual framework to understand the structure of the transcriptional regulation, both at local and global levels of organization. Several studies suggest that the transcriptional network inferred from model organisms may be approximated by a scale-free topology, which in turn implies the presence of a relatively small group of highly connected regulators (hubs or global regulators). While the graph theoretical principles have been applied to infer various properties of such networks, there have been few studies that have actually investigated the evolution of the transcriptional regulatory networks across diverse organisms. Using recently developed computational methods that exploit various evolutionary principles, we have attempted to reconstruct and compare these networks across a wide-range of prokaryotes. This has provided several insights on the modification and diversification of network structures of various organisms in course of evolution. Firstly, we observed that target genes show a much higher level of conservation than their transcriptional regulators. This in turn suggested that the same set of functions could be differently controlled across diverse organisms, contributing significantly to their adaptive radiations. In particular, at the local level of network structure, organism-specific optimization of the transcription network has evolved primarily via tinkering

  14. Adolescent threat-related interpretive bias and its modification: the moderating role of regulatory control

    NARCIS (Netherlands)

    Salemink, E.; Wiers, R.W.

    2012-01-01

    Dual process models describe psychopathology as the consequence of an imbalance between a fast, impulsive system and a regulatory control system and have recently been applied to anxiety disorders. The aim of the current study was to specifically examine the role of a regulatory control system in re

  15. 78 FR 62728 - Self Regulatory Organizations; Chicago Stock Exchange, Inc.; Notice of Filing and Immediate...

    Science.gov (United States)

    2013-10-22

    ... responsibilities. Therefore, the Series 14 measures the knowledge and skills related to the position of a... provide direction to Participant Firms designing their supervisory systems and reinforce the importance of... regulatory, compliance and sales practice matters in the industry. Currently, there are two Regulatory...

  16. Impact of Safety-Related Regulatory Action on Clinical Practice A Systematic Review

    NARCIS (Netherlands)

    Piening, Sigrid; Haaijer-Ruskamp, Flora M.; de Vries, Jonie T. N.; van der Elst, Menno E.; de Graeff, Pieter A.; Straus, Sabine M. J. M.; Mol, Peter G. M.

    2012-01-01

    Background: After market approval, new serious safety issues are regularly identified for drugs that lead to regulatory action to inform healthcare professionals. However, the effectiveness of these safety-related regulatory actions is under question. We currently lack a comprehensive overview of th

  17. Why some groups just feel better : The regulatory fit of group power

    NARCIS (Netherlands)

    Sassenberg, K.; Jonas, K.J; Shah, J.Y; Brazy, P.C

    2007-01-01

    The current research applied the regulatory fit hypothesis (E. T. Higgins, 2000) to the evaluation of groups, suggesting that individuals' group appraisal depends on how well the groups fit their regulatory needs. Specifically, it was predicted that higher power groups would fit and be more valued b

  18. 77 FR 13258 - Biotechnology Regulatory Services; Changes Regarding the Solicitation of Public Comment for...

    Science.gov (United States)

    2012-03-06

    ... Animal and Plant Health Inspection Service Biotechnology Regulatory Services; Changes Regarding the.... FOR FURTHER INFORMATION CONTACT: Dr. T. Clint Nesbitt, Chief of Staff, Biotechnology Regulatory...://www.aphis.usda.gov/biotechnology/pet_proc_imp.shtml . Current Comment Process for Petitions for...

  19. 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.

  20. Assessing citation networks for dissemination and implementation research frameworks.

    Science.gov (United States)

    Skolarus, Ted A; Lehmann, Todd; Tabak, Rachel G; Harris, Jenine; Lecy, Jesse; Sales, Anne E

    2017-07-28

    A recent review of frameworks used in dissemination and implementation (D&I) science described 61 judged to be related either to dissemination, implementation, or both. The current use of these frameworks and their contributions to D&I science more broadly has yet to be reviewed. For these reasons, our objective was to determine the role of these frameworks in the development of D&I science. We used the Web of Science™ Core Collection and Google Scholar™ to conduct a citation network analysis for the key frameworks described in a recent systematic review of D&I frameworks (Am J Prev Med 43(3):337-350, 2012). From January to August 2016, we collected framework data including title, reference, publication year, and citations per year and conducted descriptive and main path network analyses to identify those most important in holding the current citation network for D&I frameworks together. The source article contained 119 cited references, with 50 published articles and 11 documents identified as a primary framework reference. The average citations per year for the 61 frameworks reviewed ranged from 0.7 to 103.3 among articles published from 1985 to 2012. Citation rates from all frameworks are reported with citation network analyses for the framework review article and ten highly cited framework seed articles. The main path for the D&I framework citation network is presented. We examined citation rates and the main paths through the citation network to delineate the current landscape of D&I framework research, and opportunities for advancing framework development and use. Dissemination and implementation researchers and practitioners may consider frequency of framework citation and our network findings when planning implementation efforts to build upon this foundation and promote systematic advances in D&I science.

  1. The SOPHY Framework

    DEFF Research Database (Denmark)

    Laursen, Karl Kaas; Pedersen, Martin Fejrskov; Bendtsen, Jan Dimon;

    The goal of the Sophy framework (Simulation, Observation and Planning in Hybrid Systems) is to implement a multi-level framework for description, simulation, observation, fault detection and recovery, diagnosis and autonomous planning in distributed embedded hybrid systems. A Java-based distributed...

  2. Overlooking the Conceptual Framework

    Science.gov (United States)

    Leshem, Shosh; Trafford, Vernon

    2007-01-01

    The conceptual framework is alluded to in most serious texts on research, described in some and fully explained in few. However, examiners of doctoral theses devote considerable attention to exploring its function within social science doctoral vivas. A literature survey explores how the conceptual framework is itself conceptualised and explained.…

  3. Frameworks in CS1

    DEFF Research Database (Denmark)

    Christensen, Henrik Bærbak; Caspersen, Michael Edelgaard

    2002-01-01

    In this paper we argue that introducing object-oriented frameworks as subject already in the CS1 curriculum is important if we are to train the programmers of tomorrow to become just as much software reusers as software producers. We present a simple, graphical, framework that we have successfully...

  4. Framework and new conceptualisations

    DEFF Research Database (Denmark)

    Søndergaard, Dorte Marie

    This paper introduces the research and new conceptual framework developed by eXbus: Exploring Bullying in Schools from 2007-2012.......This paper introduces the research and new conceptual framework developed by eXbus: Exploring Bullying in Schools from 2007-2012....

  5. Unicam Activity Framework (UAF)

    Science.gov (United States)

    Gagliardi, R.; Mauri, M.; Polzonetti, A.

    2016-01-01

    This presentation illustrates the framework of processing performance of the faculty of the University of Camerino. The evaluation criteria are explained and the technological structure that allows automatic performance assessment available online anywhere and anytime. The designed framework is usually applied to the performance evaluation of…

  6. Fisheries regulatory regimes and resilience to climate change.

    Science.gov (United States)

    Ojea, Elena; Pearlman, Isaac; Gaines, Steven D; Lester, Sarah E

    2017-05-01

    Climate change is already producing ecological, social, and economic impacts on fisheries, and these effects are expected to increase in frequency and magnitude in the future. Fisheries governance and regulations can alter socio-ecological resilience to climate change impacts via harvest control rules and incentives driving fisher behavior, yet there are no syntheses or conceptual frameworks for examining how institutions and their regulatory approaches can alter fisheries resilience to climate change. We identify nine key climate resilience criteria for fisheries socio-ecological systems (SES), defining resilience as the ability of the coupled system of interacting social and ecological components (i.e., the SES) to absorb change while avoiding transformation into a different undesirable state. We then evaluate the capacity of four fisheries regulatory systems that vary in their degree of property rights, including open access, limited entry, and two types of rights-based management, to increase or inhibit resilience. Our exploratory assessment of evidence in the literature suggests that these regulatory regimes vary widely in their ability to promote resilient fisheries, with rights-based approaches appearing to offer more resilience benefits in many cases, but detailed characteristics of the regulatory instruments are fundamental.

  7. Regulatory processes in Aspergillus niger

    DEFF Research Database (Denmark)

    Poulsen, Lars

    some disadvantages as well, those are byproduct formation, secretion of proteolytic enzymes and formation of mycotoxins. The aim of this project was to reduce these disadvantages, though investigating the regulatory processes. The first objective was to study the regulatory events leading to A. niger......T. The physiological batch characterization showed that the ΔprtT strain had the lowest protease activity (fivefold reduced), but also featured excessive CO2 yield, reduced growth rate and lower biomass yields. The ΔprtB strain had a close to twofold reduced levels of secreted proteases but with additional beneficial...

  8. Towards medicines regulatory authorities' quality performance improvement: value for public health.

    Science.gov (United States)

    Pejović, Gordana; Filipović, Jovan; Tasić, Ljiljana; Marinković, Valentina

    2016-01-01

    The purpose of this article is to explore the possibility of implementing total quality management (TQM) principles in national medicines regulatory authorities in Europe to achieve all public health objectives. Bearing in mind that medicines regulation is a governmental function that serves societal objectives to protect and promote public health, measuring the effective achievement of quality objectives related to public health is of utmost importance. A generic TQM model for meeting public health objectives was developed and was tested on 10 European national medicines regulatory authorities with different regulatory performances. Participating national medicines regulatory authorities recognised all TQM factors of the proposed model in implemented systems with different degrees of understanding. An analysis of responses was performed within the framework of two established criteria-the regulatory authority's category and size. The value of the paper is twofold. First, the new generic TQM model proposes to integrate four public health objectives with six TQM factors. Second, national medicines regulatory authorities were analysed as public organisations and health authorities to develop a proper tool for assessing their regulatory performance. The paper emphasises the importance of designing an adequate approach to performance measurement of quality management systems in medicines regulatory authorities that will support their public service missions.

  9. A Scalable Testing Framework for Location-Based Services

    Institute of Scientific and Technical Information of China (English)

    Jiang Yu; Andrew Tappenden; James Miller; Michael Smith

    2009-01-01

    A novel testing framework for location based services is introduced. In particular, the paper showcases a novel architecture for such a framework. The implementation of the framework illustrates both the functionality and the feasibility of the framework proposed and the utility of the architecture. The new framework is evaluated through comparison to several other methodologies currently available for the testing of location-based applications. A case study is presented in which the testing framework was applied to a typical mobile service tracking system. It is concluded that the proposed testing framework achieves the best coverage of the entire location based service testing problem of the currently available methodologies; being equipped to test the widest array of application attributes and allowing for the automation of testing activities.

  10. Conceptual Framework To Extend Life Cycle Assessment ...

    Science.gov (United States)

    Life Cycle Assessment (LCA) is a decision-making tool that accounts for multiple impacts across the life cycle of a product or service. This paper presents a conceptual framework to integrate human health impact assessment with risk screening approaches to extend LCA to include near-field chemical sources (e.g., those originating from consumer products and building materials) that have traditionally been excluded from LCA. A new generation of rapid human exposure modeling and high-throughput toxicity testing is transforming chemical risk prioritization and provides an opportunity for integration of screening-level risk assessment (RA) with LCA. The combined LCA and RA approach considers environmental impacts of products alongside risks to human health, which is consistent with regulatory frameworks addressing RA within a sustainability mindset. A case study is presented to juxtapose LCA and risk screening approaches for a chemical used in a consumer product. The case study demonstrates how these new risk screening tools can be used to inform toxicity impact estimates in LCA and highlights needs for future research. The framework provides a basis for developing tools and methods to support decision making on the use of chemicals in products. This paper presents a conceptual framework for including near-field exposures into Life Cycle Assessment using advanced human exposure modeling and high-throughput tools

  11. An Integrated Conceptual Framework for RFID Enabled Healthcare

    Directory of Open Access Journals (Sweden)

    Gaurav Gupta

    2015-12-01

    Full Text Available Radio frequency identification (RFID technology is a wireless communication technology that facilitates automatic identification and data capture without human intervention. Since 2000s, RFID applications in the health care industry are increasing.  RFID has brought many improvements in areas like patient care, patient safety, equipment tracking, resource utilization, processing time reduction and so on. On the other hand, often deployment of RFID is questioned on the issues like high capital investment, technological complexity, and privacy concerns. Exploration of existing literature indicates the presence of works on the topics like asset management, patient management, staff management, institutional advantages, and organizational issues. However, most of the works are focused on a particular issue. Still now, scholarly attempts to integrate all the facades of RFID-enabled healthcare are limited. In this paper, we propose a conceptual framework that represents the scope for implementation of this technology and the various dimensions of RFID-enabled healthcare and demonstrate them in detail. Also, we have discussed the critical issues that can prove to be potential barriers to its successful implementation and current approaches to resolving these. We also discuss some of the regulatory initiatives encouraging its adoption in the healthcare industry. Also, we have highlighted the future research opportunities in this domain.

  12. The Existing Regulatory Conditions for 'Energy Smart Water Utilities'

    DEFF Research Database (Denmark)

    Basse, Ellen Margrethe

    2014-01-01

    conditions. Based on these facts, the resource efficiency and low–carbon policy of the EU as well as the EU’s rules of relevance for the utilities are highlighted in section 4. It is concluded that the current EU legislation makes it possible for the Member States to promote energy–smart water utilities...... of the national regulatory design and the problems related to legal barriers are illustrated in section 5 with examples from Danish legislation. The Danish regulatory style is more inflexible than necessary. The benchmarking model and price-cap systems – established as mandatory legal conditions together...

  13. Optimal finite horizon control in gene regulatory networks

    Science.gov (United States)

    Liu, Qiuli

    2013-06-01

    As a paradigm for modeling gene regulatory networks, probabilistic Boolean networks (PBNs) form a subclass of Markov genetic regulatory networks. To date, many different stochastic optimal control approaches have been developed to find therapeutic intervention strategies for PBNs. A PBN is essentially a collection of constituent Boolean networks via a probability structure. Most of the existing works assume that the probability structure for Boolean networks selection is known. Such an assumption cannot be satisfied in practice since the presence of noise prevents the probability structure from being accurately determined. In this paper, we treat a case in which we lack the governing probability structure for Boolean network selection. Specifically, in the framework of PBNs, the theory of finite horizon Markov decision process is employed to find optimal constituent Boolean networks with respect to the defined objective functions. In order to illustrate the validity of our proposed approach, an example is also displayed.

  14. Computational Genetic Regulatory Networks Evolvable, Self-organizing Systems

    CERN Document Server

    Knabe, Johannes F

    2013-01-01

    Genetic Regulatory Networks (GRNs) in biological organisms are primary engines for cells to enact their engagements with environments, via incessant, continually active coupling. In differentiated multicellular organisms, tremendous complexity has arisen in the course of evolution of life on earth. Engineering and science have so far achieved no working system that can compare with this complexity, depth and scope of organization. Abstracting the dynamics of genetic regulatory control to a computational framework in which artificial GRNs in artificial simulated cells differentiate while connected in a changing topology, it is possible to apply Darwinian evolution in silico to study the capacity of such developmental/differentiated GRNs to evolve. In this volume an evolutionary GRN paradigm is investigated for its evolvability and robustness in models of biological clocks, in simple differentiated multicellularity, and in evolving artificial developing 'organisms' which grow and express an ontogeny starting fr...

  15. Framework for Connections on Facebook

    DEFF Research Database (Denmark)

    Sudzina, Frantisek

    There is a substantial amount of current information systems and marketing research focused on social networking sites, most frequently on Facebook. Often, these studies utilize available metadata on user on-line behavior, such as what links the users clicked on. In order to better understand...... behavior of Facebook users, it makes sense to investigate also whom the users connect to. It is possible to hypothesize that behavior of people, who connect only to relatives on Facebook, differs from behavior of people, who are connected only to their classmates. The paper offers a framework of Facebook...

  16. Colloidal Covalent Organic Frameworks

    Science.gov (United States)

    2017-01-01

    Covalent organic frameworks (COFs) are two- or three-dimensional (2D or 3D) polymer networks with designed topology and chemical functionality, permanent porosity, and high surface areas. These features are potentially useful for a broad range of applications, including catalysis, optoelectronics, and energy storage devices. But current COF syntheses offer poor control over the material’s morphology and final form, generally providing insoluble and unprocessable microcrystalline powder aggregates. COF polymerizations are often performed under conditions in which the monomers are only partially soluble in the reaction solvent, and this heterogeneity has hindered understanding of their polymerization or crystallization processes. Here we report homogeneous polymerization conditions for boronate ester-linked, 2D COFs that inhibit crystallite precipitation, resulting in stable colloidal suspensions of 2D COF nanoparticles. The hexagonal, layered structures of the colloids are confirmed by small-angle and wide-angle X-ray scattering, and kinetic characterization provides insight into the growth process. The colloid size is modulated by solvent conditions, and the technique is demonstrated for four 2D boronate ester-linked COFs. The diameter of individual COF nanoparticles in solution is monitored and quantified during COF growth and stabilization at elevated temperature using in situ variable-temperature liquid cell transmission electron microscopy imaging, a new characterization technique that complements conventional bulk scattering techniques. Solution casting of the colloids yields a free-standing transparent COF film with retained crystallinity and porosity, as well as preferential crystallite orientation. Collectively this structural control provides new opportunities for understanding COF formation and designing morphologies for device applications. PMID:28149954

  17. Colloidal Covalent Organic Frameworks.

    Science.gov (United States)

    Smith, Brian J; Parent, Lucas R; Overholts, Anna C; Beaucage, Peter A; Bisbey, Ryan P; Chavez, Anton D; Hwang, Nicky; Park, Chiwoo; Evans, Austin M; Gianneschi, Nathan C; Dichtel, William R

    2017-01-25

    Covalent organic frameworks (COFs) are two- or three-dimensional (2D or 3D) polymer networks with designed topology and chemical functionality, permanent porosity, and high surface areas. These features are potentially useful for a broad range of applications, including catalysis, optoelectronics, and energy storage devices. But current COF syntheses offer poor control over the material's morphology and final form, generally providing insoluble and unprocessable microcrystalline powder aggregates. COF polymerizations are often performed under conditions in which the monomers are only partially soluble in the reaction solvent, and this heterogeneity has hindered understanding of their polymerization or crystallization processes. Here we report homogeneous polymerization conditions for boronate ester-linked, 2D COFs that inhibit crystallite precipitation, resulting in stable colloidal suspensions of 2D COF nanoparticles. The hexagonal, layered structures of the colloids are confirmed by small-angle and wide-angle X-ray scattering, and kinetic characterization provides insight into the growth process. The colloid size is modulated by solvent conditions, and the technique is demonstrated for four 2D boronate ester-linked COFs. The diameter of individual COF nanoparticles in solution is monitored and quantified during COF growth and stabilization at elevated temperature using in situ variable-temperature liquid cell transmission electron microscopy imaging, a new characterization technique that complements conventional bulk scattering techniques. Solution casting of the colloids yields a free-standing transparent COF film with retained crystallinity and porosity, as well as preferential crystallite orientation. Collectively this structural control provides new opportunities for understanding COF formation and designing morphologies for device applications.

  18. Quality Assurance Framework for Mini-Grids

    Energy Technology Data Exchange (ETDEWEB)

    Esterly, Sean; Baring-Gould, Ian; Booth, Samuel

    2017-05-04

    To address the root challenges of providing quality power to remote consumers through financially viable mini-grids, the Global Lighting and Energy Access Partnership (Global LEAP) initiative of the Clean Energy Ministerial and the U.S. Department of Energy teamed with the National Renewable Energy Laboratory (NREL) and Power Africa to develop a Quality Assurance Framework (QAF) for isolated mini-grids. The framework addresses both alternating current (AC) and direct current (DC) mini-grids, and is applicable to renewable, fossil-fuel, and hybrid systems.

  19. 75 FR 70757 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2010-11-18

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a... 12, 2010. I. Introduction On August 6, 2010, the Financial Industry Regulatory Authority, Inc... Kimmel, Executive Director, Financial Information Forum, to Elizabeth M. Murphy, Secretary,...

  20. 77 FR 47470 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

    Science.gov (United States)

    2012-08-08

    ... From the Federal Register Online via the Government Publishing Office SECURITIES AND EXCHANGE COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Withdrawal... FINRA Rulebook August 2, 2012. On April 22, 2009, the Financial Industry Regulatory Authority,...

  1. 77 FR 55517 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2012-09-10

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a.... Introduction On May 24, 2012, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the... General Counsel, Securities Industry and Financial Markets Association, dated June 26, 2012...

  2. 75 FR 62439 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2010-10-08

    ...-2010-043] Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving..., 2010. I. Introduction On August 6, 2010, the Financial Industry Regulatory Authority, Inc. (``FINRA..., 2010 (``Wiesenberg Letter''); Letter from Manisha Kimmel, Executive Director, Financial...

  3. 77 FR 12340 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting...

    Science.gov (United States)

    2012-02-29

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting... Accounting Support Fee February 23, 2012. I. Introduction On December 20, 2011, the Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission...

  4. 76 FR 20757 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting...

    Science.gov (United States)

    2011-04-13

    ... From the Federal Register Online via the Government Publishing Office SECURITIES AND EXCHANGE COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting... February 4, 2011, the Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the...

  5. 75 FR 61793 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-10-06

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving... Encrypted September 29, 2010. I. Introduction On June 2, 2010, the Financial Industry Regulatory Authority... Taunt, Chief Executive Officer, Regal Financial Group, to Elizabeth M. Murphy, Secretary,...

  6. Subordinate regulatory mode and leader power: Interpersonal regulatory complementarity predicts task performance

    NARCIS (Netherlands)

    Hamstra, M.R.W.; Orehek, E.; Holleman, M.

    2014-01-01

    This research examines the implications of locomotion regulatory mode (orientation toward making progress on goals) and assessment regulatory mode (orientation toward critically evaluating alternatives) for employees' performance. Regulatory mode theory suggests that, although these are both integra

  7. Conceptual framework for biosecurity levels.

    Energy Technology Data Exchange (ETDEWEB)

    Gaudioso, Jennifer Marie; Salerno, Reynolds Mathewson

    2004-10-01

    Biosecurity must be implemented without impeding biomedical and bioscience research. Existing security literature and regulatory requirements do not present a comprehensive approach or clear model for biosecurity, nor do they wholly recognize the operational issues within laboratory environments. To help address these issues, the concept of Biosecurity Levels should be developed. Biosecurity Levels would have increasing levels of security protections depending on the attractiveness of the pathogens to adversaries. Pathogens and toxins would be placed in a Biosecurity Level based on their security risk. Specifically, the security risk would be a function of an agent's weaponization potential and consequences of use. To demonstrate the concept, examples of security risk assessments for several human, animal, and plant pathogens will be presented. Higher security than that currently mandated by federal regulations would be applied for those very few agents that represent true weapons threats and lower levels for the remainder.

  8. Overplanting in offshore wind power plants in different regulatory regimes

    DEFF Research Database (Denmark)

    Wolter, Christoph; Klinge Jacobsen, Henrik; Rogdakis, Georgios

    2016-01-01

    framework results more favourable to overplanting. The results indicate that current conceivable offshore wind power plants in the UK can increase their economic value by around 30 mio AC when optimising their capacity setup. In Denmark, current regulations are not suitable for overplanting causing loss...

  9. Fit of CAD/CAM implant frameworks: a comprehensive review.

    Science.gov (United States)

    Abduo, Jaafar

    2014-12-01

    Computer-aided design and computer-aided manufacturing (CAD/CAM) is a strongly emerging prosthesis fabrication method for implant dentistry. Currently, CAD/CAM allows the construction of implant frameworks from different materials. This review evaluates the literature pertaining to the precision fit of fixed implant frameworks fabricated by CAD/CAM. Following a comprehensive electronic search through PubMed (MEDLINE), 14 relevant articles were identified. The results indicate that the precision fit of CAD/CAM frameworks exceeded the fit of the 1-piece cast frameworks and laser-welded frameworks. A similar fit was observed for CAD/CAM frameworks and bonding of the framework body to prefabricated cylinders. The influence of CAD/CAM materials on the fit of a framework is minimal.

  10. Frameworking a collaborative approach to control systems development

    CERN Document Server

    González-Berges, M; Bernard, F

    2005-01-01

    The use of frameworks in software engineering is a common practice to ease the development and maintenance phases. In our terminology, a framework is a set of practices and software components from which a developer can select a subset for his application. Three frameworks are currently in use at CERN for the development of control systems: the JCOP (Joint COntrols Project) Framework, the UNICOS (UNified Industrial COntrol System) Framework and the LHC GCS (Gas Control System) Framework. The three projects originate from different domains, with different requirements and timescales. Still there are many commonalities and considerable effort has been invested in establishing and maintaining a collaboration between the three projects. The paper will talk first about the reasons for a framework based approach. The different Frameworks will then be described, with their domain of applicability, their scope and a short overview of the technical details. Afterwards, the underlying tools will be presented. The relat...

  11. EU risk governance of 'cloned food': regulatory uncertainty between trade and non-trade

    NARCIS (Netherlands)

    Weimer, M.; van Asselt, M.B.A.; Versluis, E.; Vos, E.

    2013-01-01

    This chapter analyzes the difficulties of creating a viable legal framework for ‘cloned food’ in the EU combining a legal perspective with insights from the interdisciplinary research on risk governance. Animal cloning offers an instructive example for the challenges of designing regulatory framewor

  12. EU risk governance of 'cloned food': regulatory uncertainty between trade and non-trade

    NARCIS (Netherlands)

    Weimer, M.; van Asselt, M.B.A.; Versluis, E.; Vos, E.

    2013-01-01

    This chapter analyzes the difficulties of creating a viable legal framework for ‘cloned food’ in the EU combining a legal perspective with insights from the interdisciplinary research on risk governance. Animal cloning offers an instructive example for the challenges of designing regulatory

  13. Public Rules on Private Schools: Measuring the Regulatory Impact of State Statutes and School Choice Programs

    Science.gov (United States)

    Catt, Andrew D.

    2014-01-01

    This report provides a framework for understanding the impacts of state government statutes regulating private schools, regulations distinct to a given school choice program, and any regulatory growth over a program's lifespan. Examining school choice programs in operation for at least a few years provides important context and comparisons for…

  14. EU risk governance of 'cloned food': regulatory uncertainty between trade and non-trade

    NARCIS (Netherlands)

    Weimer, M.; van Asselt, M.B.A.; Versluis, E.; Vos, E.

    2013-01-01

    This chapter analyzes the difficulties of creating a viable legal framework for ‘cloned food’ in the EU combining a legal perspective with insights from the interdisciplinary research on risk governance. Animal cloning offers an instructive example for the challenges of designing regulatory framewor

  15. Current limiters

    Energy Technology Data Exchange (ETDEWEB)

    Loescher, D.H. [Sandia National Labs., Albuquerque, NM (United States). Systems Surety Assessment Dept.; Noren, K. [Univ. of Idaho, Moscow, ID (United States). Dept. of Electrical Engineering

    1996-09-01

    The current that flows between the electrical test equipment and the nuclear explosive must be limited to safe levels during electrical tests conducted on nuclear explosives at the DOE Pantex facility. The safest way to limit the current is to use batteries that can provide only acceptably low current into a short circuit; unfortunately this is not always possible. When it is not possible, current limiters, along with other design features, are used to limit the current. Three types of current limiters, the fuse blower, the resistor limiter, and the MOSFET-pass-transistor limiters, are used extensively in Pantex test equipment. Detailed failure mode and effects analyses were conducted on these limiters. Two other types of limiters were also analyzed. It was found that there is no best type of limiter that should be used in all applications. The fuse blower has advantages when many circuits must be monitored, a low insertion voltage drop is important, and size and weight must be kept low. However, this limiter has many failure modes that can lead to the loss of over current protection. The resistor limiter is simple and inexpensive, but is normally usable only on circuits for which the nominal current is less than a few tens of milliamperes. The MOSFET limiter can be used on high current circuits, but it has a number of single point failure modes that can lead to a loss of protective action. Because bad component placement or poor wire routing can defeat any limiter, placement and routing must be designed carefully and documented thoroughly.

  16. Employee flourishing strategic framework

    Directory of Open Access Journals (Sweden)

    Stelzner, Samuel Georg Eric

    2016-11-01

    Full Text Available This paper produces a preliminary version of a strategic framework for managing employee flourishing. ‘Flourishing’, a term from positive psychology, describes the experience of ‘the good life’. Providing this experience benefits employees. It also motivates them to sustain the enterprise that provides it. This positions employee flourishing as a strategy for long-term enterprise performance, a key concern of industrial engineering. The framework incorporates a systems approach and literature from a variety of bodies of knowledge, including organisational behaviour and human resource management. The framework includes a process, tools, and elements that assist enterprises to manage employee flourishing.

  17. Gene regulatory network modeling via global optimization of high-order dynamic Bayesian network

    Directory of Open Access Journals (Sweden)

    Xuan Nguyen

    2012-06-01

    Full Text Available Abstract Background Dynamic Bayesian network (DBN is among the mainstream approaches for modeling various biological networks, including the gene regulatory network (GRN. Most current methods for learning DBN employ either local search such as hill-climbing, or a meta stochastic global optimization framework such as genetic algorithm or simulated annealing, which are only able to locate sub-optimal solutions. Further, current DBN applications have essentially been limited to small sized networks. Results To overcome the above difficulties, we introduce here a deterministic global optimization based DBN approach for reverse engineering genetic networks from time course gene expression data. For such DBN models that consist only of inter time slice arcs, we show that there exists a polynomial time algorithm for learning the globally optimal network structure. The proposed approach, named GlobalMIT+, employs the recently proposed information theoretic scoring metric named mutual information test (MIT. GlobalMIT+ is able to learn high-order time delayed genetic interactions, which are common to most biological systems. Evaluation of the approach using both synthetic and real data sets, including a 733 cyanobacterial gene expression data set, shows significantly improved performance over other techniques. Conclusions Our studies demonstrate that deterministic global optimization approaches can infer large scale genetic networks.

  18. The regulatory pyramid meets the food pyramid: can regulatory theory improve controls on television food advertising to Australian children?

    Science.gov (United States)

    Reeve, Belinda

    2011-09-01

    This article examines whether responsive regulation has potential to improve the regulatory framework which controls free-to-air television advertising to children, so that the regulatory scheme can be used more effectively as a tool for obesity prevention. It presents two apparently conflicting arguments, the first being that responsive regulation, particularly monitoring and enforcement measures, can be used to refine the regulation of children's food advertising. The second argument is that there are limits to the improvements that responsive regulation can achieve, since it is trying to achieve the wrong goal, namely placing controls on misleading or deceptive advertising techniques rather than diminishing the sheer volume of advertisements to which children are exposed. These two positions reflect a conflict between public health experts and governments regarding the role of industry in chronic disease prevention, as well as a broader debate about how best to regulate industry.

  19. Regulating Cannabis Social Clubs: A comparative analysis of legal and self-regulatory practices in Spain, Belgium and Uruguay.

    Science.gov (United States)

    Decorte, Tom; Pardal, Mafalda; Queirolo, Rosario; Boidi, Maria Fernanda; Sánchez Avilés, Constanza; Parés Franquero, Òscar

    2017-05-01

    Cannabis Social Clubs (CSCs) are a model of non-profit production and distribution of cannabis among a closed circuit of adult cannabis users. CSCs are now operating in several countries around the world, albeit under very different legal regimes and in different socio-political contexts. In this paper we describe and compare the legal framework and the self-regulatory practices of Cannabis Social Clubs in three countries (Spain, Belgium, and Uruguay). The objective of our comparative analysis is to investigate how CSCs operate in each of these countries. To foster discussions about how one might regulate CSCs to promote public health objectives, we conclude this paper with a discussion on the balance between adequate governmental control and self-regulatory competences of CSCs. The data used for this analysis stem from independently conducted local studies by the authors in their countries. Although the particular designs of the studies differ, the data in all three countries was collected through similar data collection methods: analysis of (legal and other documents), field visits to the clubs, interviews with staff members, media content analysis. We identified a number of similarities and differences among the CSCs' practices in the three countries. Formal registration as non-profit association seems to be a common standard among CSCs. We found nevertheless great variation in terms of the size of these organisations. Generally, only adult nationals and/or residents are able to join the CSCs, upon the payment of a membership fee. While production seems to be guided by consumption estimates of the members (Spain and Belgium) or by the legal framework (Uruguay), the thresholds applied by the clubs vary significantly across countries. Quality control practices remain an issue in the three settings studied here. The CSCs have developed different arrangements with regards to the distribution of cannabis to their members. By uncovering the current practices of CSCs

  20. Lymph node trafficking of regulatory T cells is prerequisite for immune suppression.

    Science.gov (United States)

    Huang, Miao-Tzu; Lin, Been-Ren; Liu, Wei-Liang; Lu, Chun-Wei; Chiang, Bor-Luen

    2016-04-01

    Regulatory T cells have a crucial role in health and disease because of their immune regulation function. However, the anatomic sites where regulatory T cells exert optimal immune regulation are open to debate. In our current study with the use of a shear-stress flow assay, we found that regulatory T cells exhibited significantly decreased adhesion to either activated endothelial monolayer or intercellular adhesion molecule 1 or E-selectin-coated surfaces compared with activated effector T cells. The less transmigration capacity of the regulatory T cells prompted our speculation of preferential lymph node localization for the regulatory T cells that endowed these cells with immune regulation function in the most efficient manner. To test this hypothesis, the role of lymph node localization in regulatory T cell-mediated immune suppression was evaluated with a footpad inflammation model. We found that adoptively transferred regulatory T cells inhibited the development of footpad inflammation. In addition, although blockage of CCR7 or CD62L had no effect on the immune suppressive function of the regulatory T cells per se, pretreatment of the regulatory T cells with either CCR7 or CD62L blocking antibodies prevented their recruitment into draining lymph nodes and concomitantly abrogated the immune suppressive effects of adoptively transferred regulatory T cells during footpad inflammation. Our data demonstrate the crucial role of lymph node localization in regulatory T cell-mediated immune suppression and suggest a probable hierarchy in the anatomic sites for optimal immune regulation. Elucidating the relationships between the transmigration characteristics of the regulatory T cells and their immune regulation function will provide insightful information for regulatory T cell-based cell therapy.