WorldWideScience

Sample records for regulatory challenges facing

  1. Regulatory challenges faced first Indonesia NPPs by independent TSOs

    International Nuclear Information System (INIS)

    Sri Budi Utami

    2010-01-01

    Technical and scientific support organizations (TSOs) dedicated to supporting national regulatory authorities. At present BAPETEN has internal TSOs. Pertaining to the regulatory control of nuclear safety, security, and safeguards for nuclear power plants (NPPs), independent TSOs providing support to the safety regulatory bodies are facing a number of technical challenges to ensuring the safety of NPPs. It is essential that BAPETEN need independent TSOs in order to warrant a sufficient level of safety, security and non proliferation in building and operating of first NPP. It is essential that BAPETEN need independent TSOs in order to warrant a sufficient level of safety, security and non proliferation in building and operating of first NPPs. (author)

  2. Facing regulatory challenges of on-line hemodiafiltration.

    Science.gov (United States)

    Kümmerle, Wolfgang

    2011-01-01

    On-line hemodiafiltration (on-line HDF) is the result of a vision that triggered multifarious changes in very different areas. Driven by the idea to offer better medical treatment for renal patients, technological innovations were developed and established that also constituted new challenges in the field of regulatory affairs. The existing regulations predominantly addressed the quality and safety of those products needed to perform dialysis treatment which were supplied by industrial manufacturers. However, the complexity of treatment system required for the provision of on-line fluids demanded a holistic approach encompassing all components involved. Hence, focus was placed not only on single products, but much more on their interfacing, and the clinical infrastructure, in particular, had to undergo substantial changes. The overall understanding of the interaction between such factors, quite different in their nature, was crucial to overcome the arising regulatory obstacles. This essay describes the evolution of the on-line HDF procedure from the regulatory point of view. A simplified diagram demonstrates the path taken from the former regulatory understanding to the realization of necessary changes. That achievement was only possible through 'management of preview' and consequent promotion of technical and medical innovations as well as regulatory re-evaluations. Copyright © 2011 S. Karger AG, Basel.

  3. A qualitative exploration of the major challenges facing pharmacovigilance in Saudi Arabia.

    Science.gov (United States)

    Aljadhey, Hisham; Mahmoud, Mansour A; Alshammari, Thamir M; Al-Dhaeefi, Mohammed; Le Louet, Herve; Perez-Gutthann, Susana; Pitts, Peter J

    2015-09-01

    To explore the challenges facing pharmacovigilance in Saudi Arabia and formulate recommendations to improve it from the perspective of healthcare professionals in Saudi Arabia. This was a qualitative study of 4 focus group discussions with pharmacists, physicians, and academicians held under the auspices of the King Saud University School of Pharmacy and the Center for Medicine in the Public Interest, Riyadh, Saudi Arabia. A total of 29 eligible healthcare professionals were invited to participate in the discussion. The predefined themes of the study were the current practice and major challenges facing pharmacovigilance in regulatory bodies, hospitals, the community, and academia, as well as recommendations to improve pharmacovigilance practice.  Of the 29 participants invited, 27 attended the discussion. Challenges facing regulatory bodies included complicated adverse drug reactions (ADR) reporting forms, lack of feedback on ADRs submitted to the Saudi Food and Drug Authority, lack of decisions from the local authority to withdraw medications, and lack of data on pharmacovigilance. The challenges to pharmacovigilance in hospitals included the lack of knowledge of the significance of ADR reporting, workload, blaming culture, and lack of collaboration between regulatory bodies and hospitals. However, challenges facing pharmaceutical industries included the lack of drug manufacturers in Saudi Arabia and lack of interest in pharmacovigilance. Recommendations to improve pharmacovigilance included the need for communication, stronger regulatory requirements, the need for research, the need for unified ADRs reporting, and continuous education and training.  The study has identified the challenges facing pharmacovigilance in Saudi Arabia and made certain recommendations to overcome them. These recommendations might be helpful for regulatory bodies to enhance spontaneous reporting and promote pharmacovigilance.

  4. Dietary Supplements: Regulatory Challenges and Research Resources.

    Science.gov (United States)

    Dwyer, Johanna T; Coates, Paul M; Smith, Michael J

    2018-01-04

    Many of the scientific and regulatory challenges that exist in research on the safety, quality and efficacy of dietary supplements are common to all countries as the marketplace for them becomes increasingly global. This article summarizes some of the challenges in supplement science and provides a case study of research at the Office of Dietary Supplements at the National Institutes of Health, USA, along with some resources it has developed that are available to all scientists. It includes examples of some of the regulatory challenges faced and some resources for those who wish to learn more about them.

  5. Challenges in Strengthening Regulatory Infrastructure in a Non-Nuclear Country

    International Nuclear Information System (INIS)

    Bosnjak, J.

    2016-01-01

    The State Regulatory Agency for Radiation and Nuclear Safety (SRARNS) is established as the effectively independent regulatory body for radiation and nuclear safety based on the Law on Radiation and Nuclear Safety in Bosnia and Herzegovina promulgated in November 2007. After its complete reorganization in the last few years, the regulatory system is compatible with relevant IAEA Safety Standards and Guides for safety and security of radioactive sources. The paper gives an overview of the new regulatory framework in Bosnia and Herzegovina, with special focus on challenges faced by Bosnia and Herzegovina, which are actually typical challenges for regulator in small non-nuclear country in strengthening regulatory infrastructure in regulating radiation sources and radioactive waste. (author)

  6. Regulatory review of safety cases and safety assessments - associated challenges

    International Nuclear Information System (INIS)

    Bennett, D.G.; Ben Belfadhel, M.; Metcalf, P.E.

    2006-01-01

    Regulatory reviews of safety cases and safety assessments are essential for credible decision making on the licensing or authorization of radioactive waste disposal facilities. Regulatory review also plays an important role in developing the safety case and in establishing stakeholders' confidence in the safety of the facility. Reviews of safety cases for radioactive waste disposal facilities need to be conducted by suitably qualified and experienced staff, following systematic and well planned review processes. Regulatory reviews should be sufficiently comprehensive in their coverage of issues potentially affecting the safety of the disposal system, and should assess the safety case against clearly established criteria. The conclusions drawn from a regulatory review, and the rationale for them should be reproducible and documented in a transparent and traceable way. Many challenges are faced when conducting regulatory reviews of safety cases. Some of these relate to issues of project and programme management, and resources, while others derive from the inherent difficulties of assessing the potential long term future behaviour of engineered and environmental systems. The paper describes approaches to the conduct of regulatory reviews and discusses some of the challenges faced. (author)

  7. Bringing nanomedicines to market: regulatory challenges, opportunities, and uncertainties.

    Science.gov (United States)

    Nijhara, Ruchika; Balakrishnan, Krishna

    2006-06-01

    Scientists and entrepreneurs who contemplate developing nanomedicine products face several unique challenges in addition to many of the traditional hurdles of product development. In this review we analyze the major physicochemical, biologic and functional characteristics of several nanomedicine products on the market and explore the question of what made them unique. What made them successful? We also focus on the regulatory challenges faced by nanomedicine product developers. Based on these analyses, we propose the factors that are most likely to contribute to the success of nanomedicine products.

  8. Facing the challenge of stakeholders involvement: the Argentine nuclear regulatory case

    International Nuclear Information System (INIS)

    Acosta, Gabriela M.; Arnaud, Marta I.; Cesario, Pablo A.

    2010-01-01

    The Nuclear Regulatory Authority of Argentina (ARN) is an autonomous body reporting to the Presidency of Argentina, empowered to regulate and control the nuclear activity with regards to radiation and nuclear safety, physical protection and nuclear non-proliferation issues. Under the executive decree 1172/2003, which makes reference to the accessibility of public information to increase transparency of government actions and specially to promote public involvement, ARN has the legal obligation to inform of its activities in an accurate, comprehensive and understandable manner. The re-launching of the nuclear plan in 2006 and the repercussions this provoked on society highlighted the need to reinforce the legitimacy of the regulatory role and the promotion of confidence on its works to ensure the safety of the people. Therefore it was considered necessary to involve the society further in this programme by achieving greater public understanding and awareness of the nuclear regulatory activities. The more the public is conscious of the role of the regulator, conceiving it as a trustworthy and autonomous authority, the easier it is for the regulator to fulfil its obligations. As ARN has a strong commitment with society and considering that communication with the general public, as an external stakeholder, is a means to establishing and maintaining public trust and confidence, the implementation of a new communication programme became a key issue. In this scenario, ARN faced a challenge it was not prepared to handle and thus created a Division to deal with institutional communication and allow and ease the interaction with society. Within this Division, one of the methods chosen to achieve a better interaction with society was the use of a technological tool to attend possible inquiries, increasing and facilitating a greater involvement of the stakeholders. With this in mind a 'Mail-Info' was established because it allows a fast, accessible, easy and informal way of

  9. Facing the challenge of stakeholders involvement: the Argentine nuclear regulatory case

    Energy Technology Data Exchange (ETDEWEB)

    Acosta, Gabriela M.; Arnaud, Marta I.; Cesario, Pablo A. [Nuclear Affairs and Institutional Communication Department, Autoridad Regulatoria Nuclear, Av. del Libertador 8250, C1429BNP (Argentina)

    2010-07-01

    The Nuclear Regulatory Authority of Argentina (ARN) is an autonomous body reporting to the Presidency of Argentina, empowered to regulate and control the nuclear activity with regards to radiation and nuclear safety, physical protection and nuclear non-proliferation issues. Under the executive decree 1172/2003, which makes reference to the accessibility of public information to increase transparency of government actions and specially to promote public involvement, ARN has the legal obligation to inform of its activities in an accurate, comprehensive and understandable manner. The re-launching of the nuclear plan in 2006 and the repercussions this provoked on society highlighted the need to reinforce the legitimacy of the regulatory role and the promotion of confidence on its works to ensure the safety of the people. Therefore it was considered necessary to involve the society further in this programme by achieving greater public understanding and awareness of the nuclear regulatory activities. The more the public is conscious of the role of the regulator, conceiving it as a trustworthy and autonomous authority, the easier it is for the regulator to fulfil its obligations. As ARN has a strong commitment with society and considering that communication with the general public, as an external stakeholder, is a means to establishing and maintaining public trust and confidence, the implementation of a new communication programme became a key issue. In this scenario, ARN faced a challenge it was not prepared to handle and thus created a Division to deal with institutional communication and allow and ease the interaction with society. Within this Division, one of the methods chosen to achieve a better interaction with society was the use of a technological tool to attend possible inquiries, increasing and facilitating a greater involvement of the stakeholders. With this in mind a 'Mail-Info' was established because it allows a fast, accessible, easy and informal

  10. Regulatory challenges facing the global nuclear energy partnership

    International Nuclear Information System (INIS)

    Lyman, Edwin S.

    2007-01-01

    In January 2006 the Department of Energy (DOE) announced the creation of the Global Nuclear Energy Partnership (GNEP), an ambitious plan to reshape the nuclear energy production sector both in the United States and worldwide. If fully realized in the United States, GNEP would entail the construction of a large number of sodium-cooled fast reactors utilizing actinide-based fuels, multiple commercial-scale reprocessing plants for both light-water and fast reactors, and fast reactor fuel fabrication plants. It appears likely that the first commercial-scale GNEP facilities, as well as a future full-scale GNEP complex, would fall under the licensing jurisdiction of the Nuclear Regulatory Commission (NRC). This will be a challenging endeavor for the NRC, primarily because the proposed GNEP facilities will in large part be based on novel and untested designs and processes that have not been developed on a commercial scale. In order to effectively regulate the GNEP complex, the NRC will have to quickly address the many technical and policy questions that will arise in any GNEP licensing scheme. This paper identifies some difficult issues that will be encountered in GNEP licensing by examining the potential implications of NRC's current policies and regulatory requirements, and analyzing the impacts of some emerging post-9/11 security issues. (author)

  11. Regulatory challenges for independent organization and licensing procedures for Egypt first nuclear power program

    International Nuclear Information System (INIS)

    Elsheikh, B.M.

    2012-01-01

    In March 2010 the Government of Egypt issued an Ordinance creating an independent regulatory body the Egypt Nuclear and Radiological Regulatory Authority (NRRA) reporting directly to the Prime Minister and responsible for matters dealing with protection of the radiation worker, public and environment from the harmful effects of ionizing radiation. A little more than 2 years have elapsed since this date. Some of the challenges faced by NRRA to its regulatory independence are given below. This paper will discuss the major challenges relating to Egyptian nuclear power program and specially the regulatory effectiveness and licensing procedures compared to international comparison.

  12. Overcoming regulatory and economic challenges facing pharmacogenomics.

    Science.gov (United States)

    Cohen, Joshua P

    2012-09-15

    The number of personalized medicines and companion diagnostics in use in the United States has gradually increased over the past decade, from a handful of medicines and tests in 2001 to several dozen in 2011. However, the numbers have not reached the potential hoped for when the human genome project was completed in 2001. Significant clinical, regulatory, and economic barriers exist and persist. From a regulatory perspective, therapeutics and companion diagnostics are ideally developed simultaneously, with the clinical significance of the diagnostic established using data from the clinical development program of the corresponding therapeutic. Nevertheless, this is not (yet) happening. Most personalized medicines are personalized post hoc, that is, a companion diagnostic is developed separately and approved after the therapeutic. This is due in part to a separate and more complex regulatory process for diagnostics coupled with a lack of clear regulatory guidance. More importantly, payers have placed restrictions on reimbursement of personalized medicines and their companion diagnostics, given the lack of evidence on the clinical utility of many tests. To achieve increased clinical adoption of diagnostics and targeted therapies through more favorable reimbursement and incorporation in clinical practice guidelines, regulators will need to provide unambiguous guidance and manufacturers will need to bring more and better clinical evidence to the market place. Copyright © 2012 Elsevier B.V. All rights reserved.

  13. 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.

  14. High-risk medical devices, children and the FDA: regulatory challenges facing pediatric mechanical circulatory support devices.

    Science.gov (United States)

    Almond, Christopher S D; Chen, Eric A; Berman, Michael R; Less, Joanne R; Baldwin, J Timothy; Linde-Feucht, Sarah R; Hoke, Tracey R; Pearson, Gail D; Jenkins, Kathy; Duncan, Brian W; Zuckerman, Bram D

    2007-01-01

    Pediatric mechanical circulatory support is a critical unmet need in the United States. Infant- and child-sized ventricular assist devices are currently being developed largely through federal contracts and grants through the National Heart, Lung, and Blood Institute (NHLBI). Human testing and marketing of high-risk devices for children raises epidemiologic and regulatory issues that will need to be addressed. Leaders from the US Food and Drug Administration (FDA), NHLBI, academic pediatric community, and industry convened in January 2006 for the first FDA Workshop on the Regulatory Process for Pediatric Mechanical Circulatory Support Devices. The purpose was to provide the pediatric community with an overview of the federal regulatory process for high-risk medical devices and to review the challenges specific to the development and regulation of pediatric mechanical circulatory support devices. Pediatric mechanical circulatory support present significant epidemiologic, logistic, and financial challenges to industry, federal regulators, and the pediatric community. Early interactions with the FDA, shared appreciation of challenges, and careful planning will be critical to avoid unnecessary delays in making potentially life-saving devices available for children. Collaborative efforts to address these challenges are warranted.

  15. Future nuclear regulatory challenges

    International Nuclear Information System (INIS)

    Royen, J.

    1998-01-01

    In December 1996, the NEA Committee on Nuclear Regulatory Activities concluded that changes resulting from economic deregulation and other recent developments affecting nuclear power programmes have consequences both for licensees and regulatory authorities. A number of potential problems and issues which will present a challenge to nuclear regulatory bodies over the next ten years have been identified in a report just released. (author)

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

    Science.gov (United States)

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

    2013-08-01

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

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

    Science.gov (United States)

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

    2015-06-01

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

  18. Safety analysis - current and future regulatory challenges

    Energy Technology Data Exchange (ETDEWEB)

    Jamieson, T., E-mail: Terry.Jamieson@cnsc-ccsn.gc.ca [Canadian Nuclear Safety Commission, Ottawa, ON (Canada)

    2015-07-01

    'Full text:' The current and future regulatory challenges associated with deterministic safety analysis are reviewed, including: 1. The CNSC's and safety control areas. 2. Traditional safety analysis approach. 3. Experience gained and impact. 4. Current analysis and regulatory approaches. 5. Current status. 6. Complexity and challenges In particular, the technical, regulatory and strategic aspects of these challenges are discussed. (author)

  19. Safety analysis - current and future regulatory challenges

    International Nuclear Information System (INIS)

    Jamieson, T.

    2015-01-01

    'Full text:' The current and future regulatory challenges associated with deterministic safety analysis are reviewed, including: 1. The CNSC's and safety control areas. 2. Traditional safety analysis approach. 3. Experience gained and impact. 4. Current analysis and regulatory approaches. 5. Current status. 6. Complexity and challenges In particular, the technical, regulatory and strategic aspects of these challenges are discussed. (author)

  20. Challenges facing procurement professionals in developing economies: Unlocking value through professional international purchasing

    Directory of Open Access Journals (Sweden)

    Marian Tukuta

    2015-04-01

    Objectives: The purpose of this article was to examine the critical role played by the procurement function in business and to reveal the challenges faced by procurement professionals in developing economies as well as to suggest solutions to these challenges. Method: A sequential literary analysis was used, complemented by cross-country qualitative data gathered from one hundred diverse procurement practitioners from Botswana, Namibia and Zimbabwe. These were primarily participants in a series of procurement workshops run by the researchers from January to June 2014. Results: Findings suggested that limited recognition, increasing unethical behaviour, poor supplier service delivery, poor regulatory environment, varying supplier standards and poor corporate governance are the main challenges faced by the procurement profession in these countries. Conclusion: The study’s findings imply that there is limited understanding regarding the role procurement plays in both government and non-government institutions in developing economies. The article suggests solutions which procurement professionals and organisations can implement in order to unlock the potential value in the procurement function.

  1. Investigating Maternal Touch and Infants' Self-Regulatory Behaviours during a Modified Face-to-Face Still-Face with Touch Procedure

    Science.gov (United States)

    Jean, Amélie D. L.; Stack, Dale M.; Arnold, Sharon

    2014-01-01

    Maternal touch and infants' self-regulatory behaviours were examined during a modified Still-Face with Touch (SF?+?T) procedure. Mothers and their 5½-month-old infants participated in one period of Normal interaction followed by three SF?+?T periods. Maternal functions of touch, and infants' self-regulatory behaviour, affect, and…

  2. The regulatory control of radiation sources in Australia -- The challenges of a federal system

    International Nuclear Information System (INIS)

    Loy, J.; Colgan, P.

    2001-01-01

    The report refers to the challenges that Australia is facing, as a federal nation having a Commonwealth Government and six States and two territories, in establishing appropriate regulatory control of radiation sources. Information on the national inventory of radiation sources and existing regulatory infrastructure, including the system of notification, registration, licensing, inspection and enforcement, is explained in the report. The national provisions for the management of disused sources; the planning, preparedness and response to abnormal events and emergencies; the recovery of control over orphan sources; and education and training; are specifically emphasized. (author)

  3. Ethical challenges facing veterinary professionals in Ireland: results from Policy Delphi with vignette methodology

    Science.gov (United States)

    Magalhães-Sant'Ana, M.; More, S. J.; Morton, D. B.; Hanlon, A.

    2016-01-01

    Ethics is key to the integrity of the veterinary profession. Despite its importance, there is a lack of applied research on the range of ethical challenges faced by veterinarians. A three round Policy Delphi with vignette methodology was used to record the diversity of views on ethical challenges faced by veterinary professionals in Ireland. Forty experts, comprising veterinary practitioners, inspectors and nurses, accepted to participate. In round 1, twenty vignettes describing a variety of ethically challenging veterinary scenarios were ranked in terms of ethical acceptability, reputational risk and perceived standards of practice. Round 2 aimed at characterising challenges where future policy development or professional guidance was deemed to be needed. In round 3, possible solutions to key challenges were explored. Results suggest that current rules and regulations are insufficient to ensure best veterinary practices and that a collective approach is needed to harness workable solutions for the identified ethical challenges. Challenges pertaining mostly to the food chain seem to require enforcement measures whereas softer measures that promote professional discretion were preferred to address challenges dealing with veterinary clinical services. These findings can support veterinary representative bodies, advisory committees and regulatory authorities in their decision making, policy and regulation. PMID:27613779

  4. Management challenges faced by managers of New Zealand long-term care facilities.

    Science.gov (United States)

    Madas, E; North, N

    2000-01-01

    This article reports on a postal survey of 78 long-term care managers in one region of New Zealand, of whom 45 (58%) responded. Most long-term care managers (73.2%) were middle-aged females holding nursing but not management qualifications. Most long-term care facilities (69%) tended to be stand-alone facilities providing a single type of care (rest home or continuing care hospital). The most prominent issues facing managers were considered to be inadequate funding to match the growing costs of providing long-term care and occupancy levels. Managers believed that political/regulatory, economic and social factors influenced these issues. Despite a turbulent health care environment and the challenges facing managers, long-term care managers reported they were coping well and valued networking.

  5. Homeland Security. Management Challenges Facing Federal Leadership

    Science.gov (United States)

    2002-12-01

    Security Management Challenges Facing Federal Leadership 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) 5d. PROJECT...including attention to management practices and key success factors. HOMELAND SECURITY Management Challenges Facing Federal Leadership www.gao.gov/cgi...significant management and coordination challenges if it is to provide this leadership and be successful in preventing and responding to any future

  6. Analytical difficulties facing today's regulatory laboratories: issues in method validation.

    Science.gov (United States)

    MacNeil, James D

    2012-08-01

    The challenges facing analytical laboratories today are not unlike those faced in the past, although both the degree of complexity and the rate of change have increased. Challenges such as development and maintenance of expertise, maintenance and up-dating of equipment, and the introduction of new test methods have always been familiar themes for analytical laboratories, but international guidelines for laboratories involved in the import and export testing of food require management of such changes in a context which includes quality assurance, accreditation, and method validation considerations. Decisions as to when a change in a method requires re-validation of the method or on the design of a validation scheme for a complex multi-residue method require a well-considered strategy, based on a current knowledge of international guidance documents and regulatory requirements, as well the laboratory's quality system requirements. Validation demonstrates that a method is 'fit for purpose', so the requirement for validation should be assessed in terms of the intended use of a method and, in the case of change or modification of a method, whether that change or modification may affect a previously validated performance characteristic. In general, method validation involves method scope, calibration-related parameters, method precision, and recovery. Any method change which may affect method scope or any performance parameters will require re-validation. Some typical situations involving change in methods are discussed and a decision process proposed for selection of appropriate validation measures. © 2012 John Wiley & Sons, Ltd.

  7. Emerging regulatory challenges facing the Indian rural electrification programme

    International Nuclear Information System (INIS)

    Bhattacharyya, Subhes C.; Srivastava, Leena

    2009-01-01

    The purpose of this paper is to present and analyse the regulatory issues emerging from the newly launched programme of rural electricity access in India. We focus on two broad areas, namely regulatory issues related to the organisation/structuring of the activities and issues related to subsidy and tariffs. The paper looks into the alternative organisational arrangements being used by the programme and identifies problem areas through a responsibility mapping. The tariff principle being followed by the programme is then analysed considering the alternative organisational forms and issues related to such pricing policies are identified. Possible alternative pricing options are then suggested. The paper finds that while the franchisee model is an innovative idea, it raises issues that the regulators should be concerned with. The programme has so far relied on the simplest franchisee model because of its ease of implementation but a transition to more complex alternatives would require careful considerations

  8. Exploring the challenges faced by polytechnic students

    Science.gov (United States)

    Matore, Mohd Effendi @ Ewan Mohd; Khairani, Ahmad Zamri

    2015-02-01

    This study aims to identify other challenges besides those already faced by students, in seven polytechnics in Malaysia as a continuation to the previous research that had identified 52 main challenges faced by students using the Rasch Model. The explorative study focuses on the challenges that are not included in the Mooney Problem Checklist (MPCL). A total of 121 polytechnic students submitted 183 written responses through the open questions provided. Two hundred fifty two students had responded from a students' perspective on the dichotomous questions regarding their view on the challenges faced. The data was analysed qualitatively using the NVivo 8.0. The findings showed that students from Politeknik Seberang Perai (PSP) gave the highest response, which was 56 (30.6%) and Politeknik Metro Kuala Lumpur (PMKL) had the lowest response of 2 (1.09%). Five dominant challenges were identified, which were the English language (32, 17.5%), learning (14, 7.7%), vehicles (13, 7.1%), information technology and communication (ICT) (13, 7.1%), and peers (11, 6.0%). This article, however, focus on three apparent challenges, namely, English language, vehicles, as well as computer and ICT, as the challenges of learning and peers had been analysed in the previous MPCL. The challenge of English language that had been raised was regarding the weakness in commanding the aspects of speech and fluency. The computer and ICT challenge covered the weakness in mastering ICT and computers, as well as computer breakdowns and low-performance computers. The challenge of vehicles emphasized the unavailability of vehicles to attend lectures and go elsewhere, lack of transportation service in the polytechnic and not having a valid driving license. These challenges are very relevant and need to be discussed in an effort to prepare polytechnics in facing the transformational process of polytechnics.

  9. 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

  10. Challenges facing production grids

    Energy Technology Data Exchange (ETDEWEB)

    Pordes, Ruth; /Fermilab

    2007-06-01

    Today's global communities of users expect quality of service from distributed Grid systems equivalent to that their local data centers. This must be coupled to ubiquitous access to the ensemble of processing and storage resources across multiple Grid infrastructures. We are still facing significant challenges in meeting these expectations, especially in the underlying security, a sustainable and successful economic model, and smoothing the boundaries between administrative and technical domains. Using the Open Science Grid as an example, I examine the status and challenges of Grids operating in production today.

  11. Grand Challenges facing Storage Systems

    CERN Multimedia

    CERN. Geneva

    2004-01-01

    In this talk, we will discuss the future of storage systems. In particular, we will focus on several big challenges which we are facing in storage, such as being able to build, manage and backup really massive storage systems, being able to find information of interest, being able to do long-term archival of data, and so on. We also present ideas and research being done to address these challenges, and provide a perspective on how we expect these challenges to be resolved as we go forward.

  12. Regulatory challenges for GM crops in developing economies: the African experience.

    Science.gov (United States)

    Nang'ayo, Francis; Simiyu-Wafukho, Stella; Oikeh, Sylvester O

    2014-12-01

    Globally, transgenic or genetically modified (GM) crops are considered regulated products that are subject to regulatory oversight during trans-boundary movement, testing and environmental release. In Africa, regulations for transgenic crops are based on the outcomes of the historic Earth Summit Conference held in Rio, Brazil two decades ago, namely, the adoption of the Convention on Biological Diversity (CBD) and the subsequent adoption of the Cartagena Protocol on Biosafety. To exploit the potential benefits of transgenic crops while safeguarding the potential risks on human health and environment, most African countries have signed and ratified the CBD and the Cartagena Protocol on Biosafety. Consequently, these countries are required to take appropriate legal, administrative and other measures to ensure that the handling and utilization of living modified organisms are undertaken in a manner that reduces the risks to humans and the environment. These countries are also expected to provide regulatory oversight on transgenic crops through functional national biosafety frameworks (NBFs). While in principle this approach is ideal, NBFs in most African countries are steeped in a host of policy, legal and operational challenges that appear to be at cross-purposes with the noble efforts of seeking to access, test and deliver promising GM crops for use by resource-limited farmers in Africa. In this paper we discuss the regulatory challenges faced during the development and commercialization of GM crops based on experiences from countries in Sub-Saharan Africa.

  13. Challenges in developing TSO to provide technical support in nuclear safety and security to Pakistan Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    Mallick, Shahid A.; Sherwani, Uzman Habib; Mehdi, M. Ammar

    2010-01-01

    This paper highlights the needs for the establishment of a technical support organization (TSO) in Pakistan Nuclear Regulatory Authority (PNRA), challenges faced during its development, application of training need assessment required for the competency development of its technical manpower and difficulties encountered after its evolution. Key issues addressed include recruitment of technical manpower and enhancing their competencies, acquisition of proper tools required for safety review and assessment, development of a sustainable education and training program consistent with the best international practices and taking the measures to get confidence of the regulatory body. (author)

  14. Facing new safety-challenges in a large particle accelerator experiment at CERN

    CERN Document Server

    Schmidt, Reiner

    1999-01-01

    An upgraded safety concept for CMS has been adapted to the size of the project and its organisational challenges under today's budgetary constraints, as well as to the increasing levels of risk. Strong magnetic fields and high radiation levels, including neutrons, pose additional hazards to materials, to operators, to maintenance and to ultimate deposit of activated materials. CMS also fits the insurer's risk-description for modern facilities, i.e. characterised by "higher energy density, more combustible materials and unattended operation". The regulatory environment, consisting essentially of CERN's autonomous regulations as well as of those of its host countries, also need to be satisfied with much attention. To face this challenge, seven distinct safety management tools have been identified, which are described in some detail, namely clear safety objectives, documented safety requirements, open items list, safety ( and design)reviews, safety risk analysis, enforcement of compliance and quality management....

  15. Future nuclear regulatory challenges. A report by the NEA Committee on Nuclear Regulatory Activities

    International Nuclear Information System (INIS)

    1998-01-01

    Future challenges are considered that may arise from technical, socio-economic and political issues; organizational, management and human aspects; and international issues. The perceived challenges have been grouped into four categories, each covered by a chapter. Technical issues are addressed that many present regulatory challenges in the future: ageing nuclear power plants. External changes to industry are considered next that have an effect on regulators, privatization, cost reduction consequences, commercialization etc. It is followed by the impacts of internal changes: organizational, managerial, human-resources, licensing, staff training etc. Finally, international issues are discussed with potential regulatory impact. (R.P.)

  16. Gender-Specific Health Challenges Facing Women

    Science.gov (United States)

    ... with facebook share with twitter share with linkedin Gender-Specific Health Challenges Facing Women Global Research Global ... adverse reactions to the drugs. Women also suffer gender-specific consequences of HIV, including recurrent vaginal yeast ...

  17. Nuclear regulatory challenges arising from competition in electricity markets

    International Nuclear Information System (INIS)

    2001-01-01

    In recent years a world-wide trend has been developing to introduce competition in electricity markets. As market competition unfolds, it produces a wide range of safety challenges for nuclear power plant operators and regulators. Nuclear regulators must be aware of the potential safety challenges produced and consider whether new regulatory response strategies are warranted. This report describes many of these challenges, their implications and possible regulatory response strategies. The intended audience is primarily nuclear safety regulators, although government authorities, nuclear power plant operators and the general public may also be interested. (author)

  18. Beyond survival: Challenges facing South African automotive component exporters

    Directory of Open Access Journals (Sweden)

    M. J. Naude

    2006-12-01

    Full Text Available Purpose and Objective: The South African automotive component industry faces huge challenges in a very competitive global market. The primary focus of this research article is to determine the challenges facing exporters within this industry with special reference to selected sub-sectors. The challenges are approached from a supply chain perspective only. Problem Investigated: The research problem of this study was to identify these unique challenges and ascertain whether the implementation of a 'philosophy of continuous improvement' could be used as a strategic tool to address the challenges they face in the market. Methodology: This study included a combination of literature review, interviews with managers in the selected sub-groups and questionnaires sent out to determine the challenges facing automotive component exporters. In order to test the content validity and the reliability of the questionnaire, a pilot study was conducted at two organisations that are the main suppliers of automotive filters for passenger vehicles. The non-probability convenience sample technique was used to select the sample and consisted of selected sub-sectors that contribute 64,1% of the total value of automotive component exports in South Africa. Out of twenty-seven questionnaires sent out, twenty (74% response rate were duly completed by the respondents and returned to the researcher. Findings: South Africa faces unique challenges and these are listed and ranked according to priority from most to least important as follows: 1. The reduction of production costs; 2. R/US$ exchange rate effect on the respondent's export sales and profit margin; 3. Exchange rate fluctuations; 4. Threats to the local automotive component market; and 5. Increased competition by way of manufactured imports being sold in the South African market. Value of Research: The study provides recommendations that can be used within the automotive component industry.

  19. Challenges and Enhancements to the Safety Culture of the Regulatory Body

    International Nuclear Information System (INIS)

    Niel, Jean-Christophe; Chevet, Pierre Franck; Sheron, Brian; Boyd, Michael; Carlsson, Lennart; Tiippana, Petteri; Burns, Stephen; Jamieson, Terry; Fuketa, Toyoshi; Rzentkowski, Greg; Weiss, Frank Peter; Le Guen, Bernard

    2015-06-01

    The workshop opened with presentations by both the NEA Director-General and the chair of the three committees directly involved with the safety culture of the regulatory body (SCRB). The opening session set the scene and gave an overview of the SCRB together with presentations and discussions on priorities and challenges. The main session focused on the principles of the SCRB, its implementation and the challenges and enhancements that are being raised and considered. The workshop concluded with a session that looked at findings and conclusions, the way forward and an agreed position on the SCRB. This document brings together the available presentations (slides) given at the workshop: 1 - Introduction: Challenges and Enhancements to the Safety Culture of the Regulatory Body (J-C. Niel); 2 - Thoughts on Safety Culture from a CSNI Perspective (B. Sheron); 3 - Radiological Protection Culture: CRPPH Work (M. Boyd); 4 - Challenges and Enhancements to Safety Culture of the Regulatory Body (L. Carlsson); 5 - Principles for the safety culture of the regulatory body (P. Tiippana); 6 - NRC's Internal Safety Culture: Successes, Challenges, and the Path Forward (S.G. Burns); 7 - Insights on the Canadian Nuclear Safety Commission's Safety Culture Journey (T. Jamieson); 8 - Lessons Learned from the Fukushima Dai-ichi Accident regarding Safety Culture of Regulatory Body (T. Fuketa); 9 - Challenges to Regulatory Bodies' safety culture (P-F. Chevet); 10 - Regulatory Safety Culture: International Perspective (G. Rzentkowski); 11 - Integration of Safety Research into Safety Culture Concepts (F-P. Weiss); 12 - Radiation Protection and Emergency Management Aspects: Culture drawn up by RP professionals (B. Le Guen); 13 - Closing session panel (L. Carlsson)

  20. 75 FR 18202 - Notice of Indo-U.S. Regulatory Workshop

    Science.gov (United States)

    2010-04-09

    ... regulatory challenges faced by commissioners from both nations. The FERC Commissioners, along with other... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Indo-U.S. Regulatory Workshop April 1, 2010. Commissioner Philip D. Moeller will convene a workshop at the Federal Energy Regulatory...

  1. International conference on challenges faced by technical and scientific support organizations in enhancing nuclear safety. Contributed papers and presentations

    International Nuclear Information System (INIS)

    2007-01-01

    Over the past two decades, the IAEA has conducted a series of major conferences that have addressed topical issues and strategies critical to nuclear safety for consideration by the world's nuclear regulators. More recently, the IAEA organized the International Conference on Effective Nuclear Regulatory Systems - Facing Safety and Security Challenges, held in Moscow in 2006. The Moscow conference was the first of its kind, because it brought together senior regulators of nuclear safety, radiation safety and security from around the world to discuss how to improve regulatory effectiveness with the objective of improving the protection of the public and the users of nuclear and radioactive material. The International Conference on Challenges Faced by Technical and Scientific Support Organizations in Enhancing Nuclear Safety was held in Aix-en-Provence, France, from 23 to 27 April 2007. This conference, again, was the first of its kind, because it was the first to address technical and scientific support organizations (TSOs), the role they play in supporting either the national regulatory bodies or the industry in making optimum safety decisions and the challenges they face in providing this support. This conference provided a forum for the TSOs to discuss these and other issues with the organizations to which they provide this support - that is, the regulators and the operators/industry - as well as with other stakeholders such as research organizations and public authorities. This conference can also be considered to have a link to the Moscow conference. The Moscow conference concluded that effective regulation of nuclear safety is vital for the safe use of nuclear energy and associated technologies, both now and in the future, and is an essential prerequisite for establishing an effective Global Nuclear Safety Regime. The Moscow conference also highlighted the importance of continued and improved international cooperation in the area of nuclear safety. These

  2. Key regulatory challenges for future nuclear power plants

    International Nuclear Information System (INIS)

    Todreas, Neil E.

    2001-01-01

    Key regulatory challenges for future nuclear power plants are concerned with fuel and cladding materials taken to higher burnup and operated at higher temperatures. Particular challenges are related to reduction in waste toxicity, understanding and control of coolant corrosion, qualification of fuel particles, new maintenance practices

  3. Regulatory Oversight for New Projects - Challenges and Improvement in Regulation

    International Nuclear Information System (INIS)

    Lall, F.

    2016-01-01

    From inception, there has been rise in number of Nuclear Power Plants (NPP) even though very few accidents / events led to intermittent setbacks. However these accidents / events have posed challenges towards enhancement of safety and scope of regulation in all phases of NPP such as siting, design, construction, commissioning and decommissioning. It is essential to ensure compliance to these enhanced safety requirements during all phases of NPP. New and evolutionary reactors are under threshold for regulatory consideration world over. The variety of technologies and genres by themselves pose challenges to regulatory bodies. These challenges are to be addressed through systematic enhancement of the regulation including updating of regulatory documents. The paper touches upon some key elements to be considered towards such enhancement of regulation during all stages of NPP. These being; ensuring quality assurance, regulatory oversight especially over supply chain and contractors, counterfeit material specifically in case of international dealings, emergency handling in case of multi-unit site, feedback and associated enhancements from international events, construction experience database and feedback for safety enhancement, qualification and acceptance of first of a kind systems, regulatory enforcement specifically in case of imported reactors and maintaining interface between safety and security. Regulation in present context has become dynamic and Regulatory bodies need to continue enhancement of its current regulation taking into account the technological developments, feedback from construction, operation and accidents in the current fleet of plants. The paper touches upon some of these elements and highlights the challenges and improvements in regulation. (author)

  4. Regulatory T-cells in autoimmune diseases: challenges, controversies and--yet--unanswered questions.

    Science.gov (United States)

    Grant, Charlotte R; Liberal, Rodrigo; Mieli-Vergani, Giorgina; Vergani, Diego; Longhi, Maria Serena

    2015-02-01

    Regulatory T cells (Tregs) are central to the maintenance of self-tolerance and tissue homeostasis. Markers commonly used to define human Tregs in the research setting include high expression of CD25, FOXP3 positivity and low expression/negativity for CD127. Many other markers have been proposed, but none unequivocally identifies bona fide Tregs. Tregs are equipped with an array of mechanisms of suppression, including the modulation of antigen presenting cell maturation and function, the killing of target cells, the disruption of metabolic pathways and the production of anti-inflammatory cytokines. Treg impairment has been reported in a number of human autoimmune conditions and includes Treg numerical and functional defects and conversion into effector cells in response to inflammation. In addition to intrinsic Treg impairment, resistance of effector T cells to Treg control has been described. Discrepancies in the literature are common, reflecting differences in the choice of study participants and the technical challenges associated with investigating this cell population. Studies differ in terms of the methodology used to define and isolate putative regulatory cells and to assess their suppressive function. In this review we outline studies describing Treg frequency and suppressive function in systemic and organ specific autoimmune diseases, with a specific focus on the challenges faced when investigating Tregs in these conditions. Copyright © 2014 Elsevier B.V. All rights reserved.

  5. Regulatory Body of Egypt: Practices and Challenges

    International Nuclear Information System (INIS)

    El-Messiry, A.

    2016-01-01

    sectors: (i)nuclear installation safety sector, (ii)radiation installations and radiation sources safety sector and (iii)security and safeguard safety sector, and a Technical Support Organization TSO includes three main divisions of (i)nuclear installation safety, (ii)radiation control division, and (iii)regulations and emergency division, in addition to departments of public communication, centre labs, radiation network monitoring, emergency, security, and administrations. In building capacity of ENRRA, and improving the present skills of the personnel’s, Egypt undertakes three current international projects with EU, IAEA, and south Korea, emphasizing on upgrading the existing capabilities of ENRRA employees related to the proposed nuclear power plant to be built, in the area of safety review and assessment, licensing, site evaluation, inspections, safeguard and security, regulation preparing and updating, which are the main challenges being faced by ENRRA. (author)

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

    African Journals Online (AJOL)

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

  7. Time-Line in HFEA Developments and Regulatory Challenges: 20 Years of Overseeing Fertility Practices and Research in the UK.

    Science.gov (United States)

    Agrawal, Rina; Burt, Elizabeth; Homburg, Roy

    2013-12-01

    In the wake of political upheaval, the Human Fertilisation and Embryo Authority (HFEA) has faced increasing insecurity over its future as a pivotal regulatory body of fertility practices in the UK. HFEA regulates activities by means of licensing, audit, and inspection of fertility centers and maintaining the Code of Practice, which ensures the optimum undertaking of licensed activities by fertility centers. In 2009, amendments to the 1990 Act came into force representing an amalgamation of cumulative proposals, debates, and changes in legislation, which have shaped the world of reproductive medicine. The medical world has, in many cases, adapted to righteous political and social demands, and continues to evolve at a rapid rate. The HFEA has faced many regulatory challenges and changes, and through this study, we aim to provide an overview of some of these changes, particularly those during the last 10 years and the implications that they may have had to fertility practices.

  8. Dietary Supplements: Regulatory Challenges and Research Resources

    OpenAIRE

    Johanna T. Dwyer; Paul M. Coates; Michael J. Smith

    2018-01-01

    Many of the scientific and regulatory challenges that exist in research on the safety, quality and efficacy of dietary supplements are common to all countries as the marketplace for them becomes increasingly global. This article summarizes some of the challenges in supplement science and provides a case study of research at the Office of Dietary Supplements at the National Institutes of Health, USA, along with some resources it has developed that are available to all scientists. It includes e...

  9. [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.

  10. Children at Risk: Global Views on Challenges Facing Children

    Science.gov (United States)

    Neugebauer, Roger

    2011-01-01

    Members of the World Forum community were invited to respond to the question: "What is the most urgent challenge facing young children in your country?" Here are some of their responses. Jamils Richard Achunji Anguaseh mentions that in Cameroon, young children face lots of insecurity, both from health hazards and poor parenting practices. There…

  11. Broadening the cancer and cognition landscape: the role of self-regulatory challenges.

    Science.gov (United States)

    Arndt, Jamie; Das, Enny; Schagen, Sanne B; Reid-Arndt, Stephanie A; Cameron, Linda D; Ahles, Tim A

    2014-01-01

    The potentially detrimental effects of cancer and related treatments on cognitive functioning have emerged as one of the key foci of cancer survivorship research, but little is known about how psychological variables other than depression influence these relationships. To illustrate the potential of social psychological perspectives, we examine how a self-regulatory analysis and specific self-regulatory challenges of contending with cancer-related expectancies and stereotypes provide conceptual frameworks for understanding some of the potential causes and consequences of cancer-related cognitive deficits. Literatures on cancer-related cognitive deficits, self-regulatory ego depletion, expectancy stereotypes, and their points of convergence are briefly reviewed. A review and conceptual integration of relevant literatures suggest that coping with cancer can impair self-regulatory capacity. There is an overlap between cognitive deficits associated with self-regulatory challenge and with cancer and its treatment, and restoring self-regulatory resources can attenuate cancer-related cognitive deficits. Examination of specific regulatory challenges of contending with expectancies and stereotypes related to treatment suggests insights that can inform when and among whom cognitive deficits may most likely emerge. Integrating social psychological ideas with a substantial knowledge base can illustrate novel research trajectories that can deepen our understanding of cancer-related cognitive deficits and their impact on psychosocial well-being. Copyright © 2013 John Wiley & Sons, Ltd.

  12. Computational challenges in modeling gene regulatory events.

    Science.gov (United States)

    Pataskar, Abhijeet; Tiwari, Vijay K

    2016-10-19

    Cellular transcriptional programs driven by genetic and epigenetic mechanisms could be better understood by integrating "omics" data and subsequently modeling the gene-regulatory events. Toward this end, computational biology should keep pace with evolving experimental procedures and data availability. This article gives an exemplified account of the current computational challenges in molecular biology.

  13. Facing Tomorrow's Challenges - An Overview

    Science.gov (United States)

    ,

    2008-01-01

    In 2007, the U.S. Geological Survey (USGS) developed a science strategy outlining the major natural-science issues facing the Nation in the next decade. The science strategy consists of six science directions of critical importance, focusing on areas where natural science can make a substantial contribution to the well-being of the Nation and the world. This fact sheet is an overview of the science strategy and describes how USGS research can strengthen the Nation with information needed to meet the challenges of the 21st century.

  14. The Challenges Facing Distance Students in Undertaking ...

    African Journals Online (AJOL)

    This paper discusses the challenges facing distance students in Geography field Practical projects (GFPs) at The Open University of Tanzania (OUT). A random sample size of 19 students who participated in GFP1 in 2009 and 2010 were selected from randomly sampled regional centres of Singida, Dodoma, Njombe, and ...

  15. Original Research Challenges facing young African scientists in ...

    African Journals Online (AJOL)

    This study aimed at identifying the challenges that young African scientists face in their career development. Methods ... The research profile of Africans is relatively new, and the .... outside the country because it will support my original ideas.”.

  16. NEW CHALLENGES FACED BY EUROPEAN COMPANIES AND THEIR STAKEHOLDERS

    Directory of Open Access Journals (Sweden)

    BOBE Claudia-Maria

    2010-07-01

    Full Text Available The European Union is currently affected by the financial crisis that spread internationally. The member states face difficulties such as price volatility, uncertainties, liquidity issues, cases of bankruptcy, increased unemployment rate, and decreasing GDP. The present paper analyses the challenges faced under these new circumstances by the European companies and their stakeholders. By taking into consideration the threats and weaknesses faced by firms and other interested parties, we emphasize the importance that transparency and communication among companies and their stakeholder have in overcoming financial difficulties.

  17. Fiber quality challenges facing the cotton industry

    Science.gov (United States)

    The cotton industry is in the midst of an exciting time with increased domestic consumption, but also facing pressure from other crops and the global marketplace. In order to ensure the US cotton crop remains the fiber of choice for the world it is important to keep an eye on the challenges to fibe...

  18. Facing the challenges of a competitive market

    International Nuclear Information System (INIS)

    Hollins, P.

    2001-01-01

    British Energy is one of the world's largest nuclear generating companies. This paper describes the business environment in which the company competes, its strategic responses to the challenges it faces, and gives some conclusions regarding the priorities for the nuclear generation industry if it is to thrive as a mainstream source of energy. (author)

  19. Challenges facing the marketing of scientific and research institutes

    OpenAIRE

    Bogdan Sojkin

    2015-01-01

    This article presents the challenges that scientific research institutions face in terms of their marketing, which have been divided into two groups of those associated with internal marketing and those linked to external marketing. The most significant and important determinants that constitute challenges to both internal and external marketing were described. The key aspects of each of the identified challenges were indicated, as was their impact on the implementation of the marketing polic...

  20. Challenges facing the marketing of scientific and research institutes

    Directory of Open Access Journals (Sweden)

    Bogdan Sojkin

    2015-12-01

    Full Text Available This article presents the challenges that scientific research institutions face in terms of their marketing, which have been divided into two groups of those associated with internal marketing and those linked to external marketing. The most significant and important determinants that constitute challenges to both internal and external marketing were described. The key aspects of each of the identified challenges were indicated, as was their impact on the implementation of the marketing policy at institutions.

  1. The challenges facing commercial motorcycle occupation in Etsako ...

    African Journals Online (AJOL)

    This study examined the challenges facing commercial motorcycle occupation in Edo State, Nigeria. A descriptive survey design was adopted. Data were collected through questionnaires and in-depth interviews (IDIs) among selected motorcyclists, police officers and road safety officials in Etsako West Local Government ...

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

    Science.gov (United States)

    Otsubo, Yasuto; Ishiguro, Akihiro; Uyama, Yoshiaki

    2013-01-01

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

  3. What are gender-based challenges facing Free Primary Education ...

    African Journals Online (AJOL)

    Rural teachers' views: What are gender-based challenges facing. Free Primary Education in Lesotho .... resulted in high levels of poverty amongst women, particularly in rural areas. Women ...... Lesotho demographics profile 2010. Available at ...

  4. IAEA Mission Says Chile Committed to Enhancing Safety, Sees Regulatory Challenges

    International Nuclear Information System (INIS)

    2018-01-01

    An International Atomic Energy Agency (IAEA) team of experts said Chile is committed to strengthening its regulatory framework for nuclear and radiation safety. To help achieve this aim, the team said the country should address challenges in some areas, including the need to ensure effective independence in regulatory decision-making. The Integrated Regulatory Review Service (IRRS) team today concluded a 12-day mission to assess the regulatory safety framework in Chile. The mission was conducted at the request of the Government and hosted by the Chilean Nuclear Energy Commission (CCHEN), which is responsible for regulatory supervision together with the Ministry of Health (MINSAL). The review mission covered all civilian nuclear and radiation source facilities and activities regulated in Chile.

  5. The Challenges Facing Catholic Education in France Today

    Science.gov (United States)

    Moog, François

    2016-01-01

    The effects of secularisation on society demand a rethinking of the identity and mission of Catholic schools in France. In 2013, the French bishops published a new directory which offers new approaches, described here, based on the three challenges facing Catholic education in France: linking social responsibility and evangelisation, setting up…

  6. A Variety of Diversity: Facing Higher Education's Educational Challenges

    Science.gov (United States)

    Dey, Eric L.

    2008-10-01

    First among the many important challenges facing American higher education is the need to improve the effectiveness of our educational programs. Public concern has heightened the sense of urgency for colleges and universities to make progress on improving and measuring educational outcomes, which is made more challenging by the varieties of diversity facing us. Diversity is not just an issue related to student recruitment or experience, but rather it is one that also relates to institutions and their faculties. New educational methods must address such diversity to be effective, and one possible example can be found in ongoing research at the University of Michigan that explores the educational implications of implementing a web-based lecture capture system in large lecture courses. Student use of and reactions to such systems is important, as is the potential to influence course performance for students in general, but also for underrepresented and at-risk student subpopulations. In addition to helping bring our current landscape into focus, this paper will identify effective practices as well as continuing challenges to improving educational practice for undergraduate students.

  7. Challenges facing primary school educators of English Second (or ...

    African Journals Online (AJOL)

    ESOL) learners identified by educators as having language disorders and being referred for Speech-Language Therapy. We describe challenges faced by Grade 1, 2 and 3 educators at government schools in the Cape Metropolitan area who ...

  8. Challenges facing water management in China

    International Nuclear Information System (INIS)

    Varis, O.; Vakkilainen, P.

    2000-01-01

    The amount of water per person in northern China is less than half of that in Egypt, a country with very scarce water resources. Clearly, then, China is one of the regions on our planet that is going to have to face severe problems of water supply in the future. Rapid urbanisation and industrialisation growing agricultural output, environmental degradation, climatic instability, a large population density and worsening regional disparities are all factors that will challenge the management and utilisation of China's water resources in the years to come. (orig.)

  9. Challenges when electricity markets face the investment phase

    International Nuclear Information System (INIS)

    Finon, Dominique; Johnsen, Tor Arnt; Midttun, Atle

    2004-01-01

    Deregulation of electricity industry in Europe has tended to start with a grace period of energy surplus inherited from the previously expansive coordinated economies and further amplified by better resource utilisation from extended international trade. The regulatory challenge has therefore primarily been to allocate existing generation to consumers in an efficient way. However, as energy demand increases, due to economic growth, the challenge of providing new capacity surfaces. The Nordic region, which has been a pioneer in internationalising and deregulating electricity, is now approaching this stage, ahead of most of the rest of Europe. While the Nordic case is characterised by specificities related to hydropower it also raises the more general challenge of capacity expansion under a deregulated market economy. The article therefore discusses how the Nordic investment challenges of today shed light on more generic challenges that may become more general European challenges of tomorrow. In a final section, the article discusses policy options available to address the investment/price-hike challenge. The argument is put forward that recursion to some degree of coordinated governance might seem necessary if solutions are confined within large-scale technical systems. However, within the context of a small-scale decentralised technological development, one may be more confident of competitive solutions. (Author)

  10. Challenges and Opportunities Facing Technology Education in Taiwan

    Science.gov (United States)

    Lee, Lung-Sheng Steven

    2009-01-01

    The technology education in Taiwan is prescribed in the national curriculum and provided to all students in grades 1-12. However, it faces the following challenges: (1) Lack of worthy image, (2) Inadequate teachers in elementary schools, (3) Deficient teaching vitality in secondary schools, and (4) Diluted technology teacher education programs. In…

  11. Regulatory control, nuclear safety regulation and waste management in Spain

    International Nuclear Information System (INIS)

    Martin, A.

    2000-01-01

    This article presents the challenges that faces the spanish regulatory authority. The deregulation of electricity industry imposes severe changes in nuclear power economics and forces nuclear power to compete with other sources of electricity. A pressure is perceived for regulatory effectiveness primarily since the cost of regulation is a component of the cost of the product. This effectiveness gain in regulatory control will be reached through systematic strategic analysis, formulation and implementation. The regulatory aspects of plant life extension and of waste management are examined

  12. Challenges Faced by Undergraduate Military Students at American Public University System

    Science.gov (United States)

    Machuca, Ana; Torres, Karin; Morris, Pamela; Whitley, William

    2014-01-01

    This paper will summarize some of challenges faced by military students enrolled in an associate and bachelors online program at American Public University System (APUS). The survey results on which the study is based exposed the following problems faced by military personnel: 48.7% had difficulties working around military obligations, 33.3%…

  13. Challenges Facing Supervisors and Students in the Process of ...

    African Journals Online (AJOL)

    The paper established that communication, supervisorstudent relationship, access to literature, plagiarism, and poor writing skills among some students are some of the key challenges facing students and supervisors in writing dissertations/theses at OUT. The paper recommends that communication between students and ...

  14. Rural teachers' views: What are gender-based challenges facing ...

    African Journals Online (AJOL)

    This paper gives prominence to rural teachers' accounts of gender-based challenges facing Free Primary Education in Lesotho. It draws on feminist interpretations of social constructionism to discuss factors within the Basotho communities that affect gender equality in the schools. The inductive analysis offered makes use ...

  15. The Face Management Challenges of Sport Celebrity

    Directory of Open Access Journals (Sweden)

    Diana-Luiza DUMITRIU

    2015-03-01

    Full Text Available While gaining centrality within the sport field, media accelerated its commodification process and facilitated sport actors becoming competitive on the celebrity market. The aim of this paper is to discuss the reconfiguration that the celebrity logic brought in terms of the mere condition of the sport actor and the face management challenges and remedial strategies that he has to cope with. I will thus focus on two main dimensions that I find to be constitutive for the celebrity status: one related to the augmented media exposure that sport stars are subject to and to the corollary symbolic reconfiguration of the boundaries between his public and his private life, and the second one related to the vulnerability that comes along with the new visibility of the complex repertoire of identities and social roles performed by the sport actors. Within this last dimension of the sport-related celebrity cycle of promotion, I will lay stress not only on the face threatening aspects for the sport stars, but also on the vulnerability transfer within the affinal branding network and the challenges it could bring for the brands that chose to associate their image with a sport celebrity. Thus, I argue that the kaleidoscopic public figures of sport celebrities requires high impression management involvement on their part, as well as more caution on the marketeers part.

  16. 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.

  17. Use of new scientific developments in regulatory risk assessments: challenges and opportunities.

    Science.gov (United States)

    Tarazona, Jose V

    2013-07-01

    Since the 1990s, science based ecological risk assessments constitute an essential tool for supporting decision making in the regulatory context. Using the European REACH Regulation as example, this article presents the challenges and opportunities for new scientific developments within the area of chemical control and environmental protection. These challenges can be sorted out in 3 main related topics (sets). In the short term, the challenges are directly associated with the regulatory requirements, required for facilitating a scientifically sound implementation of the different obligations for industry and authorities. It is important to mention that although the actual tools are different due to the regulatory requirements, the basic needs are still the same as those addressed in the early 1990s: understanding the ecological relevance of the predicted effects, including the uncertainty, and facilitating the link with the socio-economic assessment. The second set of challenges covers the opportunities for getting an added value from the regulatory efforts. The information compiled through REACH registration and notification processes is analyzed as source for new integrative developments for assessing the combined chemical risk at the regional level. Finally, the article discusses the challenge of inverting the process and developing risk assessment methods focusing on the receptor, the individual or ecosystem, instead of on the stressor or source. These approaches were limited in the past due to the lack of information, but the identification and dissemination of standard information, including uses, manufacturing sites, physical-chemical, environmental, ecotoxicological, and toxicological properties as well as operational conditions and risk management measures for thousands of chemicals, combined by the knowledge gathered through large scale monitoring programs and spatial information systems is generating new opportunities. The challenge is liking

  18. Myth 15: High-Ability Students Don't Face Problems and Challenges

    Science.gov (United States)

    Moon, Sidney M.

    2009-01-01

    One rationale for failure to address the needs of high-ability students in schools is that high-ability students do not need special services because they do not face any special problems or challenges. A more extreme corollary of this attitude is the notion that high ability is so protective that students with high ability do not face problems or…

  19. Challenges facing young African scientists in their research careers ...

    African Journals Online (AJOL)

    Background: Africa accounts for 14% of world's population, and the economies of most African countries are considered to be growing, but this is not reflected in the amount of research published by Africans. This study aimed at identifying the challenges that young African scientists face in their career development.

  20. Recommendations on Arresting Global Health Challenges Facing Adolescents and Young Adults.

    Science.gov (United States)

    Lassi, Zohra S; Salam, Rehana A; Bhutta, Zulfiqar A

    The health challenges faced by young people are more complex than adults and can compromise their full growth and development. Attention must be paid to the health of this age group, yet adolescents and youth remain largely invisible and often disappear from the major global datasets. The aim of this paper is to discuss the global health challenges faced by adolescents and youth, global legislations and guidelines pertaining to this particular age group, recommendations to arrest these challenges, and research priorities. Major direct and indirect global health risks faced by adolescents include early pregnancy and childbirth, femicide, honor killing, female genital mutilation, nutritional habits and choices, social media, and peer pressure. There are no standard legal age cut-offs for adulthood; rather, the age varies for different activities, such as age of consent or the minimum age that young people can legally work, leave school, drive, buy alcohol, marry, be held accountable for criminal action, and make medical decisions. This reflects the fact that the existing systems and structures are focused on either children or adults, with very few investments and interventions directed specifically to young people. Existing legislation and guidelines need transformation to bring about a specific focus on adolescents in the domains of substance use and sexual behaviors, and the capacity for adolescent learning should be exploited through graduated legal and policy frameworks. Sustainable development goals provide an opportunity to target this neglected and vulnerable age group. A multisectoral approach is needed to bring about healthy change and address the challenges faced by adolescents and youth, from modifications at a broader legislative and policy level to ground-level (community-level) implementations. Copyright © 2017 Icahn School of Medicine at Mount Sinai. Published by Elsevier Inc. All rights reserved.

  1. Challenges Facing Healthwatch, a New Consumer Champion in England.

    Science.gov (United States)

    Carter, Pam; Martin, Graham

    2016-01-21

    This article engages with debates about the conceptualisation and practical challenges of patient and public involvement (PPI) in health and social care services. Policy in this area in England has shifted numerous times but increasingly a consumerist discourse seems to override more democratic ideas concerning the relationship between citizens and public services. Recent policy change in England has seen the creation of new consumer champion bodies in the form of local Healthwatch. The article describes these new organisational structures for PPI and shows how those who seek to influence planning and delivery of services or comment or complain about aspects of their care face considerable complexity. This is due, in part, to the ambiguous remit set out for newly instigated Healthwatch organisations by government. Drawing on governance theory, we show that it can also be understood as a function of an increasingly polycentric governance arena. Challenges that flow from this include problems of specifying jurisdictional responsibility, accountability, and legitimacy. We review Healthwatch progress to date, then we set out four challenges facing local Healthwatch organisations before discussing the implications of these for patients and the public. The first challenge relates to non-coterminous boundaries and jurisdictional integrity. Secondly, establishing the unique features of Healthwatch is problematic in the crowded PPI arena. The third challenge arises from limited resources as well as the fact that resources flow to Healthwatch from the local authorities that Healthwatch are expected to hold to account. The fourth challenge we identify is how local Healthwatch organisations negotiate the complexity of being a partner to statutory and other organisations, while at the same time being expected to champion local people's views. © 2016 by Kerman University of Medical Sciences.

  2. Challenges posed to the European pharmaceutical regulatory system by highly personalized medicines.

    Science.gov (United States)

    Johnston, John D; Feldschreiber, Peter

    2014-03-01

    The European pharmaceutical regulatory system has not yet been challenged by issues related to highly personalized medicines such as those to be found with active substances that affect RNA biochemistry. We review the current status of RNA-based pharmacology and present three possible case histories. The implications for the European pharmaceutical regulatory system are discussed. © 2013 The British Pharmacological Society.

  3. IAEA Mission Concludes Peer Review of Jordan's Nuclear Regulatory Framework

    International Nuclear Information System (INIS)

    2014-01-01

    Senior international nuclear safety and radiation protection experts today concluded an 11-day International Atomic Energy Agency (IAEA) Integrated Regulatory Review Service (IRRS) mission to review the regulatory framework for nuclear and radiation safety in Jordan. The mission team said in its preliminary findings that Jordan's nuclear regulator, the Energy and Minerals Regulatory Commission (EMRC), faces challenges because it is a relatively new body that handles a high workload while also working to recruit, train and keep competent staff. The team also noted that a recent merger provided the regulator with more of the resources it needs to perform its duty. The team made recommendations and suggestions to the regulatory body and the Government to help them strengthen the effectiveness of Jordan's regulatory framework and functions in line with IAEA Safety Standards. The main observations of the IRRS Review team comprised the following: The regulatory body, founded in 2007 and merged with other regulators in April 2014 to form EMRC, faces large challenges in terms of its regulatory workload, management system building and staff recruitment and training; The new EMRC structure and revision of the radiation and nuclear safety law represents an important opportunity to strengthen Jordan's radiation and nuclear safety infrastructure; The Government has shown commitment to radiation and nuclear safety through measures including becoming party to international conventions. It could further demonstrate its commitment by adopting a formal national policy and strategy for safety that defines the role of the Minister of Energy in relation to EMRC and protects the independence of regulatory decision-making

  4. The Challenges Faced by New Science Teachers in Saudi Arabia

    Science.gov (United States)

    Alsharari, Salman

    Growing demand for science teachers in the Kingdom of Saudi Arabia, fed by increasing numbers of public school students, is forcing the Saudi government to attract, recruit and retain well-qualified science teachers. Beginning science teachers enter the educational profession with a massive fullfilment and satisfaction in their roles and positions as teachers to educating children in a science classroom. Nevertheless, teachers, over their early years of practice, encounter numerous challenges to provide the most effective science instruction. Therefore, the current study was aimed to identify academic and behavioral classroom challenges faced by science teachers in their first three years of teaching in the Kingdom of Saudi Arabia. In addition, new science teacher gender, school level and years of teaching experience differences in perceptions of the challenges that they encountered at work were analyzed. The present study also investigated various types of support that new science teachers may need to overcome academic and behavioral classroom challenges. In order to gain insights about ways to adequately support novice science teachers, it was important to examine new science teachers' beliefs, ideas and perceptions about effective science teaching. Three survey questionnaires were developed and distributed to teachers of both sexes who have been teaching science subjects, for less than three years, to elementary, middle and high school students in Al Jouf public schools. A total of 49 novice science teachers responded to the survey and 9 of them agreed to participate voluntarily in a face-to-face interview. Different statistical procedures and multiple qualitative methodologies were used to analyze the collected data. Findings suggested that the top three academic challenges faced by new science teachers were: poor quality of teacher preparation programs, absence of appropriate school equipment and facilities and lack of classroom materials and instructional

  5. Threat ≠ prevention, challenge ≠ promotion: the impact of threat, challenge and regulatory focus on attention to negative stimuli.

    Science.gov (United States)

    Sassenberg, Kai; Sassenrath, Claudia; Fetterman, Adam K

    2015-01-01

    The purpose of the current experiment was to distinguish between the impact of strategic and affective forms of gain- and loss-related motivational states on the attention to negative stimuli. On the basis of the counter-regulation principle and regulatory focus theory, we predicted that individuals would attend more to negative than to neutral stimuli in a prevention focus and when experiencing challenge, but not in a promotion focus and under threat. In one experiment (N = 88) promotion, prevention, threat, or challenge states were activated through a memory task, and a subsequent dot probe task was administered. As predicted, those in the prevention focus and challenge conditions had an attentional bias towards negative words, but those in promotion and threat conditions did not. These findings provide support for the idea that strategic mindsets (e.g., regulatory focus) and hot emotional states (e.g., threat vs. challenge) differently affect the processing of affective stimuli.

  6. The Future Regulatory Challenges of Liquidity Risk Management

    OpenAIRE

    Petr Teply

    2011-01-01

    Liquidity risk management ranks to key concepts applied in finance. Liquidity is defined as a capacity to obtain funding when needed, while liquidity risk means as a threat to this capacity to generate cash at fair costs. In the paper we present challenges of liquidity risk management resulting from the 2007- 2009 global financial upheaval. We see five main regulatory liquidity risk management issues requiring revision in coming years: liquidity measurement, intra-day and...

  7. 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. PMID:25843565

  8. Regulatory Issues and Challenges in Preparing for the Regulation of New Reactor Siting: Malaysia's Experience

    International Nuclear Information System (INIS)

    Jais, Azlina Mohammad; Hassan, Halimah; Yasir, Muhamad Samudi; Roslan, Ridha

    2011-01-01

    This paper aims at giving an overview about the issues and challenges facing regulatory authority, the Atomic Energy Licensing Board (AELB) in ensuring nuclear safety, security and safeguards (3S's) and other relevant authorities to meet an impending nuclear power programme post-2020, in particular at the beginning stage of preparation for the regulation of nuclear power reactor siting. A comparison with an international framework and guidelines of the International Atomic Energy Agency (IAEA) and other countries' practice was made to get an overview of the present adequacy of Malaysia's nuclear regulatory framework in preparation for Malaysia to consider and perhaps decide for a safe, secure and peaceful nuclear power project in Malaysia, in utilising nuclear power in a quest for energy diversity and security. The important stage in the development of a nuclear power project is the evaluation of a suitable site to establish the site-related design inputs for the NPP. The evaluation of suitable site is the result of a process to ensure adequate protection of workers, public and the environment from the undue risk of ionizing radiation arising from NPP taking into account impact to the social communities and public acceptance, thus it will depend on the regulators to ensure a high level safety standards and security are met, in addition to its peaceful uses. Development of regulatory criteria for the site evaluation is a pre-initiatives licensing work for a possible nuclear power plant to performing effective nuclear safety and security reviews in an efficient and timely manner regardless whether Malaysia embarks on a nuclear power programme with anticipating challenges, learning from others' experiences in preparing for the demands for new licensing processes by collaborating internationally, in an expanding global environment

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

    NARCIS (Netherlands)

    Ubacht, J.

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

  10. Medical physics and challenges faced in Africa

    International Nuclear Information System (INIS)

    Nakatudde, R.

    2010-01-01

    Individual medical physicists have presented many challenges which have greatly inhibited their input in patient care and management. To improve the role and recognition of medical physicists in Africa, FAMPO was established. This is the Federation of African Medical Physics Organisations. Its main role is to bridge the gap between individual medical physicists, existing medical physicist bodies and the International Organisation of Medical Physics (IOMP). It is a non profit making organisation. A qualified medical physicist is an individual who is competent to practice independently one or more of the sub fields of medical physics. i.e. therapeutic radiological, diagnostic radiological, medical nuclear and medical health. Their time should on average be distributed equally among three areas, clinical service and consultation, research and development, and teaching. All diagnostic and radiotherapy centres should have a well established comprehensive quality assurance programme in place, which should involve machine installation and calibration, source delivery and safety, operational procedures, clinical dosimetry and the whole treatment planning process. This should be followed according to national and international recommendations. A study was carried out to identify the challenges faced by medical physicists in Africa and the objectives of the study were; To identify the number of qualified medical physicists and their working experience in hospitals in African countries. To identify the level of involvement of medical physicists in the three areas of Nuclear medicine, Radiology and Radiotherapy in hospitals in African countries.To identify countries with recognised professional bodies governing medical physicists in African countries.To identify the challenges faced by medical physicists in African countries Methods and materials The study was conducted on thirteen medical physicists from seven African countries. i.e. Nigeria, Kenya, Libya, Tanzania, Zambia

  11. Strategies being followed in India to face challenge of drug ...

    Indian Academy of Sciences (India)

    First page Back Continue Last page Overview Graphics. Strategies being followed in India to face challenge of drug resistance in tuberculosis. Increasing the coverage with DOTS. Operational research to monitor the trends in drug resistance. Research in methods for rapid detection of drug resistance. Improving methods/ ...

  12. Higher education in the face of social challenges

    Directory of Open Access Journals (Sweden)

    Adrián Cuevas Jiménez

    2016-08-01

    Full Text Available Higher education refers to the subsequent training to high school education; that is undergraduate and graduate; whose mission is to preserve; develop and disseminate culture. Throughout the history of higher education it has undergone a process of transformation; mainly due to the development of knowledge and the transformation of society. In the process they highlighted two great moments; in the first; which culminated in the mid-twentieth century; it conceived the higher education institution encompassing all knowledge of society; and who graduated was ready to perform professionally throughout life; the second time; after those dates; it is conceivable that knowledge is no longer exclusive to the institution of higher education; and there can be no efficient performance without continuous training and continuous updating of knowledge. The objective of this work is to point out the general goals and some strategies of the students’ formation of superior education; to confront the big challenges that it faces today the society. To define this goals and strategies four challenge levels are considered: a physical; structural and politicalideological challenges; b challenges around the scientifictechnician and of the knowledge advances; c challenges of the internal structure of the formative process and the access to the superior education; and d challenges in the formation of values in the students. 

  13. Legitimacy challenges of intermediary gatekeeping in the Chinese internet regulatory system

    NARCIS (Netherlands)

    Wei, Lulu

    2018-01-01

    Legitimacy Challenges of Intermediary Gatekeeping in the Chinese Internet Regulatory System In the Chinese legal and political framework, in order for the government to maintain control over information posted on social media platforms, commercial internet intermediaries are assigned the role of

  14. Challenges faced by young persons living with HIV: The case of ...

    African Journals Online (AJOL)

    Challenges faced by young persons living with HIV: The case of children on the ... Journal of Social Development in Africa ... to 34 randomly selected children who were beneficiaries of an initiative called the Community Outreach Programme.

  15. A Content Analysis Concerning the Studies on Challenges Faced by Novice Teachers

    Science.gov (United States)

    Kozikoglu, Ishak

    2017-01-01

    The purpose of this research is to analyze the studies concerning challenges faced by novice teachers in terms of various aspects and compare challenges according to location of the studies conducted in Turkey and abroad. A total of 30 research studies were included in detailed analysis. This is a descriptive study based on qualitative research…

  16. Becoming a nurse faculty leader: facing challenges through reflecting, persevering and relating in new ways.

    Science.gov (United States)

    Horton-Deutsch, Sara; Young, Patricia K; Nelson, Kristine A

    2010-05-01

    The aim of the present study was to explore the experience of becoming a nurse faculty leader. In a recent interpretation of 23 interviews conducted with nurse faculty leaders from across the United States about their experiences of becoming a leader three themes were identified: being thrust into leadership, taking risks and facing challenges. This interpretive phenomenological study further explicates three aspects of how nurse educators faced challenges in becoming and serving as a leader. Facing challenges meant reflecting, persevering through difficulties and learning to relate to others in new ways. Exemplars of participant experiences are provided for concreteness, to assist readers in determining how findings resonate with their own experience and how they can actualize this resonance in their own leadership practice. In the present study, reflecting, persevering through difficulties and learning to relate with others in a new way was how leaders faced challenges. Leadership development opportunities that facilitate self-exploration, caring and thoughtful interactions with others and values clarification serve as the foundation for becoming a nurse faculty leader who is, in turn, able to build leadership capacity in other individuals and organizations.

  17. Construction and Operation of a Deep Geological Spent Fuel Repository in Sweden; Some Regulatory Aspects and Challenges

    International Nuclear Information System (INIS)

    Hedberg, Bengt

    2014-01-01

    The implementation of a deep geological spent fuel disposal concept in Sweden poses challenges on both implementer and regulator in many aspects. One such challenge is the application of the regulatory framework in a different situation compared to conventional process type nuclear facilities. A specific challenge in this regard is how to understand and address constraints from post-closure safety related to the construction and operation of the repository. The maybe most challenging aspect, however, is the unusually long time frame, i.e. many generations, for realization of the project. This paper addresses some of these challenges from a regulatory perspective. (authors)

  18. Innovation in the face of future challenges

    International Nuclear Information System (INIS)

    Albistur, F. X.

    2006-01-01

    The Chairman of the Senate Commission for Industry. Tourism and Commerce emphasises the legitimate ambition felt by the citizens of all democratic States with respect to safety and underlines his trust in the regulatory body. He analyses the interesting example of the Spanish Nuclear Safety Council, true reflection of the democracy achieved in the country, from the standpoint of its history, the functions that have been added to its realm of competence in recent years environmental radiological surveillance, intervention in emergencies and activities at non-regulated facilities- and the need for it to adapt, within a framework of overall consensus, to improve its response to future challenges and to the goal of promoting credibility and forging a closer relationship with the public. (Author)

  19. Towards new regulatory concepts for the regulation of audiovisual media

    NARCIS (Netherlands)

    Schulz, W.; van Eijk, N.

    2016-01-01

    European media regulation currently faces several challenges: technology, media and markets have become convergent, while – at the same time – the situations in the individual member states differ in respect of media use, the usage of end devices as well as regulatory aims and frameworks. These

  20. 77 FR 2556 - Ethical and Regulatory Challenges in the Development of Pediatric Medical Countermeasures; Public...

    Science.gov (United States)

    2012-01-18

    ...] Ethical and Regulatory Challenges in the Development of Pediatric Medical Countermeasures; Public Workshop... Administration (FDA), Office of Pediatric Therapeutics, is announcing a public workshop entitled ``Ethical and... provide a forum for careful consideration of scientific, ethical, and regulatory issues confronting FDA...

  1. New Challenges Facing Universities in the Internet-Driven Global Environment

    Science.gov (United States)

    Rajasingham, Lalita

    2011-01-01

    This paper explores some new challenges facing universities in a global multimediated Internet-based environment, as they seek alternative paradigms and options to remain true to their core business. At a time of rapid technological change, and contested, complex concepts associated with globalisation, knowledge is becoming a primary factor of…

  2. IAEA Mission Sees Significant Progress in Georgia’s Regulatory Framework, Challenges Ahead

    International Nuclear Information System (INIS)

    2018-01-01

    An International Atomic Energy Agency (IAEA) team of experts said Georgia has made significant progress in strengthening its regulatory framework for nuclear and radiation safety. The team also pointed to challenges ahead as Georgia seeks to achieve further progress. The Integrated Regulatory Review Service (IRRS) team concluded a 10-day mission on 28 February to assess the regulatory safety framework in Georgia. The mission was conducted at the request of the Government and hosted by the Agency of Nuclear and Radiation Safety (ANRS), which is responsible for regulatory oversight in the country. IRRS missions are designed to strengthen the effectiveness of the national safety regulatory infrastructure, while recognizing the responsibility of each State to ensure nuclear and radiation safety. Georgia uses radioactive sources in medicine and industry and operates radioactive waste management facilities. It has decommissioned its only research reactor and has no nuclear power plants. In recent years, the Government and ANRS, with assistance from the IAEA, introduced new safety regulations and increased the number of regulatory inspections.

  3. Gene Editing of Microalgae: Scientific Progress and Regulatory Challenges in Europe.

    Science.gov (United States)

    Spicer, Andrew; Molnar, Attila

    2018-03-06

    It is abundantly clear that the development of gene editing technologies, represents a potentially powerful force for good with regard to human and animal health and addressing the challenges we continue to face in a growing global population. This now includes the development of approaches to modify microalgal strains for potential improvements in productivity, robustness, harvestability, processability, nutritional composition, and application. The rapid emergence and ongoing developments in this area demand a timely review and revision of the current definitions and regulations around genetically modified organisms (GMOs), particularly within Europe. Current practices within the EU provide exemptions from the GMO directives for organisms, including crop plants and micro-organisms that are produced through chemical or UV/radiation mutagenesis. However, organisms generated through gene editing, including microalgae, where only genetic changes in native genes are made, remain currently under the GMO umbrella; they are, as such, excluded from practical and commercial opportunities in the EU. In this review, we will review the advances that are being made in the area of gene editing in microalgae and the impact of regulation on commercial advances in this area with consideration to the current regulatory framework as it relates to GMOs including GM microalgae in Europe.

  4. 76 FR 66078 - Notice of Industry Workshop on Technical and Regulatory Challenges in Deep and Ultra-Deep Outer...

    Science.gov (United States)

    2011-10-25

    ...-0087] Notice of Industry Workshop on Technical and Regulatory Challenges in Deep and Ultra-Deep Outer... discussions expected to help identify Outer Continental Shelf (OCS) challenges and technologies associated... structured venue for consultation among offshore deepwater oil and gas industry and regulatory experts in...

  5. Examining the Challenging Hindrances facing in the Construction Projects: South India’s Perspective

    Science.gov (United States)

    Subramanyam, K.; Haridharan, M. K.

    2017-07-01

    Developing countries like India require a huge infrastructure to facilitate needs of the people. Construction industry provides several opportunities to the individuals. Construction manager work is to supervise and organize the construction activities in construction projects. Now a day construction manager facing challenges. This paper aimed to study the challenges facing by the construction manager in the perception of construction professionals. 39 variables were taken from the literature review which found to be severe impact on construction managers’ performance. Construction manager, project manager and site engineers are the respondents for this survey. Using SPSS, regression analysis was done and recognized significant challenges. These challenges were classified into 5 domains. In management challenges, resource availability and allocation, risks and uncertainties existing in the project onsite, top management support and cost constraints are the most significant variables. In skills requirement of a construction manager challenges, technical skills required to learn and adapt new technology in the project, decision making and planning according to the situation in site are the most significant variables. In performance challenges, implementation of tasks according to the plan is the important variable whereas in onsite challenges, manage project risks, develop project policies and procedures are the most important.

  6. Crisis Communication of Nuclear Regulatory Organisations: Towards global thinking

    International Nuclear Information System (INIS)

    Martell, Meritxell; Menendez, Susan; Calvo, Marina

    2013-01-01

    The OECD Nuclear Energy Agency (NEA) Committee on Nuclear Regulatory Activities (CNRA) Working Group on Public Communication of Nuclear Regulatory Organisations (WGPC) organised the workshop 'Crisis communication: facing the challenges' on 9-10 May 2012 in Madrid to address the international dimension of the communicative responses to crises by assessing the experience of Nuclear Regulatory Organisations of the NEA member countries and their stakeholders. The CNRA/WGPC also prepared in 2011, before the Fukushima-Daiichi nuclear accident occurred, a Road Map for Crisis Communication of Nuclear Regulatory Organisations which focused only on national aspects. This 'road map' had not considered the international dimension. CNRA mandated the WGPC to expand the Road Map so as to conclude the follow-up activity on crisis communication. The objective of the present document is to firstly, identify the key messages which can be extracted from three surveys carried out among the WGPC members after Fukushima-Daiichi's accident (Appendices II, III and IV), and incorporate them into the Road Map for Crisis Communication. Secondly, the good practices on public communication of NROs, which were presented during the OECD/NEA Workshop on Crisis Communication: Facing the Challenges, are reported. Following the structure of the road map for public communication responses during crisis included in the NEA report entitled 'Road Map for Crisis Communication of Nuclear Regulatory Organisations - National aspects', the good practices on communication before, during and after a crisis are provided. Overall, the emphasis of this report is on the international aspects of crisis communication, rather than the national dimension. (authors)

  7. 78 FR 56719 - Challenging Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of...

    Science.gov (United States)

    2013-09-13

    ...] Challenging Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Metabolic Diseases... announcing a public workshop entitled ``Changing Regulatory and Reimbursement Paradigms for Medical Devices... registration information on the AGA Web site. If you need special accommodations due to a disability, please...

  8. Educational challenges faced by international medical graduates in the UK

    Directory of Open Access Journals (Sweden)

    Hashim A

    2017-06-01

    Full Text Available Ahmed Hashim Gastroenterology Department, Brighton and Sussex University Hospitals NHS Trust, Brighton, UK Introduction: International medical graduates (IMGs in the UK constitute approximately one-quarter of the total number of doctors registered in the General Medical Council (GMC. The transition of IMGs into the health care system in the UK is accompanied by significant sociocultural and educational challenges. This study aims to explore the views of IMGs in medical training on the educational challenges they face.Methods: This study was conducted in the Kent, Surrey and Sussex region in 2015. All IMGs who work in medical (physicianly training programs were included. Data were collected through a questionnaire and semi-structured interviews. Thematic approach was used to analyze the qualitative data.Results: Of the total 61 IMGs included, 17 responded to the survey and 3 were interviewed. The common educational barriers faced by IMGs were related to lack of appreciation of the values and structure of the National Health Service (NHS, ethical and medicolegal issues, receiving feedback from colleagues and the different learning strategies in the UK. IMGs suggested introduction of a mandatory dedicated induction program in the form of formal teaching sessions. They also believed that a supervised shadowing period prior in the first job in the UK would be beneficial. Further assessment areas should be incorporated into the prequalifying examinations to address specific educational needs such as NHS structure and hospital policies. Other measures such as buddying schemes with senior IMGs and educating NHS staff on different needs of IMGs should also be considered.Conclusion: This study highlighted important educational challenges faced by IMGs and generated relevant solutions. However, the opinions of the supervisors and other health care professionals need to be explored. Keywords: international medical graduates, IMG, educational barriers

  9. Regulatory practices for nuclear power plants in India

    International Nuclear Information System (INIS)

    Bajaj, S.S.

    2013-01-01

    The Atomic Energy Regulatory Board (AERB) is the national authority for ensuring that the use of ionizing radiation and nuclear energy does not cause any undue risk to the health of workers, members of the public and to the environment. AERB is responsible for the stipulation and enforcement of rules and regulations pertaining to nuclear and radiological safety. This paper describes the regulatory process followed by AERB for ensuring the safety of nuclear power plants (NPPs) during their construction as well as operation. This regulatory process has been continuously evolving to cater to the new developments in reactor technology. Some of the recent initiatives taken by AERB in this direction are briefly described. Today, AERB faces new challenges like simultaneous review of a large number of new projects of diverse designs, a fast growing nuclear power program and functioning of operating plants in a competitive environment. This paper delineates how AERB is gearing up to meet these challenges in an effective manner. (author)

  10. Exploring strategies to overcome extra-organisational challenges faced by community pharmacies in Sarawak, Malaysia.

    Science.gov (United States)

    Kho, Boon Phiaw; Hassali, Mohamed Azmi; Lim, Ching Jou; Saleem, Fahad

    2018-03-15

    The aims of this research were to determine extra-organisational challenges (e.g. market competition, governing policies) faced by community pharmacies in Sarawak, the coping strategies employed to deal with these challenges and explore potential legislative changes that can attenuate the intensity of these challenges. Survey questionnaires (n = 184) were posted to all eligible community pharmacies in Sarawak, Malaysia. The questionnaire included sections on participants' demographic data, extra-organisational challenges faced, coping strategies employed and proposals to improve community pharmacy legislations. Items were constructed based on the findings of a prior qualitative research supplemented with relevant literature about these issues. High levels of homogeneity in responses were recorded on various extra-organisational challenges faced, particularly those economy-oriented. Strategic changes to counter these challenges were focused on pricing and product stocked, rather than services provision. Highly rated strategies included increasing discounts for customers (n = 54; 68%) and finding cheaper suppliers (n = 70; 88%). Legislative changes proposed that might increase their share of the pharmaceutical market were strongly supported by respondents, particularly about making it compulsory for general practitioners to provide patients the option to have their medicines dispensed in community pharmacies (n = 72; 90%). Current legislative conditions and Malaysian consumer mindset may have constrained the strategic choices of community pharmacies to deal with the strong extra-organisational challenges. A long-term multipronged approach to address these issues and increased involvement of community pharmacists themselves in this agenda are required to influence practice change. © 2018 Royal Pharmaceutical Society.

  11. Identity Issues and Challenges Faced by Russian Immigrants in New Zealand

    Directory of Open Access Journals (Sweden)

    Elena Maydell

    2009-08-01

    Full Text Available Among the processes cosmopolitan societies undergo at the present moment, is the unprecedented increase in mass migration across cultures. What challenges are faced by both immigrants, who have to settle in novel socio-cultural environments, and by the host populations accepting them? The current qualitative study investigates the nature of identity construction among Russian-speaking immigrants in New Zealand, applying thematic analysis for the interpretation of the data collected via 23 in-depth interviews. Among the most common themes articulated by the participants was the feeling of identity loss. A taken-for-granted sense of identity, brought by the participants from their culture of origin, was not validated by their new society of residence, mostly due to the lack of appropriate cultural resources. The participants were faced with a challenge of re-constructing their old identity, or constructing a new one, utilising the available resources in the community around them. At the same time, there was a sub-group for whom this challenge brought the realisation that the nature of their identity is cosmopolitan, rather than located within any particular culture or geographical space.

  12. Challenges faced by parents of children with learning disabilities in Opuwo, Namibia.

    Science.gov (United States)

    Taderera, Clever; Hall, Herna

    2017-01-01

    Parenting children with learning disabilities requires a high level of knowledge and access to resources, information and services. In developing countries, however, these resources and services are not always available. Parents in Namibia, a developing country, therefore face challenges addressing children's learning and other developmental disabilities, including challenges related to preventative and supportive interventions. This research focuses on challenges faced by parents as they parent children with learning disabilities in Opuwo, Namibia. In-depth interviews were conducted with eight parents regarding the challenges they face in parenting their children with learning disabilities. Thematic analysis enabled the researchers to identify, analyse and report on themes that emerged from the qualitative interview data. Analysis of the interviews indicated that some participants had only a vague understanding of learning disabilities, as they did not have access to essential knowledge about this phenomenon. They also lacked an awareness of the availability of programmes, services and policies meant to benefit their children with learning disabilities. Participants voiced that they, their children with learning disabilities and community members have stereotypes and prejudices regarding learning disabilities. In this study, most of the children with learning disabilities were raised by single, unemployed parents who seemed to have access to less support from external sources than married couples parenting children with learning disabilities. These single parents are usually not married and because of lack of financial support from the other parent, the majority of them indicated that they struggle to meet the financial and material needs of their children. The researchers concluded that the participants in this study experience a range of challenges in parenting their children with learning disabilities. The main challenges emanate from financial instability, as

  13. The Challenges Facing Small-Scale Women Entrepreneurs: A Case of Kenya

    OpenAIRE

    Fridah Muriungi Mwobobia

    2012-01-01

    The study sought to identify the challenges facing small scale women entrepreneurs in Kenya and initiatives put in place to counter the challenges. The study employed desktop research. MSEs Baseline survey, recorded that 612,848 women in Micro and Small Enterprises (MSEs) in Kenya, accounting for 47.4 per cent of all those in MSEs. The study showed that women tended to operate enterprises associated with traditional women¡¯s roles, such as hairstyling. The small and micro enterprises (SMEs) p...

  14. The role of women in nuclear - attracting public participation in regulatory decision-making process

    Science.gov (United States)

    Mohamad Jais, Azlina; Hassan, Najwa

    2018-01-01

    Public participation is vital in demonstrating transparency and enhancing effectiveness of a nuclear regulatory process. As such, it is necessary for nuclear practitioners to involve the public in key nuclear delivery milestones. This paper specifically discusses challenges faced in attracting public participation throughout the nuclear regulatory decision-making process, and highlights the roles of women in nuclear (WiN) in initiating the said public discourse.

  15. Finding a Trans-Affirmative Provider: Challenges Faced by Trans and Gender Diverse Psychologists and Psychology Trainees.

    Science.gov (United States)

    Dickey, Lore M; Singh, Anneliese A

    2017-08-01

    This article explores some of the challenges faced by trans and gender diverse (TGD) individuals who not only are attempting to access trans-affirmative care, but who are also members of the very profession from which they are seeking services. The authors explore challenges related to finding supervision, accessing care for assessment services, and finding a provider for personal counseling. With each example, the authors unpack the challenges and also address the implications for training for all involved. Based on these challenges that TGD psychologists and trainees face in attempting to access care, the authors provide recommendations related to trans-affirmative training for psychologists. © 2017 Wiley Periodicals, Inc.

  16. E-learning challenges faced by academics in higher education

    OpenAIRE

    Islam, Nurul; Beer, Martin; Slack, Frances

    2015-01-01

    E-learning has become a necessity in higher education institutions and is being deployed in educational establishments throughout the world. Researchers have made much emphasis on its benefits but not much is discussed on the disadvantages of e-learning technology. This paper references some of the research work on the limitations of e-learning technology, categorises it in five challenges that teachers are faced with and suggestions for a successful e-learning outcome. This paper also discus...

  17. Regulatory challenges related to the licensing of a new nuclear power plant

    International Nuclear Information System (INIS)

    Maris, M.

    2010-01-01

    Assuring the safety and security of nuclear power plants is recognized world-wide as a challenge for all stakeholders. Particular attention goes to plants planned to be built in countries with not sufficiently developed industrial and regulatory infrastructure and experience. A construction and commissioning project, which is usually an international undertaking, gives opportunities to all national stakeholders to develop further their organisations and competences. In the present paper the duties of a regulatory body are recalled as well as the human resources and competences needed for the licensing of a new nuclear power plant. The regulatory body and its technical safety organization(s) should be strengthened and the international cooperation should contribute to this in a systematic and coordinated way. In particular, the donor country should support the necessary development of the regulatory competences and of an effective safety assessment process supporting the national licensing process. Appropriate support can be provided by the International Atomic Energy Agency (IAEA) and through other bi-lateral or multi-lateral programmes

  18. The Regulatory Framework for Privacy and Security

    Science.gov (United States)

    Hiller, Janine S.

    The internet enables the easy collection of massive amounts of personally identifiable information. Unregulated data collection causes distrust and conflicts with widely accepted principles of privacy. The regulatory framework in the United States for ensuring privacy and security in the online environment consists of federal, state, and self-regulatory elements. New laws have been passed to address technological and internet practices that conflict with privacy protecting policies. The United States and the European Union approaches to privacy differ significantly, and the global internet environment will likely cause regulators to face the challenge of balancing privacy interests with data collection for many years to come.

  19. Challenges faced by international nurses when migrating: an integrative literature review.

    Science.gov (United States)

    Pung, L-X; Goh, Y-S

    2017-03-01

    Results from this literature review were used to identify the challenges faced by international nurses in their host countries following migration. The increasing strain of nursing shortages in the healthcare system has led to the recruitment of international nurses among many countries. However, following migration, international nurses are faced with challenges that may result in poor integration with their host countries. Using Cooper's five stages for integrative research reviews, a literature search was conducted across seven databases using a PRISMA search strategy. Additional manual searches were also conducted on the end-references of the retrieved articles. The authors then independently reviewed the selected articles using the Joanna Briggs Institute appraisal form to extract and generate the themes for the review. Twenty-four articles were selected for the review. The themes generated included: (i) difficulty orientating; (ii) a longing for what is missing; (iii) professional development and devaluing; (iv) communication barriers; (v) discrimination and marginalization; (vi) personal and professional differences; and (vii) a meaningful support system. By identifying the challenges faced by international nurses, interventions that ensure equal treatment (e.g. multifaceted transition programmes and culturally sensitive 'buddy' systems) can be implemented to help international nurses adapt to their new environments. Adequate communication can be achieved by encouraging international nurses to speak English and learn the colloquial language and non-verbal behaviours used by native nurses. With good integration international nurses may be able to reach their full career potential as professional nurses in their host countries. The adaptation process is a dynamic process that requires effort from both international and native nurses. Thus, any strategies that are developed and implemented must be multifaceted. © 2016 International Council of Nurses.

  20. Challenges facing the veterinary profession in Ireland: 3. emergency and casualty slaughter certification.

    Science.gov (United States)

    Magalhães-Sant'Ana, Manuel; More, Simon J; Morton, David B; Hanlon, Alison J

    2017-01-01

    Veterinarians are faced with significant conflicts of interest when issuing certificates for the transport and slaughter of acutely injured and casualty livestock. In a recent Policy Delphi study, emergency and casualty slaughter certification was a key concern identified by veterinary professionals in Ireland. In this case study (the third in a series of three resulting from a research workshop exploring challenges facing the veterinary profession in Ireland; the other two case studies investigate clinical veterinary services and the on-farm use of veterinary antimicrobials), we aim to provide a value-based reflection on the constraints and opportunities for best practice in emergency and casualty slaughter certification in Ireland. Using a qualitative focus group approach, this study gathered evidence from relevant stakeholders, namely a representative from the regulatory body, local authority veterinarians with research experience in emergency slaughter, an animal welfare research scientist, official veterinarians from the competent authority, a private veterinary practitioner, and a member of a farming organisation. Results revealed a conflict between the responsibility of private veterinary practitioners (PVPs) to safeguard the welfare of acutely injured bovines on-farm and the client's commercial concerns. As a consequence, some PVPs may feel under pressure to certify, for example, an acutely injured animal for casualty slaughter instead of recommending either on-farm emergency slaughter or disposal by the knackery service. Among Official Veterinarians, there are concerns about the pressure within processing plants to accept acutely injured livestock as casualty animals. Confusion pertaining to legislation and definition of fitness to travel also contribute to these dilemmas. Conflicts of interest arise due to the gap between governance and provision to facilitate on-farm emergency slaughter of livestock. Increased availability and acceptance of on

  1. The challenges that parents of children with epilepsy face

    DEFF Research Database (Denmark)

    Kampra, Matina; Tzerakis, Nikolas; Thomsen, Louise Lund Holm

    2017-01-01

    , parents/caregivers found that they needed more education about the existing sources of psychosocial and emotional support to cope with their child's epilepsy personally and as a family. Finally, the parents/caregivers who let their child know about the epilepsy and discussed the implications......Objective This qualitative study explored the challenges that Greek parents/caregivers of children with controlled epilepsy (CwE) face regarding the disorder. Methods Interviews were conducted based on open-ended questions guided by a review of the literature. A total of 91 parents/caregivers were...... recruited by neurologists at the neurology clinics of two Athens public hospitals. A hermeneutic phenomenological approach was used to explore parent/caregiver experiences. The data were grouped and analyzed through a textual interpretation. Results Two key challenges were identified for parents of Cw...

  2. As to achieve regulatory action, regulatory approaches

    International Nuclear Information System (INIS)

    Cid, R.; Encinas, D.

    2014-01-01

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

  3. A 3D bioprinting exemplar of the consequences of the regulatory requirements on customized processes.

    Science.gov (United States)

    Hourd, Paul; Medcalf, Nicholas; Segal, Joel; Williams, David J

    2015-01-01

    Computer-aided 3D printing approaches to the industrial production of customized 3D functional living constructs for restoration of tissue and organ function face significant regulatory challenges. Using the manufacture of a customized, 3D-bioprinted nasal implant as a well-informed but hypothetical exemplar, we examine how these products might be regulated. Existing EU and USA regulatory frameworks do not account for the differences between 3D printing and conventional manufacturing methods or the ability to create individual customized products using mechanized rather than craft approaches. Already subject to extensive regulatory control, issues related to control of the computer-aided design to manufacture process and the associated software system chain present additional scientific and regulatory challenges for manufacturers of these complex 3D-bioprinted advanced combination products.

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

    Science.gov (United States)

    Kozarewicz, Piotr; Loftsson, Thorsteinn

    2018-05-21

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

  5. Challenges faced when identifying patients for combination immunotherapy.

    Science.gov (United States)

    Ernstoff, Marc S; Gandhi, Shipra; Pandey, Manu; Puzanov, Igor; Grivas, Petros; Montero, Alberto; Velcheti, Vamsidhar; Turk, Mary Jo; Diaz-Montero, Claudia Marcela; Lewis, Lionel D; Morrison, Carl

    2017-08-01

    In 1996, Jim Allison demonstrated that blocking the immune regulatory molecule CTLA-4 with anit-CTLA4 antibody led to enhance tumor responses in mice. It would take an additional 15 years for human studies to confirm the potency and clinical efficacy of anti-CTLA4, ultimately leading to US FDA approval of the first checkpoint inhibitor, ipilimumab. Now with a plethora of immune-modulating agents demonstrating single agent safety and benefit across many tumor types, investigation on the optimal combination of immune-based therapies has begun in earnest. While there are many challenges, a central one is how to select which combination for which patient is the best. Here we review the current approaches that a practitioner can use to achieve this therapeutic goal.

  6. Regulatory challenges of robotics : Some guidelines for addressing legal and ethical issues

    NARCIS (Netherlands)

    Leenes, Ronald; Palmerini, Erica; Koops, Bert-Jaap; Bertolini, Andrea; Salvini, Pericle; Lucivero, Federica

    2017-01-01

    Robots are slowly, but certainly, entering people’s professional and private lives. They require the attention of regulators due to the challenges they present to existing legal frameworks and the new legal and ethical questions they raise. This paper discusses four major regulatory dilemmas in the

  7. Synthetic Biology and the U.S. Biotechnology Regulatory System: Challenges and Options

    Energy Technology Data Exchange (ETDEWEB)

    Carter, Sarah R. [J. Craig Venter Inst., Rockville, MD (United States); Rodemeyer, Michael [Univ. of Virginia, Charlottesville, VA (United States); Garfinkel, Michele S. [EMBO, Heidelberg (Germany); Friedman, Robert M. [J. Craig Venter Inst., Rockville, MD (United States)

    2014-05-01

    Synthetic Biology and the U.S. Biotechnology Regulatory System: Challenges and Options Sarah R. Carter, Ph.D., J. Craig Venter Institute; Michael Rodemeyer, J.D., University of Virginia; Michele S. Garfinkel, Ph.D., EMBO; Robert M. Friedman, Ph.D., J. Craig Venter Institute In recent years, a range of genetic engineering techniques referred to as “synthetic biology” has significantly expanded the tool kit available to scientists and engineers, providing them with far greater capabilities to engineer organisms than previous techniques allowed. The field of synthetic biology includes the relatively new ability to synthesize long pieces of DNA from chemicals, as well as improved methods for genetic manipulation and design of genetic pathways to achieve more precise control of biological systems. These advances will help usher in a new generation of genetically engineered microbes, plants, and animals. The JCVI Policy Center team, along with researchers at the University of Virginia and EMBO, examined how well the current U.S. regulatory system for genetically engineered products will handle the near-term introduction of organisms engineered using synthetic biology. In particular, the focus was on those organisms intended to be used or grown directly in the environment, outside of a contained facility. The study concludes that the U.S. regulatory agencies have adequate legal authority to address most, but not all, potential environmental, health and safety concerns posed by these organisms. Such near-term products are likely to represent incremental changes rather than a marked departure from previous genetically engineered organisms. However, the study also identified two key challenges for the regulatory system, which are detailed in the report. First, USDA’s authority over genetically engineered plants depends on the use of an older engineering technique that is no longer necessary for many applications. The shift to synthetic biology and other newer genetic

  8. Power distribution faced with the challenges posed by competition

    International Nuclear Information System (INIS)

    Angelier, J.P.; Hadjsaid, N.; Sabonnadiere, J.C.

    2009-01-01

    The introduction of liberalization, the increasing share of decentralized electricity generation, the aging of electrical infrastructures, ambitious generation objectives and technological evolution are the key drivers that require substantial investments in the distribution grid. The most urgent challenges are to adapt the network architecture and operation, modernize and improve metering equipment, renovate existing facilities. The Energy Regulatory Commission sets the price to be paid by users of the distribution grid; this price is set rather low, in order to encourage the system operator to make productivity gains. But resultant low income may deprive the operator of the financial resources needed to adapt the system to the new conditions. (authors)

  9. Regulatory assessment of safety culture in nuclear organisations - current trends and challenges

    International Nuclear Information System (INIS)

    Tronea, M.

    2010-01-01

    The paper gives an overview of the current practices in the area of regulatory assessment of safety culture in nuclear organisations and of the associated challenges. While the assessment and inspection procedures currently in use by regulatory authorities worldwide are directed primarily at verifying compliance with the licensing basis, there is a recognised need for a more systematic approach to the identification, collection and review of data relevant to the safety culture in licensees' organisations. The paper presents a proposal for using the existing regulatory inspection practices for gathering information relevant to safety culture and for assessing it in an integrated manner. The proposal is based on the latest requirements and guidance issued by the International Atomic Energy Agency (IAEA) on management systems for nuclear facilities and activities, particularly as regards the attributes needed for a strong nuclear safety culture. (author)

  10. Regulatory challenges in using nuclear operating experience

    International Nuclear Information System (INIS)

    2006-01-01

    The fundamental objective of all nuclear safety regulatory bodies is to ensure that nuclear utilities operate their plants in an acceptably safe manner at all times. Learning from experience has been a key element in meeting this objective. It is therefore very important for nuclear power plant operators to have an active programme for collecting, analysing and acting on the lessons of operating experience that could affect the safety of their plants. NEA experts have noted that almost all of the recent, significant events reported at international meetings have occurred earlier in one form or another. Counteractions are usually well-known, but information does not always seem to reach end users, or corrective action programmes are not always rigorously applied. Thus, one of the challenges that needs to be met in order to maintain good operational safety performance is to ensure that operating experience is promptly reported to established reporting systems, preferably international in order to benefit from a larger base of experience, and that the lessons from operating experience are actually used to promote safety. This report focuses on how regulatory bodies can ensure that operating experience is used effectively to promote the safety of nuclear power plants. While directed at nuclear power plants, the principles in this report may apply to other nuclear facilities as well. (author)

  11. Current status of developmental neurotoxicity: regulatory view

    DEFF Research Database (Denmark)

    Hass, Ulla

    2003-01-01

    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....... 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...

  12. Regulatory forum opinion piece*: immunotoxicology assessments in nonhuman primates--challenges and opportunities.

    Science.gov (United States)

    Lebrec, Hervé N

    2013-01-01

    The immune system has been recognized for decades as a potential "target organ" of toxicity. Immune system activation can result in cytokine release resulting in severe systemic toxicity. Immunosuppression can result in impaired host defense and an increase in opportunistic infection, reemergence of latent infection, poor responses to vaccination, or increased risk of certain cancers. Several regulatory documents have addressed various aspects of immunotoxicity assessments. Nonhuman primates (NHPs) and in particular macaques are often the only relevant species for biotechnology-derived investigational new drugs based on cross-reactivity with human and NHP targets. This article reviews the challenges and opportunities associated with monitoring immune function in NHPs in the context of regulatory expectations. The article emphasizes how a comprehensive assessment of immunotoxicity remains a challenge due to interanimal variability associated with certain parameters (e.g., T-dependent antibody response)and it identifies gaps, such as the stage of development of certain assays (e.g., cytotoxic T-cell function). Despite these challenges, a thorough assessment of target biology-driven theoretical risks, in combination with proper integration of all information from the standard toxicology studies, and the refinement of certain assays should enable proper risk assessment. To this effect, emphasis should be placed on leveraging predictive in vitro assays using human cells.

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

    Science.gov (United States)

    Närhi, Marko; Nordström, Katrina

    2005-04-01

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

  14. Challenges new entrant countries face in establishing a nuclear program

    International Nuclear Information System (INIS)

    Brister, J.

    2012-01-01

    Challenges new entrant countries face in establishing a nuclear programme are distilled into four major categories: human resource development, financing, infrastructure and process. In implementing a successful nuclear programme role of the government is key to success. It requires clear and sustained policy support, international and bilateral agreements, developing the depth required of technical skills and infrastructure, proven delivery programme, management of radioactive waste and spent fuel, decommissioning and electricity market regulation.

  15. Challenges for modeling global gene regulatory networks during development: insights from Drosophila.

    Science.gov (United States)

    Wilczynski, Bartek; Furlong, Eileen E M

    2010-04-15

    Development is regulated by dynamic patterns of gene expression, which are orchestrated through the action of complex gene regulatory networks (GRNs). Substantial progress has been made in modeling transcriptional regulation in recent years, including qualitative "coarse-grain" models operating at the gene level to very "fine-grain" quantitative models operating at the biophysical "transcription factor-DNA level". Recent advances in genome-wide studies have revealed an enormous increase in the size and complexity or GRNs. Even relatively simple developmental processes can involve hundreds of regulatory molecules, with extensive interconnectivity and cooperative regulation. This leads to an explosion in the number of regulatory functions, effectively impeding Boolean-based qualitative modeling approaches. At the same time, the lack of information on the biophysical properties for the majority of transcription factors within a global network restricts quantitative approaches. In this review, we explore the current challenges in moving from modeling medium scale well-characterized networks to more poorly characterized global networks. We suggest to integrate coarse- and find-grain approaches to model gene regulatory networks in cis. We focus on two very well-studied examples from Drosophila, which likely represent typical developmental regulatory modules across metazoans. Copyright (c) 2009 Elsevier Inc. All rights reserved.

  16. Four Challenges That Global Health Networks Face

    Directory of Open Access Journals (Sweden)

    Jeremy Shiffman

    2017-04-01

    Full Text Available Global health networks, webs of individuals and organizations with a shared concern for a particular condition, have proliferated over the past quarter century. They differ in their effectiveness, a factor that may help explain why resource allocations vary across health conditions and do not correspond closely with disease burden. Drawing on findings from recently concluded studies of eight global health networks—addressing alcohol harm, early childhood development (ECD, maternal mortality, neonatal mortality, pneumonia, surgically-treatable conditions, tobacco use, and tuberculosis—I identify four challenges that networks face in generating attention and resources for the conditions that concern them. The first is problem definition: generating consensus on what the problem is and how it should be addressed. The second is positioning: portraying the issue in ways that inspire external audiences to act. The third is coalition-building: forging alliances with these external actors, particularly ones outside the health sector. The fourth is governance: establishing institutions to facilitate collective action. Research indicates that global health networks that effectively tackle these challenges are more likely to garner support to address the conditions that concern them. In addition to the effectiveness of networks, I also consider their legitimacy, identifying reasons both to affirm and to question their right to exert power.

  17. Developing Strategies for Islamic Banks to Face the Future Challenges of Financial Globalization

    OpenAIRE

    Al Ajlouni, Ahmed

    2004-01-01

    Developing Strategies for Islamic Banks to Face the Future Challenges of Financial Globalization Ahmed Al-Ajlouni Abstract This study aims at forming strategic response to assess the ability of Islamic banks in benefiting from the opportunities that may be provided by financial globalization and limits its threats, through assessing the capability of Islamic banks to meet the requirements and challenges of financial globalization, then suggests the suitable strategies that may be ...

  18. NTL 11 spent fuel flask - meeting the challenge of regulatory and technological change

    International Nuclear Information System (INIS)

    Cory, A.R.

    2004-01-01

    By June 2005, when shipments of spent fuel for reprocessing from Germany are concluded, the NTL11 flask type will have been responsible for transporting a total of 1500 tonnes of heavy metal in the form of spent fuel. Excluding domestic transports in France and the UK, this represents 25% of the total European spent fuel transported for reprocessing since the flasks came into service in 1977. Approximately 40% of the total for the flask type will have been transported to BNFL's Sellafield facility, the remainder to Cogema at La Hague. The NTL11 flask can justifiably be described as being the workhorse of BNFL's European spent fuel transport business. The NTL11 flask started life under the ownership of Nuclear Transport Limited, an associate company of BNFL, and in recent years the original fleet of five flasks has been absorbed into the BNFL inventory. A recent build programme has seen a further four flasks added to the fleet, an expedient measure to cope with the additional transport requirements imposed by the need to meet the June 2005 deadline for the removal of contracted fuels from Germany. While there have been certain evolutionary changes affecting the package design, there have also been more significant changes in the Design Safety Case. These have sometimes been necessary to meet regulatory changes, or the challenges posed by the regulators. In other cases advantage has been taken of improvements in analytical techniques to demonstrate increased margins of operational safety. Where possible those margins have also been increased by other means, such as taking advantage of commercial trends to reduce package thermal loads. The NTL11 flask was designed around the reactor and fuel characteristics prevailing in the 1970's. Over the lifetime of the flask the responsible engineering teams have faced and met the successive challenges to develop the capability of the Package to face the changing requirements of the industry and the Transport Regulations. Both

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

    Science.gov (United States)

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

    2016-07-01

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

  20. Adoptive regulatory T cell therapy: challenges in clinical transplantation.

    Science.gov (United States)

    Safinia, Niloufar; Sagoo, Pervinder; Lechler, Robert; Lombardi, Giovanna

    2010-08-01

    The identification and characterisation of regulatory T cells (Tregs) has recently opened up exciting opportunities for Treg cell therapy in transplantation. In this review, we outline the basic biology of Tregs and discuss recent advances and challenges for the identification, isolation and expansion of these cells for cell therapy. Tregs of thymic origin have been shown to be key regulators of immune responses in mice and humans, preventing autoimmunity, graft-versus-host disease and organ graft rejection in the transplantation setting. To date, a variety of different methods to isolate and expand Tregs ex vivo have been advocated. Although promising, relatively few clinical trials of human Treg cell infusion have been initiated. Many key questions about Treg cell therapy still remain and here we provide an in-depth analysis and highlight the challenges and opportunities for immune intervention with Treg-based therapeutics in clinical transplantation.

  1. Regulatory Considerations for Gene Therapy Products in the US, EU, and Japan.

    Science.gov (United States)

    Halioua-Haubold, Celine-Lea; Peyer, James G; Smith, James A; Arshad, Zeeshaan; Scholz, Matthew; Brindley, David A; MacLaren, Robert E

    2017-12-01

    Developers of gene therapy products (GTPs) must adhere to additional regulation beyond that of traditional small-molecule therapeutics, due to the unique mechanism-of-action of GTPs and the subsequent novel risks arisen. We have provided herein a summary of the regulatory structure under which GTPs fall in the United States, the European Union, and Japan, and a comprehensive overview of the regulatory guidance applicable to the developer of GTP. Understanding the regulatory requirements for seeking GTP market approval in these major jurisdictions is crucial for an effective and expedient path to market. The novel challenges facing GTP developers is highlighted by a case study of alipogene tiparvovec (Glybera).

  2. Challenges Facing Women Academic Leadership in Secondary Schools of Irbid Educational Area

    Science.gov (United States)

    Al-Jaradat, Mahmoud Khaled Mohammad

    2014-01-01

    This study aimed at identifying the challenges facing women academic leadership in secondary schools of Irbid Educational Area. A random sample of 187 female leaders were chosen. They responded to a 49-item questionnaire prepared by the researcher. The items were distributed into four domains: organizational, personal, social and physical…

  3. Regulatory challenges and approaches to characterize nanomedicines and their follow-on similars.

    Science.gov (United States)

    Mühlebach, Stefan; Borchard, Gerrit; Yildiz, Selcan

    2015-03-01

    Nanomedicines are highly complex products and are the result of difficult to control manufacturing processes. Nonbiological complex drugs and their biological counterparts can comprise nanoparticles and therefore show nanomedicine characteristics. They consist of not fully known nonhomomolecular structures, and can therefore not be characterized by physicochemical means only. Also, intended copies of nanomedicines (follow-on similars) may have clinically meaningful differences, creating the regulatory challenge of how to grant a high degree of assurance for patients' benefit and safety. As an example, the current regulatory approach for marketing authorization of intended copies of nonbiological complex drugs appears inappropriate; also, a valid strategy incorporating the complexity of such systems is undefined. To demonstrate sufficient similarity and comparability, a stepwise quality, nonclinical and clinical approach is necessary to obtain market authorization for follow-on products as therapeutic alternatives, substitution and/or interchangeable products. To fill the regulatory gap, harmonized and science-based standards are needed.

  4. The Challenges Faced by Informal Traders in Greater Letaba Municipality in Limpopo Province, South Africa

    Directory of Open Access Journals (Sweden)

    Kole Legodi

    2015-12-01

    Full Text Available Informal trade has grown at an alarming rate in South Africa because of lack of employment opportunities in both the private and public sectors. This has resulted in many unemployed members of the population joining the informal business sector. The majority of people in this sector do not have skills that are needed in the formal employment sector, others are semi-literate and a small percentage has some level of qualification. Nevertheless, this sector is plagued by a number of challenges which this article presents.  The article reports on the study that was conducted at Greater Letaba Municipality in Limpopo Province. The aim of the study was to investigate the challenges that were faced by informal traders in Greater Letaba Municipality in Limpopo Province in South Africa. The area was chosen because of its accessibility to the researchers and its potential to provide relevant and accurate information for the research project. Thus, a qualitative research method was used to collect data through face to face interviews. The research discovered that some of the challenges experienced by the informal traders in the area ranged from lack of support from the local municipality to structural challenges like lack of ablution facilities and limited access to electricity. Furthermore, other challenges concerned safety and health issues that were also gender based. Most of the traders in the area were women; an element which attest to the fact that it is difficult to find employment in the country when one is less educated and is also a woman.

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

    International Nuclear Information System (INIS)

    Lyman, Edwin S.

    2001-01-01

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

  6. Sponge systematics facing new challenges.

    Science.gov (United States)

    Cárdenas, P; Pérez, T; Boury-Esnault, N

    2012-01-01

    Systematics is nowadays facing new challenges with the introduction of new concepts and new techniques. Compared to most other phyla, phylogenetic relationships among sponges are still largely unresolved. In the past 10 years, the classical taxonomy has been completely overturned and a review of the state of the art appears necessary. The field of taxonomy remains a prominent discipline of sponge research and studies related to sponge systematics were in greater number in the Eighth World Sponge Conference (Girona, Spain, September 2010) than in any previous world sponge conferences. To understand the state of this rapidly growing field, this chapter proposes to review studies, mainly from the past decade, in sponge taxonomy, nomenclature and phylogeny. In a first part, we analyse the reasons of the current success of this field. In a second part, we establish the current sponge systematics theoretical framework, with the use of (1) cladistics, (2) different codes of nomenclature (PhyloCode vs. Linnaean system) and (3) integrative taxonomy. Sponges are infamous for their lack of characters. However, by listing and discussing in a third part all characters available to taxonomists, we show how diverse characters are and that new ones are being used and tested, while old ones should be revisited. We then review the systematics of the four main classes of sponges (Hexactinellida, Calcispongiae, Homoscleromorpha and Demospongiae), each time focusing on current issues and case studies. We present a review of the taxonomic changes since the publication of the Systema Porifera (2002), and point to problems a sponge taxonomist is still faced with nowadays. To conclude, we make a series of proposals for the future of sponge systematics. In the light of recent studies, we establish a series of taxonomic changes that the sponge community may be ready to accept. We also propose a series of sponge new names and definitions following the PhyloCode. The issue of phantom species

  7. Challenges: a state and compact perspective

    International Nuclear Information System (INIS)

    Brown, H.

    1987-01-01

    The challenges facing states and compacts in their efforts to implement the Low-Level Waste Policy Amendments Act are described. Institutional challenges include: small-volume sites; compact maintenance; shifting agencies and changing personnel; and timing of progress. The technical challenge lies in the enormous number of plans, procedures, and regulations that have to be developed over the next four years. There are two main fiscal challenges: funding of day-to-day operations of compact commissions; and financing the siting and construction of new disposal sites. There are also two main regulatory challenges: host states must develop regulations for siting and selection of technology; and all states have to await federal regulations to be completed. The final challenge is political: whether a region can overcome public opposition and actually site a facility

  8. The organisational and human resource challenges facing primary care trusts: protocol of a multiple case study

    Directory of Open Access Journals (Sweden)

    Tim Scott J

    2001-11-01

    Full Text Available Abstract Background The study is designed to assess the organisational and human resource challenges faced by Primary Care Trusts (PCTs. Its objectives are to: specify the organisational and human resources challenges faced by PCTs in fulfilling the roles envisaged in government and local policy; examine how PCTs are addressing these challenges, in particular, to describe the organisational forms they have adopted, and the OD/HR strategies and initiatives they have planned or in place; assess how effective these structures, strategies and initiatives have been in enabling the PCTs to meet the organisational and human resources challenges they face; identify the factors, both internal to the PCT and in the wider health community, which have contributed to the success or failure of different structures, strategies and initiatives. Methods The study will be undertaken in three stages. In Stage 1 the key literature on public sector and NHS organisational development and human resources management will be reviewed, and discussions will be held with key researchers and policy makers working in this area. Stage 2 will focus on detailed case studies in six PCTs designed to examine the organisational and human resources challenges they face. Data will be collected using semi-structured interviews, group discussion, site visits, observation of key meetings and examination of local documentation. The findings from the case study PCTs will be cross checked with a Reference Group of up to 20 other PCG/Ts, and key officers working in organisational development or primary care at local, regional and national level. In Stage 3 analysis of findings from the preparatory work, the case studies and the feedback from the Reference Group will be used to identify practical lessons for PCTs, key messages for policy makers, and contributions to further theoretical development.

  9. 'If it ain't broke, don't fix it': Challenges facing institutional ...

    African Journals Online (AJOL)

    recruitment and retention of blacks and women in senior posts is still the major challenge facing .... classed social space in order to gain trust and to succeed in their careers. ... In this paper, we examine how participants in one particular ADP experience the .... they didn't want a new way of doing things and they believed the.

  10. Organic Coasts? Regulatory Challenges of Certifying Integrated Shrimp-Mangrove Production Systems in Vietnam

    Science.gov (United States)

    Ha, Tran Thi Thu; Bush, Simon R.; Mol, Arthur P. J.; van Dijk, Han

    2012-01-01

    The Vietnamese government aims to expand the scale of Naturland certified organic production in integrated shrimp-mangrove farming systems across the coast of Ca Mau province by 2015. In doing so the division between public and private regulation has become blurred. We analyze the government's goal by examining the regulatory challenges of using…

  11. The changing face of nanomaterials: Risk assessment challenges along the value chain.

    Science.gov (United States)

    Mattsson, Mats-Olof; Simkó, Myrtill

    2017-03-01

    Risk assessment (RA) of manufactured nanomaterials (MNM) is essential for regulatory purposes and risk management activities. Similar to RA of "classical" chemicals, MNM RA requires knowledge about exposure as well as of hazard potential and dose response relationships. What makes MNM RA especially challenging is the multitude of materials (which is expected to increase substantially in the future), the complexity of MNM value chains and life cycles, the accompanying possible changes in material properties over time and in contact with various environmental and organismal milieus, and the difficulties to obtain proper exposure data and to consider the proper dose metric. This article discusses these challenges and also critically overviews the current state of the art regarding MNM RA approaches. Copyright © 2016 Elsevier Inc. All rights reserved.

  12. Challenges Facing 3-D Audio Display Design for Multimedia

    Science.gov (United States)

    Begault, Durand R.; Null, Cynthia H. (Technical Monitor)

    1998-01-01

    The challenges facing successful multimedia presentation depend largely on the expectations of the designer and end user for a given application. Perceptual limitations in distance, elevation and azimuth sound source simulation differ significantly between headphone and cross-talk cancellation loudspeaker listening and therefore must be considered. Simulation of an environmental context is desirable but the quality depends on processing resources and lack of interaction with the host acoustical environment. While techniques such as data reduction of head-related transfer functions have been used widely to improve simulation fidelity, another approach involves determining thresholds for environmental acoustic events. Psychoacoustic studies relevant to this approach are reviewed in consideration of multimedia applications

  13. Statistical challenges in a regulatory review of cardiovascular and CNS clinical trials.

    Science.gov (United States)

    Hung, H M James; Wang, Sue-Jane; Yang, Peiling; Jin, Kun; Lawrence, John; Kordzakhia, George; Massie, Tristan

    2016-01-01

    There are several challenging statistical problems identified in the regulatory review of large cardiovascular (CV) clinical outcome trials and central nervous system (CNS) trials. The problems can be common or distinct due to disease characteristics and the differences in trial design elements such as endpoints, trial duration, and trial size. In schizophrenia trials, heavy missing data is a big problem. In Alzheimer trials, the endpoints for assessing symptoms and the endpoints for assessing disease progression are essentially the same; it is difficult to construct a good trial design to evaluate a test drug for its ability to slow the disease progression. In CV trials, reliance on a composite endpoint with low event rate makes the trial size so large that it is infeasible to study multiple doses necessary to find the right dose for study patients. These are just a few typical problems. In the past decade, adaptive designs were increasingly used in these disease areas and some challenges occur with respect to that use. Based on our review experiences, group sequential designs (GSDs) have borne many successful stories in CV trials and are also increasingly used for developing treatments targeting CNS diseases. There is also a growing trend of using more advanced unblinded adaptive designs for producing efficacy evidence. Many statistical challenges with these kinds of adaptive designs have been identified through our experiences with the review of regulatory applications and are shared in this article.

  14. Regulatory challenges in the management of aging of structural materials in nuclear power plants

    International Nuclear Information System (INIS)

    Castelo, C.; Mendoza, C.; Mas, E.; Conde, J. M.

    2013-01-01

    The article discusses two major pathways by which a regulatory body, and in particular the CSN, may participate in the acquisition of the necessary knowledge on mechanisms of aging of nuclear structural materials: to participate in forums to share operational experience and R and R project, both nationally and internationally. It notes the importance of this participation to carry out its regulatory function based on the knowledge acquired and the unique challenge of transferring that knowledge to rules and guidelines for their application. The article discusses various R and D projects in which the CSN participates directly. It calls for the presence of regulatory bodies in R and D project funded by the EU and the transfer of the results of such projects to codes, standards or guidelines for feasible implementation. (Author)

  15. Challenges faced by cocoyam farmers in adapting to climate change in Southeast Nigeria

    Directory of Open Access Journals (Sweden)

    C.C. Ifeanyi-Obi

    2017-01-01

    Full Text Available The study examined the challenges faced by cocoyam farmers in adapting to climate change in Southeast, Nigeria. Three hundred and eighty-four respondents selected through multi-stage sampling technique were used for the study. Data were collected using structured questionnaire and interview schedule and analysed using both descriptive and inferential statistical tools. Findings showed that majority were females (67%, married (92% and maintain average household size of 6 persons and a mean age of 51 years. They were mainly primary (32% and secondary (34% school certificate holders with farming (77% as their major occupation. The major cropping pattern practiced was mixed farming with cassava (63% and maize (58% as the major crops cultivated by the farmers. Majority of the farmers owned farms of one hectare and below accessed mainly through inheritance (76% and labour sourced mainly through hiring (50%. Most (81% of the farmers have spent more than ten years in farming. Climate change information was accessed mainly through their personal experience (64%, radio (42% and fellow villagers (39%. The study identified eight major challenges faced by cocoyam farmers in adapting to climate change namely Lack/high cost of farm inputs and low soil fertility (Factor 1, Land and labour constraints (Factor 2, Poor access to information and ineffectiveness of cooperatives (Factor 3, lack of/poor access to fund and credit facilities and poor government support (Factor 4, lack of improved varieties of cocoyam (factor 5, poor value attached to cocoyam (Factor 6, poor infrastructural capacity and technology know-how (Factor 7 and Transportation constraint (Factor 8. Analysis of variance identified significant variations in the challenges faced by cocoyam farmers in the study area. The study recommends enrollment in cooperatives and revitalizing existing cooperatives, re-orientation of farmers on the benefits of cocoyam and increased used of climate change

  16. Electronic health systems: challenges faced by hospital-based providers.

    Science.gov (United States)

    Agno, Christina Farala; Guo, Kristina L

    2013-01-01

    The purpose of this article is to discuss specific challenges faced by hospitals adopting the use of electronic medical records and implementing electronic health record (EHR) systems. Challenges include user and information technology support; ease of technical use and software interface capabilities; compliance; and financial, legal, workforce training, and development issues. Electronic health records are essential to preventing medical errors, increasing consumer trust and use of the health system, and improving quality and overall efficiency. Government efforts are focused on ways to accelerate the adoption and use of EHRs as a means of facilitating data sharing, protecting health information privacy and security, quickly identifying emerging public health threats, and reducing medical errors and health care costs and increasing quality of care. This article will discuss physician and nonphysician staff training before, during, and after implementation; the effective use of EHR systems' technical features; the selection of a capable and secure EHR system; and the development of collaborative system implementation. Strategies that are necessary to help health care providers achieve successful implementation of EHR systems will be addressed.

  17. Discovery of innovative therapeutics: today's realities and tomorrow's vision. 1. Criticisms faced by the pharmaceutical industry.

    Science.gov (United States)

    Abou-Gharbia, Magid; Childers, Wayne E

    2013-07-25

    The pharmaceutical industry is facing enormous challenges, including reduced efficiency, declining innovation, key patent expirations, fierce price competition from generics, high regulatory hurdles, and a tarnished image. There is a clear need for change in the paradigms designed to address these challenges. Pharma has responded by embarking on a range of initiatives. However, along the way the industry has accrued critics whose accusations have tainted its reputation. The first part of this two-part series will discuss the criticisms that have been leveled at the pharmaceutical industry and summarize the supporting data for and against these criticisms. The second installment will focus on the current challenges facing the pharmaceutical industry and Pharma's responses to address these challenges. It will describe the industry's changing perspective and new business models for coping with the recent loss of talent and declining clinical pipelines as well as present some examples of recent drug discovery successes.

  18. Global regulatory developments for clinical stem cell research: diversification and challenges to collaborations.

    Science.gov (United States)

    Rosemann, Achim; Bortz, Gabriela; Vasen, Federico; Sleeboom-Faulkner, Margaret

    2016-10-01

    In this article, we explore regulatory developments in stem cell medicine in seven jurisdictions: Japan, China, India, Argentina, Brazil, the USA and the EU. We will show that the research methods, ethical standards and approval procedures for the market use of clinical stem cell interventions are undergoing an important process of global diversification. We will discuss the implications of this process for international harmonization and the conduct of multicountry clinical research collaborations. It will become clear that the increasing heterogeneity of research standards and regulations in the stem cell field presents a significant challenge to international clinical trial partnerships, especially with countries that diverge from the regulatory models that have been developed in the USA and the EU.

  19. Face Attention Network: An Effective Face Detector for the Occluded Faces

    OpenAIRE

    Wang, Jianfeng; Yuan, Ye; Yu, Gang

    2017-01-01

    The performance of face detection has been largely improved with the development of convolutional neural network. However, the occlusion issue due to mask and sunglasses, is still a challenging problem. The improvement on the recall of these occluded cases usually brings the risk of high false positives. In this paper, we present a novel face detector called Face Attention Network (FAN), which can significantly improve the recall of the face detection problem in the occluded case without comp...

  20. Transition Program: The Challenges Faced by Special Needs Students in Gaining Work Experience

    Science.gov (United States)

    Alias, Aliza

    2014-01-01

    Transition program for special needs students is known to open opportunities for students with learning disabilities to gain work experience in actual work environment. The program provides training activities and also an opportunity to go for internship to gain work experience. Therefore, this study is to identify the challenges faced by special…

  1. Continuous improvement of the regulatory framework for the control of medical exposure

    International Nuclear Information System (INIS)

    Larcher, Ana M.; Ortiz Lopez, Pedro; Arias, Cesar; Marechal, Maria H.; Hernandez Alvarez, Ramon; Ferrer Garcia, Natividad; Castaneda Mucino, Antonia; Faller, Blanca

    2008-01-01

    One of the key elements to guide the improvement of the regulatory control is the availability of a self-assessment tool for regulatory performance. Although there is general guidance on self-assessment for regulators and users (IAEA), there is a need for more specific advice on how to address challenges and difficulties faced by regulatory bodies, when regulating radiation protection of patients. Examples of these challenges are the need for regulatory initiatives, in cooperation with health and education authorities, professional bodies and equipment suppliers, and to put in place necessary elements that are beyond responsibility of individual user of radiation, to enable them compliance with safety standards. Purpose: Within the programme of the Ibero American Forum of Nuclear and Radiation Safety Regulatory Organizations, a project to develop such a self-assessment tool for the regulatory control of medical exposure has been designed. Method: National experiences in transposing and enforcing the international radiation safety standards, as to how the requirements are included in national regulations are reviewed. Further, difficulties to the implementation of safety requirements are analyzed and a self-assessment approach and possible regulatory solutions a are presented. Results and discussion: In this study the following documents are being produced: 1) transposition of international requirements into national regulations in the six countries of the Forum, 2) difficulties to implement and enforce the requirements, 3) guidance on self-assessment of regulatory framework for medical exposure, 4) suggested contribution to the revision of international radiation safety standards. (author)

  2. European cinema: face to face with Hollywood

    NARCIS (Netherlands)

    Elsaesser, T.

    2005-01-01

    In the face of renewed competition from Hollywood since the early 1980s and the challenges posed to Europe's national cinemas by the fall of the Wall in 1989, independent filmmaking in Europe has begun to re-invent itself. European Cinema: Face to Face with Hollywood re-assesses the different

  3. Challenges and Specifications for Robust Face and Gait Recognition Systems for Surveillance Application

    Directory of Open Access Journals (Sweden)

    BUCIU Ioan

    2014-05-01

    Full Text Available Automated person recognition (APR based on biometric signals addresses the process of automatically recognize a person according to his physiological traits (face, voice, iris, fingerprint, ear shape, body odor, electroencephalogram – EEG, electrocardiogram, or hand geometry, or behavioural patterns (gait, signature, hand-grip, lip movement. The paper aims at briefly presenting the current challenges for two specific non-cooperative biometric approaches, namely face and gait biometrics as well as approaches that consider combination of the two in the attempt of a more robust system for accurate APR, in the context of surveillance application. Open problems from both sides are also pointed out.

  4. Regulatory challenges in developing long-acting antiretrovirals for treatment and prevention of HIV infection.

    Science.gov (United States)

    Arya, Vikram; Au, Stanley; Belew, Yodit; Miele, Peter; Struble, Kimberly

    2015-07-01

    To outline some of the regulatory challenges inherent to the development of long-acting antiretrovirals (ARVs) for the treatment or prevention of HIV infection. Despite advances in drug development that have reduced ARV dosing to once daily, suboptimal drug adherence remains an obstacle to successful HIV treatment. Further, large randomized trials of once daily oral ARVs for preexposure prophylaxis (PrEP) have shown that drug adherence correlates strongly with prophylactic effect and study outcomes. Thus, the prospect of developing long-acting ARVs, which may mitigate drug adherence issues, has attracted considerable attention lately. Because of their pharmacokinetic properties, the development of long-acting ARVs can present novel regulatory challenges. Chief among them is determining the appropriate dosing regimen, the need for an oral lead-in, and whether existing data with an approved oral agent, if available, can be leveraged for a treatment or prevention indication. For PrEP, because validated biomarkers are lacking, additional nonclinical studies and evaluation of tissue concentrations in multiple compartments may be necessary to identify optimal dosages. Study design and choice of controls for registrational trials of new long-acting PrEP agents might also prove challenging following the availability of an oral PrEP drug.

  5. Oil producers facing a common challenge

    International Nuclear Information System (INIS)

    Galal, E.E.

    1992-01-01

    Among the numerous challenges facing our modern world, perhaps the most urgent and dominant are energy related. From the perspective of developing countries they are, in order of priorities, development, energy security and environment. Oil covers above 38% of the global commercial energy needs and gas about 20%. In some commanding sectors of the economy, like transport, oil is for now virtually the irreplaceable source of energy. In addition, oil and gas are two valuable primary materials of the chemical industry. It also happens that oil consumption is one of the sources of environmental pollution through the emission of CO 2 . Utilisation of the world's finite fossil energy resources (88% of total commercial energy) in the service of development reflects all the negative attributes of the mismanagement of the global economy, exemplified by waste, inefficiency, unfair terms of trade, market instability and short-sighted policies. These serious inequities have been further compounded by the growing menace of environmental and climatic degradation. In dealing with the interactions between these three complex systems, i.e., energy, environment and development, it is important for oil producers to delineate their priorities clearly, if they are to disentangle credible common goals for an international convention. (author)

  6. Challenges and motivators to physical activity faced by retired men when ageing: a qualitative study.

    Science.gov (United States)

    Bredland, Ebba Langum; Söderström, Sylvia; Vik, Kjersti

    2018-05-15

    Active ageing reflects the message from World Health Organisation about addressing the challenge faced by the rapidly ageing population. Knowledge about barriers and facilitators to an active lifestyle must be given more attention. In addition, men seem to participate less in cultural activities and less in fall-prevention groups than women do. When mostly women work with the elderly in primary care, one might question whether the activities offered to older men meet their activity preferences. The aim of this study is to provide new knowledge about challenges and motivators encountered by retired men in maintaining physical activity when ageing. Nine retired men, aged between 66 and 83, wrote a Time Geographic Diary for 7 days each. Two focus group discussions with the men were held. A Systemic Text Condensation was used to analyse the data. The analyses identified three categories to describe challenges in being physical active: differences between men and women; meaningful physical activity; and environmental - especially socio-cultural - constraints. Motivating conditions were seen as: new activities to get younger friends, and more information about how to cope. To achieve the aim of active ageing, service providers as well as local authorities need to have a better understanding of the challenges retired men encounter when ageing. This study highlights vital aspects of the challenges faced by retired men in maintaining their physical activity level.

  7. The future regulatory environment - a South African perspective

    International Nuclear Information System (INIS)

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

    2000-01-01

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

  8. The future regulatory environment - a South African perspective

    Energy Technology Data Exchange (ETDEWEB)

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

    2000-07-01

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

  9. Medical revalidation as professional regulatory reform: Challenging the power of enforceable trust in the United Kingdom.

    Science.gov (United States)

    Spendlove, Zoey

    2018-05-01

    For more than two decades, international healthcare crises and ensuing political debates have led to increasing professional governance and regulatory policy reform. Governance and policy reforms, commonly representing a shift from embodied trust in professionals to state enforceable trust, have challenged professional power and self-regulatory privileges. However, controversy remains as to whether such policies do actually shift the balance of power and what the resulting effects of policy introduction would be. This paper explores the roll-out and operationalisation of revalidation as medical regulatory reform within a United Kingdom National Health Service hospital from 2012 to 2013, and its impact upon professional power. Revalidation policy was subject to the existing governance and management structures of the organisation, resulting in the formal policy process being shaped at the local level. This paper explores how the disorganised nature of the organisation hindered rather than facilitated robust processes of professional governance and regulation, fostering formalistic rather than genuine professional engagement with the policy process. Formalistic engagement seemingly assisted the medical profession in retaining self-regulatory privileges whilst maintaining professional power over the policy process. The paper concludes by challenging the concept of state enforceable trust and the theorisation that professional groups are effectively regulated and controlled by means of national and organisational objectives, such as revalidation. Copyright © 2018 Elsevier Ltd. All rights reserved.

  10. Anticipated Ethics and Regulatory Challenges in PCORnet: The National Patient-Centered Clinical Research Network.

    Science.gov (United States)

    Ali, Joseph; Califf, Robert; Sugarman, Jeremy

    2016-01-01

    PCORnet, the National Patient-Centered Clinical Research Network, seeks to establish a robust national health data network for patient-centered comparative effectiveness research. This article reports the results of a PCORnet survey designed to identify the ethics and regulatory challenges anticipated in network implementation. A 12-item online survey was developed by leadership of the PCORnet Ethics and Regulatory Task Force; responses were collected from the 29 PCORnet networks. The most pressing ethics issues identified related to informed consent, patient engagement, privacy and confidentiality, and data sharing. High priority regulatory issues included IRB coordination, privacy and confidentiality, informed consent, and data sharing. Over 150 IRBs and five different approaches to managing multisite IRB review were identified within PCORnet. Further empirical and scholarly work, as well as practical and policy guidance, is essential if important initiatives that rely on comparative effectiveness research are to move forward.

  11. Maritime Education and Research to Face the XXI-st Century Challenges in Gdynia Maritime University’s Experience Part I – Maritime Universities Facing Today and Tomorrow’s Challenges

    Directory of Open Access Journals (Sweden)

    Janusz Mindykowski

    2013-12-01

    Full Text Available In the paper, divided into two parts, a problem of advancements in maritime education and research facing the 21st century challenges, based on the case study of the Gdynia Maritime University (GMU experience is discussed. Part I is devoted to the main directions of advances in the maritime education and research towards the challenges in a global meaning. In this context, the education and research potential of the Gdynia Maritime University, as one of the world-leading maritime universities, is shortly presented. Part II is dedicated to the Gdynia Maritime University experiencing the 21st century challenges. The GMU’s contribution and good practices concerning the participation in modification of the processes of the IMO STCW 78/2010 convention, adoption of programmes into the international and national qualification frameworks’ standards and procedures, as well as the development of research addressed to a new technological and organizational solution are described and analyzed.

  12. A motivational determinant of facial emotion recognition: regulatory focus affects recognition of emotions in faces.

    Science.gov (United States)

    Sassenrath, Claudia; Sassenberg, Kai; Ray, Devin G; Scheiter, Katharina; Jarodzka, Halszka

    2014-01-01

    Two studies examined an unexplored motivational determinant of facial emotion recognition: observer regulatory focus. It was predicted that a promotion focus would enhance facial emotion recognition relative to a prevention focus because the attentional strategies associated with promotion focus enhance performance on well-learned or innate tasks - such as facial emotion recognition. In Study 1, a promotion or a prevention focus was experimentally induced and better facial emotion recognition was observed in a promotion focus compared to a prevention focus. In Study 2, individual differences in chronic regulatory focus were assessed and attention allocation was measured using eye tracking during the facial emotion recognition task. Results indicated that the positive relation between a promotion focus and facial emotion recognition is mediated by shorter fixation duration on the face which reflects a pattern of attention allocation matched to the eager strategy in a promotion focus (i.e., striving to make hits). A prevention focus did not have an impact neither on perceptual processing nor on facial emotion recognition. Taken together, these findings demonstrate important mechanisms and consequences of observer motivational orientation for facial emotion recognition.

  13. Challenges in Regulating Radiation Sources and Associated Waste Management

    International Nuclear Information System (INIS)

    Shehzad, A.

    2016-01-01

    Radiation sources are widely used in the fields of medical, industry, agriculture, research, etc. Owing to the inherent risk of exposure to ionizing radiations while using the radiation sources and management of associated waste, safety measures are of utmost importance including robust regulatory control. Pakistan Nuclear Regulatory Authority (PNRA) is responsible for supervising all matters pertaining to nuclear safety and radiation protection in the country. Since its inception, PNRA has made rigorous efforts to regulate the radiation facilities for which regulatory framework was further strengthened by taking into account international norms/practices and implemented afterwards. However, due to vibrant use of these facilities, there are numerous challenges being faced while implementing the regulatory framework. These challenges pertains to shielding design of some facilities, control over service provider for QC/repair maintenance of radiation equipment, assessment of patient doses, and establishment of national diagnostic reference levels for radiological procedures. Further, the regulatory framework also delineate requirements to minimize the generation of associated radioactive waste as low as practicable. The requirements also necessitates that certain sealed radioactive sources (SRS) are returned to the supplier upon completion of their useful life, while other radioactive sources are required to be transported for storage at designated radioactive waste storage facilities in the country, which requires commitment from the licensee. This paper will briefly describe the challenges in regulating the radiation sources and issues related to the waste management associated with these facilities. (author)

  14. Women In Action: Challenges Facing Women Entrepreneurs In The Gauteng Province Of South Africa

    OpenAIRE

    Elizabeth Chinomona; Eugine Tafadzwa Maziriri

    2015-01-01

    In today’s post-modern era, the role of women entrepreneurs in economic development is inevitable and women are willing to take action in business and contribute to the nation’s growth. Women are stepping up to own and run businesses in numbers that would have been hard to imagine a mere few decades ago. However, women entrepreneurs face a wide variety of challenges both in starting and in growing their business ventures. The objective of this paper is to investigate the challenges women entr...

  15. "Accounting Education at a Crossroad in 2010" and "Challenges Facing Accounting Education in Australia"

    Science.gov (United States)

    de Lange, Paul; Watty, Kim

    2011-01-01

    Of the various reports released in 2010, two purport to examine the state of accounting education in Australia. These are "Accounting Education at a Crossroad in 2010" and "Challenges Facing Accounting Education in Australia". Both were released as collaborations of the leading academic organisation, the Accounting and Finance…

  16. Gender-specific Regulatory Challenges to Product Approval: a panel discussion.

    Science.gov (United States)

    McGregor, Alyson J; Barr, Helen; Greenberg, Marna R; Safdar, Basmah; Wildgoose, Peter; Wright, David W; Hollander, Judd E

    2014-12-01

    On May 13, 2014, a 1-hour panel discussion session titled "Gender-specific Regulatory Challenges to Product Approval" was held during the Academic Emergency Medicine consensus conference, "Gender-specific Research in Emergency Medicine: Investigate, Understand, and Translate How Gender Affects Patient Outcomes." The session sought to bring together leaders in emergency medicine (EM) research, authors, and reviewers in EM research publications, as well as faculty, fellows, residents, and students engaged in research and clinical practice. A panel was convened involving a representative from the Office of Women's Health of the U.S. Food and Drug Administration, two pharmaceutical executives, and a clinical EM researcher. The moderated discussion also involved audience members who contributed significantly to the dialogue. Historical background leading up to the session along with the main themes of the discussion are reproduced in this article. These revolve around sex- and gender-specific research, statistical analysis of sex and gender, clinical practice, financial costs associated with pharmaceutical development, adaptive design, and specific recommendations on the regulatory process as it affects the specialty of EM. © 2014 by the Society for Academic Emergency Medicine.

  17. The Nigerian Economy in the Face of Socio-Political Challenges: A Retrospective View and Ways Forward

    Directory of Open Access Journals (Sweden)

    Tomola M Obamuyi

    2016-04-01

    Full Text Available This paper examines the Nigerian economy and the tendency for its growth in the face of several socio-political challenges facing the country, which have hampered the rate of economic development in spite of the tremendous human and material resources inherent. The paper identifies the socio-political challenges to include corruption, poverty, unemployment, insecurity, politics and governance, among others. The central argument of the paper is that steady economic growth can be achieved and financial crisis mitigated in Nigeria, if the effects of socio-political challenges, which are the key factors that have contributed to the high poverty, unemployment and economic instability in the country, are minimised. To ensure economic growth and move the country forward politically and economically, government must be more accountable in managing the nation’s resources in order to avoid wastage, poverty and unemployment. Close attention should be given to those socio-political challenges in the formulation of policies that aimed at maintaining economic growth at a level commensurate with the country’s growth rate. This study put forward that government must be proactive in all issues relating to the socio-political challenges to prevent resource mismanagement, poverty, unemployment, insecurity and slow economic growth in future.

  18. Ethical and legal challenges in bioenergy governance: Coping with value disagreement and regulatory complexity

    International Nuclear Information System (INIS)

    Gamborg, Christian; Anker, Helle Tegner; Sandøe, Peter

    2014-01-01

    The article focuses on the interplay between two factors giving rise to friction in bioenergy governance: profound value disagreements (e.g. the prioritizing of carbon concerns like worries over GHG emissions savings over non-carbon related concerns) and regulatory complexity (in terms of regulatory measures and options). We present ethical and legal analyses of the current stalemate on bioenergy governance in the EU using two illustrative cases: liquid biofuels for transport and solid biomass-based bioenergy. The two cases disclose some similarities between these two factors, but the remaining differences may partly explain, or justify, contrasting forms of governance. While there seems to be no easy way in which the EU and national governments can deal with the multiple sustainability issues raised by bioenergy, it is argued that failure to deal explicitly with the underlying value disagreements, or to make apparent the regulatory complexity, clouds the issue of how to move forward with governance of bioenergy. We suggest that governance should be shaped with greater focus on the role of value disagreements and regulatory complexity. There is a need for more openness and transparency about such factors, and about the inherent trade-offs in bioenergy governance. - Highlights: • Ethical and legal challenges in governance of liquid biofuels and wood pellets. • EU sustainability criteria legal and ethical analysis—EU bioenergy policy options. • Analysis of interplay between carbon and non-carbon concerns and regulatory options. • Governance must cope with value disagreement and regulatory complexity

  19. Continuous Improvement of the Regulatory Framework for the Control of Medical Exposure

    International Nuclear Information System (INIS)

    Larcher, A.M.; Ortiz lopez, Pedro; Arias, Cesar; Marechal, Maria H.; Hernandez Alvarez, Ramon; Ferrer Garcia, Natividad; Castaneda Mucino, Antonia; Faller, Blanca

    2011-01-01

    Background: One of the key elements to guide the improvement of the regulatory control is the availability of a self-assessment tool for regulatory performance. Although there is general guidance on self-assessment for regulators and users (IAEA), there is a need for specific advice on how to address challenges and difficulties faced by regulatory bodies, when regulating radiation protection of patients. Examples of these challenges are the need of regulatory initiatives, in cooperation with health and education authorities, professional bodies and equipment suppliers, and to put in place necessary elements that are beyond responsibility of individual users of radiation, to enable them compliance with safety standards. Purpose: within the programme of the Ibero American Forum of Nuclear and Radiation Safety Regulatory Organizations, a project to develop such a self assessment tool for the regulatory control of medical exposure has been designed. Method: national experiences in transposing and enforcing the international radiation safety standards, as to how the requirements are included in national regulations are reviewed. Further, difficulties to the implementation of safety requirements are included in national regulations are analyzed and a self assessment approach and possible regulatory solutions are presented. Results and discussion: in tis study the following documents are being produced: 1) Transposition of international requirements into national regulations in the six countries of the Forum, 2) difficulties to implement and enforce the requirements, 3) guidance on self assessment of regulatory framework for medical exposure, 4) suggested contribution to the revision of international radiation safety standards. (authors)

  20. Rural Teachers' Views: What Are Gender-Based Challenges Facing Free Primary Education in Lesotho?

    Science.gov (United States)

    Morojele, Pholoho

    2013-01-01

    This paper gives prominence to rural teachers' accounts of gender-based challenges facing Free Primary Education in Lesotho. It draws on feminist interpretations of social constructionism to discuss factors within the Basotho communities that affect gender equality in the schools. The inductive analysis offered makes use of the data generated from…

  1. OPPORTUNITIES AND CHALLENGES FOR MICRO-SMALL AND MEDIUM BUSINESS IN INDONESIA FACING ASEAN ECONOMIC COMMUNITY

    OpenAIRE

    Raden Aswin Rahadi

    2016-01-01

    This research is a part of a continuous study to analyze the opportunities and challenges for micro-small and medium business in Indonesia when facing ASEAN Economic Community (AEC) in 2016. It has its own uniqueness, as it will combine the point of view between current business owners and current literature study synthesis on business perception towards AEC. Ten business owners have been interviewed. The results suggested AEC provides challenges for the business owners, particularly in terms...

  2. Challenges for decommissioning policies

    International Nuclear Information System (INIS)

    Riotte, H.

    2007-01-01

    In the coming years, OECD member countries will be increasingly faced with the need to make appropriate provisions, in terms of policy, finance and management, for all aspects of decommissioning. Decommissioning requires regulatory approval and oversight, the directions of which are guided by national policy. In several instances, governments have only recently begun to address their approaches to decommissioning policy and regulation in national legislation, and international overviews of such approaches, which may eventually lead to international harmonization, are only now beginning to emerge. In parallel, policy and regulation have been evolving and a broadened competence has developed in relevant regulatory authorities. The challenge lying ahead is to establish a framework that will allow for the growth of nuclear industrial activities in competitive, globalized markets, while maintaining and assuring the safety of decommissioning for the public and for workers. Within this context, institutional arrangements, stakeholder issues, costs and funding, waste management and policies for release from regulatory control, as well as the availability of technologies and skills, need to be reviewed. (author)

  3. Challenges facing the distribution of an artificial-intelligence-based system for nursing.

    Science.gov (United States)

    Evans, S

    1985-04-01

    The marketing and successful distribution of artificial-intelligence-based decision-support systems for nursing face special barriers and challenges. Issues that must be confronted arise particularly from the present culture of the nursing profession as well as the typical organizational structures in which nurses predominantly work. Generalizations in the literature based on the limited experience of physician-oriented artificial intelligence applications (predominantly in diagnosis and pharmacologic treatment) must be modified for applicability to other health professions.

  4. Menstrual Hygiene, Management, and Waste Disposal: Practices and Challenges Faced by Girls/Women of Developing Countries

    OpenAIRE

    Rajanbir Kaur; Kanwaljit Kaur; Rajinder Kaur

    2018-01-01

    Menstruation and menstrual practices still face many social, cultural, and religious restrictions which are a big barrier in the path of menstrual hygiene management. In many parts of the country especially in rural areas girls are not prepared and aware about menstruation so they face many difficulties and challenges at home, schools, and work places. While reviewing literature, we found that little, inaccurate, or incomplete knowledge about menstruation is a great hindrance in the path of p...

  5. Oral Academic Discourse Socialisation: Challenges Faced by International Undergraduate Students in a Malaysian Public University

    Science.gov (United States)

    Mahfoodh, Omer Hassan Ali

    2014-01-01

    This paper reports a qualitative study which examines the challenges faced by six international undergraduate students in their socialisation of oral academic discourse in a Malaysian public university. Data were collected employing interviews. Students' presentations were also collected. Semi-structured interviews were transcribed verbatim and…

  6. Decoding of faces and face components in face-sensitive human visual cortex

    Directory of Open Access Journals (Sweden)

    David F Nichols

    2010-07-01

    Full Text Available A great challenge to the field of visual neuroscience is to understand how faces are encoded and represented within the human brain. Here we show evidence from functional magnetic resonance imaging (fMRI for spatially distributed processing of the whole face and its components in face-sensitive human visual cortex. We used multi-class linear pattern classifiers constructed with a leave-one-scan-out verification procedure to discriminate brain activation patterns elicited by whole faces, the internal features alone, and the external head outline alone. Furthermore, our results suggest that whole faces are represented disproportionately in the fusiform cortex (FFA whereas the building blocks of faces are represented disproportionately in occipitotemporal cortex (OFA. Faces and face components may therefore be organized with functional clustering within both the FFA and OFA, but with specialization for face components in the OFA and the whole face in the FFA.

  7. The challenges facing today's operators

    Energy Technology Data Exchange (ETDEWEB)

    Walach, T. [Canadian District Energy Association, Vaughan, ON (Canada)

    2004-07-01

    A summary of how the Northwind Windsor plant operates was presented along with reasons why it is advantageous to get connected to a district heating system. The plant is a joint venture between Exelon Thermal Technologies and Ontario Power Generation. The plant produces and sells hot water, chilled water, steam and electricity to the Windsor Utilities Commission. Energy is then piped out to buildings in the area, including the Art Gallery of Windsor, the Royal Bank Business Centre, the Windsor Justice Facility, the Windsor Casino, and Northwind Windsor. The energy, which is transferred through heat exchangers, is used for space heating, domestic hot water heating, and air conditioning. The plant offers less management costs, lower energy costs, a lower level of risk management, stable energy rates, better use of building space, reliable service, and a cleaner environment. However, operators face significant challenges in terms of plant operation. They must be knowledgeable in the operation and maintenance of innovative equipment, and must have detailed information regarding operating efficiencies. District Energy requires more complex plants that use various energy saving technologies that deliver a broad range of energy types.

  8. 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.

  9. Challenges in sexual medicine

    DEFF Research Database (Denmark)

    Cellek, Selim; Giraldi, Annamaria

    2012-01-01

    The sexual medicine field has been in mode of revolution until recently. Like all other fields of biomedical research, the economic situation around the world has had a negative impact on the field's momentum-research funding bodies, regulatory bodies and pharmaceutical companies seem to have...... placed sexual medicine in their low-priority list. But this is not the only challenge the field is facing. The successful development of phosphodiesterase type 5 (PDE5) inhibitors for treatment of erectile dysfunction (ED) means that research in this area seems to have slowed. However, there remain...... several unmet medical needs within sexual medicine such as premature ejaculation, severe ED and hypoactive sexual desire disorder, which await novel therapeutic approaches. Despite these challenges, research into finding and developing such therapies is likely to continue in the sexual medicine field...

  10. Western United States Dams Challenges Faced, Options, and Opportunities

    Science.gov (United States)

    Raff, D.

    2017-12-01

    Water management in the Western United States relies significantly upon a fleet of small to very large engineered dams to store water during times of runoff and distribute that water during times of need. Much of this infrastructure is Federally owned and/or operated, and was designed and funded during the first half of the twentieth century through a complex set of repayment contracts for Federally authorized purposes addressing water supply, recreation, and hydropower, and other water management objectives. With environmental laws, namely the Endangered Species Act, and other environmental concerns taking a more active role in water resources in the mid to latter half of the twentieth century, this infrastructure is being stressed even greater than anticipated to provide authorized purposes. Additionally, weather and climate norms being experienced are certainly near the edges, if not outside, of anticipated variability in the climate and hydrology scenarios for which the infrastructure was designed. And, finally, these dams, economically designed for a lifespan of 50 - 100 years, are experiencing maintenance challenges from routine to significant. This presentation will focus on identifying some of the history and challenges facing the water infrastructure in the Western United States. Additionally, some perspectives on future paths to meet the needs of western irrigation and hydropower production will be provided.

  11. Ethics and Regulatory Challenges and Opportunities in Patient-Centered Comparative Effectiveness Research.

    Science.gov (United States)

    Sugarman, Jeremy

    2016-04-01

    The Affordable Care Act includes provisions for the conduct of large-scale, patient-centered comparative effectiveness research. Such efforts aim toward the laudable moral goal of having evidence to improve health care decision making. Nevertheless, these pragmatic clinical research efforts that typically pose minimal incremental risk and are enmeshed in routine care settings perhaps surprisingly encounter an array of ethics and regulatory challenges and opportunities for academic health centers. An emphasis on patient-centeredness forces an examination of the appropriateness of traditional methods used to protect the rights, interests, and welfare of participants. At the same time, meaningful collaboration with patients throughout the research process also necessitates ensuring that novel approaches to research (including recruitment and consent) entail necessary protections regarding such issues as privacy. As the scientific and logistical aspects of this research are being developed, substantial attention is being focused on the accompanying ethics and regulatory issues that have emerged, which should help to facilitate ethically appropriate research in a variety of contexts.

  12. Challenges and issues facing the future of nursing education: implications for ethnic minority faculty and students.

    Science.gov (United States)

    Davis, Sheila P; Davis, Danyetta D

    2010-01-01

    Current trends in higher education in the United States demand that nursing take stock of how it is prepared or being prepared to face challenges and issues impacting on its future. The intense effort made to attract students to pursue advanced training in science and engineering in the United States pales in comparison to the numbers of science and engineering majors produced yearly in international schools. As a result, more and more jobs are being outsourced to international markets. Could international outsourcing become a method of nursing education? Authors submit that to remain competitive, the nursing profession must attract a younger cohort of technologically savvy students and faculty reflective of the growing diverse population in the United States. Additionally, nursing programs in research universities face even more daunting challenges as it relates to mandates for funded research programs of educational units. This article offers suggestions and recommendations for nursing programs in higher education institutions on ways to attract and retain ethnic minorities and of how to harness the power of research to address burgeoning societal health challenges.

  13. [Brazilian Army nurses and transportation of the wounded: a challenge faced during World War II].

    Science.gov (United States)

    Bernardes, Margarida Maria Rocha; Lopes, Gertrudes Teixeira

    2007-01-01

    This historic-sociologic study aims to analyse the challenges faced by the Brazilian Expeditionary Force's Air Transportation Nurses of the Army with the Theatre of Operations on the course of World War II. The primary source was comprised of a photograph from this time period and oral testimonies of those who participated in the conflict. Ideas by sociologist Pierre Bourdieu support the discussion. Results suggest that Brazilian nurses were challenged to transport the wounded without medical advice. We conclude that the challenge to fulfill the task imposed, which led to independent decision-making, gave confidence and autonomy to the ones already responsible for the transportation of the wounded.

  14. Corporate Social Responsibility in the Financial Sector: Are Financial Cooperatives Ready to the Challenge?

    OpenAIRE

    Élias Rizkallah; Inmaculada Buendía Martínez

    2011-01-01

    After the crash of financial institutions and the negative effects of the financial crisis, financial service cooperatives (FSCs) emerged as good performer compared to commercial banks. But this condition will not be enough to face the challenges that the new financial panorama will bring on the banking arena. Among them, challenges related to the corporate social responsibility (CSR) sphere will play a special role. In Canada, the financial regulatory framework forces some federal institutio...

  15. Challenges Pre-Service Teachers Face When Implementing a 5E Inquiry Model of Instruction

    Science.gov (United States)

    Enugu, Ramya; Hokayem, Hayat

    2017-01-01

    This study examined the challenges that pre-service teachers faced when implementing inquiry and their perspective on how to overcome them. The data sample was 55 pre-service teachers (PSTs) enrolled into two sections of a science methods course in a private university in North Texas. The data sources consisted of inquiry-based lesson plans, PST…

  16. Post-industrial landscape - its identification and classification as contemporary challenges faced by geographic research

    Czech Academy of Sciences Publication Activity Database

    Kolejka, Jaromír

    2010-01-01

    Roč. 14, č. 2 (2010), s. 67-78 ISSN 1842-5135 Institutional research plan: CEZ:AV0Z30860518 Keywords : classification * geographical research * identification method * landscape structure Subject RIV: DE - Earth Magnetism, Geodesy, Geography http://studiacrescent.com/images/02_2010/09_jaromir_kolejka_post_industrial_landscape_its_identification_and_classification_as_contemporary_challenges_faced_by_geographic_.pdf

  17. Compulsive exercise: links, risks and challenges faced

    Directory of Open Access Journals (Sweden)

    Lichtenstein MB

    2017-03-01

    Full Text Available Mia Beck Lichtenstein,1 Cecilie Juul Hinze,2 Bolette Emborg,3 Freja Thomsen,2 Simone Daugaard Hemmingsen4 1Department of Psychology, Faculty of Health Sciences, University of Southern Denmark, 2Research Unit for Telepsychiatry and E-mental Health, Mental Health Services in the Region of Southern Denmark, Odense, 3Department of Public Health, Aarhus University, Aarhus, 4Research Unit, Child and Adolescent Psychiatry, Mental Health Services in the Region of Southern Denmark, Odense, Denmark Abstract: Compulsive exercise is a condition described since 1970s. It is characterized by a craving for physical training, resulting in uncontrollable excessive exercise behavior with harmful consequences, such as injuries and impaired social relations. It has not been accepted as a mental disorder in either International Classification of Diseases or Diagnostic and Statistical Manual of Mental Disorders. The aim of this literature review was to critically examine the research on links (comorbidity, risks (negative consequences, and challenges faced (problems in a treatment context. This review found that compulsive exercise is associated with eating disorder pathology, perfectionism, neuroticism, narcissism, and obsessive compulsive traits. The most prominent negative consequences were injuries, social impairment, and depression, but more research is needed to uncover the potential dysfunction resulting from compulsive exercise. As the condition is not recognized as a psychiatric disorder, studies on treatment interventions are sparse. Problems with compliance have been reported; therefore, motivational interviewing has been proposed as a treatment approach, in combination with cognitive behavioral therapy. This review summarizes and discusses findings on links/comorbidity, risks/negative consequences, and treatment challenges. We suggest that future studies should pay attention to both prevention and counseling in sports settings, where compulsive exercise

  18. A New World for Museum Marketing? Facing the Old Dilemmas while Challenging New Market Opportunities

    Directory of Open Access Journals (Sweden)

    Tanja Komarac

    2014-12-01

    Full Text Available Museums are part of a wider cultural and entertainment environment, which is ruled by highly demanding visitors who seek immersive experiences (edutainment and time-saving arrangement. This has encouraged and, in some opinions, forced museums to turn their focus from collections to visitors. In addition, museums have faced competition and new technologies in the form of virtual museums and virtual reality. This has emphasized the need to accept marketing as a survival tool and to make it into a link between museums and visitors. This article attempts to give current insights into museum marketing as part of the arts marketing field. Its aim is also to identify and explain some of the major challenges and opportunities facing everyday museum business, in order to provide insight into the complex world of museum marketing. Former findings about the development of museum marketing and its biggest changes and challenges are presented, summarized and analyzed.

  19. ‘Everyone has a secret they keep close to their hearts’: challenges faced by adolescents living with HIV infection at the Kenyan coast

    Directory of Open Access Journals (Sweden)

    Amina Abubakar

    2016-02-01

    Full Text Available Abstract Background The upsurge in the uptake of antiretroviral therapy (ART has led to a significant increase in the survival of vertically acquired HIV infected children, many of whom are currently living into adolescence and early adulthood. However little if anything is known of the lived experiences and the challenges faced by HIV positive adolescents in the African context. We set out to investigate psychosocial challenges faced by HIV infected adolescents on the Kenyan coast. Methods A total of 44 participants (12 HIV-infected adolescents, 7 HIV uninfected adolescents, and 25 key informants took part in this qualitative study, using individually administered in-depth interviews. A framework approach was used to analyze the data using NVIVO software. Results We observed that the challenges faced by adolescents in rural Kenya could be placed into six major themes: poverty, poor mental and physical health, the lack of a school system that is responsive to their needs, challenges in how to disclose to peers and family members, high levels of stigma in its various forms, and challenges of medical adherence leading to the need for close monitoring. Conclusion In this African community, vertically acquired HIV-infected adolescents face a complex set of social, economic and medical challenges. Our study points to the urgent need to develop multisectorial intervention support programmes to fully address these challenges.

  20. Facing the Challenges

    DEFF Research Database (Denmark)

    He, Kai

    2014-01-01

    China's rise signifies a gradual transformation of the international system from unipolarity to a non-unipolar world. ,4s an organization of small and middle powers, ASEAN faces strategic uncertainties brought about by the power transition in the system. Deepening economic interdependence between...... Summit (EAS), the Regional Comprehensive Economic Partnership (RCEP), and the ASEAN Community, to constrain and shape China's behaviour in the region in the post-Cold War era. It argues that due to globalization and economic interdependence, the power transition in the 21st century is different from...... the previous ones. ASEAN can potentially make a great contribution to a peaceful transformation of the international system. How to resolve the South China Sea disputes peacefully will be a critical task for both the ASEAN and Chinese leaders in the next decade or two....

  1. Indigenous mothers face more than three delays: The challenges of multiculturalism in health

    Directory of Open Access Journals (Sweden)

    Roosta-G., Manigeh

    2015-08-01

    Full Text Available Although the maternal mortality ratio has descended in Bolivia from 416 (1989 to 229 deaths (DHS 2003 per one hundred thousand live births, it is one of the highest in the region. As a national average, the ratio conceals the rural-urban, socio-economics differences and the reality of the indigenous population. Maternal mortality is one of the major challenges at national level. Reduction of maternal mortality, in addition of technical-medical measures offering health services, requires to focus on socio-cultural aspects that hamper the access to health services. This article examines challenges faced by indigenous mothers accessing the health services. In addition to the geographic, economic and administrative barriers that generate delays in access to the health services, there are others that are presented in the context of multiculturalism resulting from discriminatory attitudes exercised in health centers. The testimonies of indigenous mothers show delays faced in health centers because of prejudice and discrimination suffered, threatening the lives of mothers and their babies. The study also suggests the need to deepen the concept of multiculturalism as a successful strategy in health, in order to promote equity and social justice on the horizon of more inclusive societies.

  2. Challenges and opportunities in clinical translation of biomedical optical spectroscopy and imaging

    Science.gov (United States)

    Wilson, Brian C.; Jermyn, Michael; Leblond, Frederic

    2018-03-01

    Medical devices face many hurdles before they enter routine clinical practice to address unmet clinical needs. This is also the case for biomedical optical spectroscopy and imaging systems that are used here to illustrate the opportunities and challenges involved. Following initial concept, stages in clinical translation include instrument development, preclinical testing, clinical prototyping, clinical trials, prototype-to-product conversion, regulatory approval, commercialization, and finally clinical adoption and dissemination, all in the face of potentially competing technologies. Optical technologies face additional challenges from their being extremely diverse, often targeting entirely different diseases and having orders-of-magnitude differences in resolution and tissue penetration. However, these technologies can potentially address a wide variety of unmet clinical needs since they provide rich intrinsic biochemical and structural information, have high sensitivity and specificity for disease detection and localization, and are practical, safe (minimally invasive, nonionizing), and relatively affordable.

  3. Talking about epilepsy: Challenges parents face when communicating with their child about epilepsy and epilepsy-related issues.

    Science.gov (United States)

    O'Toole, Stephanie; Lambert, Veronica; Gallagher, Pamela; Shahwan, Amre; Austin, Joan K

    2016-04-01

    The aim of this qualitative study was to explore the challenges that parents of children with epilepsy experienced when engaging in dialog with their child about epilepsy and epilepsy-related issues. Using a qualitative exploratory approach, interviews were conducted with 34 parents of children with epilepsy (aged 6-16 years), consisting of 27 mothers and 7 fathers. Data were transcribed verbatim and thematically analyzed. Findings revealed five main themes: normalizing epilepsy, the invisibility of epilepsy, information concealment, fear of misinforming the child, and difficulty in discussing particular epilepsy-related issues. Many of the communicative challenges experienced by parents impacted on their ability to engage openly in parent-child dialog about epilepsy in the home. Parents face specific challenges when choosing to communicate with their child about epilepsy, relating to creating a sense of normality, reducing fear of causing their child worry, and having a lack of epilepsy-related knowledge. Healthcare professionals who work closely with families living with epilepsy should remain mindful of the importance of discussing family communication surrounding epilepsy and the challenges parents of children with epilepsy face when talking about epilepsy within the home. Copyright © 2016 Elsevier Inc. All rights reserved.

  4. Nanotechnology: Nanomaterials are Widely Used in Commerce, but EPA Faces Challenges in Regulating Risk

    Science.gov (United States)

    2010-05-01

    549 Nanotechnology equivalent.17 In addition, nanotechnology -enabled water desalination and filtration systems may offer affordable...Senate NANOTECHNOLOGY Nanomaterials Are Widely Used in Commerce, but EPA Faces Challenges in Regulating Risk May 2010 GAO-10-549...2010 2. REPORT TYPE 3. DATES COVERED 00-00-2010 to 00-00-2010 4. TITLE AND SUBTITLE Nanotechnology : Nanomaterials Are Widely Used in Commerce

  5. Immigrant to Canada, newcomer to childhood cancer: a qualitative study of challenges faced by immigrant parents.

    Science.gov (United States)

    Klassen, Anne F; Gulati, Sonia; Watt, Lisa; Banerjee, Ananya T; Sung, Lillian; Klaassen, Robert J; Dix, David; Poureslami, Iraj M; Shaw, Nicola

    2012-05-01

    Given the increasing numbers of immigrant families in Canada, it is imperative that healthcare providers (HCPs) understand the caregiving experiences of immigrant family caregivers. Our study aimed to explore any special challenges faced by immigrant parents of children with cancer and to identify supportive factors. A constructivist grounded theory approach was used. Participants included 50 first generation Chinese and South Asian parents of children with cancer who were at least six months post-diagnosis. Recruitment took place at six Canadian pediatric oncology centres. Interviews were conducted in English, Cantonese, Mandarin, Urdu, Punjabi or Hindi. Analysis involved coding and the use of the constant comparison method. Interviewing continued until no new themes emerged. While immigrant parents described many challenges faced by any parent of a child with cancer, the context of being an immigrant made certain experiences particularly challenging. Parents described challenges in the following areas: managing caregiving demand and financial strain, accessing support from others, and interfacing with the healthcare system. Parents described receiving a range of practical, emotional, social and informational support from extended family, their workplace, other cancer families, community organizations and HCPs. Our study addresses an important gap in the research literature by providing practical insight into the experiences of immigrant family caregivers. Our findings may help to inform the development of pediatric oncology policies and programs in ways that respond to the unique needs and challenges of culturally and linguistically diverse families. Copyright © 2011 John Wiley & Sons, Ltd.

  6. Assessing Students Perceptions on Intensive Face to Face in Open ...

    African Journals Online (AJOL)

    Therefore, this study assessed students‟ perception on Intensive Face to Face sessions. The study specifically aimed at identifying students‟ perception on quality of interaction between tutors and students and between students on the other hand. It also explored the nature of challenges students meet in attending face to ...

  7. Challenges faced by former child soldiers in the aftermath of war in Uganda.

    Science.gov (United States)

    Vindevogel, Sofie; De Schryver, Maarten; Broekaert, Eric; Derluyn, Ilse

    2013-06-01

    Warfare takes a profound toll of all layers of society, creating multiple and multilevel challenges that impinge on the psychosocial well-being of affected individuals. This study aims to assess the scope and salience of challenges confronting former child soldiers and at identifying additional challenges they face compared to non-recruited young people in war-affected northern Uganda. The study was carried out with a stratified random sample of northern Ugandan adolescents (n = 1,008), of whom a third had formerly been recruited (n = 330). The mixed-method comparison design consisted of a constrained free listing task to determine the challenges; a free sorting task to categorize them into clusters; and statistical analysis of their prevalence among formerly recruited youth and of how they compare with those of nonrecruited youth. Altogether, 237 challenges were identified and clustered into 15 categories, showing that formerly recruited participants mainly identified "emotional" and "training and skills"-related challenges. Compared with nonrecruited counterparts, they reported significantly more "emotional" and fewer "social and relational" challenges, with the exception of stigmatization. Overall, there was similarity between the challenges reported by both groups. The challenges confronting formerly recruited youths reach well beyond the effects of direct war exposure and emerge mainly from multiple influence spheres surrounding them. These challenges are largely shared in common with nonrecruited youths. This multidimensional and collective character of challenges calls for comprehensive psychosocial interventions through which healing the psychological wounds of war is complemented by mending the war-affected surroundings at all levels and in all life areas. Copyright © 2013 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

  8. Challenges Facing Crop Production And (Some) Potential Solutions

    Science.gov (United States)

    Schnable, P. S.

    2017-12-01

    To overcome some of the myriad challenges facing sustainable crop production we are seeking to develop statistical models that will predict crop performance in diverse agronomic environments. Crop phenotypes such as yield and drought tolerance are controlled by genotype, environment (considered broadly) and their interaction (GxE). As a consequence of the next generation sequencing revolution genotyping data are now available for a wide diversity of accessions in each of the major crops. The necessary volumes of phenotypic data, however, remain limiting and our understanding of molecular basis of GxE is minimal. To address this limitation, we are collaborating with engineers to construct new sensors and robots to automatically collect large volumes of phenotypic data. Two types of high-throughput, high-resolution, field-based phenotyping systems and new sensors will be described. Some of these technologies will be introduced within the context of the Genomes to Fields Initiative. Progress towards developing predictive models will be briefly summarized. An administrative structure that fosters transdisciplinary collaborations will be briefly described.

  9. First liver transplant in Qatar: an evolving program facing many challenges.

    Science.gov (United States)

    Khalaf, Hatem; Derballa, Moataz; Elmasry, Mohammed; Khalil, Ahmed; Yakoob, Rafie; Almohannadi, Muneera; Almaslamani, Muna; Fadhil, Riadh; Al-Kaabi, Saad; Al-Ansari, Abdulla; Almaslamani, Yousuf

    2013-10-01

    Beginning to do liver transplants in a developing country is challenging. We report on the first few liver transplants performed in Qatar and discuss future exceptions and challenges facing our program. The first liver transplant was performed in Qatar on December 6, 2011. Since starting the program, 4 deceased-donor liver transplants have been performed in Qatar. All recipients underwent a standard deceased-donor liver transplant procedure, which included a duct-to-duct biliary anastomosis without a veno-venous bypass. All liver transplants were performed at the Hamad Medical Corporation by a local team of surgeons without external assistance. The 4 patients were all men, with a median age of 56 years (age range, 46-63 y). Indications for liver transplant included hepatitis C cirrhosis in 2 patients, and 1 patient with hepatitis B cirrhosis with hepatocellular carcinoma, and the other patient with cryptogenic liver cirrhosis. Median amount of blood transfused was 6 units (range, 0-10 U); median time spent in the intensive care unit was 2 days (range, 2-5 d); median amount of time spent in the hospital was 10 days (range, 9-16 d). All 4 recipients have survived after a median follow-up of 438 days (range, 33-602 d) and are enjoying a healthy life, with no significant posttransplant complications. A deceased-donor liver transplant can be performed in Qatar with no external assistance. However, a severe organ shortage remains the biggest obstacle facing us. Efforts should be directed toward improving the number and quality of available deceased donors in Qatar. Meanwhile, live-donor liver transplant may be the only way for us, going forward, to prevent deaths on the waiting list.

  10. Challenges in healthcare delivery in an economic downturn, in the Republic of Ireland.

    Science.gov (United States)

    Carney, Marie

    2010-07-01

    The purpose of the present study was to discuss some of effects of the downturn in the Irish economy and to demonstrate that in the face of economic difficulties innovation in health care is still occurring. Staff that are managing and delivering healthcare need to know the challenges facing them and have an awareness of the importance of maintaining interest in innovative practice in turbulent times. Information obtained from several sources including government papers, the nursing regulatory board and quality authority documents and current best practice articles. Information was evaluated based on the study's aim. Issues emerging were that current challenges facing Irish health care delivery relate mainly to economic, clinical management, education and information technology factors and further reductions in the cost base of health care delivery remains focused on value for money. In the face of the economic downturn Ireland is achieving health targets and is now sitting in 13th place on the European health index, down from number 28 in 2008. This improvement in position has resulted from several new innovative work practices. As a result of cost reduction measures in place nurse managers will face greater challenges than ever before in meeting the objectives of the healthcare transformation programme.

  11. The Dessau workshop on bioaccumulation: state of the art, challenges and regulatory implications.

    Science.gov (United States)

    Treu, Gabriele; Drost, Wiebke; Jöhncke, Ulrich; Rauert, Caren; Schlechtriem, Christian

    2015-01-01

    Bioaccumulation plays a vital role in understanding the fate of a substance in the environment and is key to the regulation of chemicals in several jurisdictions. The current assessment approaches commonly use the octanol-water partition coefficient (log K OW ) as an indicator for bioaccumulation and the bioconcentration factor (BCF) as a standard criterion to identify bioaccumulative substances show limitations. The log K OW does not take into account active transport phenomena or special structural properties (e.g., amphiphilic substances or dissociating substances) and therefore additional screening criteria are required. Regulatory BCF studies are so far restricted to fish and uptake through the gills. Studies on (terrestrial) air-breathing organisms are missing. Though there are alternative tests such as the dietary exposure bioaccumulation fish test described in the recently revised OECD test guideline 305, it still remains unclear how to deal with results of alternative tests in regulatory decision-making processes. A substantial number of bioaccumulation fish tests are required in regulation. The development of improved test systems following the 3R principles, namely to replace, reduce and refine animal testing, is thus required. All these aspects stress the importance to further develop the assessment of bioaccumulation. The Dessau Workshop on Bioaccumulation which was held from June 26th to 27th 2014, in Dessau, Germany, provided a comprehensive overview of the state of the art of bioaccumulation assessment, provided insights into the problems and challenges addressed by the regulatory authorities and described new research concepts and their regulatory implications. The event was organised by UBA (Dessau, Germany) and Fraunhofer IME (Schmallenberg, Germany). About 50 participants from industry, regulatory bodies and academia listened to 14 lectures on selected topics and joined the plenary discussions.

  12. Comprehensive genomic studies: emerging regulatory, strategic, and quality assurance challenges for biorepositories.

    Science.gov (United States)

    McDonald, Sandra A; Mardis, Elaine R; Ota, David; Watson, Mark A; Pfeifer, John D; Green, Jonathan M

    2012-07-01

    As part of the molecular revolution sweeping medicine, comprehensive genomic studies are adding powerful dimensions to medical research. However, their power exposes new regulatory, strategic, and quality assurance challenges for biorepositories. A key issue is that unlike other research techniques commonly applied to banked specimens, nucleic acid sequencing, if sufficiently extensive, yields data that could identify a patient. This evolving paradigm renders the concepts of anonymized and anonymous specimens increasingly outdated. The challenges for biorepositories in this new era include refined consent processes and wording, selection and use of legacy specimens, quality assurance procedures, institutional documentation, data sharing, and interaction with institutional review boards. Given current trends, biorepositories should consider these issues now, even if they are not currently experiencing sample requests for genomic analysis. We summarize our current experiences and best practices at Washington University Medical School, St Louis, MO, our perceptions of emerging trends, and recommendations.

  13. Securing classification and regulatory approval for deepwater projects: management challenges in a global environment

    Energy Technology Data Exchange (ETDEWEB)

    Feijo, Luiz P.; Burton, Gareth C. [American Bureau of Shipping (ABS), Rio de Janeiro, RJ (Brazil)

    2008-07-01

    As the offshore industry continues to develop and move into increasingly deeper waters, technological boundaries are being pushed to new limits. Along with these advances, the design, fabrication and installation of deepwater oil and gas projects has become an increasingly global endeavor. After providing an overview of the history and role of Classification Societies, this paper reviews the challenges of securing classification and regulatory approval in a global environment. Operational, procedural and technological changes which one Classification Society; the American Bureau of Shipping, known as ABS, has implemented to address these challenges are presented. The result of the changes has been a more customized service aiming at faster and more streamlined classification approval process. (author)

  14. TELECOMMUTING: Overview of Challenges Facing Federal Agencies

    National Research Council Canada - National Science Library

    RObertson, Robert

    2001-01-01

    .... Last spring, the House Majority Leader asked us to identify potential regulatory, tax, and liability barriers that concern private sector employers considering telecommuting programs for their employees...

  15. 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.

  16. Challenges Facing Group Work Online

    Science.gov (United States)

    Chang, Bo; Kang, Haijun

    2016-01-01

    Online group work can be complicated because of its asynchronous characteristics and lack of physical presence, and its requirements for skills in handling technology, human relationships, and content-related tasks. This study focuses on the administrative, logistical and relationship-related challenges in online group work. Challenges in areas…

  17. A Short Twenty Years: Meeting the Challenges Facing Teachers Who Bring Rwanda into the Classroom

    Science.gov (United States)

    Gudgel, Mark

    2013-01-01

    As the twentieth anniversary of the 1994 genocide in Rwanda approaches, Mark Gudgel argues that we should face the challenges posed by teaching about Rwanda. Drawing on his experience as a history teacher in the US, his experience researching and supporting others' classrooms in the US and UK, his training in Holocaust education and his knowledge…

  18. Tolerance for distorted faces: challenges to a configural processing account of familiar face recognition.

    Science.gov (United States)

    Sandford, Adam; Burton, A Mike

    2014-09-01

    Face recognition is widely held to rely on 'configural processing', an analysis of spatial relations between facial features. We present three experiments in which viewers were shown distorted faces, and asked to resize these to their correct shape. Based on configural theories appealing to metric distances between features, we reason that this should be an easier task for familiar than unfamiliar faces (whose subtle arrangements of features are unknown). In fact, participants were inaccurate at this task, making between 8% and 13% errors across experiments. Importantly, we observed no advantage for familiar faces: in one experiment participants were more accurate with unfamiliars, and in two experiments there was no difference. These findings were not due to general task difficulty - participants were able to resize blocks of colour to target shapes (squares) more accurately. We also found an advantage of familiarity for resizing other stimuli (brand logos). If configural processing does underlie face recognition, these results place constraints on the definition of 'configural'. Alternatively, familiar face recognition might rely on more complex criteria - based on tolerance to within-person variation rather than highly specific measurement. Copyright © 2014 Elsevier B.V. All rights reserved.

  19. Water and sanitation policies in Argentina: the challenge of universalizing services

    Directory of Open Access Journals (Sweden)

    Verónica L. Cáceres

    2014-08-01

    Full Text Available This article is aimed at contributing to the reflection and debate on the water and sanitation policies in Argentina. For this purpose, regulatory and institutional aspects are discussed regarding services management in the country. The paper also includes a characterization of the five stages of such policies that have marked the progress of the sector. Finally, the main challenges faced by the sector are mentioned as a conclusion.

  20. Who governs energy? The challenges facing global energy governance

    International Nuclear Information System (INIS)

    Florini, Ann; Sovacool, Benjamin K.

    2009-01-01

    This article conceptualizes the energy problems facing society from a global governance perspective. It argues that a notion of 'global energy governance,' taken to mean international collective action efforts undertaken to manage and distribute energy resources and provide energy services, offers a meaningful and useful framework for assessing energy-related challenges. The article begins by exploring the concepts of governance, global governance, and global energy governance. It then examines some of the existing institutions in place to establish and carry out rules and norms governing global energy problems and describes the range of institutional design options available to policymakers. It briefly traces the role of a selection of these institutions, from inter-governmental organizations to summit processes to multilateral development banks to global action networks, in responding to energy issues, and points out their strengths and weaknesses. The article concludes by analyzing how the various approaches to global governance differ in their applicability to addressing the conundrums of global energy problems.

  1. Who governs energy? The challenges facing global energy governance

    Energy Technology Data Exchange (ETDEWEB)

    Florini, Ann; Sovacool, Benjamin K. [Centre on Asia and Globalisation, Lee Kuan Yew School of Public Policy, National University of Singapore, Singapore 259772 (Singapore)

    2009-12-15

    This article conceptualizes the energy problems facing society from a global governance perspective. It argues that a notion of 'global energy governance,' taken to mean international collective action efforts undertaken to manage and distribute energy resources and provide energy services, offers a meaningful and useful framework for assessing energy-related challenges. The article begins by exploring the concepts of governance, global governance, and global energy governance. It then examines some of the existing institutions in place to establish and carry out rules and norms governing global energy problems and describes the range of institutional design options available to policymakers. It briefly traces the role of a selection of these institutions, from inter-governmental organizations to summit processes to multilateral development banks to global action networks, in responding to energy issues, and points out their strengths and weaknesses. The article concludes by analyzing how the various approaches to global governance differ in their applicability to addressing the conundrums of global energy problems. (author)

  2. Juvenile Toxicology: Relevance and Challenges for Toxicologists and Pathologists

    Science.gov (United States)

    Remick, Amera K.; Catlin, Natasha R.; Quist, Erin M.; Steinbach, Thomas J.; Dixon, Darlene

    2015-01-01

    The Society of Toxicologic Pathology (STP) Education Committee and the STP Reproductive Special Interest Group held a North Carolina regional meeting entitled, “Juvenile Toxicology: Relevance and Challenges for Toxicologists and Pathologists” on March 13, 2015, at the National Institute of Environmental Health Sciences/National Toxicology Program in Research Triangle Park, North Carolina. The purpose of this regional meeting was to familiarize attendees with the topic of juvenile toxicity testing and discuss its relevance to clinical pediatric medicine, regulatory perspectives, challenges of appropriate study design confronted by toxicologists, and challenges of histopathologic examination and interpretation of juvenile tissues faced by pathologists. The 1-day meeting was a success with over 60 attendees representing industry, government, research organizations, and academia. PMID:26220944

  3. Economic regulation of Canada's natural gas delivery industry : policy and regulatory principles

    International Nuclear Information System (INIS)

    Gormley, B.

    2006-03-01

    This policy paper demonstrated how restoring balance and clarity to Canada's regulatory environment will ensure the continued strength of the economy, environment, and communities. It was noted that regulatory outcomes that reflect the broad public interest can be achieved if 4 basic principles for economic regulation are pursued. These principles include strength, balance, efficiency, and clarity. In particular, this paper addressed the challenge facing Canada's natural gas delivery industry in terms of increased energy demand, tight supply, ageing infrastructure and increasing cost pressures on the energy system. It emphasized that transparent, efficient energy policy developed through informed debate can provide the foundation for a reliable, environmentally acceptable and sustainable energy future. It was suggested that immediate attention be given to rebalancing the regulatory processes that have placed short term considerations above the longer term strength of the natural gas system; improving the support for new natural gas supply development; reconsidering pricing in some energy markets where information has been distorted; and revisiting the regulatory processes that have become inefficient

  4. Challenges facing air management for fuel cell systems

    Energy Technology Data Exchange (ETDEWEB)

    Davis, P.B. [Department of Energy (United States); Sutton, R. [Argonne National Lab. (United States); Wagner, F.W. [Energetics Incorporated (United States)

    2000-07-01

    The U.S. Department of Energy (DOE) and the U.S. automotive industry are working cooperatively under the auspices of the Partnership for a New Generation of Vehicles (PNGV) to develop a six-passenger automobile that can achieve up to 80 mpg. while meeting customer needs and all safety and emission requirements. These partners are continuing to invest heavily in the research and development of polymer electrolyte membrane (PEM) fuel cells as a clean and efficient energy conversion system for the PNGV. A critical challenge facing fuel cell systems for the PNGV is the development of efficient, compact, cost-effective air management systems. The U.S. Department of Energy has been exploring several compressor/expander options for pressurized fuel cell systems, including scroll, toroidal intersecting vane, turbine, twin screw, and piston technologies. Each of these technologies has strengths and weaknesses regarding efficiency, pressure ratio over turndown, size and weight, and cost. This paper will present data from the U.S. Department of Energy's research and development efforts on air management systems and will discusses recent program developments resulting from an independent peer review evaluation. (author)

  5. The African Health Profession Regulatory Collaborative for Nurses and Midwives

    Directory of Open Access Journals (Sweden)

    McCarthy Carey F

    2012-08-01

    professional standards in this region of Africa. The African Health Regulatory Collaborative for Nurses and Midwives will measure the progress of country projects and conduct an annual evaluation of the initiative’s regional impact, thereby contributing to the global evidence base of health workforce interventions. Conclusion The African Health Regulatory Collaborative for Nurses and Midwives is designed to address priority needs in health workforce development and improve regulation of the health workforce. This model may assist others countries and regions facing similar workforce challenges.

  6. Japan's shift to a proactive defense architecture: Challenges faced by industry, government, and society

    OpenAIRE

    Chung, Hoyoon

    2017-01-01

    Approved for public release; distribution is unlimited As a result of the changing security environment in the Asia-Pacific, Japan is shifting to a more proactive defense policy, as outlined in the National Defense Program Guidelines (NDPG). This thesis investigates the challenges faced by Japan's industry, government, and society in meeting the NDPG objectives. To do this, this thesis probes the following problem areas: difficulties with indigenous production of weapons systems, inability...

  7. Exploring Temporal Sequences of Regulatory Phases and Associated Interactions in Low- and High-Challenge Collaborative Learning Sessions

    Science.gov (United States)

    Sobocinski, Márta; Malmberg, Jonna; Järvelä, Sanna

    2017-01-01

    Investigating the temporal order of regulatory processes can explain in more detail the mechanisms behind success or lack of success during collaborative learning. The aim of this study is to explore the differences between high- and low-challenge collaborative learning sessions. This is achieved through examining how the three phases of…

  8. Translational and regulatory challenges for exon skipping therapies.

    Science.gov (United States)

    Aartsma-Rus, Annemieke; Ferlini, Alessandra; Goemans, Nathalie; Pasmooij, Anna M G; Wells, Dominic J; Bushby, Katerine; Vroom, Elizabeth; Balabanov, Pavel

    2014-10-01

    Several translational challenges are currently impeding the therapeutic development of antisense-mediated exon skipping approaches for rare diseases. Some of these are inherent to developing therapies for rare diseases, such as small patient numbers and limited information on natural history and interpretation of appropriate clinical outcome measures. Others are inherent to the antisense oligonucleotide (AON)-mediated exon skipping approach, which employs small modified DNA or RNA molecules to manipulate the splicing process. This is a new approach and only limited information is available on long-term safety and toxicity for most AON chemistries. Furthermore, AONs often act in a mutation-specific manner, in which case multiple AONs have to be developed for a single disease. A workshop focusing on preclinical development, trial design, outcome measures, and different forms of marketing authorization was organized by the regulatory models and biochemical outcome measures working groups of Cooperation of Science and Technology Action: "Networking towards clinical application of antisense-mediated exon skipping for rare diseases." The workshop included participants from patient organizations, academia, and members of staff from the European Medicine Agency and Medicine Evaluation Board (the Netherlands). This statement article contains the key outcomes of this meeting.

  9. Nanomaterials for Polymer Electrolyte Membrane Fuel Cells; Materials Challenges Facing Electrical Energy Storate

    Energy Technology Data Exchange (ETDEWEB)

    Gopal Rao, MRS Web-Editor; Yury Gogotsi, Drexel University; Karen Swider-Lyons, Naval Research Laboratory

    2010-08-05

    Symposium T: Nanomaterials for Polymer Electrolyte Membrane Fuel Cells Polymer electrolyte membrane (PEM) fuel cells are under intense investigation worldwide for applications ranging from transportation to portable power. The purpose of this seminar is to focus on the nanomaterials and nanostructures inherent to polymer fuel cells. Symposium topics will range from high-activity cathode and anode catalysts, to theory and new analytical methods. Symposium U: Materials Challenges Facing Electrical Energy Storage Electricity, which can be generated in a variety of ways, offers a great potential for meeting future energy demands as a clean and efficient energy source. However, the use of electricity generated from renewable sources, such as wind or sunlight, requires efficient electrical energy storage. This symposium will cover the latest material developments for batteries, advanced capacitors, and related technologies, with a focus on new or emerging materials science challenges.

  10. United States-Mexican Borderlands: Facing tomorrow's challenges through USGS science

    Science.gov (United States)

    Updike, Randall G.; Ellis, Eugene G.; Page, William R.; Parker, Melanie J.; Hestbeck, Jay B.; Horak, William F.

    2013-01-01

    Along the nearly 3,200 kilometers (almost 2,000 miles) of the United States–Mexican border, in an area known as the Borderlands, we are witnessing the expression of the challenges of the 21st century. This circular identifies several challenge themes and issues associated with life and the environment in the Borderlands, listed below. The challenges are not one-sided; they do not originate in one country only to become problems for the other. The issues and concerns of each challenge theme flow in both directions across the border, and both nations feel their effects throughout the Borderlands and beyond. The clear message is that our two nations, the United States and Mexico, face the issues in these challenge themes together, and the U.S. Geological Survey (USGS) understands it must work with its counterparts, partners, and customers in both countries.Though the mission of the USGS is not to serve as land manager, law enforcer, or code regulator, its innovation and creativity and the scientific and technical depth of its capabilities can be directly applied to monitoring the conditions of the landscape. The ability of USGS scientists to critically analyze the monitored data in search of signals and trends, whether they lead to negative or positive results, allows us to reach significant conclusions—from providing factual conclusions to decisionmakers, to estimating how much of a natural resource exists in a particular locale, to predicting how a natural hazard phenomenon will unfold, to forecasting on a scale from hours to millennia how ecosystems will behave.None of these challenge themes can be addressed strictly by one or two science disciplines; all require well-integrated, cross-discipline thinking, data collection, and analyses. The multidisciplinary science themes that have become the focus of the USGS mission parallel the major challenges in the border region between Mexico and the United States. Because of this multidisciplinary approach, the USGS

  11. Regulatory dendritic cell therapy: from rodents to clinical application.

    Science.gov (United States)

    Raïch-Regué, Dalia; Glancy, Megan; Thomson, Angus W

    2014-10-01

    Dendritic cells (DC) are highly-specialized, bone marrow-derived antigen-presenting cells that induce or regulate innate and adaptive immunity. Regulatory or "tolerogenic" DC play a crucial role in maintaining self tolerance in the healthy steady-state. These regulatory innate immune cells subvert naïve or memory T cell responses by various mechanisms. Regulatory DC (DCreg) also exhibit the ability to induce or restore T cell tolerance in many animal models of autoimmune disease or transplant rejection. There is also evidence that adoptive transfer of DCreg can regulate T cell responses in non-human primates and humans. Important insights gained from in vitro studies and animal models have led recently to the development of clinical grade human DCreg, with potential to treat autoimmune disease or enhance transplant survival while reducing patient dependency on immunosuppressive drugs. Phase I trials have been conducted in type-1 diabetes and rheumatoid arthritis, with results that emphasize the feasibility and safety of DCreg therapy. This mini-review will outline how observations made using animal models have been translated into human use, and discuss the challenges faced in further developing this form of regulatory immune cell therapy in the fields of autoimmunity and transplantation. Copyright © 2013 Elsevier B.V. All rights reserved.

  12. Web-Based vs. Face-to-Face MBA Classes: A Comparative Assessment Study

    Science.gov (United States)

    Brownstein, Barry; Brownstein, Deborah; Gerlowski, Daniel A.

    2008-01-01

    The challenges of online learning include ensuring that the learning outcomes are at least as robust as in the face-to-face sections of the same course. At the University of Baltimore, both online sections and face-to-face sections of core MBA courses are offered. Once admitted to the MBA, students are free to enroll in any combination of…

  13. Challenges for health care providers, parents and patients who face a child hood cancer diagnosis in Zambia.

    Science.gov (United States)

    Walubita, Mulima; Sikateyo, Bornwell; Zulu, Joseph M

    2018-05-02

    Zambia is experiencing high prevalence of childhood cancer. However, very few children access and complete treatment for cancer. This study aimed to document the challenges for health care providers, parents and patients who face a child hood cancer diagnosis in Zambia, and their coping strategies. This was an exploratory health facility-based qualitative study that was conducted at a Paediatric oncology ward at referral hospital in Zambia. In-depth individual interviews conducted with fifteen (15) caregivers and seven (7) key informants were analysed using thematic analysis. Several challenges related to managing the childhood cancer diagnosis were recorded. Individual and family challenges were inadequate knowledge on childhood cancer, lack of finances to meet treatment and transport costs as well as long period of hospitalisation that affected women's ability to perform multiple responsibilities. Whereas challenges at community level were inadequate support to address emotional and physical distress and social stigmatisation experienced by caregivers. Health systems issues included inadequate specialised health workers, poor communication among health workers, limited space and beds as well as insufficient supplies such as blood. Cultural related factors were the belief that cancer is a product of witchcraft as well as religious beliefs regarding the role of faith healing in childhood cancer treatment. Coping strategies used by parents/ caregivers included praying to God, material support from organisations and church as well as delaying having another child. Addressing the challenges for health care providers, parents and patients who face a childhood cancer diagnosis may require adopting a systems or an ecological approach that allows developing strategies that simultaneously address challenges related to the individual, family, community, health system and cultural aspects.

  14. Improving nuclear regulation. NEA regulatory guidance booklets volumes 1-14

    International Nuclear Information System (INIS)

    2011-01-01

    A common theme throughout the series of NEA regulatory guidance reports, or 'green booklets', is the premise that the fundamental objective of all nuclear safety regulatory bodies is to ensure that nuclear facilities are continuously maintained and operated in an acceptably safe manner. In meeting this objective the regulator must bear in mind that it is the operator that has responsibility for safely operating the nuclear facility; the role of the regulator is to assess and to provide assurance regarding the operator's activities in terms of assuming that responsibility. The full series of these reports was brought together in one edition for the first time in 2009 and was widely found to be a useful resource. This second edition comprises 14 volumes, including the latest on The Nuclear Regulator's Role in Assessing Licensee Oversight of Vendor and Other Contracted Services. The reports address various challenges that could apply throughout the lifetime of a nuclear facility, including design, siting, manufacturing, construction, commissioning, operation, maintenance and decommissioning. The compilation is intended to serve as a knowledge management tool both for current regulators and the new nuclear professionals and organisations entering the regulatory field. Contents: Executive Summary; Regulatory Challenges: 1. The Role of the Nuclear Regulator in Promoting and Evaluating Safety Culture; 2. Regulatory Response Strategies for Safety Culture Problems; 3. Nuclear Regulatory Challenges Related to Human Performance; 4. Regulatory Challenges in Using Nuclear Operating Experience; 5. Nuclear Regulatory Review of Licensee Self-assessment (LSA); 6. Nuclear Regulatory Challenges Arising from Competition in Electricity Markets; 7. The Nuclear Regulatory Challenge of Judging Safety Back-fits; 8. The Regulatory Challenges of Decommissioning Nuclear Reactors; 9. The Nuclear Regulator's Role in Assessing Licensee Oversight of Vendor and Other Contracted Services

  15. Operational HOF Practices in the AREVA Group to Face New Challenges

    International Nuclear Information System (INIS)

    Coye de Brunélis, T.; Bachellerie, E.; Sidaner, J.-F.

    2016-01-01

    Operating experience from TMI and and more general experience from three decades of nuclear facility operations, have shown the value of safety culture’s contribution to nuclear risk management. More than ever, this particular aspect of human and organizational factors (HOF) is central to the AREVA group’s concerns as it faces new challenges. The first generation of operators commissioned the facilities and optimized their operation. This first phase gave them a better understanding of operations and related limits, particularly through testing and start-up operations and the responses that were found for all of the technical issues that arose. All of these interactions offered opportunities to make the safety challenges of processes and facilities tangible and directly perceptible. The young operators of those bygone years are now the ones who are “in the know” in the organizations, the ones with unique technical know-how and a multi-layered perception of the risks involved. Those first generations of operators, with their unique operational knowledge, are gradually leaving the industrial world. Replacing those skills creates a new set of challenges. Concomitantly, the French nuclear safety authority benefited from these facility start-ups to increase its skills by sharing in the learning process concerning the facilities’ operational realities and in the construction of a safety configuration program, and by gaining a concrete perception of risk. This fostered the mutual trust that is vital and integral to facility safety.

  16. Safety-Related Contractor Activities at Nuclear Power Plants. New Challenges for Regulatory Oversight

    International Nuclear Information System (INIS)

    Chockie, Alan

    2005-09-01

    The use of contractors has been an integral and important part of the design, construction, operation, and maintenance of nuclear power plants. To ensure the safe and efficient completion of contracted tasks, each nuclear plant licensee has developed and refined formal contract management processes to meet their specific needs and plant requirements. Although these contract management processes have proven to be effective tools for the procurement of support and components tailored to the needs of nuclear power plants, contractor-related incidents and accidents have revealed some serious weaknesses with the implementation of these processes. Identifying and addressing implementation problems are becoming more complicated due to organizational and personnel changes affecting the nuclear power industry. The ability of regulators and licensees to effectively monitor and manage the safety-related performance of contractors will likely be affected by forthcoming organization and personnel changes due to: the aging of the workforce; the decline of the nuclear industry; and the deregulation of nuclear power. The objective of this report is to provide a review of current and potential future challenges facing safety-related contractor activities at nuclear power plants. The purpose is to assist SKI in establishing a strategy for the proactive oversight of contractor safety-related activities at Swedish nuclear power plants and facilities. The nature and role of contractors at nuclear plants is briefly reviewed in the first section of the report. The second section describes the essential elements of the contract management process. Although organizations have had decades of experience with the a contract management process, there remain a number of common implantation weaknesses that have lead to serious contractor-related incidents and accidents. These implementation weaknesses are summarized in the third section. The fourth section of the report highlights the

  17. Safety-Related Contractor Activities at Nuclear Power Plants. New Challenges for Regulatory Oversight

    Energy Technology Data Exchange (ETDEWEB)

    Chockie, Alan [Chockie Group International, Inc., Seattle, WA (United States)

    2005-09-15

    The use of contractors has been an integral and important part of the design, construction, operation, and maintenance of nuclear power plants. To ensure the safe and efficient completion of contracted tasks, each nuclear plant licensee has developed and refined formal contract management processes to meet their specific needs and plant requirements. Although these contract management processes have proven to be effective tools for the procurement of support and components tailored to the needs of nuclear power plants, contractor-related incidents and accidents have revealed some serious weaknesses with the implementation of these processes. Identifying and addressing implementation problems are becoming more complicated due to organizational and personnel changes affecting the nuclear power industry. The ability of regulators and licensees to effectively monitor and manage the safety-related performance of contractors will likely be affected by forthcoming organization and personnel changes due to: the aging of the workforce; the decline of the nuclear industry; and the deregulation of nuclear power. The objective of this report is to provide a review of current and potential future challenges facing safety-related contractor activities at nuclear power plants. The purpose is to assist SKI in establishing a strategy for the proactive oversight of contractor safety-related activities at Swedish nuclear power plants and facilities. The nature and role of contractors at nuclear plants is briefly reviewed in the first section of the report. The second section describes the essential elements of the contract management process. Although organizations have had decades of experience with the a contract management process, there remain a number of common implantation weaknesses that have lead to serious contractor-related incidents and accidents. These implementation weaknesses are summarized in the third section. The fourth section of the report highlights the

  18. Facing the challenges of nuclear power at Ontario Power Generation

    International Nuclear Information System (INIS)

    Howes, H.

    1999-01-01

    Nuclear power represents a major portion of Ontario Power Generation's generation mix and it will be the bedrock upon which we build a successful, competitive company. Our nuclear units offer many environmental and economic benefits, the one most relevant to this meeting is their significant contribution to the relatively low carbon intensity of Ontario's and Canada's electricity supply. In recent weeks, we have listened with great interest to the endorsement by our federal Minister of the Environment of nuclear technology as a means of reducing global warming. But endorsements of this type alone are not sufficient to ensure that nuclear remains an acceptable option for managing greenhouse gas emissions. Without public acceptance and support, the entire nuclear investment is endangered. At OPG we face three challenges to building this public support: we must continue to improve our safety margins and operating performance; we must continue to improve the environmental performance at our stations; and we must increase our community outreach. Today I would like to focus on the last two challenges and the actions that we are taking to maintain our social and environmental 'licence to operate.' But before I describe these initiatives, I will tell you about: the new company - Ontario Power Generation; the changes in store for Ontario's electricity sector; and our greenhouse gas emissions - the legacy from Ontario Hydro. (author)

  19. Side-View Face Recognition

    NARCIS (Netherlands)

    Santemiz, P.; Spreeuwers, Lieuwe Jan; Veldhuis, Raymond N.J.

    2010-01-01

    Side-view face recognition is a challenging problem with many applications. Especially in real-life scenarios where the environment is uncontrolled, coping with pose variations up to side-view positions is an important task for face recognition. In this paper we discuss the use of side view face

  20. Faces

    DEFF Research Database (Denmark)

    Mortensen, Kristine Køhler; Brotherton, Chloe

    2018-01-01

    for the face the be put into action. Based on an ethnographic study of Danish teenagers’ use of SnapChat we demonstrate how the face is used as a central medium for interaction with peers. Through the analysis of visual SnapChat messages we investigate how SnapChat requires the sender to put an ‘ugly’ face...... already secured their popular status on the heterosexual marketplace in the broad context of the school. Thus SnapChat functions both as a challenge to beauty norms of ‘flawless faces’ and as a reinscription of these same norms by further manifesting the exclusive status of the popular girl...

  1. Scientific and regulatory challenges in evaluating clinical trial protocols for HIV-1/AIDS vaccines - A review from a regulatory perspective.

    Science.gov (United States)

    Sheets, Rebecca L; Zhou, TieQun; Knezevic, Ivana

    2016-03-01

    Clinical development of prophylactic HIV/AIDS vaccines presents many scientific challenges that result in challenges for regulators reviewing clinical trial applications (CTAs). The World Health Organization (WHO) has the responsibility to provide technical support to these regulators. The search for an HIV/AIDS vaccine will only succeed through well-designed, -conducted and -controlled human efficacy studies reviewed and approved by regulators in countries worldwide, particularly in countries where the epidemic has hit hardest, such as in sub-Saharan Africa and Asia. This review summarizes the current candidates in development and focuses on challenges regulators face when reviewing CTAs, such as the evolving landscape of "standard of prevention," trials in adolescents, adaptive trial designs, correlates of protection and their analysis, and access to successful vaccines. There are many unknowns in the field of HIV/AIDS vaccine development and often, there is not a clear right or wrong approach because of the scientific challenges described in this review. Consequently, regulators should not feel that decisions need be made in isolation, when there are many available international collaborative efforts and opportunities to seek expert advice. The WHO provides many such opportunities and support to regulators across the globe. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  2. Challenges faced in rural hospitals: the experiences of nurse managers in Uganda.

    Science.gov (United States)

    Kakyo, T A; Xiao, L D

    2018-04-19

    The aim of this study was to understand nurse ward managers perceived challenges in the rural healthcare setting in Uganda. The health workforce, essential medicines and equipment and political unrest are the main factors affecting the international community in addressing the hefty disease burden in World Health Organization African regions. Nurse ward managers have an important role to play to mitigate these factors in health facilities in these regions through leadership, supervision and support for staff. This study utilized interpretive phenomenology based on Gadamer's hermeneutical principles. Eleven nurse managers from two rural public hospitals in Uganda were interviewed. Those with more than a 2-year experience in their management role were invited to participate in the study. Nurse managers pointed out four major challenges with staffing, while they worked in the rural healthcare settings. These are summarized into themes: 'Numbers do matter'; 'I cannot access them when I need them at work'; 'Challenges in dealing with negative attitudes'; and 'Questioning own ability to manage health services'. Health facilities in rural areas face extremely low staff-to-patient ratio, a high level of workload, lack of essential medicines and equipment, low salaries and delayed payment for staff. Nurse managers demonstrated situation-based performance to minimize the impact of these challenges on the quality and safety of patient care, but they had less influence on policy and resource development. It is imperative to mobilize education for nurse ward managers to enable them to improve leadership, management skills and to have a greater impact on policy and resource development. © 2018 International Council of Nurses.

  3. Challenges faced by nurses in managing pain in a critical care setting.

    Science.gov (United States)

    Subramanian, Pathmawathi; Allcock, Nick; James, Veronica; Lathlean, Judith

    2012-05-01

    To explore nurses' challenges in managing pain among ill patients in critical care. Pain can lead to many adverse medical consequences and providing pain relief is central to caring for ill patients. Effective pain management is vital since studies show patients admitted to critical care units still suffer from significant levels of acute pain. The effective delivery of care in clinical areas remains a challenge for nurses involved with care which is dynamic and constantly changing in critically ill. Qualitative prospective exploratory design. This study employed semi structured interviews with nurses, using critical incident technique. Twenty-one nurses were selected from critical care settings from a large acute teaching health care trust in the UK. A critical incident interview guide was constructed from the literature and used to elicit responses. Framework analysis showed that nurses perceived four main challenges in managing pain namely lack of clinical guidelines, lack of structured pain assessment tool, limited autonomy in decision making and the patient's condition itself. Nurses' decision making and pain management can influence the quality of care given to critically ill patients. It is important to overcome the clinical problems that are faced when dealing with pain experience. There is a need for nursing education on pain management. Providing up to date and practical strategies may help to reduce nurses' challenges in managing pain among critically ill patients. Broader autonomy and effective decision making can be seen as beneficial for the nurses besides having a clearer and structured pain management guidelines. © 2011 Blackwell Publishing Ltd.

  4. Challenges faced by nuclear research centres in Indonesia

    International Nuclear Information System (INIS)

    Subki, I.R.; Soentono, S.

    2001-01-01

    Nuclear research centres in Indonesia are mainly owned and operated by the National Nuclear Energy Agency, covering basically various research and development facilities for non-energy and energy related activities. The research and development activities cover a broad spectrum of basic, applied, and developmental research involving nuclear science and technology in supporting various fields ranging from basic human needs, e.g. food and health; natural resources and nuclear and environmental safety; as well as industry. Recent economic crisis, triggered by monetary turmoil, has dictated the IAEA to face new challenges and to give more efforts on the application of the so called 'instant technology' i.e. the technology which has been developed and is ready for implementation, especially on food and health, to be better utilized to overcome various problems in the society. Various short and medium term programmes on the application of isotopes, radiation, and nuclear techniques for non-energy related activities have emerged in accord with these efforts. In this regard, besides the intensification of the instant technology implementation on food and health, the nuclear research and development on food plant mutation, fertilizers, radio-vaccines, production of meat and milk, production processes of various radiopharmaceuticals, and radioisotopes as well as radiation processing related to agro-industry have to be intensified using the available laboratories processing facilities. The possibility of the construction of irradiators for post harvesting processes in some provinces is being studied, while the designing and manufacturing of various prototypes of devices, equipment, and instruments for nuclear techniques in health and industry are continued. Considering the wide applications of accelerators for non-energy and energy related research and development, construction of accelerator-based laboratories is being studied. In energy related research the feasibility of

  5. The Human Face of Digital Preservation: Organizational and Staff Challenges, and Initiatives at the Bibliothèque nationale de France

    Directory of Open Access Journals (Sweden)

    Emmanuelle Bermès

    2011-03-01

    Full Text Available The process of setting up a digital preservation repository in compliance with the OAIS model is not only a technical challenge: libraries also need to develop and maintain appropriate skills and organizations. Digital activities, including digital preservation, are nowadays moving into the mainstream activity of the Library and are integrated in its workflows.The Bibliothèque nationale de France (BnF has been working on the definition of digital preservation activities since 2003. This paper aims at presenting the organizational and human resources challenges that have been faced by the library in this context, and those that are still awaiting us.The library has been facing these challenges through a variety of actions at different levels: organizational changes, training sessions, dedicated working group and task forces, analysis of skills and processes, etc. The results of these actions provide insights on how a national library is going digital, and what is needed to reach this longstanding goal.

  6. Technological challenges at ITER plasma facing components production in Russia

    Energy Technology Data Exchange (ETDEWEB)

    Mazul, I.V., E-mail: mazuliv@niiefa.spb.su [Efremov Institute, 196641 St. Petersburg (Russian Federation); Belyakov, V.A.; Gervash, A.A.; Giniyatulin, R.N.; Guryeva, T.M.; Kuznetsov, V.E.; Makhankov, A.N.; Okunev, A.A. [Efremov Institute, 196641 St. Petersburg (Russian Federation); Sevryukov, O.N. [MEPhI, 115409 Moscow (Russian Federation)

    2016-11-01

    Highlights: • Technological aspects of ITER PFC manufacturing in Russia are presented. • Range of technologies to be used during manufacturing of ITER PFC at Efremov Institute has been, in general, defined and their complexity, originality and difficulty are described. • Some features and challenges of welding, brazing and various tests are discussed. - Abstract: Major part of ITER plasma facing components will be manufactured in the Russian Federation (RF). Operational conditions and other requirements to these components, as well as the scale of production, are quite unique. These unique features and related technological solutions found in the frame of the project are discussed. Procedure breakdown and results of qualification for the proposed technologies and potential producers are presented, based on mockups production and testing. Design of qualification mockups and prototypes, testing programs and results are described. Basic quantitative and qualitative parameters of manufactured components and methods of quality control are presented. Critical manufacturing issues and prospects for unique production for future fusion needs are discussed.

  7. Challenges facing primary school educators of English Second (or Other Language learners in the Western Cape

    Directory of Open Access Journals (Sweden)

    Julie O'Connor

    2009-05-01

    Full Text Available We were prompted by the prevalence of English Second or Other Language (ESOL learners identified by educators as having language disorders and being referred for Speech-Language Therapy. We describe challenges faced by Grade 1, 2 and 3 educators at government schools in the Cape Metropolitan area who were working with such learners. Applying a mixed-methods descriptive design, a self-administered questionnaire and three focus groups were used for data collection. Educator perceptions and experiences regarding ESOL learners were described. Some participant educators at schools that were not former Model C schools had large classes, including large proportions of ESOL learners. Fur­thermore, there was a shortage of educators who were able to speak isiXhosa, the most frequently occurring first (or home language of the region's ESOL learners. Challenges faced by educators when teaching ESOL learners included learners' academic and socio-emotional difficulties and a lack of parent in­volvement in their children's education. Participant educators indicated a need for departmental, professional and parental support, and additional training and resources. Implications and recommendations for speech-language thera­pist and educator collaborations and speech-language therapists' participation in educator training were identified.

  8. Lost in Translation: Adapting a Face-to-Face Course Into an Online Learning Experience.

    Science.gov (United States)

    Kenzig, Melissa J

    2015-09-01

    Online education has grown dramatically over the past decade. Instructors who teach face-to-face courses are being called on to adapt their courses to the online environment. Many instructors do not have sufficient training to be able to effectively move courses to an online format. This commentary discusses the growth of online learning, common challenges faced by instructors adapting courses from face-to-face to online, and best practices for translating face-to-face courses into online learning opportunities. © 2015 Society for Public Health Education.

  9. Tolerance to spatial-relational transformations in unfamiliar faces: A further challenge to a configural processing account of identity recognition.

    Science.gov (United States)

    Lorenzino, Martina; Caminati, Martina; Caudek, Corrado

    2018-05-25

    One of the most important questions in face perception research is to understand what information is extracted from a face in order to recognize its identity. Recognition of facial identity has been attributed to a special sensitivity to "configural" information. However, recent studies have challenged the configural account by showing that participants are poor in discriminating variations of metric distances among facial features, especially for familiar as opposed to unfamiliar faces, whereas a configural account predicts the opposite. We aimed to extend these previous results by examining classes of unfamiliar faces with which we have different levels of expertise. We hypothesized an inverse relation between sensitivity to configural information and expertise with a given class of faces, but only for neutral expressions. By first matching perceptual discriminability, we measured tolerance to subtle configural transformations with same-race (SR) versus other-race (OR) faces, and with upright versus upside-down faces. Consistently with our predictions, we found a lower sensitivity to at-threshold configural changes for SR compared to OR faces. We also found that, for our stimuli, the face inversion effect disappeared for neutral but not for emotional faces - a result that can also be attributed to a lower sensitivity to configural transformations for faces presented in a more familiar orientation. The present findings question a purely configural account of face processing and suggest that the role of spatial-relational information in face processing varies according to the functional demands of the task and to the characteristics of the stimuli. Copyright © 2018 Elsevier B.V. All rights reserved.

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

    Science.gov (United States)

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

    2016-04-01

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

  11. Regulatory barriers to clinical trial enrollment of adolescent and young adult oncology patients.

    Science.gov (United States)

    Felgenhauer, Judy; Hooke, Mary C

    2014-06-01

    Adolescent and young adult (AYA) patients with cancer may face unique challenges if they and their families wish to participate in clinical oncology trials. Regulatory guidelines and funding requirements put in place to protect patients may actually raise barriers to enrollment in clinical trials. Hospital age guidelines may need to be readdressed to better suit the needs of AYA patients. Finally, the creation of the National Clinical Trials Network will provide new opportunities for pediatric and medical oncologists to collaborate in the care of AYA patients. Copyright © 2014 by the American Academy of Pediatrics.

  12. Development of Critical Thinking Skills through Writing Tasks: Challenges Facing Maritime English Students at Aqaba College, AlBalqa Applied University, Jordan

    Science.gov (United States)

    Alidmat, Ali Odeh Hammoud; Ayassrah, Mohamed Ayed

    2017-01-01

    Teaching English for Special Purposes (ESP) in a context where English is taught as a Foreign Language (EFL) is no easy task. There is in fact extensive research reporting on challenges facing both teacher and student in the Foreign Language classroom where language skills must be learnt outside their usual context. Even more challenging is…

  13. Challenges Involved in the Development and Delivery of Abuse-deterrent Formulations of Opioid Analgesics.

    Science.gov (United States)

    Cohen, Joshua P; Mendoza, Mario; Roland, Carl

    2018-02-01

    This commentary examines the development, regulatory, and reimbursement challenges facing abuse-deterrent formulation (ADF) products. In January 2017, the Tufts Center for the Study of Drug Development convened a roundtable to explore clinical development, regulatory, and reimbursement challenges with respect to ADFs of opioid analgesics. Roundtable participants, who included a range of pharmaceutical industry and other experts, discussed multiple challenges. First, several key clinical development challenges were identified and discussed. These challenges pertain to prodrug development and development of deterrents against oral abuse. Second, experts suggested that more clarity is needed from regulatory authorities regarding standards for proving ADF labeling claims and for being rewarded with 3-year data exclusivity. Similarly, given the substantial burdens associated with the development of postapproval evidence generation, experts raised the need for a consistent regulatory policy related to postapproval evidence generation for all ADFs (branded and generic). Third, despite the public health benefits of certain ADF products, current coverage and access policies impede patient access. Payer justification for restrictive policies appears to be based more on budget impact considerations than cost-effectiveness. Fourth, there remains a need to further expand the evidence base regarding clinical and cost-effectiveness as well as abuse deterrence in a real-world setting for all ADF products. Clinical development challenges need to be overcome with respect to novel ADF technologies, such as prodrugs and deterrents against oral abuse. More clarity is needed from regulatory authorities on labeling claims and data exclusivity eligibility with respect to ADFs. Ensuring prescriber training and awareness of various options for treating pain, including ADF products, is an important step, as is educating payers about the public health benefits of ADFs in appropriate

  14. Animal models of binge drinking, current challenges to improve face validity.

    Science.gov (United States)

    Jeanblanc, Jérôme; Rolland, Benjamin; Gierski, Fabien; Martinetti, Margaret P; Naassila, Mickael

    2018-05-05

    Binge drinking (BD), i.e., consuming a large amount of alcohol in a short period of time, is an increasing public health issue. Though no clear definition has been adopted worldwide the speed of drinking seems to be a keystone of this behavior. Developing relevant animal models of BD is a priority for gaining a better characterization of the neurobiological and psychobiological mechanisms underlying this dangerous and harmful behavior. Until recently, preclinical research on BD has been conducted mostly using forced administration of alcohol, but more recent studies used scheduled access to alcohol, to model more voluntary excessive intakes, and to achieve signs of intoxications that mimic the human behavior. The main challenges for future research are discussed regarding the need of good face validity, construct validity and predictive validity of animal models of BD. Copyright © 2018 Elsevier Ltd. All rights reserved.

  15. [The Quebec Healthy Cities and Towns Network: a powerful movement faced with new challenges].

    Science.gov (United States)

    Simard, Paule

    2007-01-01

    After twenty years serving its members, the Quebec Healthy Cities and Towns Network (QHCTN) faces several challenges. There are currently many changes being made in the local organization and the administration of services. The Network, through its capacity to mobilize the different municipalities, is the best placed to advocate and support a coordinated approach to government initiatives and also to encourage partnerships with other institutions (education, health, socio-economic) and communities. There is, nonetheless, a need to rethink its direct support to members, especially in terms of communication and networking among them.

  16. Challenges of microtome‐based serial block‐face scanning electron microscopy in neuroscience

    Science.gov (United States)

    WANNER, A. A.; KIRSCHMANN, M. A.

    2015-01-01

    Summary Serial block‐face scanning electron microscopy (SBEM) is becoming increasingly popular for a wide range of applications in many disciplines from biology to material sciences. This review focuses on applications for circuit reconstruction in neuroscience, which is one of the major driving forces advancing SBEM. Neuronal circuit reconstruction poses exceptional challenges to volume EM in terms of resolution, field of view, acquisition time and sample preparation. Mapping the connections between neurons in the brain is crucial for understanding information flow and information processing in the brain. However, information on the connectivity between hundreds or even thousands of neurons densely packed in neuronal microcircuits is still largely missing. Volume EM techniques such as serial section TEM, automated tape‐collecting ultramicrotome, focused ion‐beam scanning electron microscopy and SBEM (microtome serial block‐face scanning electron microscopy) are the techniques that provide sufficient resolution to resolve ultrastructural details such as synapses and provides sufficient field of view for dense reconstruction of neuronal circuits. While volume EM techniques are advancing, they are generating large data sets on the terabyte scale that require new image processing workflows and analysis tools. In this review, we present the recent advances in SBEM for circuit reconstruction in neuroscience and an overview of existing image processing and analysis pipelines. PMID:25907464

  17. Air toxics regulatory issues facing urban settings

    Energy Technology Data Exchange (ETDEWEB)

    Olden, K.; Guthrie, J. [National Institute of Environmental Health Sciences, Research Triangle Park, NC (United States)

    1996-10-01

    Biomarker research does not exist in isolation. Its usefulness can only be realized when it is translated into prevention strategies to protect public health. In the context of air toxics, these prevention strategies begin with the development of regulatory standards derived from risk assessment schemes. The Clean Air Act Amendments of 1990 list 189 air toxics, including many volatile organics, metals, and pesticides. The National Institute of Environmental Health Sciences (NIEHS), through its affiliation with the National Toxicology Program, has generated toxicity and carcinogenicity data on more than 100 of these air toxics. The NIEHS extramural and intramural research portfolios support a variety of projects that develop and validate biomarkers for use in environmental health science and risk assessment. Biomarkers have a tremendous potential in the areas of regulating air toxics and protecting public health. Risk assessors need data provided by biomarkers of exposure, biomarkers of close/pharmacokinetics, biomarkers of susceptibility or individual variability, and biomarkers of effects. The greatest benefit would be realized if biomarkers could be employed in four areas of primary and secondary prevention. The first is the use of biomarkers to enhance extrapolation of animal data to human exposure situations in establishing risk standards. The second is the use of biomarkers that assess noncancer, as well as cancer, end points. Important health end points include pulmonary dysfunction, immunotoxicity, and neurotoxicity. Third, biomarkers that serve as early warning signs to detect intermediate effects would enhance our ability to design timely and cost-effective intervention strategies. Finally, biomarkers used to evaluate the effectiveness of intervention strategies both in clinical and regulatory settings, would enable us to ensure that programs designed to protect public health do, in fact, achieve the desired outcome. 9 refs., 2 tabs.

  18. Challenges Facing Managers in Managing Conflict in Schools in the South and South Central Regions of Botswana

    Science.gov (United States)

    Morake, Nnior Machomi; Monobe, Ratau John; Dingwe, Stephonia

    2011-01-01

    The purpose of this study was to examine the challenges facing managers in managing conflict in schools of South and South Central Regions of Botswana. In this study, the schedule of interview was used to collect empirical data. A random sample of 50 school managers and deputy school managers was selected for interviews. Major findings of the…

  19. Tolerogenic dendritic cells for regulatory T cell induction in man

    Directory of Open Access Journals (Sweden)

    Verena eRaker

    2015-11-01

    Full Text Available Dendritic cells are (DC highly specialized professional antigen-presenting cells (APC that regulate immune responses, maintaining the balance between tolerance and immunity. Mechanisms via which they can promote central and peripheral tolerance include clonal deletion, inhibition of memory T cell responses, T cell anergy and induction of regulatory T cells. These properties have led to the analysis of human tolerogenic DC as a therapeutic strategy for induction or re-establishment of tolerance. In the recent years, numerous protocols for the generation of human tolerogenic DC have been developed and their tolerogenic mechanisms, including induction of regulatory T cells, are relatively well understood. Phase I trials have been conducted in autoimmune disease, with results that emphasize the feasibility and safety of treatments with tolerogenic DC. Therefore, the scientific rationale for the use of tolerogenic DC therapy in the fields of transplantation medicine and allergic and autoimmune diseases is strong. This review will give an overview on efforts and protocols to generate human tolerogenic DC with focus on IL-10-modulated DC as inducers of regulatory T cells and discuss their clinical applications and challenges faced in further developing this form of immunotherapy.

  20. Automatic landmark detection and face recognition for side-view face images

    NARCIS (Netherlands)

    Santemiz, P.; Spreeuwers, Lieuwe Jan; Veldhuis, Raymond N.J.; Broemme, Arslan; Busch, Christoph

    2013-01-01

    In real-life scenarios where pose variation is up to side-view positions, face recognition becomes a challenging task. In this paper we propose an automatic side-view face recognition system designed for home-safety applications. Our goal is to recognize people as they pass through doors in order to

  1. Using an Iterative Mixed-Methods Research Design to Investigate Schools Facing Exceptionally Challenging Circumstances within Trinidad and Tobago

    Science.gov (United States)

    De Lisle, Jerome; Seunarinesingh, Krishna; Mohammed, Rhoda; Lee-Piggott, Rinnelle

    2017-01-01

    In this study, methodology and theory were linked to explicate the nature of education practice within schools facing exceptionally challenging circumstances (SFECC) in Trinidad and Tobago. The research design was an iterative quan>QUAL-quan>qual multi-method research programme, consisting of 3 independent projects linked together by overall…

  2. When health systems are barriers to health care: challenges faced by uninsured Mexican kidney patients.

    Science.gov (United States)

    Kierans, Ciara; Padilla-Altamira, Cesar; Garcia-Garcia, Guillermo; Ibarra-Hernandez, Margarita; Mercado, Francisco J

    2013-01-01

    Chronic Kidney Disease disproportionately affects the poor in Low and Middle Income Countries (LMICs). Mexico exemplifies the difficulties faced in supporting Renal Replacement Therapy (RRT) and providing equitable patient care, despite recent attempts at health reform. The objective of this study is to document the challenges faced by uninsured, poor Mexican families when attempting to access RRT. The article takes an ethnographic approach, using interviewing and observation to generate detailed accounts of the problems that accompany attempts to secure care. The study, based in the state of Jalisco, comprised interviews with patients, their caregivers, health and social care professionals, among others. Observations were carried out in both clinical and social settings. In the absence of organised health information and stable pathways to renal care, patients and their families work extraordinarily hard and at great expense to secure care in a mixed public-private healthcare system. As part of this work, they must navigate challenging health and social care environments, negotiate treatments and costs, resource and finance healthcare and manage a wide range of formal and informal health information. Examining commonalities across pathways to adequate healthcare reveals major failings in the Mexican system. These systemic problems serve to reproduce and deepen health inequalities. A system, in which the costs of renal care are disproportionately borne by those who can least afford them, faces major difficulties around the sustainability and resourcing of RRTs. Attempts to increase access to renal therapies, therefore, need to take into account the complex social and economic demands this places on those who need access most. This paper further shows that ethnographic studies of the concrete ways in which healthcare is accessed in practice provide important insights into the plight of CKD patients and so constitute an important source of evidence in that effort.

  3. The nuclear regulatory challenge of judging safety back fits

    International Nuclear Information System (INIS)

    2002-01-01

    The economic pressures of electricity market competition have led nuclear power plant operators to seek ways to increase electricity production and to reduce operating costs at their plants. Corresponding pressures on the regulatory bodies include operator demand to reduce regulatory burdens perceived as unnecessary and general resistance to consider safety back-fits sought by the regulator. The purpose of this report is to describe potential situations giving rise to safety back-fit questions and to discuss regulatory approaches for judging the back-fits. The intended audience for this report is primarily nuclear regulators, although the information and ideas may also be of interest to nuclear operating organisations, other industry organisations and the general public. (author)

  4. Interpretative challenges in face analysis

    DEFF Research Database (Denmark)

    de Oliveira, Sandi Michele; Hernández-Flores, Nieves

    2015-01-01

    In current research on face analysis questions of who and what should be interpreted, as well as how, are of central interest. In English language research, this question has led to a debate on the concepts of P1 (laypersons, representing the “emic” perspective) and P2 (researchers, representing...... in Spanish and address forms in European Portuguese, we view P1 and P2 as being far more complex than the literature suggests, with subgroups (different types of laypersons and researchers, respectively). At the micro-level we will describe the roles each subgroup plays in the interpretative process...

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

    Science.gov (United States)

    Johnson, F Reed; Zhou, Mo

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

  6. Are reading and face processing related?

    DEFF Research Database (Denmark)

    Starrfelt, Randi; Klargaard, Solja; Petersen, Anders

    2015-01-01

    Traditionally, perceptual processing of faces and words is considered highly specialized, strongly lateralized, and largely independent. This has, however, recently been challenged by studies showing that learning to read may affect the perceptual and neural processes involved in face recognition......, a lower perceptual threshold, and higher processing speed for words compared to letters. In sum, we find no evidence that reading skills are abnormal in developmental prosopagnosia, a finding that may challenge the recently proposed hypothesis that reading development and face processing abilities...

  7. Addressing professional resource challenges facing modern utilities with technological solutions

    Energy Technology Data Exchange (ETDEWEB)

    Goldie, T. [Hydro One Networks Inc., Toronto, ON (Canada); Hodder, S. [GE Digital Energy, Toronto, ON (Canada)

    2008-07-01

    The challenges facing electric utilities regarding a shortage of highly qualified labour to maintain, refurbish and expand electrical infrastructure can be attributed to a wave of retirements in skilled employees, a shortage of entry-level workers and a rapidly increasing workload caused by investment in electricity infrastructure. Two solutions were presented for finding and sustaining an adequate personnel base. The first involved developing local talent, both entry-level and mid-career staff to ensure that work continuity and workplace safety are maintained. The second involved the implementation of technological solutions to help optimize the use of existing and future labour resources. This paper presented the human resource programs developed by Hydro One, the largest electrical transmission and distribution utility in the province of Ontario. Their initiatives include raising the profile of the utility work environment through strategic partnerships with educational institutions and developing in house offerings to supplement existing academic programs. This paper also presented a technical solution to address the resources challenges specifically associated with power system protection and control. The solution targets professional and skilled trades involved in the design, installation and maintenance of automated substations and protection and control systems. It is based on the premise that resource optimization can be achieved by reducing inconsistent design and construction practices and replacing these designs with highly standardized materials with digital communications using IEC 61850. This new technology should attract young professionals to the power engineering field while still maintaining a high comfort level with the established professional workforce. 5 refs., 4 figs.

  8. Article Commentary: The interRAI Pediatric Home Care (PEDS HC Assessment: Evaluating the Long-term Community-Based Service and Support Needs of Children Facing Special Healthcare Challenges

    Directory of Open Access Journals (Sweden)

    Charles D. Phillips

    2015-01-01

    Full Text Available The vast majority of assessment instruments developed to assess children facing special healthcare challenges were constructed to assess children within a limited age range or children who face specific conditions or impairments. In contrast, the interRAI Pediatric Home Care (PEDS HC Assessment Form was specifically designed to assess the long-term community-based service and support needs of children and youth aged from four to 20 years who face a wide range of chronic physical or behavioral health challenges. Initial research indicates that PEDS HC items exhibit good predictive validity–-explaining significant proportions of the variance in parents’ perceptions of needs, case managers’ service authorizations, and Medicaid program expenditures for long-term community-based services and supports. In addition, PEDS HC items have been used to construct scales that summarize the strengths and needs of children facing special healthcare challenges. Versions of the PEDS HC are now being used in Medicaid programs in three states in the United States.

  9. Challenges faced by women with disabilities in accessing sexual and reproductive health in Zimbabwe: The case of Chitungwiza town

    Directory of Open Access Journals (Sweden)

    Tafadzwa Rugoho

    2017-05-01

    Conclusion: The government, in partnership with other stakeholders, should address challenges faced by women with disabilities when accessing sexual and reproductive health services. Non-government, private hospitals and profit-making organisations should join hands with government in funding health requirements for women with disabilities.

  10. Missed Opportunities for Science Learning: Unacknowledged Unscientific Arguments in Asynchronous Online and Face-to-Face Discussions

    Science.gov (United States)

    Callis-Duehl, Kristine; Idsardi, Robert; Humphrey, Eve A.; Gougis, Rebekka Darner

    2018-02-01

    We explored the scientific argumentation that occurs among university biology students during an argumentation task implemented in two environments: face-to-face in a classroom and online in an asynchronous discussion. We observed 10 student groups, each composed of three students. Our analysis focused on how students respond to their peers' unscientific arguments, which we define as assertions, hypotheses, propositions, or explanations that are inaccurate or incomplete from a scientific perspective. Unscientific arguments provide opportunities for productive dissent, scientific argumentation, and conceptual development of scientifically desirable conceptions. We found that students did not respond to the majority of unscientific arguments in both environments. Challenges to unscientific arguments were expressed as a question or through explanation, although the latter was more common online than face-to-face. Students demonstrated significantly more epistemic distancing in the face-to-face environment than the online environment. We discuss the differences in discourse observed in both environments and teaching implications. We also provide direction for future research seeking to address the challenges of engaging students in productive scientific argumentation in both face-to-face and online environments.

  11. Safety assessment of immunomodulatory biologics: the promise and challenges of regulatory T-cell modulation.

    Science.gov (United States)

    Ponce, Rafael A

    2011-01-01

    Regulatory T-cell (T(reg)) modulation is developing as an important therapeutic opportunity for the treatment of a number of important diseases, including cancer, autoimmunity, infection, and organ transplant rejection. However, as demonstrated with IL-2 and TGN-1412, our understanding of the complex immunological interactions that occur with T(reg) modulation in both non-clinical models and in patients remains limited and appears highly contextual. This lack of understanding will challenge our ability to identify the patient population who might derive the highest benefit from T(reg) modulation and creates special challenges as we transition these therapeutics from non-clinical models into humans. Thus, in vivo testing in the most representative animal model systems, with careful progress in the clinic, will remain critical in developing therapeutics targeting T(reg) and understanding their clinical utility. Moreover, toxicology models can inform some of the potential liabilities associated with T(reg) modulation, but not all, suggesting a continued need to explore and validate predictive models.

  12. Challenges facing post-war tourism development: the case of Iran

    Directory of Open Access Journals (Sweden)

    Jamal Mohammadi

    2015-12-01

    Full Text Available This study presents an empirical investigation to study the post-war tourism in sought west region of Iran. This region is the host of many Iranian who wish remember the events of War between Iran and Iraq. Many high school or university students travel to the region through cultural as well as religious communities. This paper tries to analyze the challenges facing these people when they travel to province of Khozestan, Iran. The study designs a questionnaire in Likert scale and distributes it among some randomly selected people who visited the region. The implementation of Pearson correlation test has determined that “Weakness of tourism infrastructure facilities and services” is to be blamed the most followed by “Underdevelopment of decision making centers”. Moreover, path analysis has been implemented to detect direct and indirect effects of different factors on development of tourism in the region. In our survey, marketing, culture and weakness in infrastructures have been determined the most important factors influencing on development of the region.

  13. Regulatory challenges in using nuclear operating experience

    International Nuclear Information System (INIS)

    2006-01-01

    There can be no doubt that the systematic evaluation of operating experience by the operator and the regulator is essential for continued safe operation of nuclear power plants. Recent concerns have been voiced that the operating experience information and insights are not being used effectively to promote safety. If these concerns foreshadow a real trend in OECD countries toward complacency in reporting and analysing operating events and taking corrective actions, then past experience suggests that similar or even more serious events will recur. This report discusses how the regulator can take actions to assure that operators have effective programmes to collect and analyse operating experience and, just as important, for taking steps to follow up with actions to prevent the events and conditions from recurring. These regulatory actions include special inspections of an operator operating experience programme and discussion with senior plant managers to emphasize the importance of having an effective operating experience programme. In addition to overseeing the operator programmes, the regulator has the broader responsibility for assuring that industry-wide trends, both national and international are monitored. To meet these responsibilities, the regulatory body must have its own operating experience programme, and this report discusses the important attributes of such regulatory programmes. It is especially important for the regulator to have the capability for assessing the full scope of operating experience issues, including those that may not be included in an operator operating experience programme, such as new research results, international operating experience, and broad industry trend information. (author)

  14. Legal, regulatory & institutional issues facing distributed resources development

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1996-10-01

    This report describes legal, regulatory, and institutional considerations likely to shape the development and deployment of distributed resources. It is based on research co-sponsored by the National Renewable Energy Laboratory (NREL) and four investor-owned utilities (Central & South West Services, Cinergy Corp., Florida Power Corporation, and San Diego Gas & Electric Company). The research was performed between August 1995 and March 1996 by a team of four consulting firms experienced in energy and utility law, regulation, and economics. It is the survey phase of a project known as the Distributed Resources Institutional Analysis Project.

  15. Challenges of atomic energy regulation in Indian context

    International Nuclear Information System (INIS)

    Bajaj, S.S.

    2010-01-01

    Over the years, India has mastered all the stages of the nuclear fuel cycle, which include mining, processing and fabrication of nuclear fuel; design, construction, and operation of nuclear power reactors and research reactors; reprocessing of spent fuel and management of radioactive wastes. Ionising radiation is also used widely in medical, industrial and research areas. Since its inception, Department of Atomic Energy (DAE) was enforcing radiological safety in the country through in-house or ad-hoc committees, till a dedicated regulatory body (AERB) was set up 25 years ago. Today India is operating 19 nuclear power plants with different vintages (2 BWRs and 17 PHWRs) and another 8 (1 PFBR, 5 PHWRs and 2 PWRs) are in various stages of construction. Recently there are new evolutionary reactors (AHWRs) for which design has been completed and are on the threshold for consideration for construction. To match the rapid growth in the need for power India is also about to take up construction of large evolutionary PWRs of foreign design. This variety in the Indian nuclear power programme has come up due to a systematic evaluation and optimisation of the resources and technology available within the country. Added to this is the growing use of radiation in non-power applications. As the safety supervision of this huge programme is the responsibility of AERB, it faces various challenges, like, - Strategies for regulating wide variety of nuclear and radiation facilities with wide dispersal; - Meeting present day expectations with regard to nuclear and radiation safety and nuclear security; - The safety and security of large number of radioactive sources spread over such a vast country and of the associated import/export guidance; - Ensuring safety of old plants by periodic reviews and by prescribing adequate safety upgradation and ageing management programme; -Adaptation of the regulatory system and of regulations to new and foreign design nuclear technologies and

  16. Challenges Faced by Development Partners in Supporting the Growth and Development of Commercial Enterprises in Lira District, Northern Uganda

    Science.gov (United States)

    Eton, Marus; Mwirumubi, Richard; Edaku, Charles

    2017-01-01

    Entrepreneurship is defined as the process where an individual discovers, evaluates and exploit opportunities independently. Most countries have embraced entrepreneurship development as ways of creating employment and economic growth and development. The objective of the study was to examine the challenges faced by commercial enterprises in Lira…

  17. Strengthening Regulatory Effectiveness in India – Lessons Learnt from Fukushima Accident

    International Nuclear Information System (INIS)

    Solanki, R.

    2016-01-01

    Following the Fukushima Daiichi accident in Japan, one of the most important lessons learnt, among other things, was the issue of strengthening the effectiveness of the regulatory bodies. Immediately after the Fukushima accident, National level safety audits were conducted on all operating NPPs in India to review safety of NPPs in India. A national action plan has been prepared to implement the identified short term, midterm and long term measures. The assessment indicates that national response to the Fukushima Accident for safety assessment of NPPs and subsequent actions and initiatives taken for safety enhancement of the NPPs in India are in-line with the objectives of the IAEA Action plan. This paper highlights the actions taken by India in the light of Fukushima Daiichi accident in order to strengthen the regulatory effectiveness through improvements in the existing core processes, challenges faced, Insights gained from the recent initiatives on safety performance indicators and assessment of safety culture, relevant observations of IRRS mission report and Indian perspectives on the further cooperation among the member states for enhancing the regulatory effectiveness for nuclear oversight of regulated organizations. (author)

  18. Side-View Face Recognition

    NARCIS (Netherlands)

    Santemiz, P.; Spreeuwers, Lieuwe Jan; Veldhuis, Raymond N.J.; van den Biggelaar, Olivier

    As a widely used biometrics, face recognition has many advantages such as being non-intrusive, natural and passive. On the other hand, in real-life scenarios with uncontrolled environment, pose variation up to side-view positions makes face recognition a challenging work. In this paper we discuss

  19. Supply constraints : Australia and Canada coal industry face logistics and capacity challenges

    International Nuclear Information System (INIS)

    Borsato, J.

    2010-01-01

    Australia and Canada are benefiting from a global increase in coal consumption, but face challenges regarding coal and coal export capacity. Coal is Australia's biggest export commodity, accounting for over 50 percent of world coking coal exports, with almost 75 percent of those exports destined for Asian markets, primarily Japan. However, the number of ships delayed at Australian ports hit a record of 223 bulk carriers in early 2010. Compared to Canada, Australia faces greater logistical issues getting coal into port and onto ships at its 9 loading terminals. Two of Canada's 3 major shipping terminals, Westshore and Neptune, have some additional capacity. Its third terminal, Ridley Island, has considerable potential to carry more coal. With 98 percent of all coal moved by rail in Australia, rail issues also hinder growth. A national approach to planning freight transport on both roads and rail is being developed. While infrastructure issues remain the single greatest barrier to export growth for Australia's coal sector, Canada's most immediate issues pertain to mine permitting and mine-site expansion. In 2009, Canada exported 28 million tonnes of coal, 90 percent of it metallurgical. With approximately 70 million tonnes of annual production, mostly in British Columbia and Alberta, coal remains the number one commodity in Canada carried by rails and shipped from ports. 1 fig.

  20. What are the challenges facing our industry

    International Nuclear Information System (INIS)

    1998-01-01

    This presentation relates to the changing business climate of the petroleum industry worldwide. The author gives a touch on the changes of what the industry is facing and the response together with the keys to long-term shareholder value

  1. What are the challenges facing our industry

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1998-12-01

    This presentation relates to the changing business climate of the petroleum industry worldwide. The author gives a touch on the changes of what the industry is facing and the response together with the keys to long-term shareholder value

  2. 47 CFR 1.1167 - Error claims related to regulatory fees.

    Science.gov (United States)

    2010-10-01

    ...) Challenges to determinations or an insufficient regulatory fee payment or delinquent fees should be made in writing. A challenge to a determination that a party is delinquent in paying a standard regulatory fee... 47 Telecommunication 1 2010-10-01 2010-10-01 false Error claims related to regulatory fees. 1.1167...

  3. Regulatory challenges of historic uranium mines in Canada

    International Nuclear Information System (INIS)

    Clement, C.H.; Stenson, R.E.

    2002-01-01

    The radium and uranium mining industry began in Canada in 1930 with the discovery of the Port Radium deposit in the Northwest Territories. During the 1950s more uranium mines opened across Canada. Most of these mines ceased operation by the end of the 1960s. Some were remediated by their owners, while others were abandoned. The Atomic Energy Control Board (AECB), predecessor to the Canadian Nuclear Safety Commission (CNSC), was created in 1946. However, it was not until the mid-1970s that the AECB took an active role in regulating health, safety and environmental aspects of uranium mining; so many of the older mines have never been licensed. With the coming into force of the Nuclear Safety and Control Act (NSCA) in May 2000, this situation has been reviewed. The NSCA requires a licence for the possession of nuclear substances (including uranium mine tailings), or the decommissioning of nuclear facilities (including uranium mines and mills). Furthermore, governments (federal and provincial) are also subject to the NSCA, a change from the previous legislation. The CNSC has an obligation to assess these sites, regardless of ownership, and to proceed with licensing or other appropriate regulatory action. The CNSC has reviewed the status of the twenty sites in Canada where uranium milling took place historically. Eight are already licensed. Licensing actions are being pursued at the other sites. A review of nearly 100 small uranium mining or exploration sites is also underway to determine the most appropriate regulatory approach. This paper focuses on regulatory issues surrounding the historic mining and milling sites, and the regulatory approach being taken, including licensing provincial and federal government bodies who own some of the sites, and ensuring the safe management of sites that were abandoned. (author)

  4. Regulatory challenges for autologous tissue engineered products on their way from bench to bedside in Europe.

    Science.gov (United States)

    Ram-Liebig, Gouya; Bednarz, Juergen; Stuerzebecher, Burkard; Fahlenkamp, Dirk; Barbagli, Guido; Romano, Giuseppe; Balsmeyer, Ulf; Spiegeler, Maria-Elsa; Liebig, Soeren; Knispel, Helmut

    2015-03-01

    Since the late eighties of last century the high potential of tissue engineered products (TEP)s has been shown for the treatment of various diseases and many scientific publications appeared in this field. However, only few products reached the market since. Development of TEPs is a promising but owing to its novelty a very challenging task that requires experts in this still developing field as well as ample financial resources. This paper summarises relevant regulatory challenges during quality, preclinical and clinical development of autologous TEPs in Europe. Selected strategies on how to manage major issues are presented, together with some examples from the development of an autologous TEP for urethroplasty. Considering these aspects may help other investigators with potential strategies during the development of novel TEPs. Copyright © 2014 Elsevier B.V. All rights reserved.

  5. Strategies to overcome clinical, regulatory, and financial challenges in the implementation of personalized medicine.

    Science.gov (United States)

    Tsimberidou, Apostolia M; Ringborg, Ulrik; Schilsky, Richard L

    2013-01-01

    This article highlights major developments over the last decade in personalized medicine in cancer. Emerging data from clinical studies demonstrate that the use of targeted agents in patients with targetable molecular aberrations improves clinical outcomes. Despite a surge of studies, however, significant gaps in knowledge remain, especially in identifying driver molecular aberrations in patients with multiple aberrations, understanding molecular networks that control carcinogenesis and metastasis, and most importantly, discovering effective targeted agents. Implementation of personalized medicine requires continued scientific and technological breakthroughs; standardization of tumor tissue acquisition and molecular testing; changes in oncology practice and regulatory standards for drug and device access and approval; modification of reimbursement policies by health care payers; and innovative ways to collect and analyze electronic patient information that are linked to prospective clinical registries and rapid learning systems. Informatics systems that integrate clinical, laboratory, radiologic, molecular, and economic data will improve clinical care and will provide infrastructure to enable clinical research. The initiative of the EurocanPlatform aims to overcome the challenges of implementing personalized medicine in Europe by sharing patients, biologic materials, and technological resources across borders. The EurocanPlatform establishes a complete translational cancer research program covering the drug development process and strengthening collaborations among academic centers, pharmaceutical companies, regulatory authorities, health technology assessment organizations, and health care systems. The CancerLinQ rapid learning system being developed by ASCO has the potential to revolutionize how all stakeholders in the cancer community assemble and use information obtained from patients treated in real-world settings to guide clinical practice, regulatory

  6. Nuclear Research Institute Rez: Its past and present and future challenges

    International Nuclear Information System (INIS)

    Pazdera, F.

    2001-01-01

    The paper gives an overview of the history of the Nuclear Research Institute Rez development over forty years of its existence. Its present activities are discussed in some detail. These historical and present activities represent the basis for discussing: challenges faced by the NRI; interactions of NRI with their environment; collaboration and co-operation. Nuclear research centres would continue to be the main source of expertise for power plant operation, radiation and isotope applications, regulatory practices and waste management. Future developments should ensure viability of these centres. (author)

  7. Early Regulatory Engagement for Successful Site Remediation: the UK Experience - 13173

    International Nuclear Information System (INIS)

    Maitland, R.P.; Senior, D.

    2013-01-01

    The Office for Nuclear Regulation (ONR) is an independent safety, security and transport regulator of the UK nuclear industry. ONR regulates all civil nuclear reactor power stations, fuel manufacture, enrichment, spent fuel reprocessing, most defence sites and installations that store and process legacy spent fuel and radioactive waste. The responsibility for funding and strategic direction of decommissioning and radioactive waste management of state owned legacy sites has rested solely with the Nuclear Decommissioning Authority (NDA) since 2005. A key component of NDA's mandate was to encourage new strategic approaches and innovation to dealing with the UK's waste legacy and which deliver value-for-money to the UK taxpayer. ONR, as an agency of the Health and Safety Executive, is entirely independent of NDA and regulates all prescribed activities on NDA's sites. NDA's competition of site management and closure contracts has attracted significant international interest and the formation of consortia comprised of major British, US, French and Swedish organizations bidding for those contracts. The prominence of US organizations in each of those consortia reflects the scale and breadth of existing waste management and D and D projects in the US. This paper will articulate, in broad terms, the challenges faced by international organizations seeking to employ 'off-the-shelf' technology and D and D techniques, successfully employed elsewhere, into the UK regulatory context. The predominantly 'goal-setting' regulatory framework in the UK does not generally prescribe a minimum standard to which a licensee must adhere. The legal onus on licensees in the UK is to demonstrate, whatever technology is selected, that in its applications, risks are reduced 'So Far As Is Reasonably Practicable' or 'SFAIRP'. By the nature of its role, ONR adopts a conservative approach to regulation; however ONR also recognises that in the decommissioning (and ultimately the site closure) domain

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

    International Nuclear Information System (INIS)

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

    2005-01-01

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

  9. Regional Power Integration : Structural and Regulatory Challenges

    OpenAIRE

    World Bank

    2011-01-01

    The Central America Regional Electricity Market (MER) trades electricity and transmission capacity among six Central American countries: Costa Rica, El Salvador, Guatemala, Honduras, Nicaragua and Panama. The market differs from other electricity markets worldwide because it has its own regulatory body and system operator. Economic integration of the Central American countries has followed...

  10. Ethics committees in India: Facing the challenges!

    Science.gov (United States)

    Kadam, Rashmi; Karandikar, Shashikant

    2012-04-01

    The past few years have seen a tremendous rise in the number of clinical trials conducted in India. This is been attributed to the huge patient population, genetic diversity, and rich technical pool in our country. However, the economical upsurge in the clinical trial industry has also caused concerns pertaining to the efficiency of the Regulatory Agencies and Ethics Committees (EC). The EC plays an important role in the regulation of clinical research at the local level. However, it is seen that many ECs are oblivious to their roles and responsibilities. It is reported that ECs lack standard operating procedures, do not have a proper composition or adequate representation, thus affecting their functions in regulating clinical research. Moreover, ECs seem to function in isolation, as self-sufficient bodies, having no communication with the regulatory agency or other ECs. This brings forth the need for ECs to come together and share their experiences and observations, with the aim of updating themselves and refining their functions. Efforts also need to be focused on capacity building, centralized registration of ECs, and bringing an oversight mechanism in place. The Ethics Committees in India need to work in close association with forums such as the Forum for Ethics Review Committees in India and the Forum for Ethical Review Committees in Asia Pacific, in an effort towards empowering themselves.

  11. Ethics committees in India: Facing the challenges!

    Directory of Open Access Journals (Sweden)

    Rashmi Kadam

    2012-01-01

    Full Text Available The past few years have seen a tremendous rise in the number of clinical trials conducted in India. This is been attributed to the huge patient population, genetic diversity, and rich technical pool in our country. However, the economical upsurge in the clinical trial industry has also caused concerns pertaining to the efficiency of the Regulatory Agencies and Ethics Committees (EC. The EC plays an important role in the regulation of clinical research at the local level. However, it is seen that many ECs are oblivious to their roles and responsibilities. It is reported that ECs lack standard operating procedures, do not have a proper composition or adequate representation, thus affecting their functions in regulating clinical research. Moreover, ECs seem to function in isolation, as self-sufficient bodies, having no communication with the regulatory agency or other ECs. This brings forth the need for ECs to come together and share their experiences and observations, with the aim of updating themselves and refining their functions. Efforts also need to be focused on capacity building, centralized registration of ECs, and bringing an oversight mechanism in place. The Ethics Committees in India need to work in close association with forums such as the Forum for Ethics Review Committees in India and the Forum for Ethical Review Committees in Asia Pacific, in an effort towards empowering themselves.

  12. Expression modeling for expression-invariant face recognition

    NARCIS (Netherlands)

    Haar, F.B. Ter; Veltkamp, R.C.

    2010-01-01

    Morphable face models have proven to be an effective tool for 3D face modeling and face recognition, but the extension to 3D face scans with expressions is still a challenge. The two main difficulties are (1) how to build a new morphable face model that deals with expressions, and (2) how to fit

  13. Revisiting hansen's disease: Recognizing the many neurodermatologic faces and its diagnostic challenges

    Directory of Open Access Journals (Sweden)

    Bhaskara P Shelley

    2018-01-01

    Full Text Available Hansen's disease (HD looms still as a public health problem. Conventional wisdom and teaching largely view HD as a predominantly dermatologic disorder with much emphasis in the dermatology postgraduate curriculum. This review attempts to reorient this view and reemphasize that HD has primarily neurologic underpinnings since Mycobacterium leprae is an intracellular neurotropic bacterium. The main thrust of this article would, therefore, be a neurologist's perspective of HD. The cutaneous manifestations of HD are the sequelae of the neurobiology of M. leprae, its selective predilection to human Schwann cells, neurovascular bundle and its localization in the intracutaneous nerve plexus of the skin. We discuss the nuances of HD as a “great imitator,” the many faces of its neurodermatologic clinical presentation, the neurologic basis of HD clinical examination, and its diagnostic and therapeutic challenges.

  14. Some environmental challenges which the uranium production industry faces in the 21st century

    International Nuclear Information System (INIS)

    Zhang Lisheng

    2004-01-01

    Some of the environmental challenges which the uranium production industry faces in the 21st century have been discussed in the paper. They are: the use of the linear non-threshold (LNT) model for radiation protection, the concept of 'controllable dose' as an alternative to the current International Commission on Radiological Protection (ICRP) system of dose limitation, the future of collective dose and the ALARA (As low As Reasonably Achievable) principle and the application of a risk-based framework for managing hazards. The author proposes that, the risk assessment/risk management framework could be used for managing the environmental, safety and decommissioning issues associated with the uranium fuel cycle. (author)

  15. Hydropower Modeling Challenges

    Energy Technology Data Exchange (ETDEWEB)

    Stoll, Brady [National Renewable Energy Lab. (NREL), Golden, CO (United States); Andrade, Juan [National Renewable Energy Lab. (NREL), Golden, CO (United States); Cohen, Stuart [National Renewable Energy Lab. (NREL), Golden, CO (United States); Brinkman, Greg [National Renewable Energy Lab. (NREL), Golden, CO (United States); Brancucci Martinez-Anido, Carlo [National Renewable Energy Lab. (NREL), Golden, CO (United States)

    2017-04-19

    Hydropower facilities are important assets for the electric power sector and represent a key source of flexibility for electric grids with large amounts of variable generation. As variable renewable generation sources expand, understanding the capabilities and limitations of the flexibility from hydropower resources is important for grid planning. Appropriately modeling these resources, however, is difficult because of the wide variety of constraints these plants face that other generators do not. These constraints can be broadly categorized as environmental, operational, and regulatory. This report highlights several key issues involving incorporating these constraints when modeling hydropower operations in terms of production cost and capacity expansion. Many of these challenges involve a lack of data to adequately represent the constraints or issues of model complexity and run time. We present several potential methods for improving the accuracy of hydropower representation in these models to allow for a better understanding of hydropower's capabilities.

  16. An exploration into pedagogic frailty: Transitioning from face-to-face to online

    Directory of Open Access Journals (Sweden)

    Irina Niculescu

    2017-09-01

    Full Text Available Pedagogic frailty and concept mapping can simultaneously encourage personal and organisational change by supporting critical reflection and resilience. These ideas are nascent within higher education institutions and currently, at the University of Surrey, are only developed through face-to-face sessions. This revealed the need for a scalable intervention which engages academics with the discourse on introspective and professional development practices. In response, we have created the design for a blended programme of online foundation for concept mapping leading to face-to-face workshops to explore the pedagogic frailty model. This paper will discuss some significant challenges arising from transitioning self-reflective practices from face-to-face to online spaces. In the process, we will consider ways in which learning design can take the learner context into account.

  17. Regulatory frameworks for decentralised energy

    International Nuclear Information System (INIS)

    Woodman, Bridget; Baker, Philip

    2008-01-01

    This paper considers aspects of the current regulatory frameworks for markets and infrastructure which can inhibit the deployment of decentralised energy. The government has stated that decentralised energy can make a positive contribution to reducing the UK's carbon emissions, but recognises that at the moment the technologies face market and regulatory barriers. If it is to become a viable alternative to centralised generation, energy market design and the regulation of energy infrastructure will have to evolve to ensure that decentralised options are no longer locked out. (author)

  18. Correct fair market value calculation needed to avoid regulatory challenges.

    Science.gov (United States)

    Dietrich, M O

    1997-09-01

    In valuing a physician practice for acquisition, it is important for buyers and sellers to distinguish between fair market value and strategic value. Although many buyers would willingly pay for the strategic value of a practice, tax-exempt buyers are required by law to consider only the fair market value in setting a bid price. Valuators must adjust group earnings to exclude items that do not apply to any willing seller and include items that do apply to any willing seller to arrive at the fair market value of the practice. In addition, the weighted average cost of capital (WACC), which becomes the discount rate in the valuation model, is critical to the measure of value of the practice. Small medical practices are assumed to have few hard assets and little long-term debt, and the WACC is calculated on the basis of those assumptions. When a small practice has considerable debt, however, this calculated WACC may be inappropriate for valuing the practice. In every case, evidence that shows that a transaction has been negotiated "at arm's length" should stave off any regulatory challenge.

  19. About-face on face recognition ability and holistic processing.

    Science.gov (United States)

    Richler, Jennifer J; Floyd, R Jackie; Gauthier, Isabel

    2015-01-01

    Previous work found a small but significant relationship between holistic processing measured with the composite task and face recognition ability measured by the Cambridge Face Memory Test (CFMT; Duchaine & Nakayama, 2006). Surprisingly, recent work using a different measure of holistic processing (Vanderbilt Holistic Face Processing Test [VHPT-F]; Richler, Floyd, & Gauthier, 2014) and a larger sample found no evidence for such a relationship. In Experiment 1 we replicate this unexpected result, finding no relationship between holistic processing (VHPT-F) and face recognition ability (CFMT). A key difference between the VHPT-F and other holistic processing measures is that unique face parts are used on each trial in the VHPT-F, unlike in other tasks where a small set of face parts repeat across the experiment. In Experiment 2, we test the hypothesis that correlations between the CFMT and holistic processing tasks are driven by stimulus repetition that allows for learning during the composite task. Consistent with our predictions, CFMT performance was correlated with holistic processing in the composite task when a small set of face parts repeated over trials, but not when face parts did not repeat. A meta-analysis confirms that relationships between the CFMT and holistic processing depend on stimulus repetition. These results raise important questions about what is being measured by the CFMT, and challenge current assumptions about why faces are processed holistically.

  20. Manufacturing human mesenchymal stem cells at clinical scale: process and regulatory challenges.

    Science.gov (United States)

    Jossen, Valentin; van den Bos, Christian; Eibl, Regine; Eibl, Dieter

    2018-05-01

    Human mesenchymal stem cell (hMSC)-based therapies are of increasing interest in the field of regenerative medicine. As economic considerations have shown, allogeneic therapy seems to be the most cost-effective method. Standardized procedures based on instrumented single-use bioreactors have been shown to provide billion of cells with consistent product quality and to be superior to traditional expansions in planar cultivation systems. Furthermore, under consideration of the complex nature and requirements of allogeneic hMSC-therapeutics, a new equipment for downstream processing (DSP) was successfully evaluated. This mini-review summarizes both the current state of the hMSC production process and the challenges which have to be taken into account when efficiently producing hMSCs for the clinical scale. Special emphasis is placed on the upstream processing (USP) and DSP operations which cover expansion, harvesting, detachment, separation, washing and concentration steps, and the regulatory demands.

  1. The national system of nuclear material control development and challenges. Vol. 3

    International Nuclear Information System (INIS)

    Badawy, I.

    1996-01-01

    This paper presents the major factors which may affect the implementation of the National System of Nuclear Material Accounting and Safeguards in Egypt. Developments of this National System-being a division of the Nuclear Regulatory Body in the country-are discussed. Also, recent requirements of the International Atomic Energy Agency within the policy of strengthening its regime of international nuclear control are reviewed. The challenges facing the National System are indicated taking in consideration the anticipated growth in the nuclear field in Egypt by the year 2000 and after. 2 figs

  2. The national system of nuclear material control development and challenges. Vol. 3

    Energy Technology Data Exchange (ETDEWEB)

    Badawy, I [National Centre for Nuclear Safety and Radiation Control, Atomic Energy Authority, Cairo (Egypt)

    1996-03-01

    This paper presents the major factors which may affect the implementation of the National System of Nuclear Material Accounting and Safeguards in Egypt. Developments of this National System-being a division of the Nuclear Regulatory Body in the country-are discussed. Also, recent requirements of the International Atomic Energy Agency within the policy of strengthening its regime of international nuclear control are reviewed. The challenges facing the National System are indicated taking in consideration the anticipated growth in the nuclear field in Egypt by the year 2000 and after. 2 figs.

  3. Assessing Student Performance and Perceptions in Lecture Capture vs. Face-to-Face Course Delivery

    Science.gov (United States)

    Euzent, Patricia; Martin, Thomas; Moskal, Patrick; Moskal, Patsy

    2011-01-01

    Public universities are currently facing a challenge in determining how to deliver quality instruction in the face of severe fiscal constraints. With recent technological advances, courses streamed over the Internet (i.e., lecture capture) are now becoming common. However, little research has been published that specifically examines student…

  4. Understanding and Facing Discipline-Related Challenges in the English as a Foreign Language Classroom at Public Schools

    Directory of Open Access Journals (Sweden)

    Josefina Quintero Corzo

    2011-07-01

    Full Text Available Complying with school regulations and teachers' instructions is a basic principle of an excellent class; both novice and experienced teachers face challenging situations when getting into real classrooms, especially those related to classroom management. There are various reasons that explain discipline problems in public schools, as well as varied strategies beginning teachers create and try when coping with those challenges. This article reports an action research study on how this methodology helped a group of teacher-trainees overcome indiscipline in English as a foreign language classrooms at public schools, and align with professional development initiatives which focus on reflection and decision-making processes that the new Colombian policies demand from new teachers seeking a higher quality of education.

  5. Challenges faced by primary care physicians when prescribing for patients with chronic diseases in a teaching hospital in Malaysia: a qualitative study.

    Science.gov (United States)

    Sellappans, Renukha; Lai, Pauline Siew Mei; Ng, Chirk Jenn

    2015-08-27

    The aim of this study was to identify the challenges faced by primary care physicians (PCPs) when prescribing medications for patients with chronic diseases in a teaching hospital in Malaysia. 3 focus group discussions were conducted between July and August 2012 in a teaching primary care clinic in Malaysia. A topic guide was used to facilitate the discussions which were audio-recorded, transcribed verbatim and analysed using a thematic approach. PCPs affiliated to the primary care clinic were purposively sampled to include a range of clinical experience. Sample size was determined by thematic saturation of the data. 14 family medicine trainees and 5 service medical officers participated in this study. PCPs faced difficulties in prescribing for patients with chronic diseases due to a lack of communication among different healthcare providers. Medication changes made by hospital specialists, for example, were often not communicated to the PCPs leading to drug duplications and interactions. The use of paper-based medical records and electronic prescribing created a dual record system for patients' medications and became a problem when the 2 records did not tally. Patients sometimes visited different doctors and pharmacies for their medications and this resulted in the lack of continuity of care. PCPs also faced difficulties in addressing patients' concerns, and dealing with patients' medication requests and adherence issues. Some PCPs lacked time and knowledge to advise patients about their medications and faced difficulties in managing side effects caused by the patients' complex medication regimen. PCPs faced prescribing challenges related to patients, their own practice and the local health system when prescribing for patients with chronic diseases. These challenges must be addressed in order to improve chronic disease management in primary care and, more importantly, patient safety. Published by the BMJ Publishing Group Limited. For permission to use (where not

  6. Challenges faced by professional nurses when implementing the Expanded Programme on Immunisation at rural clinics in Capricorn District, Limpopo

    Directory of Open Access Journals (Sweden)

    Tebogo M. Mothiba

    2016-05-01

    Full Text Available Background: Immunisation is the cornerstone of primary healthcare. Apart from the provision of safe water, immunisation remains the most cost-effective public health intervention currently available. Immunisation prevents infectious conditions that are debilitating, fatal and have the potential to cause huge public health burdens, both financially and socially, in South Africa. Aim: To determine the challenges faced by professional nurses when implementing the Expanded Programme on Immunisation (EPI at rural clinics in Capricorn District, Limpopo Province, South Africa. Setting: The study was conducted in selected primary healthcare clinics of Capricorn District, Limpopo Province. Methods: A qualitative explorative descriptive contextual research design was used to gather data related to the challenges faced by professional nurses when implementing EPI at rural clinics in Capricorn District. Results: The findings revealed that professional nurses had knowledge of the programme, but that they experienced several challenges during implementation of EPI that included staff shortages and problems related to maintenance of the vaccines’ potency. Conclusions: The Department of Health as well as the nursing administration should monitor policies and guidelines, and especially maintenance of a cold chain for vaccines, to ensure that they are practised throughout Limpopo Province. The problem of staff shortages also needs to be addressed so that the EPI can achieve its targeted objectives. Keywords: Professional nurse, knowledge, EPI-SA, immunisation

  7. Factors influencing men entering the nursing profession, and understanding the challenges faced by them: Iranian and developed countries' perspectives.

    Science.gov (United States)

    Zamanzadeh, Vahid; Valizadeh, Leila; Negarandeh, Reza; Monadi, Morteza; Azadi, Arman

    2013-12-01

    Men entering the nursing profession have been investigated from several different perspectives. Due to male gender characteristics and existing public image, nursing is often not considered as a career choice by men. Whether nursing would benefit from increased number of men is a key question in the literature. The purpose of this integrative review of the literature was to identify factors influencing men to enter the nursing profession. In addition, it sought to understand the challenges they are confronted within this profession. A systematic search of the existing literature was performed using an Internet search with broad keywords to access related articles in both Persian and English databases. Finally, 34 studies (written between 2000 and early 2013) were selected and surveyed. Most of the studies were conducted in developed counties. The review identified reasons why males choose nursing, and other challenges facing men entering and working in nursing. Themes that emerged from the literature include educational and societal barriers experienced by men in nursing, recruitment, career choice, and role strain. Regarding men's influences on professional development, and also the importance of gender-based caring, policies for recruitment and retention of men in nursing must be followed hastily. However, there is a need for further research regarding the challenges faced by men entering nursing, in both Iran and other developing countries.

  8. OPPORTUNITIES AND CHALLENGES FOR MICRO-SMALL AND MEDIUM BUSINESS IN INDONESIA FACING ASEAN ECONOMIC COMMUNITY

    Directory of Open Access Journals (Sweden)

    Raden Aswin Rahadi

    2016-03-01

    Full Text Available This research is a part of a continuous study to analyze the opportunities and challenges for micro-small and medium business in Indonesia when facing ASEAN Economic Community (AEC in 2016. It has its own uniqueness, as it will combine the point of view between current business owners and current literature study synthesis on business perception towards AEC. Ten business owners have been interviewed. The results suggested AEC provides challenges for the business owners, particularly in terms of capital; competitiveness; sales system; innovation; finance, bureaucracy; and government preparedness. AEC also provides opportunities, in terms of market potential; creativity; export opportunities; business owners’ resistances and sustainability; and knowledge of local market. From all of the keywords mentioned by the respondents, there are four main attributes considered as important: human resources; creativities; market share; and capital. Finally, most of the respondents suggested that AEC will bring more positive influences for the development of micro-small and medium business in Indonesia.

  9. Hyper-realistic face masks: a new challenge in person identification.

    Science.gov (United States)

    Sanders, Jet Gabrielle; Ueda, Yoshiyuki; Minemoto, Kazusa; Noyes, Eilidh; Yoshikawa, Sakiko; Jenkins, Rob

    2017-01-01

    We often identify people using face images. This is true in occupational settings such as passport control as well as in everyday social environments. Mapping between images and identities assumes that facial appearance is stable within certain bounds. For example, a person's apparent age, gender and ethnicity change slowly, if at all. It also assumes that deliberate changes beyond these bounds (i.e., disguises) would be easy to spot. Hyper-realistic face masks overturn these assumptions by allowing the wearer to look like an entirely different person. If unnoticed, these masks break the link between facial appearance and personal identity, with clear implications for applied face recognition. However, to date, no one has assessed the realism of these masks, or specified conditions under which they may be accepted as real faces. Herein, we examined incidental detection of unexpected but attended hyper-realistic masks in both photographic and live presentations. Experiment 1 (UK; n = 60) revealed no evidence for overt detection of hyper-realistic masks among real face photos, and little evidence of covert detection. Experiment 2 (Japan; n = 60) extended these findings to different masks, mask-wearers and participant pools. In Experiment 3 (UK and Japan; n = 407), passers-by failed to notice that a live confederate was wearing a hyper-realistic mask and showed limited evidence of covert detection, even at close viewing distance (5 vs. 20 m). Across all of these studies, viewers accepted hyper-realistic masks as real faces. Specific countermeasures will be required if detection rates are to be improved.

  10. Perceptions of regulatory approaches

    International Nuclear Information System (INIS)

    Halin, Magnus; Leinonen, Ruusaliisa

    2012-01-01

    Ms. Ruusaliisa Leinonen and Mr. Magnus Halin from Fortum gave a joint presentation on industry perceptions of regulatory oversight of LMfS/SC. It was concluded that an open culture of discussion exists between the regulator (STUK) and the licensee, based on the common goal of nuclear safety. An example was provided of on how regulatory interventions helped foster improvements to individual and collective dose rate trends, which had remained static. Regulatory interventions included discussions on the ALARA concept to reinforce the requirement to continuously strive for improvements in safety performance. Safety culture has also been built into regulatory inspections in recent years. Training days have also been organised by the regulatory body to help develop a shared understanding of safety culture between licensee and regulatory personnel. Fortum has also developed their own training for managers and supervisors. Training and ongoing discussion on LMfS/SC safety culture is considered particularly important because both Fortum and the regulatory body are experiencing an influx of new staff due to the demographic profile of their organisations. It was noted that further work is needed to reach a common understanding of safety culture on a practical level (e.g., for a mechanic setting to work), and in relation to the inspection criteria used by the regulator. The challenges associated with companies with a mix of energy types were also discussed. This can make it more difficult to understand responsibilities and decision making processes, including the role of the parent body organisation. It also makes communication more challenging due to increased complexity and a larger number of stakeholders

  11. The Challenges Facing Accounting Education: The Nigerian ...

    African Journals Online (AJOL)

    The need of the accounting profession to effectively and continuously meet new challenges confronting it and adapt its services to changing conditions and circumstances has become a necessity to the survival of the profession and the society. The challenges confronting the accountant on his role to the society at large in a ...

  12. The Awareness and Challenges of Cloud Computing Adoption on Tertiary Education in Malaysia

    Science.gov (United States)

    Hazreeni Hamzah, Nor; Mahmud, Maziah; Zukri, Shamsunarnie Mohamed; Yaacob, Wan Fairos Wan; Yacob, Jusoh

    2017-09-01

    This preliminary study aims to investigate the awareness of the adoption of cloud computing among the academicians in tertiary education in Malaysia. Besides, this study also want to explore the possible challenges faced by the academician while adopting this new technology. The pilot study was done on 40 lecturers in Universiti Teknologi MARA Kampus Kota Bharu (UiTMKB) by using self administered questionnaire. The results found that almost half (40 percent) were not aware on the existing of cloud computing in teaching and learning (T&L) process. The challenges confronting the adoption of cloud computing are data insecurity, data insecurity, unsolicited advertisement, lock-in, reluctance to eliminate staff positions, privacy concerns, reliability challenge, regulatory compliance concerns/user control and institutional culture/resistance to change in technology. This possible challenges can be factorized in two major factors which were security and dependency factor and user control and mentality factor.

  13. Technical progress faced with the challenges of the energy sector in the future

    International Nuclear Information System (INIS)

    Maillard, D.

    1999-01-01

    The colloquium organised by the Association of Energy Economists dealing with the theme 'Technical progress faced with the challenges of the energy sector in the future' takes place against a backdrop of ever-increasing initiatives in this field, for example at the World Energy Council or the International Energy Agency Faith in technical progress is widespread but should be supported by studies without any preconceived ideas. Research and development efforts must be fully supported, and in a climate of opening markets and liberalization the public authorities have a major role to pay. Historically, the markets have always been able to meet new needs thanks to technology, but the ambitious targets that the international community has set itself regarding the emission of greenhouse gases imply technical improvements and major investments. (authors)

  14. Issues, challenges, and approaches for risk-informed decommissioning in the United States

    International Nuclear Information System (INIS)

    Orlando, D.A.; Johnson, R.L.

    2005-01-01

    'lessons learned' in implementing US-NRC's risk-informed approach to decommissioning; and ensuring that the public understands that risk-informed does not mean that safety is reduced, are all challenges that the US-NRC staff will need to address as they implement the US-NRC risk-informed decommissioning program. Finally, a successful risk-informed decommissioning program requires that both the staff and licensees commit to constantly review their processes, approaches, and regulatory decisions to ensure that they remain risk-informed. The US-NRC has faced numerous challenges in the development of its decommissioning program, from the determination of the appropriate level of cleanup to ensuring that current activities do not adversely impact future decommissioning. However, the principal regulatory challenges associated with risk-informing a regulatory program for decommissioning is to maintain an acceptable level of safety while improving effectiveness, efficiency, and realism in agency decisions, practices, and processes, and reducing unnecessary regulatory burden on licensees. (authors)

  15. Meeting Cathala-Letort named: the challenges of the processes engineering facing the hydrogen-energy; Journee Cathala-Letort intitulee: les defis du genie des procedes face a l'hydrogene-energie

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2004-07-01

    This document provides the presentations proposed during the day Cathala-Letort on the challenges of the processes engineering facing the hydrogen-energy. In the context of the greenhouse effect increase and the fossil energies resources decrease, it brings information on researches on hydrogen technologies, carbon dioxide sequestration, hydrogen supply, production, storage and distribution and the thermo-chemical cycles. (A.L.B.)

  16. Collaborative Random Faces-Guided Encoders for Pose-Invariant Face Representation Learning.

    Science.gov (United States)

    Shao, Ming; Zhang, Yizhe; Fu, Yun

    2018-04-01

    Learning discriminant face representation for pose-invariant face recognition has been identified as a critical issue in visual learning systems. The challenge lies in the drastic changes of facial appearances between the test face and the registered face. To that end, we propose a high-level feature learning framework called "collaborative random faces (RFs)-guided encoders" toward this problem. The contributions of this paper are three fold. First, we propose a novel supervised autoencoder that is able to capture the high-level identity feature despite of pose variations. Second, we enrich the identity features by replacing the target values of conventional autoencoders with random signals (RFs in this paper), which are unique for each subject under different poses. Third, we further improve the performance of the framework by incorporating deep convolutional neural network facial descriptors and linking discriminative identity features from different RFs for the augmented identity features. Finally, we conduct face identification experiments on Multi-PIE database, and face verification experiments on labeled faces in the wild and YouTube Face databases, where face recognition rate and verification accuracy with Receiver Operating Characteristic curves are rendered. In addition, discussions of model parameters and connections with the existing methods are provided. These experiments demonstrate that our learning system works fairly well on handling pose variations.

  17. Nonverbal Learning Disabilities : What kind of communication challenges do parents face when communicating with their children with Nonverbal Learning Disabilities, and what kind of strategies the parents use to overcome the challenges?

    OpenAIRE

    Ramos, Alexandra Jacinta

    2011-01-01

    This is a qualitative study that explores and tries to understand what kind of communicational challenges do parents face when communicating with their children with Nonverbal Learning Disabilities, and to comprehend what kind of strategies these parents use to overcome these challenges. The designation of the Nonverbal Learning Disabilities (NLD) was formerly proposed by Johnson and Myklebust. NLD were firstly described by Myklebust as an inability to read and understand nonverbal aspect...

  18. Are we facing new health challenges and diseases in reindeer in Fennoscandia?

    Directory of Open Access Journals (Sweden)

    Morten Tryland

    2013-03-01

    Full Text Available A large number of semi-domesticated reindeer is lost every year. Predators are the single most important factor for these losses, whereas restrictions on food availability some years also may cause high mortality. In the past, reindeer herding was challenged by severe infectious diseases, killing hundreds and thousands of animals, and having huge economic and social impact on reindeer herding in Fennoscandia. The general zoo-sanitary situation in Fennoscandia is very favourable for the time being, but reindeer herding is sometimes challenged by disease outbreaks, and diseases play an important role for survival and fitness of reindeer. Reindeer herding is also facing changes and challenges, which also may impact reindeer health and the disease status. Introduction of infectious agents not commonly present in the reindeer population may take place through import of animals, as well as by contact between reindeer, livestock and wildlife. Further, changes in the herding, such as increased feeding, transport, size of herds, animal density and stress load on the animals, may affect the animals ability to cope with infectious diseases. Also changes in weather conditions and climate, such as increased precipitation and mean temperature, may over time lead to restricted availability of pastures, changes in vegetation and changed conditions for parasites and insect vectors. These changes might be especially important for the reproductive success, including fitness of the calves during their first winter. To be able to cope with these changes and their potential impact on reindeer health, increased efforts should be made to gather reference data on health and disease parameters from the different reindeer herding districts, along with epidemiological risk factor analysis. This would increase the ability for the reindeer herding to cope with changes and to continue to produce quality meat products for the market.

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

    Science.gov (United States)

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

    2015-01-01

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

  20. Illumination robust face recognition using spatial adaptive shadow compensation based on face intensity prior

    Science.gov (United States)

    Hsieh, Cheng-Ta; Huang, Kae-Horng; Lee, Chang-Hsing; Han, Chin-Chuan; Fan, Kuo-Chin

    2017-12-01

    Robust face recognition under illumination variations is an important and challenging task in a face recognition system, particularly for face recognition in the wild. In this paper, a face image preprocessing approach, called spatial adaptive shadow compensation (SASC), is proposed to eliminate shadows in the face image due to different lighting directions. First, spatial adaptive histogram equalization (SAHE), which uses face intensity prior model, is proposed to enhance the contrast of each local face region without generating visible noises in smooth face areas. Adaptive shadow compensation (ASC), which performs shadow compensation in each local image block, is then used to produce a wellcompensated face image appropriate for face feature extraction and recognition. Finally, null-space linear discriminant analysis (NLDA) is employed to extract discriminant features from SASC compensated images. Experiments performed on the Yale B, Yale B extended, and CMU PIE face databases have shown that the proposed SASC always yields the best face recognition accuracy. That is, SASC is more robust to face recognition under illumination variations than other shadow compensation approaches.

  1. Discovery of innovative therapeutics: today's realities and tomorrow's vision. 2. Pharma's challenges and their commitment to innovation.

    Science.gov (United States)

    Abou-Gharbia, Magid; Childers, Wayne E

    2014-07-10

    The pharmaceutical industry is facing enormous challenges, including reduced efficiency, stagnant success rate, patent expirations for key drugs, fierce price competition from generics, high regulatory hurdles, and the industry's perceived tarnished image. Pharma has responded by embarking on a range of initiatives. Other sectors, including NIH, have also responded. Academic drug discovery groups have appeared to support the transition of innovative academic discoveries and ideas into attractive drug discovery opportunities. Part 1 of this two-part series discussed the criticisms that have been leveled at the pharmaceutical industry over the past 3 decades and summarized the supporting data for and against these criticisms. This second installment will focus on the current challenges facing the pharmaceutical industry and Pharma's responses, focusing on the industry's changing perspective and new business models for coping with the loss of talent and declining clinical pipelines as well as presenting some examples of recent drug discovery successes.

  2. Pose-Invariant Face Recognition via RGB-D Images.

    Science.gov (United States)

    Sang, Gaoli; Li, Jing; Zhao, Qijun

    2016-01-01

    Three-dimensional (3D) face models can intrinsically handle large pose face recognition problem. In this paper, we propose a novel pose-invariant face recognition method via RGB-D images. By employing depth, our method is able to handle self-occlusion and deformation, both of which are challenging problems in two-dimensional (2D) face recognition. Texture images in the gallery can be rendered to the same view as the probe via depth. Meanwhile, depth is also used for similarity measure via frontalization and symmetric filling. Finally, both texture and depth contribute to the final identity estimation. Experiments on Bosphorus, CurtinFaces, Eurecom, and Kiwi databases demonstrate that the additional depth information has improved the performance of face recognition with large pose variations and under even more challenging conditions.

  3. Web-based versus face-to-face interprofessional team encounters with standardized patients.

    Science.gov (United States)

    Lempicki, Kelly A; Holland, Christine S

    2018-03-01

    Challenges exist in developing interprofessional education (IPE) activities including coordinating schedules and obtaining appropriate space for teams to work. Virtual worlds have been explored as a means to overcome some of these challenges. We sought to develop a web-based interprofessional team interaction with a standardized patient (SP), as compared to a face-to-face SP interaction, focusing on the competency area of interprofessional communication. Interprofessional teams of students were randomized to complete a web-based or face-to-face SP encounter. The web-based encounter was conducted via video conference that students accessed using their own electronic device. Interprofessional communication was evaluated by faculty observers and the SPs. Participants of the web-based encounter also completed a perceptions questionnaire. Interprofessional communication was rated as average/above average by the authors and SPs. Perceptions of the web-based encounter were mixed with not all students willing to complete such an encounter again despite finding it enjoyable and a positive learning experience. The need for adequate preparation was identified, including the opportunity to review the patient case before the encounter. The web-based SP encounter afforded students the opportunity to utilize communication technology to provide patient-centered care while collaborating as an interprofessional team. Video conferencing presents an opportunity to bypass some logistical challenges in scheduling IPE experiences and can be implemented as a co-curricular activity, avoiding course revisions. Additional studies are needed to further explore student and patient perspectives and clarify when, and with what level of trainees, the experiences are most valuable. Copyright © 2017 Elsevier Inc. All rights reserved.

  4. Learning Race from Face: A Survey.

    Science.gov (United States)

    Fu, Siyao; He, Haibo; Hou, Zeng-Guang

    2014-12-01

    Faces convey a wealth of social signals, including race, expression, identity, age and gender, all of which have attracted increasing attention from multi-disciplinary research, such as psychology, neuroscience, computer science, to name a few. Gleaned from recent advances in computer vision, computer graphics, and machine learning, computational intelligence based racial face analysis has been particularly popular due to its significant potential and broader impacts in extensive real-world applications, such as security and defense, surveillance, human computer interface (HCI), biometric-based identification, among others. These studies raise an important question: How implicit, non-declarative racial category can be conceptually modeled and quantitatively inferred from the face? Nevertheless, race classification is challenging due to its ambiguity and complexity depending on context and criteria. To address this challenge, recently, significant efforts have been reported toward race detection and categorization in the community. This survey provides a comprehensive and critical review of the state-of-the-art advances in face-race perception, principles, algorithms, and applications. We first discuss race perception problem formulation and motivation, while highlighting the conceptual potentials of racial face processing. Next, taxonomy of feature representational models, algorithms, performance and racial databases are presented with systematic discussions within the unified learning scenario. Finally, in order to stimulate future research in this field, we also highlight the major opportunities and challenges, as well as potentially important cross-cutting themes and research directions for the issue of learning race from face.

  5. Technical support organization of national regulators: Challenges and strategy

    International Nuclear Information System (INIS)

    Mallick, S.A.; Maqbul, N.; Kanwal, S.; Hashmi, J.A.

    2007-01-01

    technical support organization called the 'Centre for Nuclear Safety' within PNRA to meet the future regulatory challenges. This paper discusses the objectives and organization of Centre for Nuclear Safety and the challenges that the centre is facing as the strategy being devised to meet those challenges. The paper includes a brief description of co-operation under an IAEA TC project titled 'Further Improvement of Nuclear Regulatory Infrastructure in Pakistan-(PAK/9/28)' which is an example of international co-operation in the establishment of technical support organization to enhance the regulatory effectiveness of the national regulator in Pakistan. (author)

  6. Exercise persistence in the face of varying exercise challenges: a test of self-efficacy theory in working mothers.

    Science.gov (United States)

    Jung, Mary E; Brawley, Lawrence R

    2011-07-01

    Self-regulatory efficacy (SRE) should influence persistence towards goals. Mothers attempting to exercise while managing work and young children (N = 49, M(age) = 35.69, M(children) = 1.88) were stratified into high or low concurrent SRE groups, then randomized to read a hypothetical scenario detailing numerous or minimal exercise barrier conditions. Consistent with self-efficacy theory, when exercise barriers were numerous, mothers with higher concurrent SRE demonstrated greater persistence towards exercise goals, and perceived concurrent management of exercise with their other valued goals as more positively challenging, than mothers with lower concurrent SRE.

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

    Science.gov (United States)

    Cheng, Alice; Xie, Zhi

    2017-01-18

    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 have begun to support rare disease patients and facilitate drug discovery through research. Recently, the Chinese FDA set new regulatory guidelines for drugs being developed in China, including an expedited review process for life-saving treatments. In this review, we discuss the effects of these new policy changes on and suggest potential solutions to innovate orphan drug development in China.

  8. Challenges of Virtual School Leadership

    Science.gov (United States)

    Richardson, Jayson W.; LaFrance, Jason; Beck, Dennis

    2015-01-01

    The purpose of this case study was to examine challenges faced by virtual school leaders in the United States. Through semistructured interviews, the researchers explored challenges faced by eighteen leaders of fully online or blended online programs. Analysis revealed six main challenges: funding, staff, accountability, time, parents, and…

  9. International regulatory issues and approaches in the transition phase from operation to decommissioning

    International Nuclear Information System (INIS)

    Pyy, P.; Hrehor, M.; ); Murley, T.; Ranieri, R.; Laaksonen, J.

    2005-01-01

    Full text: The paper summarizes the work performed by an international group of senior nuclear safety regulators which was convened by the Committee on Nuclear Regulatory Activities (CNRA) of the OECD/Nuclear Energy Agency. The fundamental objective of this work was to identify the safety, environmental, organizational, human factors and public policy issues arising from decommissioning that will produce new challenges for the regulator. The study begins by recognizing that decommissioning is not simply an extension of operation and thus it is important for both the management of the facility and the regulator to understand the fundamental nature of the change taking place. Major regulatory policy issues discussed during this study include assurance of adequate funds, waste storage and disposal sites, material release criteria and site release criteria. Some of the important regulatory challenges relate to organizational and human factors, to safety and security requirements and to waste disposal and license termination. The importance of regular communication with both the corporate and site management and with public is recognized in the study as one of the key factors. When a nuclear facility ceases operation and enters into the decommissioning phase, both the operator and the regulator face a new set of challenges very different from those of an operating facility. The operator should have in place a strategic plan for decommissioning, prepared well in advance and reviewed by the regulatory body, to guide the facility managers and personnel through the changed circumstances. An essential part of the strategic plan should be the operator's plan for securing adequate funds to complete the decommissioning activities. In fact, the regulator should ensure that the operator sets aside funds, perhaps in a trust fund, while the facility is still operating and generating revenues. Both the operator and the regulator should expect a heightened public interest and concern

  10. Knowledge Production and Transmission in a Changing Society: Challenges Facing Law Lecturers in a Distance Education Environment in South Africa

    Science.gov (United States)

    Scott, Susan

    2006-01-01

    In this article I highlight the challenges facing a law lecturer in a multicultural society in transformation where the student is being prepared to serve society in different occupational fields as a professional person. I indicate that the law itself cannot effect change. For this we need properly trained lawyers. For an effective transformation…

  11. 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.

  12. Early Regulatory Engagement for Successful Site Remediation: the UK Experience - 13173

    Energy Technology Data Exchange (ETDEWEB)

    Maitland, R.P.; Senior, D. [Office for Nuclear Regulation, Redgrave Court, Liverpool L20 7HS (United Kingdom)

    2013-07-01

    The Office for Nuclear Regulation (ONR) is an independent safety, security and transport regulator of the UK nuclear industry. ONR regulates all civil nuclear reactor power stations, fuel manufacture, enrichment, spent fuel reprocessing, most defence sites and installations that store and process legacy spent fuel and radioactive waste. The responsibility for funding and strategic direction of decommissioning and radioactive waste management of state owned legacy sites has rested solely with the Nuclear Decommissioning Authority (NDA) since 2005. A key component of NDA's mandate was to encourage new strategic approaches and innovation to dealing with the UK's waste legacy and which deliver value-for-money to the UK taxpayer. ONR, as an agency of the Health and Safety Executive, is entirely independent of NDA and regulates all prescribed activities on NDA's sites. NDA's competition of site management and closure contracts has attracted significant international interest and the formation of consortia comprised of major British, US, French and Swedish organizations bidding for those contracts. The prominence of US organizations in each of those consortia reflects the scale and breadth of existing waste management and D and D projects in the US. This paper will articulate, in broad terms, the challenges faced by international organizations seeking to employ 'off-the-shelf' technology and D and D techniques, successfully employed elsewhere, into the UK regulatory context. The predominantly 'goal-setting' regulatory framework in the UK does not generally prescribe a minimum standard to which a licensee must adhere. The legal onus on licensees in the UK is to demonstrate, whatever technology is selected, that in its applications, risks are reduced 'So Far As Is Reasonably Practicable' or 'SFAIRP'. By the nature of its role, ONR adopts a conservative approach to regulation; however ONR also recognises that in the

  13. Ask the experts: the challenges and benefits of flow chemistry to optimize drug development.

    Science.gov (United States)

    Anderson, Neal; Gernaey, Krist V; Jamison, Timothy F; Kircher, Manfred; Wiles, Charlotte; Leadbeater, Nicholas E; Sandford, Graham; Richardson, Paul

    2012-09-01

    Against a backdrop of a struggling economic and regulatory climate, pharmaceutical companies have recently been forced to develop new ways to provide more efficient technology to meet the demands of a competitive drug industry. This issue, coupled with an increase in patent legislation and a rising generics market, makes these themes common issues in the growth of drug development. As a consequence, the importance of process chemistry and scale-up has never been more under the spotlight. Future Medicinal Chemistry wishes to share the thoughts and opinions of a variety of experts from this field, discussing issues concerning the use of flow chemistry to optimize drug development, the potential regulatory and environmental challenges faced with this, and whether the academic and industrial sectors could benefit from a more harmonized system relevant to process chemistry.

  14. Challenges facing the advertising world in the digital era :  A comparison between Dutch and Swedish advertising agencies

    OpenAIRE

    Rozenveld, Marc; Heinonen, Tapio

    2013-01-01

    Date: June 7th of 2013 Level: Master thesis in marketing, 15 ECTS Institution: School of Business, Society and Engineering, Mälardalen University Authors: Tapio Heinonen & Marc Rozenveld 18 thof November 1988 & 16th of June 1990 Title: Challenges facing the advertising world in the digital era. Subtitle: A comparison between Dutch and Swedish advertising agencies. Tutor: Peter Selegård Keywords: media logic, advertising industry, advertising agencies, advertising and digital ma...

  15. A face a mother could love: depression-related maternal neural responses to infant emotion faces.

    Science.gov (United States)

    Laurent, Heidemarie K; Ablow, Jennifer C

    2013-01-01

    Depressed mothers show negatively biased responses to their infants' emotional bids, perhaps due to faulty processing of infant cues. This study is the first to examine depression-related differences in mothers' neural response to their own infant's emotion faces, considering both effects of perinatal depression history and current depressive symptoms. Primiparous mothers (n = 22), half of whom had a history of major depressive episodes (with one episode occurring during pregnancy and/or postpartum), were exposed to images of their own and unfamiliar infants' joy and distress faces during functional neuroimaging. Group differences (depression vs. no-depression) and continuous effects of current depressive symptoms were tested in relation to neural response to own infant emotion faces. Compared to mothers with no psychiatric diagnoses, those with depression showed blunted responses to their own infant's distress faces in the dorsal anterior cingulate cortex. Mothers with higher levels of current symptomatology showed reduced responses to their own infant's joy faces in the orbitofrontal cortex and insula. Current symptomatology also predicted lower responses to own infant joy-distress in left-sided prefrontal and insula/striatal regions. These deficits in self-regulatory and motivational response circuits may help explain parenting difficulties in depressed mothers.

  16. Robust online face tracking-by-detection

    NARCIS (Netherlands)

    Comaschi, F.; Stuijk, S.; Basten, T.; Corporaal, H.

    2016-01-01

    The problem of online face tracking from unconstrained videos is still unresolved. Challenges range from coping with severe online appearance variations to coping with occlusion. We propose RFTD (Robust Face Tracking-by-Detection), a system which combines tracking and detection into a single

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

    Science.gov (United States)

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

    2017-11-01

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

  18. In Pursuit of Ethical Research: Studying Hybrid Communities Using Online and Face-to-Face Communications

    Science.gov (United States)

    Busher, Hugh; James, Nalita

    2015-01-01

    Hybrid communities using online and face-to-face communications to construct their practices are increasingly part of everyday life amongst people who have easy access to the internet. Researching these communities raises a number of challenges for researchers in the pursuit of ethical research. The paper begins by exploring what is understood by…

  19. Challenges for fuel cells as stationary power resource in the evolving energy enterprise

    Science.gov (United States)

    Rastler, Dan

    The primary market challenges for fuel cells as stationary power resources in evolving energy markets are reviewed. Fuel cell power systems have significant barriers to overcome in their anticipated role as decentralized energy power systems. Market segments for fuel cells include combined heat and power; low-cost energy, premium power; peak shaving; and load management and grid support. Understanding the role and fit of fuel cell systems in evolving energy markets and the highest value applications are a major challenge for developers and government funding organizations. The most likely adopters of fuel cell systems and the challenges facing each adopter in the target market segment are reviewed. Adopters include generation companies, utility distribution companies, retail energy service providers and end-users. Key challenges include: overcoming technology risk; achieving retail competitiveness; understanding high value markets and end-user needs; distribution and service channels; regulatory policy issues; and the integration of these decentralized resources within the electrical distribution system.

  20. Common Practices of Transparency in the Nuclear Regulatory Organizations

    International Nuclear Information System (INIS)

    Lee, Chang Ju; Hah, Yeon Hee; Oh, Kju Myeng

    2010-01-01

    Along with greater access to information, particularly through the Internet, there is the increasing demand of the public for transparency, particularly in matters and decisions affecting their lives. The public demands to know more about Nuclear Regulatory Organization's (NROs) and their activities resulting in more interactions with the public to help make nuclear safety activities more understandable and transparent. As a general concept, 'transparency' means literally that something can be seen through. The definition tells us that it is, more actively, to provide the public with factual information about our activities, and to respond promptly to 'the public's right to know' about the information acquired by NROs. NROs around the world recognize the importance of openness and transparency to the success of their programs to protect public health and safety. All agree that good practice in transparency and being proactive with information help to protect against perceptions of secrecy and to instil public confidence and accountability in what they do. On the other hand, NROs face many challenges in their quest to be open and transparent with their stakeholders. government, nuclear operators, NGOs, media, our colleagues, and particularly with the general public. The most frequently identified challenge was striking the right balance between openness and security-related considerations with many responders citing the need to protect proprietary information whilst still accommodating the public's desire to be well informed. Other challenges include deciding how much transparency is needed to satisfy the public and how information, that is often highly technical and complex, can be presented in a meaningful way through the use of clear and simple language. In this paper, we summarize the survey results done by WGPC on relevant practices of NRO's flux of work concerning public communication matters. By comprehensively searching the international status, we may have

  1. Are reading and face processing related?

    DEFF Research Database (Denmark)

    Starrfelt, Randi; Klargaard, Solja K.; Petersen, Anders

    Traditionally, perceptual processing of faces and words is considered highly specialized, strongly lateralized, and largely independent. This has, however, recently been challenged by studies showing that learning to read may affect the perceptual and neural processes involved in face recognition......, reflected in better overall accuracy, a lower perceptual threshold, and higher processing speed for words compared to letters. In sum, we find no evidence that reading skills are abnormal in developmental prosopagnosia, a finding that may challenge the recently proposed hypothesis that reading development...

  2. [Political challenges facing the consolidation of the Sistema Único de Saúde: a historical approach].

    Science.gov (United States)

    Rodrigues, Paulo Henrique de Almeida

    2014-01-01

    This article investigates the circumstances in which Brazil’s sanitation reform was conceived and the Sistema Único de Saúde (SUS) was constructed. A brief analysis is conducted of Brazil’s political transition to democracy, focusing on three political challenges facing the consolidation of SUS: its weak support base amongst workers, competition with the private sector, and the fragmentation of its administration caused by its municipalization. Finally, the changes in the scenario caused by the weakening of neoliberalism since the 2008 crisis, the reemergence of a multipolar political scenario internationally, and the financing conditions of the Brazilian State are described.

  3. The Kent Face Matching Test.

    Science.gov (United States)

    Fysh, Matthew C; Bindemann, Markus

    2018-05-01

    This study presents the Kent Face Matching Test (KFMT), which comprises 200 same-identity and 20 different-identity pairs of unfamiliar faces. Each face pair consists of a photograph from a student ID card and a high-quality portrait that was taken at least three months later. The test is designed to complement existing resources for face-matching research, by providing a more ecologically valid stimulus set that captures the natural variability that can arise in a person's appearance over time. Two experiments are presented to demonstrate that the KFMT provides a challenging measure of face matching but correlates with established tests. Experiment 1 compares a short version of this test with the optimized Glasgow Face Matching Test (GFMT). In Experiment 2, a longer version of the KFMT, with infrequent identity mismatches, is correlated with performance on the Cambridge Face Memory Test (CFMT) and the Cambridge Face Perception Test (CFPT). The KFMT is freely available for use in face-matching research. © 2017 The British Psychological Society.

  4. Unconventional combinations of prospective parents: ethical challenges faced by IVF providers.

    Science.gov (United States)

    Klitzman, Robert

    2017-02-28

    Professional guidelines have addressed ethical dilemmas posed by a few types of nontraditional procreative arrangements (e.g., gamete donations between family members), but many questions arise regarding how providers view and make decisions about these and other such arrangements. Thirty-seven ART providers and 10 patients were interviewed in-depth for approximately 1 h each. Interviews were systematically analyzed. Providers faced a range of challenges and ethical dilemmas concerning both the content and the process of decisions about requests for unconventional interfamilial and other reproductive combinations. Providers vary in how they respond - what they decide, who exactly decides (e.g., an ethics committee or not), and how - often undergoing complex decision-making processes. These combinations can involve creating or raising the child, and can shift over time - from initial ART treatment through to the child's birth. Patients' requests can vary from fully established to mere possibilities. Arrangements may also be unstable, fluid, or unexpected, posing challenges. Difficulties emerge concerning not only familial but social, combinations (e.g., between friends). These arrangements can involve blurry and confusing roles, questions about the welfare of the unborn child, and unanticipated and unfamiliar questions about how to weigh competing moral and scientific concerns - e.g., the autonomy of the individuals involved, and the potential risks and benefits. Clinicians may feel that these requests do not "smell right"; and at first respond with feelings of "yuck," and only later, carefully and explicitly consider the ethical principles involved. Proposed arrangements may, for instance, initially be felt to involve consanguineous individuals, but not in fact do so. Obtaining and verifying full and appropriate informed consent can be difficult, given implicit familial and/or cultural expectations and senses of duty. Social attitudes are changing, yet patients

  5. Challenges in the Licensing of New Nuclear Power Plant, Service Life Extension of Operating Ones (Safeguards-Safety-Security Aspects)

    International Nuclear Information System (INIS)

    Horvath, K.

    2016-01-01

    The Hungarian Atomic Energy Authority (HAEA), as the Hungarian nuclear regulator is faced with dual challenges meant by the licensing of the planned construction of two AES-2006 type nuclear power plant units and the licensing of the service life extension of the existing units that have been operating for more than 30 years. The HAEA has full regulatory competence; its mission is to oversee the safety and security of all the peaceful applications of atomic energy. Accordingly, the licensing scope covers safeguards, safety as well as security. The paper shows the current status of the Hungarian nuclear programme and the future plans, as well as summarizes the regulatory approach followed by HAEA. (author)

  6. THE CHALLENGES FACED BY THE MALE GENDER EXECUTIVE SECRETARY PROFESSIONAL IN CONTEMPORARY ORGANIZATIONS

    Directory of Open Access Journals (Sweden)

    Conceição de Maria Pinheiro Barros

    2011-10-01

    Full Text Available The Professional Executive Secretary has been occupying space increasingly evident in the labor market and organizational structure, both because of market demand, the needs of dynamism in the modern administration that demonstrates the growth of the reference to it. It has sought in his field vision and attitude of performance excellence with fulfilling its role with its own characteristics. This study aims to investigate the general challenges for the Executive Secretariat professional male in contemporary organizations. We defined the following objectives: to analyze the insertion of the male in the profession of Executive Secretary and identify the challenges faced by the Executive Secretary of the males to their development and professional growth. To this end, we performed a literature search, followed by a field survey. It is a qualitative research because data collected, and then make a qualitative analysis of results from selected literature. The survey was conducted in organizations from the public and private, state of Ceará. The sample was represented by professional male graduates in the executive secretariat at the Federal University of Ceará and working in the area. After analyzing the data it was concluded that despite the obstacles to be overcome, the tendency is that these opportunities work for the professional male grow, requiring that all actors in the field to seek gender equity in the profession.

  7. Challenges in Establishing New Regulatory Body in Sri Lanka

    International Nuclear Information System (INIS)

    Hikkaduwa Liyanage, A.R.

    2016-01-01

    Sri Lanka's involvement with Nuclear Science and Technology began in 1957 when it became a member of the International Atomic Energy Agency. This was followed by the establishment of the Radioisotope Centre of the University of Colombo in 1962 and the establishment of the Atomic Energy Authority (AEA) in 1969 by the Atomic Energy Authority Act no. 19 of 1969. The Atomic Energy Authority Act delegated two main responsibilities to the AEA, namely, promotion of the utilization of nuclear technology for the benefit of the people of Sri Lanka, and protection of workers engaged in using radiation and radioisotopes and the public from harmful effects of ionizing radiation. Until 2014, the Atomic Energy Authority functioned as the national regulatory authority on use of radiation and radioisotopes, the national organization responsible for facilitating the use of nuclear technology in medical, industrial and agricultural sectors and as the focal point of the International Atomic Energy Agency in Sri Lanka. With the expansion of uses of radiation in Sri Lanka and commencement of use of high activity sources by the AEA for development and business activities, the need for an independent regulatory authority was realized. The importance of establishment of independent regulatory body for Sri Lanka was also emphasized by the IAEA in several advisory missions conducted in Sri Lanka and as results; a new Act on Atomic Energy was promulgated.

  8. Recurrent subcutaneous emphysema of the face: a challenging clinical problem.

    Science.gov (United States)

    Hojjati, Hossein; Davani, Sam Zeraatian Nejad; Johari, Hamed Ghoddusi

    2007-01-01

    In the neck or face, there are different causes for subcutaneous emphysema such as injury to the sinuses, the hypopharynx, the laryngotracheal complex, the pulmonary parenchyma, the esophagus or the presence of gas-forming organisms. However, factitious subcutaneous emphysema, a rare cause, must be considered in the differential diagnosis. In this clinical report, we discuss a 20-year-old girl who was under follow-up because of recurrent subcutaneous emphysema of the face and periorbital area. After 2 years of work-ups, including a period of close observation in the intensive care unit, self air injection by syringe was found as the cause of recurrent subcutaneous emphysema of the face, and the patient was labeled as having factitious recurrent subcutaneous emphysema. Therefore, when a patient presents with unexplained recurrent subcutaneous emphysema, one should suspect self-infliction and examine for puncture marks.

  9. Off-Patent Transgenic Events: Challenges and Opportunities for New Actors and Markets in Agriculture

    Directory of Open Access Journals (Sweden)

    Patrick Rüdelsheim

    2018-06-01

    Full Text Available More than 20 years ago, the first genetically modified (GM plants entered the seed market. The patents covering the first GM plants have begun to expire and these can now be considered as Off-Patent Events. Here we describe the challenges that will be faced by a Secondary Party by further use and development of these Off-Patent Events. Indeed, the conditions for Off-Patent Events are not available yet to form the basis for a new viable industry similar to the generic manufacturers of agrochemicals or pharmaceutical products, primarily because of (i unharmonized global regulatory requirements for GM organisms, (ii inaccessibility of regulatory submissions and data, and (iii potential difficulties to obtain seeds and genetic material of the unique genotypes used to generate regulatory data. We propose certain adaptations by comparing what has been done in the agrochemical and pharmaceutical markets to facilitate the development of generics. Finally, we present opportunities that still exist for further development of Off-Patent Events in collaboration with Proprietary Regulatory Property Holders in emerging markets, provided (i various countries approve these events without additional regulatory burdens (i.e., acceptance of the concept of data transportability, and (ii local breeders agree to meet product stewardship requirements.

  10. The challenges that parents of children with epilepsy face: A qualitative study.

    Science.gov (United States)

    Kampra, Matina; Tzerakis, Nikolaos; Lund Holm Thomsen, Louise; Katsarou, Efstathia; Voudris, Konstantinos; D Mastroyianni, Sotiria; Mouskou, Stella; Drossou, Kyriaki S; Siatouni, Anna; Gatzonis, Stylianos

    2017-06-01

    This qualitative study explored the challenges that Greek parents/caregivers of children with controlled epilepsy (CwE) face regarding the disorder. Interviews were conducted based on open-ended questions guided by a review of the literature. A total of 91 parents/caregivers were recruited by neurologists at the neurology clinics of two Athens public hospitals. A hermeneutic phenomenological approach was used to explore parent/caregiver experiences. The data were grouped and analyzed through a textual interpretation. Two key challenges were identified for parents of CwE: the disclosure of epilepsy and the absence of adequate information about coping with epilepsy. Parents in Greece were hesitant to reveal their child's epilepsy to school staff and their wider social milieu. Also, although satisfied with the patient-centered approach they experienced with their hospital doctor, parents/caregivers found that they needed more education about the existing sources of psychosocial and emotional support to cope with their child's epilepsy personally and as a family. Finally, the parents/caregivers who let their child know about the epilepsy and discussed the implications with the child found that parent-child communication improved. This study provides valuable insight into the impact of epilepsy on parents of CwE, which might help hospital and school staff support families with greater understanding, sensitivity, and skill. The findings suggest that Greek authorities should staff hospitals and schools with experts and more systematically advertise sources of information about epilepsy and ways to cope with it. Copyright © 2017 Elsevier Inc. All rights reserved.

  11. PNRA: Practically Improving Safety Culture within the Regulatory Body

    International Nuclear Information System (INIS)

    Bhatti, S.A.N.; Habib, M.A.

    2016-01-01

    The prevalence of a good safety culture is equally important for all kind of organizations involved in nuclear business including operating organizations, designers, regulator, etc., and this should be reflected through the processes and activities of these organizations. The need for inculcating safety culture into regulatory processes and practices is gradually increasing since the major nuclear accident of Fukushima, Japan. Accordingly, several international fora in last few years repeatedly highlighted the importance of prevalence of safety culture in regulatory bodies as well. The utilisation of concept of safety culture remained applicable in regulatory activities of PNRA in the form of core values. After the Fukushima accident, PNRA considered it important to check the extent of utilisation of safety culture concept in organizational activities and decided to conduct its “Safety Culture Self-Assessment (SCSA)” for presenting itself as role model in-order to endorse the fact that safety culture at regulatory authority plays an important role to influence safety culture at licenced facilities. Considering the complexity of cultural assessment starting from visual manifestations to the basic assumptions at the deeper level, PNRA decided to utilise IAEA emerging methodology for assessment of culture and then used modified IAEA normative framework (made it applicable for regulatory body) for assessing safety culture at a regulatory body. PNRA SCSA team utilised safety culture assessment tools (observations, focus groups, surveys, interviews and document analysis) for collecting cultural facts by including all level of personnel involved in different activities and functions in the organization. Different challenges were encountered during implementation of these tools which were tackled with the background of training on SCSA and with the help of experts during support missions arranged by IAEA. Before formally starting the SCSA process, pre-launch activities

  12. 21st century challenges faced by nursing faculty in educating for compassionate practice: embodied interpretation of phenomenological data.

    Science.gov (United States)

    Curtis, Katherine

    2013-07-01

    Nursing faculty are facing challenges in facilitating student learning of complex concepts such as compassionate practice. Compassion is a stated expectation of Registered Nurse (RN) and student nurse practice, and yet how it is enabled and learned within the challenging environments of university and health service provider organisations are not yet understood. There is currently an international concern that student nurses are not being adequately prepared for compassion to flourish and for compassionate practice to be sustained upon professional qualification. In order to investigate the experiences of nursing faculty in their preparation of student nurses for compassionate practice, an exploratory aesthetic phenomenological research study was undertaken using in depth interviews with five nurse teachers in the North of England. Findings from this study were analysed and presented using embodied interpretation, and indicate that nurse teachers recognise the importance of the professional ideal of compassionate practice alongside specific challenges this expectation presents. They have concerns about how the economically constrained and target driven practice reality faced by RNs promotes compassionate practice, and that students are left feeling vulnerable to dissonance between learned professional ideals and the RNs' practice reality they witness. Nurse teachers also experience dissonance within the university setting, between the pressures of managing large student groups and the time and opportunity required for small group discussion with students that enables compassion to develop in a meaningful and emotionally sustainable way. Teachers also express discomfort due to a perceived promotion of an 'unachievable utopia' within practice, identifying how the constraints within practice could be better managed to support professional ideals. The nurse teachers within this exploratory study identify the need for strong nurse leadership in practice to challenge

  13. Meeting the regulatory information needs of users of radioactive materials

    International Nuclear Information System (INIS)

    MacDurmon, G.W.

    1996-01-01

    The use of radioactive materials is one of the most regulated areas of research. Researchers face ever increasing regulatory requirements and issues involving the disposal of radioactive material, while meeting the demands of higher productivity. Radiation safety programs must maximize regulatory compliance, minimize barriers, provide services and solutions, and effectively communicate with users of radioactive materials. This talk will discuss methods by which a radiation safety program can meet the needs of both the research staff and regulatory compliance staff

  14. Meeting the regulatory information needs of users of radioactive materials

    Energy Technology Data Exchange (ETDEWEB)

    MacDurmon, G.W. [American Cyanamid Company, Princeton, NJ (United States)

    1996-10-01

    The use of radioactive materials is one of the most regulated areas of research. Researchers face ever increasing regulatory requirements and issues involving the disposal of radioactive material, while meeting the demands of higher productivity. Radiation safety programs must maximize regulatory compliance, minimize barriers, provide services and solutions, and effectively communicate with users of radioactive materials. This talk will discuss methods by which a radiation safety program can meet the needs of both the research staff and regulatory compliance staff.

  15. Challenging today's nuclear industry to be competitive in a changing tomorrow

    International Nuclear Information System (INIS)

    Plug, B.

    1996-01-01

    As the millennium approaches, the future of the nuclear power generation appears desolate. Today's nuclear executives are facing challenges resulting from worldwide change and have forced utilities to reevaluate their corporation's future directions. The nuclear industry must be competitive more than ever to address today's rapid changing marketplace and pressures exerted from: regulatory reformation; increased competition; changes in technology; customer evolution; and globalization. These factors have compelled nuclear executives to address questions such as: What impact will these changes have on today's marketplace, and on my corporation? What will characterize tomorrow's successful nuclear facility? How can today's nuclear corporation compete in tomorrow's marketplace? Will my corporation survive? (author)

  16. Regulatory challenges

    International Nuclear Information System (INIS)

    Austvik, Ole Gunnar

    2003-01-01

    The problem for policy makers wanting to liberalize natural gas markets is that its concentrated structure may also be the socially most efficient one. Because of scale economies, more firms operating in the market may incur higher transportation costs unless the market grows sufficiently in each geographic segment. This argument goes for product extension through vertical (or horizontal) integration and the exploitation of economies of scope as well. Thus, the challenge for governments is to intervene in a way that preserves a market structure that has the potential to minimize cost, and at the same lime change its behavior in order to avoid possible lax cost control and exploitation of market power. The existence of scope advantages indicates that liberalization of the market should open for the possibility to bundle services in competition with provision of unbundled services. If operations are unbundled and there exist economies of scope, the gain from increased competition should be weighed against the losses of less efficient operations of each firm. Thus, with the growth in the European market, gradually more arguments support the idea of unbundling. The significant scale economy in trunk pipelines, sunk investments and capital immobility, possible economies of scope in vertical integration and companies' bundling of services influences vertical and horizontal ownership relations and contractual terms in the European gas market. In specific segments of the markets, these relationships may promote efficient investments and pricing without public interference, but the strong concentration of market power indicates that this is rather the exception than the rule. In order to design an efficient and welfare maximizing way of regulating the market one needs a closer identification of the actual goal of the regulation. Microeconomic theory is often used for this purpose. The author discusses the alternatives of laissez-faire, nationalization or regulation for the

  17. Manufacturing models permitting roll out/scale out of clinically led autologous cell therapies: regulatory and scientific challenges for comparability.

    Science.gov (United States)

    Hourd, Paul; Ginty, Patrick; Chandra, Amit; Williams, David J

    2014-08-01

    Manufacturing of more-than-minimally manipulated autologous cell therapies presents a number of unique challenges driven by complex supply logistics and the need to scale out production to multiple manufacturing sites or near the patient within hospital settings. The existing regulatory structure in Europe and the United States imposes a requirement to establish and maintain comparability between sites. Under a single market authorization, this is likely to become an unsurmountable burden beyond two or three sites. Unless alternative manufacturing approaches can be found to bridge the regulatory challenge of comparability, realizing a sustainable and investable business model for affordable autologous cell therapy supply is likely to be extremely demanding. Without a proactive approach by the regulators to close this "translational gap," these products may not progress down the development pipeline, threatening patient accessibility to an increasing number of clinician-led autologous cellular therapies that are already demonstrating patient benefits. We propose three prospective manufacturing models for the scale out/roll out of more-than-minimally manipulated clinically led autologous cell therapy products and test their prospects for addressing the challenge of product comparability with a selected expert reference panel of US and UK thought leaders. This paper presents the perspectives and insights of the panel and identifies where operational, technological and scientific improvements should be prioritized. The main purpose of this report is to solicit feedback and seek input from key stakeholders active in the field of autologous cell therapy in establishing a consensus-based manufacturing approach that may permit the roll out of clinically led autologous cell therapies. Copyright © 2014 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

  18. Regulatory challenges associated with conducting multicountry clinical trials in resource-limited settings.

    Science.gov (United States)

    Ndebele, Paul; Blanchard-Horan, Christina; Shahkolahi, Akbar; Sanne, Ian

    2014-01-01

    International public health and infectious diseases research has expanded to become a global enterprise transcending national and continental borders in organized networks addressing high-impact diseases. In conducting multicountry clinical trials, sponsors and investigators have to ensure that they meet regulatory requirements in all countries in which the clinical trials will be conducted. Some of these requirements include review and approval by national drug regulatory authorities and recognized research ethics committees. A limiting factor to the efficient conduct of multicountry clinical trials is the regulatory environment in each collaborating country, with significant differences determined by various factors including the laws and the procedures used in each country. The long regulatory processes in resource-limited countries may hinder the efficient implementation of multisite clinical trials, delaying research important to the health of populations in these countries and costing millions of dollars a year.

  19. Strategies for environmental restoration in an evolving regulatory environment

    International Nuclear Information System (INIS)

    Keller, J.F.; Geffen, C.A.

    1990-03-01

    The US Department of Energy (DOE) is faced with the immense challenge of effectively implementing a program to mitigate and manage the environmental impacts created by past and current operations at its facilities. Such a program must be developed and administered in accordance with the Comprehensive Environmental Response, Compensation and Liability Act and the Resource Conservation and Recovery Act. These regulations are extremely complex, burdening the environmental restoration process with a number of planning and public interaction requirements that must be met before remediation of a site may begin. Existing regulatory and institutional requirements for environmental restoration dictate that extensive planning, characterization and assessment activities be conducted. An important part of the process is the involvement of regulators and the public in the site characterization and assessment activities and in developing reasonable solutions for cleanup. This paper identifies the regulatory requirements and highlights implementation strategies for key aspects of the environmental restoration process for DOE. Trends in legislation and policy relevant to the DOE environmental restoration process are highlighted, with strategies identified for dealing with the evolution of the regulations while maintaining continuity in the technical activities required for cleaning up the DOE hazardous and mixed waste sites. 10 refs

  20. A global regulatory science agenda for vaccines.

    Science.gov (United States)

    Elmgren, Lindsay; Li, Xuguang; Wilson, Carolyn; Ball, Robert; Wang, Junzhi; Cichutek, Klaus; Pfleiderer, Michael; Kato, Atsushi; Cavaleri, Marco; Southern, James; Jivapaisarnpong, Teeranart; Minor, Philip; Griffiths, Elwyn; Sohn, Yeowon; Wood, David

    2013-04-18

    The Decade of Vaccines Collaboration and development of the Global Vaccine Action Plan provides a catalyst and unique opportunity for regulators worldwide to develop and propose a global regulatory science agenda for vaccines. Regulatory oversight is critical to allow access to vaccines that are safe, effective, and of assured quality. Methods used by regulators need to constantly evolve so that scientific and technological advances are applied to address challenges such as new products and technologies, and also to provide an increased understanding of benefits and risks of existing products. Regulatory science builds on high-quality basic research, and encompasses at least two broad categories. First, there is laboratory-based regulatory science. Illustrative examples include development of correlates of immunity; or correlates of safety; or of improved product characterization and potency assays. Included in such science would be tools to standardize assays used for regulatory purposes. Second, there is science to develop regulatory processes. Illustrative examples include adaptive clinical trial designs; or tools to analyze the benefit-risk decision-making process of regulators; or novel pharmacovigilance methodologies. Included in such science would be initiatives to standardize regulatory processes (e.g., definitions of terms for adverse events [AEs] following immunization). The aim of a global regulatory science agenda is to transform current national efforts, mainly by well-resourced regulatory agencies, into a coordinated action plan to support global immunization goals. This article provides examples of how regulatory science has, in the past, contributed to improved access to vaccines, and identifies gaps that could be addressed through a global regulatory science agenda. The article also identifies challenges to implementing a regulatory science agenda and proposes strategies and actions to fill these gaps. A global regulatory science agenda will enable

  1. 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......-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...

  2. Partner Country Series: Gas Pricing - China's Challenges and IEA Experience

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2012-07-01

    China will play a positive role in the global development of gas, the International Energy Agency’s (IEA) Executive Director, Maria Van der Hoeven has said in Beijing on 11 September, 2012 when launching a new IEA report: Gas Pricing and Regulation, China’s challenges and IEA experiences. In line with its aim to meet growing energy demand while shifting away from coal, China has set an ambitious goal of doubling its use of natural gas from 2011 levels by 2015. Prospects are good for significant new supplies – both domestic and imported, conventional and unconventional – to come online in the medium-term, but notable challenges remain, particularly concerning gas pricing and the institutional and regulatory landscape. While China’s circumstances are, in many respects unique, some current issues are similar to those a number of IEA countries have faced. This report highlights some key challenges China faces in its transition to greater reliance on natural gas, then explores in detail relevant experiences from IEA countries, particularly in the United Kingdom, the Netherlands, and the United States as well as the European Union (EU). Preliminary suggestions about how lessons learned in other countries could be applied to China’s situation are offered as well. The aim of this report is to provide stakeholders in China with a useful reference as they consider decisions about the evolution of the gas sector in their country.

  3. Technical Challenges in the Application and Licensing of Digital Instrumentation and Control Systems in Nuclear Power Plants

    International Nuclear Information System (INIS)

    2015-01-01

    With the modernization of existing analogue instrumentation and control (I&C) systems in nuclear power plants through digital I&C technology, and the implementation of digital I&C systems in new plants, the industry is faced with significant challenges. These challenges appear in the form of difficulties in managing the necessarily incremental transition, highly integrated (and interdependent) architectures, the flexible configurability enabled by digital technology, and uncertainty and inconsistency in licensing digital I&C systems and equipment in the different Member States. This publication discusses 17 major issues that utilities, developers, suppliers and regulatory stakeholders need to consider, so that the industry can capture and benefit from shared experience, recent technological developments, and emerging best practices

  4. US decommissioning strategy in today's regulatory, technical, political, and economic environments

    International Nuclear Information System (INIS)

    Colvin, J.F.

    1995-01-01

    The United States commercial nuclear power industry is nearly forty years old. Soon after the turn of the century, the United States expects to see a significant rise in the number of plants requiring decommissioning. This, coupled with recent economic pressures which are impacting the U.S. electrical generation industry and have resulted in the premature shutdown of some nuclear power plants, heighten the need for clear regulations and standards addressing facility closure and decommissioning. Since the issue of decommissioning involves public health and safety, technical, environmental and financial aspects, this complex regulatory environment poses a major challenge to the industry in this area. There are three fundamental issues facing utilities as they develop strategies for the eventual decommissioning of their nuclear power plants. These issues are the regulatory approach to decommissioning, the question of the availability of adequate funding, including the uncertainty resulting from the uncertainty of waste disposal options, and the need to meet environmental standards for the protection of health and safety. Futhermore, these issues, in particular the economic-related issues, are magnified in the event of prematurely shut down nuclear power plant. (Author)

  5. 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 methods are time consuming and expensive, it is not realistic to identify TFBS for all uncharacterized genes in the genome by purely experimental means. Computational methods aimed at predicting potential regulatory regions can increase the efficiency of wet-lab experiments significantly. Here, methods...

  6. From Toques to Tokes: Two challenges facing nationwide legalization of cannabis in Canada.

    Science.gov (United States)

    Bear, Daniel

    2017-04-01

    In 2015, a new Liberal Government came to power in Canada, elected on a platform that included legalization and regulation of cannabis for recreational purposes. Their legislation, based on recommendations from a Federal Task Force on Marijuana Legalization and Regulation, is due in early April 2017. This commentary utilizes Canadian Federal policy papers, previous literature, and internal and international agreements to examine two key areas critical to the development of a nationwide regulated market for cannabis in Canada; the need to overcome restrictions to legalizing cannabis in United Nations' drug control treaties, and the unique challenges that non-medical cannabis creates for navigating interprovincial trade policies in Canada. Irrespective of UN conventions that appear to prohibit legalization of cannabis the Government is preparing to bring forward legislation as this article goes to print. At the same time significant squabbles impede the selling of even beer and wine inter-provincially in Canada. This paper identifies the challenges facing Canadian legalization efforts, but also shows how the legalization legislation may provide opportunities to engender significant change beyond the simple legalization of a specific drug. This commentary does not argue for any specific course of action for Canada, but rather explores the nuance of legalization absent from the declaration in the Liberal party platform. The paper argues that Canada's efforts may hasten the dismantling of the UN drug control structure, and provide renewed opportunities for intern-provincial trade in Canada. Copyright © 2017 Elsevier B.V. All rights reserved.

  7. Material Challenges For Plasma Facing Components in Future Fusion Reactors

    International Nuclear Information System (INIS)

    Linke, J; Pintsuk, G.; Rödig, M.

    2013-01-01

    Increasing attention is directed towards thermonuclear fusion as a possible future energy source. Major advantages of this energy conversion technology are the almost inexhaustible resources and the option to produce energy without CO2-emissions. However, in the most advanced field of magnetic plasma confinement a number of technological challenges have to be met. In particular high-temperature resistant and plasma compatible materials have to be developed and qualified which are able to withstand the extreme environments in a commercial thermonuclear power reactor. The plasma facing materials (PFMs) and components (PFCs) in such fusion devices, i.e. the first wall (FW), the limiters and the divertor, are strongly affected by the plasma wall interaction processes and the applied intense thermal loads during plasma operation. On the one hand, these mechanisms have a strong influence on the plasma performance; on the other hand, they have major impact on the lifetime of the plasma facing armour. In present-day and next step devices the resulting thermal steady state heat loads to the first wall remain below 1 MWm-2; the limiters and the divertor are expected to be exposed to power densities being at least one order of magnitude above the FW-level, i.e. up to 20 MWm-2 for next step tokamaks such as ITER or DEMO. These requirements are responsible for high demands on the selection of qualified PFMs and heat sink materials as well as reliable fabrication processes for actively cooled plasma facing components. The technical solutions which are considered today are mainly based on the PFMs beryllium, carbon or tungsten joined to copper alloys or stainless steel heat sinks. In addition to the above mentioned quasi-stationary heat loads, short transient thermal pulses with deposited energy densities up to several tens of MJm-2 are a serious concern for next step tokamak devices. The most frequent events are so-called Edge Localized Modes (type I ELMs) and plasma disruptions

  8. Incident reporting to BfArM - regulatory framework, results and challenges.

    Science.gov (United States)

    Seidel, Robin; Stößlein, Ekkehard; Lauer, Wolfgang

    2016-04-01

    Medical devices are manifold and one of the most innovative fields of technology. As technologies advance, former limits cease to exist and complex devices become reality. Medical devices represent a very dynamic field with high economic relevance. The manufacturer of a medical device is obliged to minimize product-related risks as well as to demonstrate compliance with the so-called "essential requirements" regarding safety and performance before placing the device on the market. Any critical incident in relation to the application of a medical device has to be reported to the competent authority for risk assessment, which in Germany is either the Federal Institute for Drugs and Medical Devices (BfArM) or the Paul Ehrlich Institute (PEI) depending on the type of device. In this article, the German regulatory framework for medical devices and the resulting tasks for BfArM are described as well as the topics of its recently installed research and development group on prospective risk identification and application safety for medical devices. Results of failure mode and root cause analyses of incident data are presented as well as further data on cases with the result "root-cause analysis not possible". Finally an outlook is given on future challenges regarding risk assessment for medical devices.

  9. Legal and Regulatory Barriers to Reverse Innovation.

    Science.gov (United States)

    Rowthorn, Virginia; Plum, Alexander J; Zervos, John

    Reverse innovation, or the importation of new, affordable, and efficacious models to high-income countries from the developing world, has emerged as a way to improve the health care system in the United States. Reverse innovation has been identified as a key emerging trend in global health systems in part because low-resourced settings are particularly good laboratories for low-cost/high-impact innovations that are developed out of necessity. A difficult question receiving scant attention is that of legal and regulatory barriers. The objective of this paper is to understand and elucidate the legal barriers faced by innovators bringing health interventions to the United States. Semistructured qualitative interviews were conducted with 9 key informants who have directly participated in the introduction of global health care approaches to the United States health system. A purposive sampling scheme was employed to identify participants. Phone interviews were conducted over one week in July 2016 with each participant and lasted an average of 35 minutes each. Purely legal barriers included questions surrounding tort liability, standard of care, and concerns around patient-administered self-care. Regulatory burdens included issues of international medical licensure, reimbursement, and task shifting and scope of work challenges among nonprofessionals (e.g. community health workers). Finally, perceived (i.e. not realized or experienced) legal and regulatory barriers to innovative modalities served as disincentives to bringing products or services developed outside of the United States to the United States market. Conflicting interests within the health care system, safety concerns, and little value placed on low-cost interventions inhibit innovation. Legal and regulatory barriers rank among, and contribute to, an anti-innovation atmosphere in healthcare for domestic and reverse innovators alike. Reverse innovation should be fostered through the thoughtful development of

  10. Lessons Learned and Regulatory Countermeasures of Nuclear Safety Issues Last Year

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Y. E. [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

    2013-05-15

    Competitiveness of nuclear as the electric resource in terms of the least cost and the carbon abatement has been debated. Some institutions insist that the radioactive wastes management cost, nuclear accident cost and cheap shale gas would make the nuclear energy less competitive, while others still address the ability of nuclear energy as economical and low-carbon electric resource. This situation reminds that ensuring nuclear safety is the most important prerequisite to use of nuclear energy. Therefore, this paper will compare the different views on future nuclear competitiveness discussed right after the Fukushima accident and summarize the lessons learned and regulatory countermeasures from nuclear safety issues last year. Korea has improved the effectiveness of safety regulation up to now and still has been making efforts on further enhancing nuclear safety. The outcomes of these efforts have resulted in a high level of safety in Korean NPPs and contributing largely to the global nuclear safety through sharing and exchanging the information and knowledge of our nuclear experiences. However, now we are faced with the new challenges such as decreasing the public. Additionally, public criticism of the regulatory activities demands more clear regulatory guides and transparent process. Recently, new president announced the 'Priority to Safety and Public Trust' as the precondition to utilize the nuclear energy. We will continue to make much more efforts for the improvement of the quality of regulatory activities and effectiveness of regulatory decision making process than we have done so far. Competence through effective capacity building would be a helpful pathway to build up the public trust and ensure the acceptable level of nuclear safety. We are set to prepare the action items to be taken in the near future for improving the technical competency and transparency as the essential components of the national safety and will make efforts to implement them

  11. Nuclear regulatory decision making

    International Nuclear Information System (INIS)

    Wieland, Patricia; Almeida, Ivan Pedro Salati de

    2011-01-01

    The scientific considerations upon which the nuclear regulations are based provide objective criteria for decisions on nuclear safety matters. However, the decisions that a regulatory agency takes go far beyond granting or not an operating license based on assessment of compliance. It may involve decisions about hiring experts or research, appeals, responses to other government agencies, international agreements, etc.. In all cases, top management of the regulatory agency should hear and decide the best balance between the benefits of regulatory action and undue risks and other associated impacts that may arise, including issues of credibility and reputation. The establishment of a decision framework based on well established principles and criteria ensures performance stability and consistency, preventing individual subjectivity. This article analyzes the challenges to the decision-making by regulatory agencies to ensure coherence and consistency in decisions, even in situations where there is uncertainty, lack of reliable information and even divergence of opinions among experts. The article explores the basic elements for a framework for regulatory decision-making. (author)

  12. Influence of drug molecules on regulatory B cells.

    Science.gov (United States)

    Amrouche, Kahina; Jamin, Christophe

    2017-11-01

    By their suppressive functions, regulatory B (Breg) cells are considered as key elements in the control and development of various disease states. Many signals can induce Bregs in vivo and in vitro and often from heterogeneous populations. Several specific signals delivered in a timely immunological context contribute to the establishment of Bregs. These are endogenous and physiological signals or stimuli, widely discussed in the literature participating in the establishment of an effective immune response. However, exogenous signals, much less clearly identified can also be considered as Bregs inducers. These extrinsic signals are capable of directly or indirectly influencing the suppressive capacity of Bregs, but also their expansion and functional restoration in its absence. Faced with the excitement generated by the development of processes favoring the expansion of Bregs in mice for therapeutic purposes, the challenge today is to extrapolate such approaches in humans. This perspective may already be in effect. Copyright © 2017 Elsevier Inc. All rights reserved.

  13. Multi-Branch Fully Convolutional Network for Face Detection

    KAUST Repository

    Bai, Yancheng

    2017-07-20

    Face detection is a fundamental problem in computer vision. It is still a challenging task in unconstrained conditions due to significant variations in scale, pose, expressions, and occlusion. In this paper, we propose a multi-branch fully convolutional network (MB-FCN) for face detection, which considers both efficiency and effectiveness in the design process. Our MB-FCN detector can deal with faces at all scale ranges with only a single pass through the backbone network. As such, our MB-FCN model saves computation and thus is more efficient, compared to previous methods that make multiple passes. For each branch, the specific skip connections of the convolutional feature maps at different layers are exploited to represent faces in specific scale ranges. Specifically, small faces can be represented with both shallow fine-grained and deep powerful coarse features. With this representation, superior improvement in performance is registered for the task of detecting small faces. We test our MB-FCN detector on two public face detection benchmarks, including FDDB and WIDER FACE. Extensive experiments show that our detector outperforms state-of-the-art methods on all these datasets in general and by a substantial margin on the most challenging among them (e.g. WIDER FACE Hard subset). Also, MB-FCN runs at 15 FPS on a GPU for images of size 640 x 480 with no assumption on the minimum detectable face size.

  14. Meeting the challenges of the new energy industry: The driving forces facing electric power generators and the natural gas industry

    International Nuclear Information System (INIS)

    Anon.

    1995-01-01

    The proceedings of the IGT national conference on meeting the challenges of the New Energy Industry: The driving forces facing Electric Power Generators and the Natural Gas Industry are presented. The conference was held June 19-21, 1995 at the Ambassador West Hotel in Downtown Chicago, Illinois. A separate abstract and indexing for each of the 18 papers presented for inclusion in the Energy Science and Technology Database

  15. Meeting the challenges of the new energy industry: The driving forces facing electric power generators and the natural gas industry

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1995-12-31

    The proceedings of the IGT national conference on meeting the challenges of the New Energy Industry: The driving forces facing Electric Power Generators and the Natural Gas Industry are presented. The conference was held June 19-21, 1995 at the Ambassador West Hotel in Downtown Chicago, Illinois. A separate abstract and indexing for each of the 18 papers presented for inclusion in the Energy Science and Technology Database.

  16. View based approach to forensic face recognition

    NARCIS (Netherlands)

    Dutta, A.; van Rootseler, R.T.A.; Veldhuis, Raymond N.J.; Spreeuwers, Lieuwe Jan

    Face recognition is a challenging problem for surveillance view images commonly encountered in a forensic face recognition case. One approach to deal with a non-frontal test image is to synthesize the corresponding frontal view image and compare it with frontal view reference images. However, it is

  17. Challenges in long-term operation of nuclear power plants - Implications for regulatory bodies

    International Nuclear Information System (INIS)

    Soda, Kunihisa; Van Wonterghem, Frederik; Khouaja, Hatem; Vilpas, Martti; Osouf, Nicolas; Harikumar, S.; Ishigaki, Hiroki; Osaki, Toru; Yamada, Tomoho; Carlsson, Lennart; Shepherd, David; Galloway, Melanie; Liszka, Ervin; Svab, Miroslav; Pereira, Ken; Huerta, Alejandro

    2012-01-01

    Nuclear power reactors have become a major source of electricity supply in many countries in the past half a century. Based on this experience, many operators have sought and have received authorisation for long-term operation, whereby plant operation continues beyond the period considered in the design of the plant. Acceptance of a nuclear power plant for extended service should be based on assurance of the fitness of the plant and the operator for safe and reliable operation over the entire period considered for long-term operation. This assurance may be obtained by establishment of appropriate regulatory requirements, specification of goals and safety levels and regulatory assessment and oversight of the operator's programme for long-term operation. The operators and regulators should ensure that operating experience continues to be evaluated during long-term operation to ensure that any relevant lessons are effectively applied. Other considerations for assurance of safe operation are effective management of ageing, possible need for safety improvements, application of lessons learnt from operating experience, evaluation of environmental impacts, adequate staff resources and performance, review of security at the plant, action in response to emerging issues, and openness and transparency in the transition to long-term operation. Even though most of these considerations are addressed under the regulatory framework that applies to the initial operating period, additional regulatory activities in these areas may be necessary for long-term operation. Although there can be significant differences in regulatory approaches used by different countries for evaluating acceptability of long-term operation, there is general agreement on the purposes and goals of the regulatory reviews. An authorisation of long-term operation could involve a licence renewal or a periodic safety review or an approach that melds elements of both. This report presents guidance that is intended

  18. Safe and Secure Transportation of Radioactive Materials in Pakistan and Future Challenges

    International Nuclear Information System (INIS)

    Muneer, Muhammad; Ejaz, Asad

    2016-01-01

    PNRA is the sole organization in the country responsible to regulate all matters pertaining to ionizing radiations. For the safety of transport of radioactive material in the country, PNRA has adopted IAEA TS-R-1 as a national regulation. To cover the security aspects and emergency situations, if any, during the transportation of radioactive material, PNRA has issued the regulatory guide on ‘Transportation of Radioactive Material by Road in Pakistan’. In Pakistan, low to medium activity radioactive sources are transported from one place to another by road for the purpose of industrial radiography, well logging, medical application, etc. According to national policy, sealed radioactive sources of half life greater than 1 year and with initial activity of 100 GBq or more imported in the country are required to be returned to country of origin (exported) after its use. Although the activities related to transport of radioactive material remained safe and secure and no major accident/incident has been reported so far, however, the improvement/enhancement in the regulatory infrastructure is a continuous process. In future, more challenges are expected to be faced in the safety of transport packages. This paper will describe the steps taken by PNRA for the safety and security of transport of radioactive material in the country and future challenges. (author)

  19. Exploring career advancement challenges people with disabilities are facing in the South African work context

    Directory of Open Access Journals (Sweden)

    Ingrid L. Potgieter

    2017-02-01

    Full Text Available Orientation: South Africa has faced a number of discriminatory practices in the past. Most of these practices are still present today. Although a considerate amount of attention has been given to discrimination based on gender, race and religion, limited emphasis has been placed on discrimination based on disability, specifically within the workplace. Research purpose: The objective of the study was to explore the perceptions of individuals living with a disability with regards to career advancement challenges they face in the South African workplace. Motivation for study: The research literature shows that irrespective of employment equity legislation, employees with disabilities have restricted opportunities to advance in their careers. Research is needed to assist these employees with their career development. Research design, approach and method: A qualitative research design with an exploratory approach was followed. Probability, purposeful and snowballing sampling techniques were applied in this study on 15 employed individuals with declared disabilities. The data were collected by means of semi-structured interviews and the verbatim transcriptions were analysed by content analysis. Main findings/results: The findings indicated that people with disabilities generally experience career advancement challenges and reach career plateau. Managers and colleagues’ lack of knowledge about disability has an adverse impact on the careers of people living with a disability. The study found that human resource practices, especially promotion opportunities, discriminate against employees with disabilities. Furthermore, the study further indicated that there is prejudice against invisible disabilities, and as a result, employees are reluctant to declare their disability. Practical implications: Human resource practitioners and managers need to recognise the influence that disabilities have on the career advancement of individuals living with a

  20. 76 FR 72220 - Incorporation of Risk Management Concepts in Regulatory Programs

    Science.gov (United States)

    2011-11-22

    ... actions? 4. What are the key characteristics for a holistic risk management regulatory structure for... accomplishing the goal of a holistic risk management regulatory structure? How could these challenges be... NUCLEAR REGULATORY COMMISSION [NRC-2011-0269] Incorporation of Risk Management Concepts in...

  1. Psychosocial challenges facing physicians of today.

    Science.gov (United States)

    Arnetz, B B

    2001-01-01

    Fundamental changes in the organization, financing, and delivery of health care have added new stressors or opportunities to the medical profession. These new potential stressors are in addition to previously recognized external and internal ones. The work environment of physicians poses both psychosocial, ergonomic, and physico-chemical threats. The psychosocial work environment has, if anything, worsened. Demands at work increase at the same time as influence over one's work and intellectual stimulation from work decrease. In addition, violence and the threat of violence is another major occupational health problem physicians increasingly face. Financial constraint, managed care and consumerism in health care are other factors that fundamentally change the role of physicians. The rapid deployment of new information technologies will also change the role of the physician towards being more of an advisor and information provider. Many of the minor health problems will increasingly be managed by patients themselves and by non-physician professionals and practitioners of complementary medicine. Finally, the economic and social status of physicians are challenged which is reflected in a slower salary increase compared to many other professional groups. The picture painted above may be seen as uniformly gloomy. In reality, that is not the case. There is growing interest in and awareness of the importance of the psychosocial work environment for the delivery of high quality care. Physicians under stress are more likely to treat patients poorly, both medically and psychologically. They are also more prone to make errors of judgment. Studies where physicians' work environment in entire hospitals has been assessed, results fed-back, and physicians and management have worked with focused improvement processes, have demonstrated measurable improvements in the ratings of the psychosocial work environment. However, it becomes clear from such studies that quality of the

  2. Regulatory challenges for preventing firearms smuggling into Mexico

    OpenAIRE

    Vargas, Eugenio Weigend; González, Silvia Villarreal

    2015-01-01

    The recent surge in illegal firearms trafficking from the U.S. into Mexico has helped empower Mexican criminal groups to adopt highly confrontational strategies, contributing to a surge of violence throughout the country. This article addresses the regulatory asymmetries between Mexico and the U.S. with respect to the production, import, export, sales and possession of firearms. It reviews several important gun laws and explores why this asymmetry limits bilateral cooperation and encourages g...

  3. Challenges, opportunities and trends in engineering education

    International Nuclear Information System (INIS)

    Rosen, M.A.

    2005-01-01

    Many challenges and opportunities face the engineering profession and engineering education. The engineering profession advances best if challenges are properly addressed, opportunities beneficially exploited and reasoned speculation made on future trends. In this article, the author presents his views on some of the challenges and opportunities facing the engineering education, and possible future trends, with the objective of fostering continued discussion of and action on these issues. This topic is of great importance because the development of engineering education is strongly influenced by the challenges and opportunities it faces and how it responds, and by anticipated future trends. (author)

  4. A personal perspective on challenges that face women scientists

    Science.gov (United States)

    Cashman, Katharine

    2016-04-01

    Gender equality has been a topic of discussion throughout my long (now three decade) career. This alone illustrates the complex nature of the issue, and the lack of a simple solution, particularly as many of the daily challenges that women face are institution or discipline-specific. For this reason, I will summarize some of the issues that appear to me to be more general, and therefore ones that may have general solutions. The first and foremost relates to demands on women's time. One way that academic institutions have sought to overcome gender bias has been to require that every university committee have a female member; in departments, schools and faculties where women represent a minority, this necessarily means that women shoulder an inequitable share of the service duties. I have experienced this myself, seen it in promotion files at all levels, and observed it with regard to my female colleagues. Clearly time spent doing service is time not spent doing science. There is also an easy solution to this problem, which is to re-think the underlying assumption that men are necessarily gender-biased if they don't have a woman sitting in the room! Additional time demands can come from informal mentoring of both students and younger colleagues, particularly in cases where senior male colleagues are viewed as too important, or too intimidating, to be consulted on personal issues. Although I suspect that this problem may also be widespread, it is more difficult to quantify, and is therefore more difficult to factor into time allotments of departmental duties. A final thought relates to hiring practices. I have now worked in both the US and UK educational systems, which have very different interview and hiring protocols. I will review both, highlighting components that I think are most likely to promote equitable hiring practices.

  5. Organisational, technological and economic innovations: the nuclear industry reinvents itself to face 2030 challenges

    International Nuclear Information System (INIS)

    Faudon, Valerie; Jouette, Isabelle; Le Ngoc, Boris

    2016-06-01

    As the French nuclear industry is facing a major challenge (financial weakness, an electric power market in crisis, 15 years without building any reactor, delayed works), this report first outlines why innovation is necessary to guarantee a low carbon and competitive electricity, to comfort the leadership position of this sector in the world, and to respond to expectations of civil society. Then, it describes how the French nuclear industry is already implementing organisational, technological and social innovations, notably through the development of digital technologies. The third part identifies priorities of new public policies: to imagine a new business model for nuclear (a better visibility for investors, taking all induced costs in the power system into account in a diversified mix, reform of the carbon market, taking avoided atmospheric pollution into account), to rethink regulation in order to free innovation spirit, and to prepare the future by investing in research

  6. Comparison of Fiscal and Regulatory Policies to Prevent Non ...

    International Development Research Centre (IDRC) Digital Library (Canada)

    India is facing a rising burden of cardiovascular disease and obesity-related diabetes ... As a result, fiscal and regulatory strategies such as food taxes have been ... International Water Resources Association, in close collaboration with IDRC, ...

  7. Regulatory issues in merchant transmission investment

    International Nuclear Information System (INIS)

    Brunekreeft, G.

    2005-01-01

    Merchant investment in electricity transmission networks (MTI) is now legally allowed. Predominantly driven by the fear of underinvestment, regulators examine this possibility and given that MTI is a possibility, the regulators face a new set of questions. This paper raises and examines regulatory questions especially from a European institutional framework. The regulatory issues concern the competition effect, the ownership, access regime and the must-offer provision. The paper argues to leave light-handed unregulated MTI light handed and refrain from additional measures. In most cases, it is justified to refrain from sector-specific arrangements because competition,law, if necessary at all, will suffice. However, details matter. (author)

  8. The contribution of youth work to address the challenges young people are facing, in particular the transition from education to employment

    DEFF Research Database (Denmark)

    Louw, Arnt Vestergaard

    The findings of the expert group detail the role of youth work and its specific contribution to addressing the challenges young people face, in particular the transition from education to employment. In this context, youth work is defined as 'actions directed towards young people regarding activi...... activities where they take part voluntarily, designed for supporting their personal and social development through non-formal and informal learning'....

  9. Vitality Detection in Face Images using Second Order Gradient

    OpenAIRE

    Aruni Singh

    2012-01-01

    Spoofing is a very big challenge in biometrics, specially in face image. So many artificial techniques are available to tamper or hide the original face. To ensure the actual presence of live face image in contrast to fake face image this research has been contributed. The intended purpose of proposed approach is also to endorse the biometric authentication, by joining the liveness awareness with Facial Recognition Technology (FRT). In this research 200 dummy face images and 200 real face ima...

  10. Regulatory pathways for vaccines for developing countries.

    Science.gov (United States)

    Milstien, Julie; Belgharbi, Lahouari

    2004-01-01

    Vaccines that are designed for use only in developing countries face regulatory hurdles that may restrict their use. There are two primary reasons for this: most regulatory authorities are set up to address regulation of products for use only within their jurisdictions and regulatory authorities in developing countries traditionally have been considered weak. Some options for regulatory pathways for such products have been identified: licensing in the country of manufacture, file review by the European Medicines Evaluation Agency on behalf of WHO, export to a country with a competent national regulatory authority (NRA) that could handle all regulatory functions for the developing country market, shared manufacturing and licensing in a developing country with competent manufacturing and regulatory capacity, and use of a contracted independent entity for global regulatory approval. These options have been evaluated on the basis of five criteria: assurance of all regulatory functions for the life of the product, appropriateness of epidemiological assessment, applicability to products no longer used in the domestic market of the manufacturing country, reduction of regulatory risk for the manufacturer, and existing rules and regulations for implementation. No one option satisfies all criteria. For all options, national infrastructures (including the underlying regulatory legislative framework, particularly to formulate and implement local evidence-based vaccine policy) must be developed. WHO has led work to develop this capacity with some success. The paper outlines additional areas of action required by the international community to assure development and use of vaccines needed for the developing world. PMID:15042235

  11. Outsource Power, Import Safety? Challenges and Opportunities of the U.S.-China Food Safety Regulatory Cooperation.

    Science.gov (United States)

    Lin, Ching-Fu

    The United States has a high stake in China’s serious food safety problem, as food products of Chinese origin have dominated the U.S. food market in numerous areas and continue to grow. The conclusion of the U.S.-China Food Safety Agreement (“the Agreement”) has allowed FDA to strengthen regulatory cooperation with its Chinese counterpart in various aspects. The Agreement also paves the way for the implementation of the new regulatory tools incorporated in FSMA, especially in the cross-border context. However, both the Agreement and FSMA have certain crucial limitations that may create future hurdles to effective implementation in the U.S.-China cooperation. This paper therefore endeavors to first examine China’s governance challenges over food safety, with a focus on the 2009 Food Safety Law, the 2015 Amendment, and the fundamental problem of “thin” rule of law. This paper moves to analyze the U.S.-China Food Safety Agreement, reviewing the agreement’s strengths and weaknesses. It further assesses FSMA’s innovative institutional design to regulate imported food products and its limitations. However, both the U.S.-China Food Safety Agreement and FSMA arguably create a regulatory dilemma for FDA when addressing imported food safety, due to structural mismatch between the broad scope of power granted to FDA and the long chain of power outsourcing to governments or private companies as primary “regulators.” Neither the Agreement nor FSMA give FDA adequate capacity to closely oversee such “agents” along the chain of power outsourcing. Framing the U.S.-China food safety cooperation as a multilayer structure that “outsources power” to “import safety,” this paper concludes by stressing the need for a robust accountability and effective mechanism for U.S.-China food safety cooperation.

  12. A survey of real face modeling methods

    Science.gov (United States)

    Liu, Xiaoyue; Dai, Yugang; He, Xiangzhen; Wan, Fucheng

    2017-09-01

    The face model has always been a research challenge in computer graphics, which involves the coordination of multiple organs in faces. This article explained two kinds of face modeling method which is based on the data driven and based on parameter control, analyzed its content and background, summarized their advantages and disadvantages, and concluded muscle model which is based on the anatomy of the principle has higher veracity and easy to drive.

  13. Regulatory challenges affecting ICT development in Ukraine

    DEFF Research Database (Denmark)

    Kretova, Olga A.

    2017-01-01

    in the region in terms of network readiness (64th place out of 139 economies) and global competitiveness (79th place out of 140 economies) in 2016. The significance of ICT policies is broadly understood at the highest political level in Ukraine, however their implementation has always posed a challenge....... And the chapter is organized as follows. Section 2.1 is the introduction; section 2.2 presents an overview of policies and regulations influencing ICTs in Ukraine; section 2.3 presents a snapshot of the national ICT sector which is dominated by the mobile market and the Broadband Access Technology market; Section...... 2.4 provides an insight into the various ICT regulations, how it affected the markets and the challenges in implementing these policies; section 2.5 highlights the role , successes and challenges of implementing regulations aimed at implementing e-government; and section 2.7 concludes this chapter...

  14. Face recognition accuracy of forensic examiners, superrecognizers, and face recognition algorithms.

    Science.gov (United States)

    Phillips, P Jonathon; Yates, Amy N; Hu, Ying; Hahn, Carina A; Noyes, Eilidh; Jackson, Kelsey; Cavazos, Jacqueline G; Jeckeln, Géraldine; Ranjan, Rajeev; Sankaranarayanan, Swami; Chen, Jun-Cheng; Castillo, Carlos D; Chellappa, Rama; White, David; O'Toole, Alice J

    2018-05-29

    Achieving the upper limits of face identification accuracy in forensic applications can minimize errors that have profound social and personal consequences. Although forensic examiners identify faces in these applications, systematic tests of their accuracy are rare. How can we achieve the most accurate face identification: using people and/or machines working alone or in collaboration? In a comprehensive comparison of face identification by humans and computers, we found that forensic facial examiners, facial reviewers, and superrecognizers were more accurate than fingerprint examiners and students on a challenging face identification test. Individual performance on the test varied widely. On the same test, four deep convolutional neural networks (DCNNs), developed between 2015 and 2017, identified faces within the range of human accuracy. Accuracy of the algorithms increased steadily over time, with the most recent DCNN scoring above the median of the forensic facial examiners. Using crowd-sourcing methods, we fused the judgments of multiple forensic facial examiners by averaging their rating-based identity judgments. Accuracy was substantially better for fused judgments than for individuals working alone. Fusion also served to stabilize performance, boosting the scores of lower-performing individuals and decreasing variability. Single forensic facial examiners fused with the best algorithm were more accurate than the combination of two examiners. Therefore, collaboration among humans and between humans and machines offers tangible benefits to face identification accuracy in important applications. These results offer an evidence-based roadmap for achieving the most accurate face identification possible. Copyright © 2018 the Author(s). Published by PNAS.

  15. Resolution of regulatory issues facing the DOE in situ vitrification program

    International Nuclear Information System (INIS)

    Corathers, L.A.

    1992-03-01

    In situ vitrification (ISV) is being developed by researchers at the Pacific Northwest Laboratory (PNL), Idaho National Engineering Laboratory (INEL), and Oak Ridge National Laboratory (ORNL) as a technology for remediating soils, underground storage tank residuals, and buried materials that have been contaminated with hazardous, radioactive, and mixed wastes (i.e., wastes containing both radioactive and hazardous wastes) at US Department of Energy (DOE) facilities. The goal of the DOE ISV technology development program (i.e., the ISV Integrated Program) is to ensure that ISV is a workable technology for environmental restoration applications for DOE and other agencies. A DOE complex-wide plan was prepared during Fiscal Year 1991 to coordinate all levels of activities associated with the deployment of ISV. As part of this plan, a programmatic regulatory strategy was developed which focused on the federal environmental, health, safety, and nuclear regulations, including the US Environmental Protection Agency (EPA) and DOE regulations, believed to have the most significant near-term impact on the use of ISV as a remediation technology. The portion of the programmatic regulatory strategy addressing compliance with the Comprehensive Environmental Response, Compensation and Liability Act, as amended, and the Resource Conservation and Recovery Act, as amended, is presented in this paper

  16. European regulatory tools for advanced therapy medicinal products.

    Science.gov (United States)

    Flory, Egbert; Reinhardt, Jens

    2013-12-01

    Increasing scientific knowledge and technical innovations in the areas of cell biology, biotechnology and medicine resulted in the development of promising therapeutic approaches for the prevention and treatment of human diseases. Advanced therapy medicinal products (ATMPs) reflect a complex and innovative class of biopharmaceuticals as these products are highly research-driven, characterised by innovative manufacturing processes and heterogeneous with regard to their origin, type and complexity. This class of ATMP integrates gene therapy medicinal products, somatic cell therapy medicinal products and tissue engineering products and are often individualized and patient-specific products. Multiple challenges arise from the nature of ATMPs, which are often developed by micro, small and medium sized enterprises, university and academia, for whom regulatory experiences are limited and regulatory requirements are challenging. Regulatory guidance such as the reflection paper on classification of ATMPs and guidelines highlighting product-specific issues support academic research groups and pharmaceutical companies to foster the development of safe and effective ATMPs. This review provides an overview on the European regulatory aspects of ATMPs and highlights specific regulatory tools such as the ATMP classification procedure, a discussion on the hospital exemption for selected ATMPs as well as borderline issues towards transplants/transfusion products.

  17. Challenges facing the development of the Arabic chatbot

    Science.gov (United States)

    AlHagbani, Eman Saad; Khan, Muhammad Badruddin

    2016-07-01

    The future information systems are expected to be more intelligent and will take human queries in natural language as input and answer them promptly. To develop a chatbot or a computer program that can chat with humans in realistic manner to extent that human get impressions that he/she is talking with other human is a challenging task. To make such chatbots, different technologies will work together ranging from artificial intelligence to development of semantic resources. Sophisticated chatbots are developed to perform conversation in number of languages. Arabic chatbots can be helpful in automating many operations and serve people who only know Arabic language. However, the technology for Arabic language is still in its infancy stage due to some challenges surrounding the Arabic language. This paper offers an overview of the chatbot application and the several obstacles and challenges that need to be resolved to develop an effective Arabic chatbot.

  18. Learning discriminant face descriptor.

    Science.gov (United States)

    Lei, Zhen; Pietikäinen, Matti; Li, Stan Z

    2014-02-01

    Local feature descriptor is an important module for face recognition and those like Gabor and local binary patterns (LBP) have proven effective face descriptors. Traditionally, the form of such local descriptors is predefined in a handcrafted way. In this paper, we propose a method to learn a discriminant face descriptor (DFD) in a data-driven way. The idea is to learn the most discriminant local features that minimize the difference of the features between images of the same person and maximize that between images from different people. In particular, we propose to enhance the discriminative ability of face representation in three aspects. First, the discriminant image filters are learned. Second, the optimal neighborhood sampling strategy is soft determined. Third, the dominant patterns are statistically constructed. Discriminative learning is incorporated to extract effective and robust features. We further apply the proposed method to the heterogeneous (cross-modality) face recognition problem and learn DFD in a coupled way (coupled DFD or C-DFD) to reduce the gap between features of heterogeneous face images to improve the performance of this challenging problem. Extensive experiments on FERET, CAS-PEAL-R1, LFW, and HFB face databases validate the effectiveness of the proposed DFD learning on both homogeneous and heterogeneous face recognition problems. The DFD improves POEM and LQP by about 4.5 percent on LFW database and the C-DFD enhances the heterogeneous face recognition performance of LBP by over 25 percent.

  19. Regulatory controls for NORM contamination: Emerging issues and strategies

    International Nuclear Information System (INIS)

    Wennerberg, Linda

    1992-01-01

    Naturally occurring and accelerator-produced radioactive material (NORM) faces the increasing likelihood of federal or state regulatory control. Public concern and limited preliminary survey data fuel the debate over the necessity, approach, and jurisdiction of a NORM regulatory strategy. This debate requires the resolution of technical controversies and potentially competing state and federal agency interests. An additional facet of the debate is the impact of regulation upon traditionally non-nuclear industries, such as oil and gas production. Regulatory response has been initiated in several states, such as Louisiana's controls on equipment used in oil and gas production, to control specific industrial activities which generate NORM. A more comprehensive, generic federal strategy to control NORM contamination is also under review by the Environmental Protection Agency. This paper will detail the emerging technical issues, federal and state regulatory strategies under consideration, and evaluate the efficacy of selected regulatory approaches. (author)

  20. Multi-task pose-invariant face recognition.

    Science.gov (United States)

    Ding, Changxing; Xu, Chang; Tao, Dacheng

    2015-03-01

    Face images captured in unconstrained environments usually contain significant pose variation, which dramatically degrades the performance of algorithms designed to recognize frontal faces. This paper proposes a novel face identification framework capable of handling the full range of pose variations within ±90° of yaw. The proposed framework first transforms the original pose-invariant face recognition problem into a partial frontal face recognition problem. A robust patch-based face representation scheme is then developed to represent the synthesized partial frontal faces. For each patch, a transformation dictionary is learnt under the proposed multi-task learning scheme. The transformation dictionary transforms the features of different poses into a discriminative subspace. Finally, face matching is performed at patch level rather than at the holistic level. Extensive and systematic experimentation on FERET, CMU-PIE, and Multi-PIE databases shows that the proposed method consistently outperforms single-task-based baselines as well as state-of-the-art methods for the pose problem. We further extend the proposed algorithm for the unconstrained face verification problem and achieve top-level performance on the challenging LFW data set.

  1. Papers of the CAMPUT 2003 educational conference : Markets in Transition : The changing face of regulation

    International Nuclear Information System (INIS)

    2003-01-01

    The North American energy landscape is evolving: markets are in transition and regulatory roles are shifting. Regulators, government policy makers, and industry representatives exchanged information concerning the changes facing regulatory agencies, industry and energy users. The eleven sessions of the conference were entitled: (1) the future of the regulator in a continental energy market, (2) gas markets in transition, (3) electricity markets in transition (including Regional Transmission Organization/Standard Market Design issues), (4) are open access markets the answer? (5) the changing face of regulation, what's up? (6) energy policy updates in British Columbia and Atlantic Canada, (7) Ontario electricity update and deregulation one year later, (8) northern issues, (9) intervener funding, (10) affiliate transactions, regulatory and business issues, and (11) cost of capital update. The conference featured 43 presentations, of which two were indexed separately for inclusion in the database

  2. RRR for NNN-a rapid research response for the Neglected Tropical Disease NGDO Network: a novel framework to challenges faced by the global programs targeting neglected tropical diseases.

    Science.gov (United States)

    Toledo, Chelsea E; Jacobson, Julie; Wainwright, Emily C; Ottesen, Eric A; Lammie, Patrick J

    2016-03-01

    While global programs targeting the control or elimination of five of the neglected tropical diseases (NTDs)-lymphatic filariasis, onchocerciasis, soil-transmitted helminthiasis, schistosomiasis and trachoma-are well underway, they still face many operational challenges. Because of the urgency of 2020 program targets, the Bill & Melinda Gates Foundation and the U.S. Agency for International Development devised a novel rapid research response (RRR) framework to engage national programs, researchers, implementers and WHO in a Coalition for Operational Research on NTDs. After 2 years, this effort has succeeded as an important basis for the research response to programmatic challenges facing NTD programs. © The Author 2016. Published by Oxford University Press on behalf of Royal Society of Tropical Medicine and Hygiene.

  3. A Challenging Giant Dermatofibrosarcoma Protuberans on the Face

    Directory of Open Access Journals (Sweden)

    Gimena Castro Pérez

    2016-01-01

    Full Text Available Dermatofibrosarcoma protuberans (DFSP is a malignant fibrohistiocytic tumor that appears exclusively on the skin. It is a low-grade malignant soft tissue tumor of subcutaneous tissues that has a propensity for local recurrence but seldom metastasizes. It may rarely occur on the head and neck accounting for less than one percent of total head and neck malignancies. We present a man with a giant DFSP on the face. Oncological, functional, and aesthetic aspects are set forth.

  4. Assessment of dietary challenges faced by Sub-Saharan immigrants ...

    African Journals Online (AJOL)

    Data relating to socio-demographic characteristics, such as continuity with ethnic food culture and the problems faced by Sub-Saharan immigrants with regard to them retaining their traditional food culture was collected. All the respondents indicated that they treasured and maintained their traditional food culture, albeit to ...

  5. Challenges Faced by Adult Learners Enrolled in Blended Distance ...

    African Journals Online (AJOL)

    This research attempted to provide an insight into major barriers facing adult learners pursuing a diploma in adult and continuing education programme through Blended Distance Learning. Participants included the adult learners, staff from the Department of Open and Distance Learning who are also the facilitators of the ...

  6. Applying quantitative benefit-risk analysis to aid regulatory decision making in diagnostic imaging: methods, challenges, and opportunities.

    Science.gov (United States)

    Agapova, Maria; Devine, Emily Beth; Bresnahan, Brian W; Higashi, Mitchell K; Garrison, Louis P

    2014-09-01

    Health agencies making regulatory marketing-authorization decisions use qualitative and quantitative approaches to assess expected benefits and expected risks associated with medical interventions. There is, however, no universal standard approach that regulatory agencies consistently use to conduct benefit-risk assessment (BRA) for pharmaceuticals or medical devices, including for imaging technologies. Economics, health services research, and health outcomes research use quantitative approaches to elicit preferences of stakeholders, identify priorities, and model health conditions and health intervention effects. Challenges to BRA in medical devices are outlined, highlighting additional barriers in radiology. Three quantitative methods--multi-criteria decision analysis, health outcomes modeling and stated-choice survey--are assessed using criteria that are important in balancing benefits and risks of medical devices and imaging technologies. To be useful in regulatory BRA, quantitative methods need to: aggregate multiple benefits and risks, incorporate qualitative considerations, account for uncertainty, and make clear whose preferences/priorities are being used. Each quantitative method performs differently across these criteria and little is known about how BRA estimates and conclusions vary by approach. While no specific quantitative method is likely to be the strongest in all of the important areas, quantitative methods may have a place in BRA of medical devices and radiology. Quantitative BRA approaches have been more widely applied in medicines, with fewer BRAs in devices. Despite substantial differences in characteristics of pharmaceuticals and devices, BRA methods may be as applicable to medical devices and imaging technologies as they are to pharmaceuticals. Further research to guide the development and selection of quantitative BRA methods for medical devices and imaging technologies is needed. Copyright © 2014 AUR. Published by Elsevier Inc. All rights

  7. Female entrepreneurship and challenges faced by women entrepreneurs to reconcile conflicts between work and family: multiple case study in travel agencies

    Directory of Open Access Journals (Sweden)

    Rivanda Meira Teixeira

    2016-03-01

    Full Text Available Women have gained more and more space in various professional areas and this development also occurs in the field of entrepreneurship. In Brazil GEM 2013 identified for the first time, that the number of new woman entrepreneurs was higher than male entrepreneurs. However, it is recognized that women entrepreneurs face many difficulties when trying to reconcile their companies with the family. The main objective of this research is to analyse the challenges faced by women entrepreneurs of travel agencies to reconcile the conflict between work and family. This study adopted the multiple cases research strategy and were selected seven women creators and managers of travel agencies in the cities of Aracaju and the Barra dos Coqueiros, in the state of Sergipe (east coast of Brazil. In an attempt to reconcile well the multiple roles these women often face the frustration and guilt. At this moment, it shows the importance of emotional contribution of husband and children. It is noticed that the search for balance between the conflicting demands generate emotional distress and / or physical.

  8. Challenges faced by health-care providers offering infant-feeding counseling to HIV-positive women in sub-Saharan Africa: a review of current research.

    Science.gov (United States)

    Tuthill, Emily L; Chan, Jessica; Butler, Lisa M

    2015-01-01

    Exclusive breastfeeding (EBF) has been identified as the optimal nutrition and critical behavior in attaining human immunodeficiency virus (HIV)-free infant survival in resource-limited settings. Health-care providers (HCPs) in clinic- and community-settings throughout sub-Saharan Africa (sSA) provide infant-feeding counseling. However, rates of EBF at 6 months of age are suboptimal. HCPs are uniquely positioned to educate HIV-positive mothers and provide support by addressing known barriers to EBF. However, limited evidence exists on the experiences faced by HCPs in providing counseling on infant feeding to HIV-positive women. Our objective is to describe experiences faced by HCPs when delivering infant-feeding counseling in the context of HIV in program settings in sSA. We searched a range of electronic databases, including PubMed, CINAHL, and PsycINFO from January 1990 to February 2013, in addition to hand-searching, cross-reference searching, and personal communications. The search was limited to publications in English. Empirical studies of HCP experiences providing infant-feeding counseling in the prevention of mother-to-child transmission (PMTCT) of HIV programs in sSA were selected. We identified 10 peer-reviewed articles reporting HCP challenges in infant-feeding counseling that met inclusion criteria. Articles included qualitative, cross-sectional and mixed-method studies, and cumulatively reported 31 challenges faced by HCPs. Among the challenges identified, the most commonly reported were personal beliefs held by the HCPs toward infant feeding in the context of HIV, contradictory messages, staff workload, directive counseling styles, and a lack of practical strategies to offer mothers, often leading to improvised counseling approaches. Counseling strategies need to be developed that are relevant, meaningful, and responsive to the needs of both HCPs and mothers.

  9. Partner Country Series: Gas Pricing - China's Challenges and IEA Experience

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2012-07-01

    China will play a positive role in the global development of gas, the International Energy Agency’s (IEA) Executive Director, Maria Van der Hoeven has said in Beijing on 11 September, 2012 when launching a new IEA report: Gas Pricing and Regulation, China’s challenges and IEA experiences. In line with its aim to meet growing energy demand while shifting away from coal, China has set an ambitious goal of doubling its use of natural gas from 2011 levels by 2015. Prospects are good for significant new supplies – both domestic and imported, conventional and unconventional – to come online in the medium-term, but notable challenges remain, particularly concerning gas pricing and the institutional and regulatory landscape. While China’s circumstances are, in many respects unique, some current issues are similar to those a number of IEA countries have faced. This report highlights some key challenges China faces in its transition to greater reliance on natural gas, then explores in detail relevant experiences from IEA countries, particularly in the United Kingdom, the Netherlands, and the United States as well as the European Union (EU). Preliminary suggestions about how lessons learned in other countries could be applied to China’s situation are offered as well. The aim of this report is to provide stakeholders in China with a useful reference as they consider decisions about the evolution of the gas sector in their country.

  10. ARTIST (Asian regional tobacco industry scientist team): Philip Morris' attempt to exert a scientific and regulatory agenda on Asia.

    Science.gov (United States)

    Tong, E K; Glantz, S A

    2004-12-01

    To describe how the transnational tobacco industry has collaborated with local Asian tobacco monopolies and companies to promote a scientific and regulatory agenda. Analysis of previously secret tobacco industry documents. Transnational tobacco companies began aggressively entering the Asia market in the 1980s, and the current tobacco industry in Asia is a mix of transnational and local monopolies or private companies. Tobacco industry documents demonstrate that, in 1996, Philip Morris led an organisation of scientific representatives from different tobacco companies called the Asian Regional Tobacco Industry Science Team (ARTIST), whose membership grew to include monopolies from Korea, China, Thailand, and Taiwan and a company from Indonesia. ARTIST was initially a vehicle for PM's strategies against anticipated calls for global smoke-free areas from a World Health Organization secondhand smoke study. ARTIST evolved through 2001 into a forum to present scientific and regulatory issues faced primarily by Philip Morris and other transnational tobacco companies. Philip Morris' goal for the organisation became to reach the external scientific and public health community and regulators in Asia. The Asian tobacco industry has changed from an environment of invasion by transnational tobacco companies to an environment of participation with Philip Morris' initiated activities. With this participation, tobacco control efforts in Asia face new challenges as Philip Morris promotes and integrates its scientific and regulatory agenda into the local Asian tobacco industry. As the local Asian tobacco monopolies and companies can have direct links with their governments, future implementation of effective tobacco control may be at odds with national priorities.

  11. Comparison of Fiscal and Regulatory Policies to Prevent Non ...

    International Development Research Centre (IDRC) Digital Library (Canada)

    India is facing a rising burden of cardiovascular disease and obesity-related diabetes due to ... As a result, fiscal and regulatory strategies such as food taxes have been ... L'Association internationale de ressources en eau (IWRA), en étroite ...

  12. Contribution of a fuzzy expert system to regulatory impact analysis

    Directory of Open Access Journals (Sweden)

    Marco Antônio da Cunha

    2015-09-01

    Full Text Available Regulatory Impact Analysis (RIA has been consolidating in Brazilian regulatory agencies throughout the last decades. The RIA methodology aims to examine the regulatory process, measure the costs and benefits generated, as well as other effects of social, political or economic nature caused by a new or an existing regulation. By analysing each regulatory option, the expert or regulator faces a myriad of variables, usually of qualitative nature, that are difficult to measure and with a high degree of uncertainty. This research complements the existing literature, given the scarcity of decision support models in RIA that – regardless of the problem treated – incorporate the tacit knowledge of the regulation expert. This paper proposes an exploratory approach using a Fuzzy Expert System, which therefore helps to enrich the decision process in the final stage of comparison of the regulatory options.

  13. Hidden in plain sight : Conceptual and Regulatory Challenges

    NARCIS (Netherlands)

    Nagenborg, Michael Herbert; Timan, Tjerk; Newell, Bryce Clayton; Koops, Bert-Jaap

    2017-01-01

    A recent off-spring of ‘privacy by design’ are artefacts and gadgets that aim to protect the privacy of the users. An example is the work of Adam Harvey, who ‘explores how fashion can be used as camouflage from face-detection technology’ (http://cvdazzle.com/). In this contribution, the author

  14. EEG source imaging assists decoding in a face recognition task

    DEFF Research Database (Denmark)

    Andersen, Rasmus S.; Eliasen, Anders U.; Pedersen, Nicolai

    2017-01-01

    of face recognition. This task concerns the differentiation of brain responses to images of faces and scrambled faces and poses a rather difficult decoding problem at the single trial level. We implement the pipeline using spatially focused features and show that this approach is challenged and source...

  15. Antibody-drug conjugates for cancer therapy: The technological and regulatory challenges of developing drug-biologic hybrids.

    Science.gov (United States)

    Hamilton, Gregory S

    2015-09-01

    Antibody-drug conjugates (ADCs) are a new class of therapeutic agents that combine the targeting ability of monoclonal antibodies (mAbs) with small molecule drugs. The combination of a mAb targeting a cancer-specific antigen with a cytotoxin has tremendous promise as a new type of targeted cancer therapy. Two ADCs have been approved and many more are in clinical development, suggesting that this new class of drugs is coming to the forefront. Because of their unique nature as biologic-small drug hybrids, ADCs are challenging to develop, from both the scientific and regulatory perspectives. This review discusses both these aspects in current practice, and surveys the current state of the art of ADC drug development. Copyright © 2015 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.

  16. Regulatory aspects of management of change - Summary and conclusions

    International Nuclear Information System (INIS)

    2002-01-01

    Nuclear licensees are increasingly required to adapt to a more challenging commercial environment as moves to de-regulate electricity markets gather pace. One of the costs that is often perceived as being amenable to control is staffing, and hence there is significant exploration of new strategies for managing staffing levels. This report presents the outputs from a Workshop convened by the Special Experts' Group in Human and Organisational Factors (SEGHOF) of the Committee for the Safety of Nuclear Installations (CSNI) and organised by the UK Nuclear Installations Inspectorate (NII). The purpose of the workshop was to facilitate the exchange of views on, and approaches towards, the regulation of organisational change. The major risks associated with organisational change were discussed, and a range of regulatory challenges was identified for detailed discussion. There was agreement that the licensee must retain the responsibility to manage its own business but that organisational issues should be subject to regulatory scrutiny if they have the potential to impact on safety. The regulator should be able to demonstrate an approach to oversight of organisational change which is valid, transparent and consistent, and should inform the licensee of its expectations in terms of information supplied, communication and timing. The workshop confirmed that there is significant agreement between regulators concerning the need for licensees to put in place arrangements to manage organisational change. There was also broad consensus on what should constitute the elements of a licensee's management of change process. Differing views were evident about the balance between regulatory scrutiny of the process, as opposed to the outcomes of change, which largely represents differing regulatory regimes and philosophies. However, it was acknowledged that the regulator must be capable of taking an early view of the adequacy of proposed changes, rather than monitoring outcomes alone

  17. 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.

  18. Confronting Ethical and Regulatory Challenges of Emergency Care Research With Conscious Patients.

    Science.gov (United States)

    Dickert, Neal W; Brown, Jeremy; Cairns, Charles B; Eaves-Leanos, Aaliyah; Goldkind, Sara F; Kim, Scott Y H; Nichol, Graham; O'Conor, Katie J; Scott, Jane D; Sinert, Richard; Wendler, David; Wright, David W; Silbergleit, Robert

    2016-04-01

    Barriers to informed consent are ubiquitous in the conduct of emergency care research across a wide range of conditions and clinical contexts. They are largely unavoidable; can be related to time constraints, physical symptoms, emotional stress, and cognitive impairment; and affect patients and surrogates. US regulations permit an exception from informed consent for certain clinical trials in emergency settings, but these regulations have generally been used to facilitate trials in which patients are unconscious and no surrogate is available. Most emergency care research, however, involves conscious patients, and surrogates are often available. Unfortunately, there is neither clear regulatory guidance nor established ethical standards in regard to consent in these settings. In this report-the result of a workshop convened by the National Institutes of Health Office of Emergency Care Research and Department of Bioethics to address ethical challenges in emergency care research-we clarify potential gaps in ethical understanding and federal regulations about research in emergency care in which limited involvement of patients or surrogates in enrollment decisions is possible. We propose a spectrum of approaches directed toward realistic ethical goals and a research and policy agenda for addressing these issues to facilitate clinical research necessary to improve emergency care. Copyright © 2015 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.

  19. Regional and International Networking to Support the Energy Regulatory Commission of Thailand

    Energy Technology Data Exchange (ETDEWEB)

    Lavansiri, Direk; Bull, Trevor

    2010-09-15

    The Energy Regulatory Commission of Thailand is a new regulatory agency. The structure of the energy sector; the tradition of administration; and, the lack of access to experienced personnel in Thailand all pose particular challenges. The Commission is meeting these challenges through regional and international networking to assist in developing policies and procedures that allow it to meet international benchmarks.

  20. Everyday risk taking as a function of regulatory focus

    NARCIS (Netherlands)

    Hamstra, Melvyn R. W.; Bolderdijk, Jan Willem; Veldstra, Janet L.

    Uncertainty is an inherent aspect of everyday life. However, faced with uncertainty, some individuals take risks more eagerly than others. Regulatory focus theory may explain such differences because risky behavior may arise naturally from the eagerness of promotion focused individuals, while safe

  1. Regulatory Infrastructure for Radiation Safety and the Security of Radioactive Sources in Sudan, Present Status, Achievements and Future Challenges

    International Nuclear Information System (INIS)

    Osman, M.Y.

    2008-01-01

    Regulation of the use of ionizing radiation started formally in 1971 when an act has been issued by which the ministry of health was entitled to establish a Radiation Protection Technical Committee (RPTC) as a regulatory body. However, this act didn't come into effect because of the lack of regulations needed to execute the regulatory functions stated in that law. In 1972 the Sudan Atomic Energy Commission (SAEC) act was issued by which the commission was designated as a promoter for the use of nuclear technology. This law was later replaced by the 1996 act by which the Sudan Atomic Energy Corporation (SAEC) was established within the ministry of higher education and latter within the Ministry of Science and Technology (MOST). The board of the corporation established a technical committee (Radiation Protection Technical Committee (RPTC)) to carry out the regulatory functions assigned to the board by the act. The 1996 act didn't repeal the 1971 act; as a result, the two conflicting and overlapping acts are still valid. In 2003 the 1996 act was cancelled and to be replaced by an Order of Establishment within a general law for corporations in the Sudan. In spite of all these mess in providing a proper legislative framework, the RPTC (MOST) managed to secure a fair control of the use of radiation in different applications within the country. In this report, the current status of regulating the use of ionizing radiation as well as major challenges is described

  2. Papers of the CAMPUT 2003 educational conference : Markets in Transition : The changing face of regulation

    International Nuclear Information System (INIS)

    2003-01-01

    The North American energy landscape is evolving: markets are in transition and regulatory roles are shifting. Regulators, government policy makers, and industry representatives exchanged information concerning the changes facing regulatory agencies, industry and energy users. The eleven sessions of the conference were entitled: (1) the future of the regulator in a continental energy market, (2) gas markets in transition, (3) electricity markets in transition (including Regional Transmission Organization/Standard Market Design issues), (4) are open access markets the answer? (5) the changing face of regulation, what's up? (6) energy policy updates in British Columbia and Atlantic Canada, (7) Ontario electricity update and deregulation one year later, (8) northern issues, (9) intervener funding, (10) affiliate transactions, regulatory and business issues, and (11) cost of capital update. The conference featured 43 presentations, of which two were indexed separately for inclusion in the database. refs., tabs., figs

  3. Review of decision methodologies for evaluating regulatory actions affecting public health and safety

    International Nuclear Information System (INIS)

    Hendrickson, P.L.; McDonald, C.L.; Schilling, A.H.

    1976-12-01

    This report examines several aspects of the problems and choices facing the governmental decision maker who must take regulatory actions with multiple decision objectives and attributes. Particular attention is given to the problems facing the U.S. Nuclear Regulatory Commission (NRC) and to the decision attribute of chief concern to NRC, the protection of human health and safety, with emphasis on nuclear power plants. The study was undertaken to provide background information for NRC to use in refining its process of value/impact assessment of proposed regulatory actions. The principal conclusion is that approaches to rationally consider the value and impact of proposed regulatory actions are available. These approaches can potentially improve the decision-making process and enable the agency to better explain and defend its decisions. They also permit consistent examination of the impacts, effects of uncertainty and sensitivity to various assumptions of the alternatives being considered. Finally, these approaches can help to assure that affected parties are heard and that technical information is used appropriately and to the extent possible. The principal aspects of the regulatory decision problem covered in the report are: the legal setting for regulatory decisions which affect human health and safety, elements of the decision-making process, conceptual approaches to decision making, current approaches to decision making in several Federal agencies, and the determination of acceptable risk levels

  4. Uterus transplantation: ethical and regulatory challenges.

    Science.gov (United States)

    Arora, Kavita Shah; Blake, Valarie

    2014-06-01

    Moving forward rapidly in the clinical research phase, uterus transplantation may be a future treatment option for women with uterine factor infertility, which accounts for three per cent of all infertility in women. This new method of treatment would allow women, who currently rely on gestational surrogacy or adoption, to gestate and birth their own genetic offspring. Since uterus transplantation carries significant risk when compared with surrogacy and adoption as well as when compared with other organ transplants, it requires greater justification because its goals are quality of life, not life-saving, in their scope. It is important to address questions regarding the physical, psychosocial and ethical risks and benefits of uterus transplantation for all three parties involved--the patient, the donor and the potential child--as well as discuss the regulatory implications as research on uterus transplantations moves forward. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  5. The mighty oak faces challenges in the Pacific West

    Science.gov (United States)

    Gail Wells

    2010-01-01

    In popular imagination, the oak tree stands for strength, endurance, and longevity. But in the coastal lowlands and central valleys of British Columbia, Washington, Oregon, and California, oaks face a battery of natural and human-induced threats. Sudden oak death, caused by a virulent pathogen identified in 2000, has killed millions of tanoaks, California black oaks,...

  6. The challenges facing sustainable and adaptive groundwater ...

    African Journals Online (AJOL)

    These are: the undervaluation of groundwater importance and significance; the need for expertise and information at all scales; the centralisation of power; and the disregard of ecosystems and the associated goods and services. As a means to tackle these challenges, it has been assumed that the concept of adaptive water ...

  7. Towards a sustainable coffee market: paradoxes faced by a multinational company

    NARCIS (Netherlands)

    Kolk, A.

    2012-01-01

    This paper examines the case of sustainable coffee as faced by Sara Lee's International Coffee and Tea Division (SL), asking which strategic direction the company should take considering its regulatory, competitive, and societal contexts. More than a decade after sustainable coffee became a

  8. Disguised face identification using multi-modal features in a quaternionic form

    DEFF Research Database (Denmark)

    Apostolopoulos, George; Tzitzilonis, Vasileios; Kappatos, Vassilios

    2017-01-01

    Disguised face recognition is considered as very challenging and important problem in the face recognition field. A disguised face recognition algorithm is proposed using quaternionic representation. The feature extraction module is accomplished with a new method, decomposing each face image...... that the proposed algorithm can achieve high recognition results under disguised conditions....

  9. Trismus in Face Transplantation Following Ballistic Trauma.

    Science.gov (United States)

    Krezdorn, Nicco; Alhefzi, Muayyad; Perry, Bridget; Aycart, Mario A; Tasigiorgos, Sotirios; Bueno, Ericka M; Green, Jordan R; Pribaz, Julian J; Pomahac, Bohdan; Caterson, Edward J

    2018-06-01

    Trismus can be a challenging consequence of ballistic trauma to the face, and has rarely been described in the setting of face transplantation. Almost half of all current face transplant recipients in the world received transplantation to restore form and function after a ballistic injury. Here we report our experience and challenges with long standing trismus after face transplantation. We reviewed the medical records of our face transplant recipients whose indication was ballistic injury. We focused our review on trismus and assessed the pre-, peri- and postoperative planning, surgery and functional outcomes. Two patients received partial face transplantation, including the midface for ballistic trauma. Both patients suffered from impaired mouth opening, speech intelligibility, and oral competence. Severe scarring of the temporomandibular joint (TMJ) required intraoperative release in both patients, and additional total condylectomy on the left side 6 months posttransplant for 1 patient. Posttransplant, both patients achieved an improvement in mouth opening; however, there was persistent trismus. One year after transplantation, range of motion of the jaw had improved for both patients. Independent oral food intake was possible 1 year after surgery, although spillage of liquids and mixed consistency solids persisted. Speech intelligibility testing showed impairments in the immediate postoperative period, with improvement to over 85% for both patients at 1 year posttransplant. Ballistic trauma to the face and subsequent reconstructive measures can cause significant scarring and covert injuries to structures such as the TMJ, resulting in long standing trismus. Meticulous individual planning prior to interventions such as face transplantation must take these into account. We encourage intraoperative evaluation of these structures as well as peri- and postoperative treatment when necessary. Due to the nature of the primary injury, functional outcomes after face

  10. Assessment of the sealing system of an ilw transport container in a 9m regulatory impact

    International Nuclear Information System (INIS)

    Sievwright, R.W.T.; Gray, I.L.S.; Bernasconi, D.J.; McGuinn, P.; Tso, C.F.

    1998-01-01

    UK Nirex Ltd is developing a range of reusable shielded transport containers (RSTCs) to ensure the safe transport of immobilised intermediate level waste to a future UK deep repository for disposal. The RSTCs use an inset lid for mechanical strength and radiation shielding, but the containment boundary is provided by a separate lid seal member (LSM). The LSM is a semi-flexible steel diaphragm surrounded by a rim which carries a double O-ring seal. The LSM rim is clamped to a flat mating surface on the container body. A finite element model has been developed for an RSTC with a wall thickness of 285 mm, in order to assess its containment performance in 9m regulatory drop tests (IAEA 1996). The challenge was to predict the size of small gaps that might appear between the LSM rim and the RSTC body seal face ; this level of detail would be 1-2 orders of magnitude smaller than the displacements experienced in the impact zone. The model was first validated against a series of one-third scale model drop tests of the RSTC. The validated model was then analysed for 9m regulatory impacts in the six worst impact attitudes. The behavior of the LSM was assessed for each attitude and the seal face (gaps) between the LSM and the body were determined. Although small gaps of about 0.5 mm are predicted, it is likely that containment would be preserved. (authors)

  11. Communication Regulatory Science: Mapping a New Field.

    Science.gov (United States)

    Noar, Seth M; Cappella, Joseph N; Price, Simani

    2017-12-13

    Communication regulatory science is an emerging field that uses validated techniques, tools, and models to inform regulatory actions that promote optimal communication outcomes and benefit the public. In the opening article to this special issue on communication and tobacco regulatory science, we 1) describe Food and Drug Administration (FDA) regulation of tobacco products in the US; 2) introduce communication regulatory science and provide examples in the tobacco regulatory science realm; and 3) describe the special issue process and final set of articles. Communication research on tobacco regulatory science is a burgeoning area of inquiry, and this work advances communication science, informs and potentially guides the FDA, and may help to withstand legal challenges brought by the tobacco industry. This research has the potential to have a major impact on the tobacco epidemic and population health by helping implement the most effective communications to prevent tobacco initiation and increase cessation. This special issue provides an example of 10 studies that exemplify tobacco regulatory science and demonstrate how the health communication field can affect regulation and benefit public health.

  12. Face Recognition in Humans and Machines

    Science.gov (United States)

    O'Toole, Alice; Tistarelli, Massimo

    The study of human face recognition by psychologists and neuroscientists has run parallel to the development of automatic face recognition technologies by computer scientists and engineers. In both cases, there are analogous steps of data acquisition, image processing, and the formation of representations that can support the complex and diverse tasks we accomplish with faces. These processes can be understood and compared in the context of their neural and computational implementations. In this chapter, we present the essential elements of face recognition by humans and machines, taking a perspective that spans psychological, neural, and computational approaches. From the human side, we overview the methods and techniques used in the neurobiology of face recognition, the underlying neural architecture of the system, the role of visual attention, and the nature of the representations that emerges. From the computational side, we discuss face recognition technologies and the strategies they use to overcome challenges to robust operation over viewing parameters. Finally, we conclude the chapter with a look at some recent studies that compare human and machine performances at face recognition.

  13. Environmental performance and financial report integrity: challenges for the mining sector in Indonesia

    Science.gov (United States)

    Mayangsari, S.

    2018-01-01

    This study investigates the influence of environmental performance on the financial report integrity. The statistics used were primary data from interviews with senior members of the mining sector regarding environmental issues, as well as secondary data using Financial Report 2016. The samples were listed mining companies with semester data. Questionnaires were used to measure their perceptions of the challenges concerning climate change faced by the mining sector. The results of this research show that regulatory interventions will be critical to environmental issues. This study employed KLD as a proxy for environmental performance, correlated with other variables regarding the integrity of disclosure. The outcome indicates that environmental issues will increase the integrity of financial reports.

  14. Challenges and opportunities in establishing scientific and regulatory standards for determining therapeutic equivalence of modified-release products: Workshop summary report.

    Science.gov (United States)

    Chen, Mei-Ling; Shah, Vinod P; Ganes, Derek; Midha, Kamal K; Caro, James; Nambiar, Prabu; Rocci, Mario L; Thombre, Avinash G; Abrahamsson, Bertil; Conner, Dale; Davit, Barbara; Fackler, Paul; Farrell, Colm; Gupta, Suneel; Katz, Russell; Mehta, Mehul; Preskorn, Sheldon H; Sanderink, Gerard; Stavchansky, Salomon; Temple, Robert; Wang, Yaning; Winkle, Helen; Yu, Lawrence

    2010-09-01

    Modified-release (MR) products are complex dosage forms designed to release drug in a controlled manner to achieve the desired efficacy and safety profiles. Inappropriate control of drug release from such products may result in reduced efficacy or increased toxicity. This paper is a summary report of the American Association of Pharmaceutical Scientists, International Pharmaceutical Federation, and Product Quality Research Institute workshop titled "Challenges and Opportunities in Establishing Scientific and Regulatory Standards for Assuring Therapeutic Equivalence of Modified Release Products", held October 1-2, 2009, in Baltimore, Maryland. The workshop provided an opportunity for pharmaceutical scientists from academia, industry, and regulatory agencies to discuss current regulatory expectations and industry practices for evaluating the pharmaceutical equivalence and bioequivalence of oral MR products. In the case of conventional monophasic MR formulations, the current regulatory approaches and criteria for bioequivalence evaluation were considered adequate for the assessment of therapeutic equivalence and inter-changeability of drug products. Additional measures may occasionally be needed to determine the bioequivalence of multiphasic MR products. The metric of partial AUC proposed by the US Food and Drug Administration received broad support as an additional measure for evaluating bioequivalence of multiphasic MR products designed to have a rapid onset of drug action followed by sustained response. The cutoff for partial AUCs may be based on the pharmacokinetic/pharmacodynamic or pharmacokinetic/ response characteristics of the products under examination. If the new metric is highly variable, the bioequivalence limits may be set based on the known within-subject variability for the reference product. The current regulatory approaches and criteria for bioequivalence evaluation were considered adequate for the assessment of therapeutic equivalence and

  15. THE CHALLENGES POLITICAL LEADERSHIP FACES IN THE MODERN WORLD

    Directory of Open Access Journals (Sweden)

    T. N. Samsonova

    2016-01-01

    Full Text Available Political leadership is a concept central to understanding political processes and outcomes, yet its definition is elusive. The study of political leadership has a long history. Many disciplines have contributed to this study, including history, philosophy, political theory, psychology etc. Leadership is a process in which leaders and followers interact dynamically in a particular situation or context. Leaders must be able to connect with followers to understand their mood and their initiative. There are essential and operational differences between a leader and a manager. Managerial effectiveness is related to an emphasis on rationality and organizational structure. Leadership effectiveness is linked to symbols and culture. The interactive nature of leader-followers-situation can help us better understand the changing nature of the leaderfollower relationship and the increasingly greater complexity of situations leaders and followers face in contemporary world. Good leadership makes a difference, and it can be enhanced through greater awareness of the important factors influencing the leadership process. The changes we are facing in today’s world demand a new breed of political leaders, new forms and mechanisms of leader-follower interaction that provide effective leadership. 

  16. Multithread Face Recognition in Cloud

    Directory of Open Access Journals (Sweden)

    Dakshina Ranjan Kisku

    2016-01-01

    Full Text Available Faces are highly challenging and dynamic objects that are employed as biometrics evidence in identity verification. Recently, biometrics systems have proven to be an essential security tools, in which bulk matching of enrolled people and watch lists is performed every day. To facilitate this process, organizations with large computing facilities need to maintain these facilities. To minimize the burden of maintaining these costly facilities for enrollment and recognition, multinational companies can transfer this responsibility to third-party vendors who can maintain cloud computing infrastructures for recognition. In this paper, we showcase cloud computing-enabled face recognition, which utilizes PCA-characterized face instances and reduces the number of invariant SIFT points that are extracted from each face. To achieve high interclass and low intraclass variances, a set of six PCA-characterized face instances is computed on columns of each face image by varying the number of principal components. Extracted SIFT keypoints are fused using sum and max fusion rules. A novel cohort selection technique is applied to increase the total performance. The proposed protomodel is tested on BioID and FEI face databases, and the efficacy of the system is proven based on the obtained results. We also compare the proposed method with other well-known methods.

  17. Categorization and selection of regulatory approaches for nuclear power plants

    International Nuclear Information System (INIS)

    Sugaya, Junko; Harayama, Yuko

    2009-01-01

    Several new regulatory approaches have been introduced to Japanese nuclear safety regulations, in which a prescriptive and deterministic approach had traditionally predominated. However, the options of regulatory approaches that can possibly be applied to nuclear safety regulations as well as the methodology for selecting the options are not systematically defined. In this study, various regulatory approaches for nuclear power plants are categorized as prescriptive or nonprescriptive, outcome-based or process-based, and deterministic or risk-informed. 18 options of regulatory approaches are conceptually developed and the conditions for selecting the appropriate regulatory approaches are identified. Current issues on nuclear regulations regarding responsibilities, transparency, consensus standards and regulatory inspections are examined from the viewpoints of regulatory approaches to verify usefulness of the categorization and selection concept of regulatory approaches. Finally, some of the challenges at the transitional phase of regulatory approaches are discussed. (author)

  18. Challenges and Opportunities for Tribal Waters: Addressing Disparities in Safe Public Drinking Water on the Crow Reservation in Montana, USA.

    Science.gov (United States)

    Doyle, John T; Kindness, Larry; Realbird, James; Eggers, Margaret J; Camper, Anne K

    2018-03-21

    Disparities in access to safe public drinking water are increasingly being recognized as contributing to health disparities and environmental injustice for vulnerable communities in the United States. As the Co-Directors of the Apsaálooke Water and Wastewater Authority (AWWWA) for the Crow Tribe, with our academic partners, we present here the multiple and complex challenges we have addressed in improving and maintaining tribal water and wastewater infrastructure, including the identification of diverse funding sources for infrastructure construction, the need for many kinds of specialized expertise and long-term stability of project personnel, ratepayer difficulty in paying for services, an ongoing legacy of inadequate infrastructure planning, and lack of water quality research capacity. As a tribal entity, the AWWWA faces additional challenges, including the complex jurisdictional issues affecting all phases of our work, lack of authority to create water districts, and additional legal and regulatory gaps-especially with regards to environmental protection. Despite these obstacles, the AWWWA and Crow Tribe have successfully upgraded much of the local water and wastewater infrastructure. We find that ensuring safe public drinking water for tribal and other disadvantaged U.S. communities will require comprehensive, community-engaged approaches across a broad range of stakeholders to successfully address these complex legal, regulatory, policy, community capacity, and financial challenges.

  19. Face identification with frequency domain matched filtering in mobile environments

    Science.gov (United States)

    Lee, Dong-Su; Woo, Yong-Hyun; Yeom, Seokwon; Kim, Shin-Hwan

    2012-06-01

    Face identification at a distance is very challenging since captured images are often degraded by blur and noise. Furthermore, the computational resources and memory are often limited in the mobile environments. Thus, it is very challenging to develop a real-time face identification system on the mobile device. This paper discusses face identification based on frequency domain matched filtering in the mobile environments. Face identification is performed by the linear or phase-only matched filter and sequential verification stages. The candidate window regions are decided by the major peaks of the linear or phase-only matched filtering outputs. The sequential stages comprise a skin-color test and an edge mask filtering test, which verify color and shape information of the candidate regions in order to remove false alarms. All algorithms are built on the mobile device using Android platform. The preliminary results show that face identification of East Asian people can be performed successfully in the mobile environments.

  20. Challenges facing the insurance industry since the modernisation of the international nuclear third party liability regime

    International Nuclear Information System (INIS)

    Quere, Alain

    2014-01-01

    events illustrate some of the challenges facing the world of insurance following the modernisation of the international nuclear third party liability regime: - Will the insurance industry be able to find funds corresponding to the new amounts that have been set? - Do the additional damages covered by the revised conventions provide adequate cover for existing risks and will private insurance be able and willing to cover such risks? Nevertheless, the insurance world has changed a great deal since 2004 and there are many additional issues that have arisen since that time. For example, the economic crisis and the introduction of the European Solvency II Directive require insurers to take a more stringent line with their commitments. Moreover, after the Fukushima Daiichi accident, a number of questions have resurfaced: are the new insurance amounts sufficient? The age of 'nuclear renaissance' has long gone and some countries are distancing themselves from nuclear power in light of its questionable costs; are operators paying a fair price in light of the risks incurred? Finally, Europe is keen to play its part and impose its own rules; what will be the consequences of this development? This article reconsiders these challenges in light of the 2004 Protocol (which has not entered into force), by focusing in particular on the situation in Europe. Section I looks back at the history behind the conventions and the key principles they set down. Section II highlights the changes made to the Paris Convention as amended by the 2004 Protocol and the problems facing the insurance industry. Section III provides an overview of the various actors involved in the insurance industry and redefines the necessary insurance foundations to cover the challenges described in Section IV. Finally, Section IV covers all the challenges facing the insurance industry since the modernisation of the international nuclear third party liability regime. (author)

  1. Haar-like Features for Robust Real-Time Face Recognition

    DEFF Research Database (Denmark)

    Nasrollahi, Kamal; Moeslund, Thomas B.

    2013-01-01

    Face recognition is still a very challenging task when the input face image is noisy, occluded by some obstacles, of very low-resolution, not facing the camera, and not properly illuminated. These problems make the feature extraction and consequently the face recognition system unstable....... The proposed system in this paper introduces the novel idea of using Haar-like features, which have commonly been used for object detection, along with a probabilistic classifier for face recognition. The proposed system is simple, real-time, effective and robust against most of the mentioned problems....... Experimental results on public databases show that the proposed system indeed outperforms the state-of-the-art face recognition systems....

  2. Regulatory challenges in the management of aging of structural materials in nuclear power plants; Retos reguladores en la gestion del envejecimiento de los materiales estructurales de centrales nucleares

    Energy Technology Data Exchange (ETDEWEB)

    Castelo, C.; Mendoza, C.; Mas, E.; Conde, J. M.

    2013-07-01

    The article discusses two major pathways by which a regulatory body, and in particular the CSN, may participate in the acquisition of the necessary knowledge on mechanisms of aging of nuclear structural materials: to participate in forums to share operational experience and R and R project, both nationally and internationally. It notes the importance of this participation to carry out its regulatory function based on the knowledge acquired and the unique challenge of transferring that knowledge to rules and guidelines for their application. The article discusses various R and D projects in which the CSN participates directly. It calls for the presence of regulatory bodies in R and D project funded by the EU and the transfer of the results of such projects to codes, standards or guidelines for feasible implementation. (Author)

  3. Face detection and facial feature localization using notch based templates

    International Nuclear Information System (INIS)

    Qayyum, U.

    2007-01-01

    We present a real time detection off aces from the video with facial feature localization as well as the algorithm capable of differentiating between the face/non-face patterns. The need of face detection and facial feature localization arises in various application of computer vision, so a lot of research is dedicated to come up with a real time solution. The algorithm should remain simple to perform real time whereas it should not compromise on the challenges encountered during the detection and localization phase, keeping simplicity and all challenges i.e. algorithm invariant to scale, translation, and (+-45) rotation transformations. The proposed system contains two parts. Visual guidance and face/non-face classification. The visual guidance phase uses the fusion of motion and color cues to classify skin color. Morphological operation with union-structure component labeling algorithm extracts contiguous regions. Scale normalization is applied by nearest neighbor interpolation method to avoid the effect of different scales. Using the aspect ratio of width and height size. Region of Interest (ROI) is obtained and then passed to face/non-face classifier. Notch (Gaussian) based templates/ filters are used to find circular darker regions in ROI. The classified face region is handed over to facial feature localization phase, which uses YCbCr eyes/lips mask for face feature localization. The empirical results show an accuracy of 90% for five different videos with 1000 face/non-face patterns and processing rate of proposed algorithm is 15 frames/sec. (author)

  4. Technology survey on video face tracking

    Science.gov (United States)

    Zhang, Tong; Gomes, Herman Martins

    2014-03-01

    With the pervasiveness of monitoring cameras installed in public areas, schools, hospitals, work places and homes, video analytics technologies for interpreting these video contents are becoming increasingly relevant to people's lives. Among such technologies, human face detection and tracking (and face identification in many cases) are particularly useful in various application scenarios. While plenty of research has been conducted on face tracking and many promising approaches have been proposed, there are still significant challenges in recognizing and tracking people in videos with uncontrolled capturing conditions, largely due to pose and illumination variations, as well as occlusions and cluttered background. It is especially complex to track and identify multiple people simultaneously in real time due to the large amount of computation involved. In this paper, we present a survey on literature and software that are published or developed during recent years on the face tracking topic. The survey covers the following topics: 1) mainstream and state-of-the-art face tracking methods, including features used to model the targets and metrics used for tracking; 2) face identification and face clustering from face sequences; and 3) software packages or demonstrations that are available for algorithm development or trial. A number of publically available databases for face tracking are also introduced.

  5. Is sustainable development attainable? Challenges facing forestry and the forest products industry

    International Nuclear Information System (INIS)

    Wrist, P.E.

    1991-01-01

    The challenges that face the forest industry in achieving sustainable development are reviewed. Sustainable development is not the same as sustained yield forest management. While sustained yield limits harvesting to an estimate of a forest's incremental annual growth, it is a policy which neither takes into account how improved forest management practices can increase future growth rates nor gives guidance on how multiple uses for the forest resource can be made compatible with periodic harvesting of that resource. Forests, in addition to meeting demands for timber production, must also meet demands for watershed management, recreation, preservation of wildlife and genetic diversity, moderation of climates, carbon sequestration, and land reclamation. Information is lacking from which to develop improved forest management programs that take these demands into account. Questions remain about such matters as the role of plantations in sustainable forestry and the maintenance of natural diversity. Some recent research being undertaken to generate better information for future forestry decision making is outlined, including work on gene pool maintenance, the interdependence of forest ecology and climate, the symbiotic role of mycorrhiza, forest fertilization, and the interdependence of sustainable forestry and sustainable fisheries. In the forest products industry, engineered wood products have been developed that meet tight specifications and require less raw material, and process changes have been introduced that greatly reduce pollutants from pulp manufacture

  6. 'Shedding light' on the challenges faced by Palestinian maternal health-care providers.

    Science.gov (United States)

    Hassan-Bitar, Sahar; Narrainen, Sheila

    2011-04-01

    to explore the challenges and barriers faced by Palestinian maternal health-care providers (HCPs) to the provision of quality maternal health-care services through a case study of a Palestinian public referral hospital in the Occupied Palestinian Territory. descriptive qualitative study. The data are from a broader study, conducted in 2005 at the same hospital as part of a baseline assessment of maternal health services. 31 maternal HCPs; nine midwives and 14 nurses and eight doctors. the quality of care provided for women and infants at this Palestinian public hospital is substandard. The maternal HCPs work within a difficult and resource-constrained environment. ISSUES INCLUDE: high workload, poor compensation, humiliation in the workplace, suboptimal supervision and the absence of professional support and guidance. Midwives are perceived to be at the bottom of the health professional hierarchy. there is a need for managers and policy makers to enable maternal HCPs to provide better quality care for women and infants during childbirth, through facilitating the roles of midwives and nurses and creating a more positive and resourceful environment. Palestinian midwives need to increase their knowledge and use evidence-based practices during childbirth. They need to unite and create their own circle of professional support in the form of a Palestinian midwifery professional body. Copyright © 2009 Elsevier Ltd. All rights reserved.

  7. Anti-racist pedagogy: challenges faced by faculty of color in predominantly white schools of nursing.

    Science.gov (United States)

    Hassouneh, Dena

    2006-07-01

    Despite the significant effects of systems of oppression on health, nursing education tends not to include anti-racist pedagogy in its curricula, preferring instead to focus more narrowly on culture. This narrow focus allows nurses to depoliticize discussions of race and other social differences, largely ignoring the influence that systems of oppression, imperialism, and historical trauma have had on health in marginalized populations. In contrast, anti-racist pedagogy educates students in ways that make racialized power relations explicit, deconstruct the social construction of race, and analyze interlocking systems of oppression that serve to marginalize and exclude some groups while privileging others. This article describes anti-racist pedagogy from the perspective of a faculty member of color, drawing on personal experience and a review of the anti-racist pedagogical literature. Specifically, this article highlights some of the personal and professional challenges faced by faculty of color when engaged in anti-racist pedagogy in predominantly white schools of nursing.

  8. Improving regulatory oversight of maintenance programs

    International Nuclear Information System (INIS)

    Cook, S.

    2008-01-01

    Safe nuclear power plant operation requires that risks due to failure or unavailability of Structures, Systems and Components (SSCs) be minimized. Implementation of an effective maintenance program is a key means for achieving this goal. In its regulatory framework, the important relationship between maintenance and safety is acknowledged by the CNSC. A high level maintenance program requirement is included in the Class I Facilities Regulations. In addition, the operating licence contains a condition based on the principle that the design function and performance of SSCs needs to remain consistent with the plant's design and analysis documents. Nuclear power plant licensees have the primary responsibility for safe operation of their facilities and consequently for implementation of a successful maintenance program. The oversight role of the Canadian Nuclear Safety Commission (CNSC) is to ensure that the licensee carries out that responsibility. The challenge for the CNSC is how to do this consistently and efficiently. Three opportunities for improvement to regulatory maintenance oversight are being pursued. These are related to the regulatory framework, compliance verification inspection activities and monitoring of self-reporting. The regulatory framework has been improved by clarifying expectations through the issuance of S-210 'Maintenance Programs for Nuclear Power Plants'. Inspection activities have been improved by introducing new maintenance inspections into the baseline program. Monitoring is being improved by making better use of self-reported and industry produced maintenance related performance indicators. As with any type of program change, the challenge is to ensure the consistent and optimal application of regulatory activities and resources. This paper is a summary of the CNSC's approach to improving its maintenance oversight strategy. (author)

  9. Alternatives to the face-to-face consultation in general practice: focused ethnographic case study.

    Science.gov (United States)

    Atherton, Helen; Brant, Heather; Ziebland, Sue; Bikker, Annemieke; Campbell, John; Gibson, Andy; McKinstry, Brian; Porqueddu, Tania; Salisbury, Chris

    2018-04-01

    NHS policy encourages general practices to introduce alternatives to the face-to-face consultation, such as telephone, email, e-consultation systems, or internet video. Most have been slow to adopt these, citing concerns about workload. This project builds on previous research by focusing on the experiences of patients and practitioners who have used one or more of these alternatives. To understand how, under what conditions, for which patients, and in what ways, alternatives to face-to-face consultations present benefits and challenges to patients and practitioners in general practice. Focused ethnographic case studies took place in eight UK general practices between June 2015 and March 2016. Non-participant observation, informal conversations with staff, and semi-structured interviews with staff and patients were conducted. Practice documents and protocols were reviewed. Data were analysed through charting and the 'one sheet of paper' mind-map method to identify the line of argument in each thematic report. Case study practices had different rationales for offering alternatives to the face-to-face consultation. Beliefs varied about which patients and health issues were suitable. Co-workers were often unaware of each other's practice; for example, practice policies for use of e-consultations systems with patients were not known about or followed. Patients reported benefits including convenience and access. Staff and some patients regarded the face-to-face consultation as the ideal. Experience of implementing alternatives to the face-to-face consultation suggests that changes in patient access and staff workload may be both modest and gradual. Practices planning to implement them should consider carefully their reasons for doing so and involve the whole practice team. © British Journal of General Practice 2018.

  10. A comparison of problem identification interviews conducted face-to-face and via videoconferencing using the consultation analysis record.

    Science.gov (United States)

    Fischer, Aaron J; Collier-Meek, Melissa A; Bloomfield, Bradley; Erchul, William P; Gresham, Frank M

    2017-08-01

    School psychologists who experience challenges delivering face-to-face consultation may utilize videoconferencing to facilitate their consultation activities. Videoconferencing has been found to be an effective method of service delivery in related fields and emerging research suggests that it may be effective for providing teacher training and support in school settings. In this exploratory investigation, we used the Consultation Analysis Record (Bergan & Tombari, 1975) and its four indices to assess the effectiveness of conducting problem identification interviews via videoconferencing versus face-to-face. Overall, findings indicated significant differences across these two conditions, with videoconference interviews coded as having higher indices of content relevance, process effectiveness, and message control, but lower content focus, compared to face-to-face interviews. As these indices have been positively associated with favorable consultation outcomes, the results provide initial support for the effectiveness of consultation delivered via videoconferencing. Copyright © 2017 Society for the Study of School Psychology. Published by Elsevier Ltd. All rights reserved.

  11. Achievements and challenges in nuclear regulatory communication with the public. Outcome from the CNRA Workshops held in 2000, 2004 and 2007

    International Nuclear Information System (INIS)

    Joerle, Anders; Besenyei, Elisabeth; Calvo, Marina; Hah, Yeon-Hee; Hayden, Elizabeth; Herwig, Laurel; Kaliberda, Elena; Ostreng, Anne Marit; Robinson, Felicity; Storey, Peter; Yano, Mari; Zemanova, Dagmar; Chanial, Luc; Degueldre, Didier; Isaksson, Risto; Van Nuffelen, Dominique; Treier, Anton; Yoshimura, Uichiro; Gauvain, Jean

    2008-06-01

    the Public. NRO communication practices show that more and more common principles and practices for public communication about nuclear regulatory activity are now shared by OECD countries' nuclear regulators. Public Communication of NROs is clearly an area where the experience of the more advanced has been used to help the less advanced. Most OECD NRO have now a communication department or at least press officers, which reflects the fact that public communication is identified as integral part of the NROs mission. To this purpose NRO Communication Plans have been developed in many countries, which define the mission statement of the organisations, their communication strategy, their communication objectives and their communication targets. Conclusions of workshops and WGPC discussions have identified Stakeholder Involvement in nuclear safety as a necessary practice which helps enhance safety and support public confidence. It requires establish communication mechanisms and tools for discussions between the interested parties and those responsible for decision making. It has been highlighted that such a stakeholder involvement policy need dedicated resources to be efficiently implement. The use of the Internet has dramatically changed the audience of original documents and papers in allowing direct access to the public. In this respect, the development of Nuclear Regulators' web sites which have dramatically improved during this decade, allows that the interpretation and transfer of decisions and technical documents for the public are not only left to the media. This is a radical change in the possibility for directly communicating with the public and the ways to build confidence. Some challenges remain for the NROs such as how to develop an efficient and timely communication towards the public in case of a crisis, for instance when an event occurs in a nuclear facility. Another challenge is to set a proper balance between the need to strive for transparency and the

  12. Challenge and Change

    Science.gov (United States)

    Mehaffy, George L.

    2012-01-01

    In the past twenty years, various industries have been forever altered by technology: newspapers, book publishing, the photography business, and many more. Higher education too faces unprecedented challenges primarily driven by rapid changes in technology. To meet these challenges and adapt to these changes, new models are needed. Six challenges…

  13. Westinghouse electric company, LLC regulatory trends in the USA nuclear power industry

    International Nuclear Information System (INIS)

    Molnar, C. M.; Cheung, A. C.; Gresham, J. A.

    2007-01-01

    The United States (US) nuclear industry is in a dynamic, exciting, and challenging time. On one hand, since the mid 90s, the US nuclear utilities have continued to demonstrate improved safety, efficient and reliable operation for the whole nuclear fleet, thus making generation costs for nuclear energy extremely attractive. On the other hand the US utilities are projecting the need to add significant new generation capacities to replace the aging fleet and to sustain the expected economic growth. In addition to the demonstrated improved operation and financial performance, the financial incentives offered in the federal energy bill passed in 2005 enticed many utilities to actively consider the purchase of new nuclear power plants. This paper will highlight the regulatory trends in the USA, the major initiatives and improvements undertaken as well as other operation support issues faced by the US nuclear power industry

  14. Challenges faced by health workers in implementing the prevention of mother-to-child HIV transmission (PMTCT) programme in Uganda.

    Science.gov (United States)

    Nuwagaba-Biribonwoha, H; Mayon-White, R T; Okong, P; Carpenter, L M

    2007-09-01

    To report the experience of health workers who had played key roles in the early stages of implementing the prevention of mother-to-child HIV transmission services (PMTCT) in Uganda. Interviews were conducted with 15 key informants including counsellors, obstetricians and PMTCT coordinators at the five PMTCT test sites in Uganda to investigate the benefits, challenges and sustainability of the PMTCT programme. Audio-taped interviews were held with each informant between January and June 2003. These were transcribed verbatim and manually analysed using the framework approach. The perceived benefits reported by informants were improvement of general obstetric care, provision of antiretroviral prophylaxis for HIV-positive mothers, staff training and community awareness. The main challenges lay in the reluctance of women to be tested for HIV, incomplete follow-up of participants, non-disclosure of HIV status and difficulties with infant feeding for HIV-positive mothers. Key informants thought that the programme's sustainability depended on maintaining staff morale and numbers, on improving services and providing more resources, particularly antiretroviral therapy for the HIV-positive women and their families. Uganda's experience in piloting the PMTCT programme reflected the many challenges faced by health workers. Potentially resource-sparing strategies such as the 'opt-out' approach to HIV testing required further evaluation.

  15. Challenge theme 2: assuring water availability and quality in the 21st century: Chapter 4 in United States-Mexican Borderlands: Facing tomorrow's challenges through USGS science

    Science.gov (United States)

    Callegary, James; Langeman, Jeff; Leenhouts, Jim; Martin, Peter

    2013-01-01

    Along the United States–Mexican border, the health of communities, economies, and ecosystems is inextricably intertwined with the availability and quality of water, but effective water management in the Borderlands is complicated. Water users compete for resources, and their needs are increasing. Managers are faced with issues such as finding a balance between agriculture and rapidly growing cities or maintaining public supplies while ensuring sufficient resources for aquatic ecosystems. In addition to human factors, the dry climate of the Borderlands, as compared to more temperate regions, also increases the challenge of balancing water supplies between humans and ecosystems. Warmer, drier, and more variable conditions across the southwestern United States—the projected results of climate change (Seager and others, 2007)—would further stress water supplies.

  16. Environment and T regulatory cells in allergy.

    Science.gov (United States)

    Braga, M; Schiavone, C; Di Gioacchino, G; De Angelis, I; Cavallucci, E; Lazzarin, F; Petrarca, C; Di Gioacchino, M

    2012-04-15

    The central role of T regulatory cells in the responses against harmless environmental antigens has been confirmed by many studies. Impaired T regulatory cell function is implicated in many pathological conditions, particularly allergic diseases. The "hygiene hypothesis" suggests that infections and infestations may play a protective role for allergy, whereas environmental pollutants favor the development of allergic diseases. Developing countries suffer from a variety of infections and are also facing an increasing diffusion of environmental pollutants. In these countries allergies increase in relation to the spreading use of xenobiotics (pesticides, herbicides, pollution, etc.) with a rate similar to those of developed countries, overcoming the protective effects of infections. We review here the main mechanisms of non-self tolerance, with particular regard to relations between T regulatory cell activity, infections and infestations such as helminthiasis, and exposure to environmental xenobiotics with relevant diffusion in developing countries. Copyright © 2010 Elsevier B.V. All rights reserved.

  17. Clustering Millions of Faces by Identity.

    Science.gov (United States)

    Otto, Charles; Wang, Dayong; Jain, Anil K

    2018-02-01

    Given a large collection of unlabeled face images, we address the problem of clustering faces into an unknown number of identities. This problem is of interest in social media, law enforcement, and other applications, where the number of faces can be of the order of hundreds of million, while the number of identities (clusters) can range from a few thousand to millions. To address the challenges of run-time complexity and cluster quality, we present an approximate Rank-Order clustering algorithm that performs better than popular clustering algorithms (k-Means and Spectral). Our experiments include clustering up to 123 million face images into over 10 million clusters. Clustering results are analyzed in terms of external (known face labels) and internal (unknown face labels) quality measures, and run-time. Our algorithm achieves an F-measure of 0.87 on the LFW benchmark (13 K faces of 5,749 individuals), which drops to 0.27 on the largest dataset considered (13 K faces in LFW + 123M distractor images). Additionally, we show that frames in the YouTube benchmark can be clustered with an F-measure of 0.71. An internal per-cluster quality measure is developed to rank individual clusters for manual exploration of high quality clusters that are compact and isolated.

  18. Online Scientific Dissemination of Knowledge Blended with Face-to-Face Learning

    DEFF Research Database (Denmark)

    Tveden-Nyborg, Svend

    2013-01-01

    is experienced differently throughout a society due to fast and slow adopters. Blending online learning with face-to-face experience will strengthen the learning curve among the targeted users and ensure a faster dissemination of knowledge and thus learning to the entire community....... between the seed scientists, seed consultants, and the seed growers, and the requirements for a knowledge website for learning new seed science. This paper describes the specification requirements set for the required website including taxonomized hierarchical meta-tagging, RSS, legal matters, together...... with limitations and potentials. However, selecting online communication media as a dissemination tool for a community comes with a challenge – among other things it risks creating a learning divide between fast and slow learners. According to the theoretical framework “Diffusion of Innovation”[1] innovation...

  19. Biosafety capacity building: experiences and challenges from a distance learning approach.

    Science.gov (United States)

    Pertry, Ine; Sabbadini, Silvia; Goormachtig, Sofie; Lokko, Yvonne; Gheysen, Godelieve; Burssens, Sylvia; Mezzetti, Bruno

    2014-01-25

    Biotechnology is revolutionizing industrial and agricultural practice as the number of commercial biotechnology products is increasing each year. Simultaneously, several regulatory approaches are put into place to allow technological advancement while preserving public health and the environment. Developing and/or emerging countries often face major barriers to access biotechnologies and biotechnology derived products as they frequently lack the institutional capacities and professional competence in exercising regulatory oversight. To address this need, intensive biosafety capacity building is required. Different training approaches can be used to train individuals in biosafety ranging from long-term leading to a postgraduate certificate or a Masters degree, to short term courses. In this paper, we discuss the applicability of a different approach to biosafety capacity building based on a distance e-learning system, the UNIDO e-Biosafety program that has been annually organized at the Marche Polytechnic University (MPU) in Italy and Ghent University (UGent) in Belgium since 2006. Even though there are some challenges, we can conclude based on our experience that distance learning in combination with on-campus tuition is amendable for biosafety capacity building. Copyright © 2013 The Authors. Published by Elsevier B.V. All rights reserved.

  20. 78 FR 38053 - Regulatory Systems Strengthening

    Science.gov (United States)

    2013-06-25

    ... current state of medical product regulation globally, including challenges, risks, and emerging trends... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0010... product regulation; generation and analysis of evidence of regulatory systems performance; and provision...

  1. Challenges Faced by Graduate Business Education in Southern Africa: Perceptions of MBA Participants

    Science.gov (United States)

    Temtime, Zelealem T.; Mmereki, Rebana N.

    2011-01-01

    Purpose: The purpose of this paper is to examine the degree of satisfaction and perceived relevance of the Graduate Business Education (GBE) programme at the University of Botswana. Design/methodology/approach: A self-administered questionnaire and face to face interviews were used to collect data from Master of Business Administration (MBA)…

  2. In silico regenerative medicine: how computational tools allow regulatory and financial challenges to be addressed in a volatile market.

    Science.gov (United States)

    Geris, L; Guyot, Y; Schrooten, J; Papantoniou, I

    2016-04-06

    The cell therapy market is a highly volatile one, due to the use of disruptive technologies, the current economic situation and the small size of the market. In such a market, companies as well as academic research institutes are in need of tools to advance their understanding and, at the same time, reduce their R&D costs, increase product quality and productivity, and reduce the time to market. An additional difficulty is the regulatory path that needs to be followed, which is challenging in the case of cell-based therapeutic products and should rely on the implementation of quality by design (QbD) principles. In silico modelling is a tool that allows the above-mentioned challenges to be addressed in the field of regenerative medicine. This review discusses such in silico models and focuses more specifically on the bioprocess. Three (clusters of) examples related to this subject are discussed. The first example comes from the pharmaceutical engineering field where QbD principles and their implementation through the use of in silico models are both a regulatory and economic necessity. The second example is related to the production of red blood cells. The described in silico model is mainly used to investigate the manufacturing process of the cell-therapeutic product, and pays special attention to the economic viability of the process. Finally, we describe the set-up of a model capturing essential events in the development of a tissue-engineered combination product in the context of bone tissue engineering. For each of the examples, a short introduction to some economic aspects is given, followed by a description of the in silico tool or tools that have been developed to allow the implementation of QbD principles and optimal design.

  3. State Electricity Regulatory Policy and Distributed Resources: Accommodating Distributed Resources in Wholesale Markets

    Energy Technology Data Exchange (ETDEWEB)

    Weston, F.; Harrington, C.; Moskovitz, D.; Shirley, W.; Cowart, R.; Sedano, R.

    2002-10-01

    Distributed resources can provide cost-effective reliability and energy services - in many cases, obviating the need for more expensive investments in wires and central station electricity generating facilities. Given the unique features of distributed resources, the challenge facing policymakers today is how to restructure wholesale markets for electricity and related services so as to reveal the full value that distributed resources can provide to the electric power system (utility grid). This report looks at the functions that distributed resources can perform and examines the barriers to them. It then identifies a series of policy and operational approaches to promoting DR in wholesale markets. This report is one in the State Electricity Regulatory Policy and Distributed Resources series developed under contract to NREL (see Annual Technical Status Report of the Regulatory Assistance Project: September 2000-September 2001, NREL/SR-560-32733). Other titles in this series are: (1) Distributed Resource Distribution Credit Pilot Programs - Revealing the Value to Consumers and Vendors, NREL/SR-560-32499; (2) Distributed Resources and Electric System Reliability, NREL/SR-560-32498; (3) Distribution System Cost Methodologies for Distributed Generation, NREL/SR-560-32500; (4) Distribution System Cost Methodologies for Distributed Generation Appendices, NREL/SR-560-32501

  4. Challenges of developing and conducting clinical trials in rare disorders.

    Science.gov (United States)

    Kempf, Lucas; Goldsmith, Jonathan C; Temple, Robert

    2018-04-01

    Rare disease drug development is a rapidly expanding field. Clinical researchers in rare diseases face many challenges when conducting trials in small populations. Disease natural history is often poorly understood and the ability to detect clinically meaningful outcomes requires understanding of their rate of occurrence and variability, both of which contribute to difficulties in powering a study. Standard trial designs are not optimized to obtain adequate safety and efficacy data from small numbers of patients, so alternative designs (enrichment, crossover, adaptive, N-of 1) need to be considered. The affected patients can be hard to identify, especially early in the course of their disease, are generally geographically dispersed, and are often children. Trials are frequently conducted on an international scale and may be subject to complex or multiple regulatory agency oversights and may be affected by local customs, cultures, and practices. A basic understanding of the FDA programs supporting development of drugs for rare diseases is provided by this review and the role of early consultation with the FDA is emphasized. Of recent FDA New Molecular Entities (NME) approvals, 41% (17 approvals) in 2014, 47% (21 approvals) in 2015, and 41% (9 approvals) in 2016 were for rare disease indications. Through effective interactions and collaborations with physicians, institutions, and patient groups, sponsors have been successful in bringing new treatments to market for individuals affected by rare diseases. Challenges to drug development have been overcome through the focused efforts of patients/families, non-profit patient advocacy groups, drug developers, and regulatory authorities. © 2017 Wiley Periodicals, Inc.

  5. Japan's regulatory and safety issues regarding nuclear materials transport

    International Nuclear Information System (INIS)

    Saito, T.; Yamanaka, T.

    2004-01-01

    This paper focuses on the regulatory and safety issues on nuclear materials transport which the Government of Japan (GOJ) faces and needs to well handle. Background information about the status of nuclear power plants (NPP) and nuclear fuel cycle (NFC) facilities in Japan will promote a better understanding of what this paper addresses

  6. International Expert Team Concludes IAEA Peer Review of Poland's Regulatory Framework for Nuclear and Radiation Safety

    International Nuclear Information System (INIS)

    2013-01-01

    the development of the nuclear power programme; and PAA's proactive approach to coordination with Poland's Office of Technical Inspection. The IRRS team made several recommendations and suggestions for PAA as it grows in the next few years, facing challenges and increasing demands as its nuclear power programme expands. To position PAA to address its growth, additional responsibilities, and the retirement of many senior managers, and to maintain its strong focus on safety for currently regulated facilities and activities, the IRRS team advised PAA to: Establish and frequently review that there is a clear link between PAA's organizational goals and objectives, and resource planning, such as staffing and strategies for external support; Consider strengthening and documenting PAA's management system; and Develop and strengthen internal guidance to document authorization processes, review, assessment and inspection procedures. In its preliminary report, the IAEA team's main conclusions have been conveyed to PAA. A final report will be submitted to the Government of Poland in about three months. PAA has informed the team that the final report will be made publicly available. The IAEA encourages nations to invite a follow-up IRRS mission about two years after the mission has been completed. Background The team reviewed the legal and regulatory framework for nuclear safety and addressed all facilities regulated by PAA. This was the 46th IRRS mission conducted by the IAEA. About IRRS Missions IRRS missions are designed to strengthen and enhance the effectiveness of the national nuclear regulatory infrastructure of States, while recognizing the ultimate responsibility of each State to ensure safety in this area. This is done through consideration of regulatory, technical and policy issues, with comparisons against IAEA safety standards and, where appropriate, good practices elsewhere. (IAEA)

  7. Lessons learned and new challenges for integrated assessment under the National Environmental Policy Act

    Energy Technology Data Exchange (ETDEWEB)

    Carnes, S.A.; Reed, R.M.

    1995-12-31

    One of the first government-sponsored demands for integrated assessment to support decision making in the United States is embodied in the National Environmental Policy Act of 1969 (NEPA). Over the past 25 years, Oak Ridge National Laboratory (ORNL) has supported federal agencies` in evaluating health and environmental impacts as required by NEPA. Many of ORNL`s efforts have focused on complex, programmatic assessments that break new ground and require and integrate expertise from a wide range of technical disciplines. Examples of ORNL projects that illustrate the use of integrated assessment approaches include environmental documentation for: (1) the Department of the Army`s Chemical Stockpile Disposal Program, (2) the Federal Energy Regulatory Commission`s licensing activities related to the Owens River Basin in eastern California and along a 500-mile reach of the upper Ohio River, and (3) the Nuclear Regulatory Commission`s decision regarding restart of the undamaged reactor (Unit 1) at Three Mile Island. Our discussion of these examples illustrates successful integrated assessment approaches and identifies new challenges facing integrated assessment activities.

  8. Challenges and regulatory considerations in the acoustic measurement of high-frequency (>20 MHz) ultrasound.

    Science.gov (United States)

    Nagle, Samuel M; Sundar, Guru; Schafer, Mark E; Harris, Gerald R; Vaezy, Shahram; Gessert, James M; Howard, Samuel M; Moore, Mary K; Eaton, Richard M

    2013-11-01

    This article examines the challenges associated with making acoustic output measurements at high ultrasound frequencies (>20 MHz) in the context of regulatory considerations contained in the US Food and Drug Administration industry guidance document for diagnostic ultrasound devices. Error sources in the acoustic measurement, including hydrophone calibration and spatial averaging, nonlinear distortion, and mechanical alignment, are evaluated, and the limitations of currently available acoustic measurement instruments are discussed. An uncertainty analysis of acoustic intensity and power measurements is presented, and an example uncertainty calculation is done on a hypothetical 30-MHz high-frequency ultrasound system. This analysis concludes that the estimated measurement uncertainty of the acoustic intensity is +73%/-86%, and the uncertainty in the mechanical index is +37%/-43%. These values exceed the respective levels in the Food and Drug Administration guidance document of 30% and 15%, respectively, which are more representative of the measurement uncertainty associated with characterizing lower-frequency ultrasound systems. Recommendations made for minimizing the measurement uncertainty include implementing a mechanical positioning system that has sufficient repeatability and precision, reconstructing the time-pressure waveform via deconvolution using the hydrophone frequency response, and correcting for hydrophone spatial averaging.

  9. The Challenges of Malaysian Dry Ports Development

    Directory of Open Access Journals (Sweden)

    Jagan Jeevan

    2015-03-01

    Full Text Available This paper examines the functions and challenges of dry ports development in Malaysia through 11 face-to-face interviews with dry port stakeholders. The findings reveal that Malaysian dry ports are developed to accelerate national and international business, to activate intermodalism in the nation, to promote regional economic development and to enhance seaport competitiveness. Malaysian dry ports perform the function of transport and logistics, information processing, seaports and value-added services. Challenges facing Malaysian dry ports include insufficient railway tracks, unorganized container planning on the rail deck, highly dependent on single mode of transportation, poor recognition from the seaport community, and competition from localized seaports. This paper further indicates strategies for coping with these challenges and identifies future opportunities for Malaysian dry ports development.

  10. Neonates' responses to repeated exposure to a still face.

    Science.gov (United States)

    Nagy, Emese; Pilling, Karen; Watt, Rachel; Pal, Attila; Orvos, Hajnalka

    2017-01-01

    The main aims of the study were to examine whether human neonates' responses to communication disturbance modelled by the still-face paradigm were stable and whether their responses were affected by their previous experience with the still-face paradigm. The still face procedure, as a laboratory model of interpersonal stress, was administered repeatedly, twice, to 84 neonates (0 to 4 day olds), with a delay of an average of 1.25 day. Frame-by-frame analysis of the frequency and duration of gaze, distressed face, crying, sleeping and sucking behaviours showed that the procedure was stressful to them both times, that is, the still face effect was stable after repeated administration and newborns consistently responded to such nonverbal violation of communication. They averted their gaze, showed distress and cried more during the still-face phase in both the first and the second administration. They also showed a carry-over effect in that they continued to avert their gaze and displayed increased distress and crying in the first reunion period, but their gaze behaviour changed with experience, in the second administration. While in the first administration the babies continued averting their gaze even after the stressful still-face phase was over, this carry-over effect disappeared in the second administration, and the babies significantly increased their gaze following the still-face phase. After excluding explanations of fatigue, habituation and random effects, a self-other regulatory model is discussed as a possible explanation for this pattern.

  11. Improving Shadow Suppression for Illumination Robust Face Recognition

    KAUST Repository

    Zhang, Wuming

    2017-10-13

    2D face analysis techniques, such as face landmarking, face recognition and face verification, are reasonably dependent on illumination conditions which are usually uncontrolled and unpredictable in the real world. An illumination robust preprocessing method thus remains a significant challenge in reliable face analysis. In this paper we propose a novel approach for improving lighting normalization through building the underlying reflectance model which characterizes interactions between skin surface, lighting source and camera sensor, and elaborates the formation of face color appearance. Specifically, the proposed illumination processing pipeline enables the generation of Chromaticity Intrinsic Image (CII) in a log chromaticity space which is robust to illumination variations. Moreover, as an advantage over most prevailing methods, a photo-realistic color face image is subsequently reconstructed which eliminates a wide variety of shadows whilst retaining the color information and identity details. Experimental results under different scenarios and using various face databases show the effectiveness of the proposed approach to deal with lighting variations, including both soft and hard shadows, in face recognition.

  12. Cognitive Behavioural Therapy: From Face to Face Interaction to a Broader Contextual Understanding of Change

    Science.gov (United States)

    Jahoda, A.; Dagnan, D.; Kroese, B. Stenfert; Pert, C.; Trower, P.

    2009-01-01

    Cognitive behavioural therapy (CBT) is increasingly used to address the emotional and interpersonal problems of people with ID. There is a limited but promising evidence base supporting this activity. However, these individuals face real and continuing challenges in their lives that have implications for their self and interpersonal perceptions.…

  13. The path from biomarker discovery to regulatory qualification

    CERN Document Server

    Goodsaid, Federico

    2013-01-01

    The Path from Biomarker Discovery to Regulatory Qualification is a unique guide that focuses on biomarker qualification, its history and current regulatory settings in both the US and abroad. This multi-contributed book provides a detailed look at the next step to developing biomarkers for clinical use and covers overall concepts, challenges, strategies and solutions based on the experiences of regulatory authorities and scientists. Members of the regulatory, pharmaceutical and biomarker development communities will benefit the most from using this book-it is a complete and practical guide to biomarker qualification, providing valuable insight to an ever-evolving and important area of regulatory science. For complimentary access to chapter 13, 'Classic' Biomarkers of Liver Injury, by John R. Senior, Associate Director for Science, Food and Drug Administration, Silver Spring, Maryland, USA, please visit the following site:  http://tinyurl.com/ClassicBiomarkers Contains a collection of experiences of different...

  14. Women in the Teaching Profession: Impacts and Challenges

    OpenAIRE

    A. M. Sultana; Norhirdawati. M. Zahir; Norzalan. H. Yaacob

    2014-01-01

    Recently in Malaysia, women's participation in teaching profession has increased. The increasing trend of women’s participation in the teaching profession poses challenges in families, especially in the developing countries like Malaysia. One of these challenges, concerns in balancing their role between family and job responsibility that faced by many women teachers. The purpose of this study is to discover how women teachers' impact on family happiness and the challenges faced by them in bal...

  15. Emerging Markets for Renewable Energy Certificates: Opportunities and Challenges

    Energy Technology Data Exchange (ETDEWEB)

    Holt, E.; Bird, L.

    2005-01-01

    Renewable energy certificates (RECs) represent the attributes of electricity generated from renewable energy sources. These attributes are unbundled from the physical electricity, and the two products-the attributes embodied in the certificates and the commodity electricity-may be sold or traded separately. RECs are quickly becoming the currency of renewable energy markets because of their flexibility and the fact that they are not subject to the geographic and physical limitations of commodity electricity. RECs are currently used by utilities and marketers to supply renewable energy products to end-use customers as well as to demonstrate compliance with regulatory requirements, such as renewable energy mandates. The purpose of this report is to describe and analyze the emerging market for renewable energy certificates. It describes how RECs are marketed, examines RECs markets including scope and prices, and identifies and describes the key challenges facing the growth and success of RECs markets.

  16. Challenges in war-related thoracic injury faced by French military surgeons in Afghanistan (2009-2013).

    Science.gov (United States)

    de Lesquen, Henri; Beranger, Fabien; Berbis, Julie; Boddaert, Guillaume; Poichotte, Antoine; Pons, Francois; Avaro, Jean-Philippe

    2016-09-01

    This study reports the challenges faced by French military surgeons in the management of thoracic injury during the latest Afghanistan war. From January 2009 to April 2013, all of the civilian, French and Coalition casualties admitted to French NATO Combat Support Hospital situated on Kabul were prospectively recorded in the French Military Health Service Registry (OPEX(®)). Only penetrating and blunt thoracic trauma patients were retrospectively included. Eighty-nine casualties were included who were mainly civilian (61%) and men (94%) with a mean age of 27.9 years old. Surgeons dealt with polytraumas (78%), severe injuries (mean Injury Severity Score=39.2) and penetrating wounds (96%) due to explosion in 37%, gunshot in 53% and stabbing in 9%. Most of casualties were first observed or drained (n=56). In this non-operative group more than 40% of casualties needed further actions. In the operative group, Damage Control Thoracotomy (n=22) was performed to stop ongoing bleeding and air leakage and Emergency Department Thoracotomy (n=11) for agonal patient. Casualties suffered from hemothorax (60%), pneumothorax (39%), diaphragmatic (37%), lung (35%), heart or great vessels (20%) injuries. The main actions were diaphragmatic sutures (n=25), lung resections (wedge n=6, lobectomy n=4) and haemostasis (intercostal artery ligation n=3, heart injury repairs n=5, great vessels injury repairs n=5). Overall mortality was 11%. The rate of subsequent surgery was 34%. The analysis of the OPEX(®) registry reflects the thoracic surgical challenges of general (visceral) surgeons serving in combat environment during the latest Afghanistan War. Copyright © 2016 Elsevier Ltd. All rights reserved.

  17. Institutional review boards: Challenges and opportunities

    Directory of Open Access Journals (Sweden)

    Ravindra B Ghooi

    2014-01-01

    Full Text Available Institutional Review Boards (IRBs are an important link in subject protection program, and their function defines ethical credentials of research. Of late there has been a furore in the country over the number of deaths in clinical research, and allegations of unethical research. Clinical trials have been discussed in medical and lay press and even in the parliament, these discussions called for strengthening the subject protection program. The Central Drug Standards and Control Organization (CDSCO, amended the Schedule Y, by issuing three amendments to introduce new compensation rules and registration of IRBs functioning in the country. IRBs in India face a variety of challenges, and need support from the regulators or independent experts. This is also an opportunity to revamp the subject protection program and strengthen the IRB functioning. An independent advisory body comprising of experts who have hands on experience in administering IRBs, is essential to provide support to IRBs in the country. This body should be independent of regulatory influence and work with IRBs to strengthen them.

  18. Regulatory, biosafety and safety challenges for novel cells as substrates for human vaccines.

    Science.gov (United States)

    Hess, Ralf D; Weber, Friedemann; Watson, Keith; Schmitt, Siegfried

    2012-04-05

    In the development of novel substrates used for production of human vaccines there has been significant progress made in recent years. Emerging and re-emerging infectious diseases like the recent porcine Influenza A virus (H1N1) pandemic necessitated the availability of unprecedented amounts of vaccines. In addition, the high demand for vaccines in the industrialised countries has also been paralleled by a steep increase in demand in developing countries. The manufacturing capability for viral vaccines produced in embryonated hen eggs and conventional/classical cell substrates, such as chicken embryo fibroblasts, has now reached its capacity limit. This constraint may be overcome by utilising other recognised cell substrates such as Madin Darby Canine Kidney (MDCK) (dog origin), Chinese Hamster Ovary (CHO) (hamster cells) or Vero cells (monkey origin) or as an alternative, introduce new cell substrates of human or avian origin. Using new cell substrates may prove to be a highly replication-proficient way of producing live viral vaccines such as Influenza A viruses. Despite some advantages, cell substrates may pose a small residual risk to humans since some of them are known to be tumourigenic in immunosuppressed animals. However, this residual risk should be considered acceptable by regulators. Safety testing requirements for cell substrates used in the manufacture of vaccines is mandated by published guidance from organisations such as World Health Organization (WHO), United States Food and Drug Administration (FDA), European Medicines Agency (EMA) and International Conferences on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human use (ICH) as well as requirements laid down in compendial monographs (Ph. Eur. and USP). This paper considers the guidance contained in these regulatory documents. In addition, the safety challenges and almost arbitrary risk-based classification of cell substrates used in the production of human

  19. An opportunity and an imperative: Chapter 11 in United States-Mexican Borderlands: Facing tomorrow's challenges through USGS science

    Science.gov (United States)

    Updike, Randall G.; Page, William R.

    2013-01-01

    Along the nearly 3,200 kilometers (almost 2,000 miles) of the United States–Mexican border, we are witnessing the expression of the challenges of the 21st century. The Borderlands have become a microcosm for the entire United States and Mexico; the issues faced in that region are felt throughout both nations—water availability and quality, ecosystem health, natural resource needs, safety from natural hazards, and human socioeconomic well-being. If these issues were not challenging enough, we now recognize that the difficulties of addressing them are exacerbated by the onset of climate change, and as we come to better understand the complexities of the components of these challenge themes, we discover that each part is inextricably intertwined with other overarching issues. Further, because we are a creative and progressive society, we all seek to understand and appreciate the natural environments associated with the Borderlands while at the same time benefitting from the region’s many social and economic values. It is little wonder that we as a society find it increasingly difficult to ask the right questions, much less find suitable answers to the questions we do ask. For the many scientists who have worked in the Borderlands and contributed to the preceding chapters, this circular is a way to describe to the two nations of the region the capabilities the U.S. Geological Survey can provide to assist in that quest for knowledge and understanding in preparation for the future.

  20. Issues and Challenges Facing the Minority Woman Dentist.

    Science.gov (United States)

    Sinkford, Jeanne C.

    1992-01-01

    The status of minority women dentists is reviewed, and initiatives to improve it are noted. Issues and challenges for African-American female dentists are outlined, including negative racial/gender stereotypes, lack of advancement opportunities, difficulties in starting practices and securing professional and social support systems, lack of…

  1. Environmental problems facing the electricity industry

    International Nuclear Information System (INIS)

    Johnson, S.

    1988-01-01

    The paper on the environmental problems facing the electricity industry was first presented at the World Electricity Conference, Nov. 1987. According to the author, the biggest immediate environmental challenge the electricity industry faces is the need for the role and importance of nuclear power to be reasserted clearly and unambiguously. The main environmental problems from electricity generation are air pollution and the carbon dioxide/greenhouse issue, and the author thinks that both could be reduced by an increased use of nuclear power as an energy source. (U.K.)

  2. Comparing Costs of Telephone versus Face-to-Face Extended Care Programs for the Management of Obesity in Rural Settings

    Science.gov (United States)

    Radcliff, Tiffany A.; Bobroff, Linda B.; Lutes, Lesley D.; Durning, Patricia E.; Daniels, Michael J.; Limacher, Marian C.; Janicke, David M.; Martin, A. Daniel; Perri, Michael G.

    2012-01-01

    Background A major challenge following successful weight loss is continuing the behaviors required for long-term weight maintenance. This challenge may be exacerbated in rural areas with limited local support resources. Objective This study describes and compares program costs and cost-effectiveness for 12-month extended care lifestyle maintenance programs following an initial 6-month weight loss program. Design A 1-year prospective controlled randomized clinical trial. Participants/Setting The study included 215 female participants age 50 or older from rural areas who completed an initial 6-month lifestyle program for weight loss. The study was conducted from June 1, 2003, to May 31, 2007. Intervention The intervention was delivered through local Cooperative Extension Service offices in rural Florida. Participants were randomly-assigned to a 12-month extended care program using either individual telephone counseling (n=67), group face-to-face counseling (n=74), or a mail/control group (n=74). Main Outcome Measures Program delivery costs, weight loss, and self-reported health status were directly assessed through questionnaires and program activity logs. Costs were estimated across a range of enrollment sizes to allow inferences beyond the study sample. Statistical Analyses Performed Non-parametric and parametric tests of differences across groups for program outcomes were combined with direct program cost estimates and expected value calculations to determine which scales of operation favored alternative formats for lifestyle maintenance. Results Median weight regain during the intervention year was 1.7 kg for participants in the face-to-face format, 2.1 kg for the telephone format, and 3.1 kg for the mail/control format. For a typical group size of 13 participants, the face-to-face format had higher fixed costs, which translated into higher overall program costs ($420 per participant) when compared to individual telephone counseling ($268 per participant) and

  3. AN EFFICIENT SELF-UPDATING FACE RECOGNITION SYSTEM FOR PLASTIC SURGERY FACE

    Directory of Open Access Journals (Sweden)

    A. Devi

    2016-08-01

    Full Text Available Facial recognition system is fundamental a computer application for the automatic identification of a person through a digitized image or a video source. The major cause for the overall poor performance is related to the transformations in appearance of the user based on the aspects akin to ageing, beard growth, sun-tan etc. In order to overcome the above drawback, Self-update process has been developed in which, the system learns the biometric attributes of the user every time the user interacts with the system and the information gets updated automatically. The procedures of Plastic surgery yield a skilled and endurable means of enhancing the facial appearance by means of correcting the anomalies in the feature and then treating the facial skin with the aim of getting a youthful look. When plastic surgery is performed on an individual, the features of the face undergo reconstruction either locally or globally. But, the changes which are introduced new by plastic surgery remain hard to get modeled by the available face recognition systems and they deteriorate the performances of the face recognition algorithm. Hence the Facial plastic surgery produces changes in the facial features to larger extent and thereby creates a significant challenge to the face recognition system. This work introduces a fresh Multimodal Biometric approach making use of novel approaches to boost the rate of recognition and security. The proposed method consists of various processes like Face segmentation using Active Appearance Model (AAM, Face Normalization using Kernel Density Estimate/ Point Distribution Model (KDE-PDM, Feature extraction using Local Gabor XOR Patterns (LGXP and Classification using Independent Component Analysis (ICA. Efficient techniques have been used in each phase of the FRAS in order to obtain improved results.

  4. Difficulties facing physician mothers in Japan.

    Science.gov (United States)

    Yamazaki, Yuka; Kozono, Yuki; Mori, Ryo; Marui, Eiji

    2011-11-01

    Despite recent increases in the number of female physicians graduating in Japan, their premature resignations after childbirth are contributing to the acute shortage of physicians. Previous Japanese studies have explored supportive measures in the workplace, but have rarely focused on the specific problems or concerns of physician-mothers. Therefore, this study explored the challenges facing Japanese physician-mothers in efforts to identify solutions for their retention. Open-ended questionnaires were mailed to 646 alumnae of Juntendo University School of Medicine. We asked subjects to describe their opinions about 'The challenges related to female physicians' resignations'. Comments gathered from alumnae who graduated between 6 and 30 years ago and have children were analyzed qualitatively. Overall, 249 physicians returned the questionnaire (response rate 38.5%), and 73 alumnae with children who graduated in the stated time period provided comments. The challenges facing physician-mothers mainly consisted of factors associated with Japanese society, family responsibilities, and work environment. Japanese society epitomized by traditional gender roles heightened stress related to family responsibilities and promoted gender discrimination at work environment. Additionally, changing Japanese society positively influenced working atmosphere and husband's support. Moreover, the introduction of educational curriculums that alleviated traditional gender role was proposed for pre- and post- medical students. Traditional gender roles encourage discrimination by male physicians or work-family conflicts. The problems facing female physicians involve more than just family responsibilities: diminishing the notion of gender role is key to helping retain them in the workforce. © 2011 Tohoku University Medical Press

  5. A long hard road? Urban freight transport challenges facing South Africa

    CSIR Research Space (South Africa)

    Ittmann, HW

    2008-05-01

    Full Text Available shown very little interest in the increasingly severe freight transport problems facing urban areas, there is now growing interest in the logistics of collection and delivery services in towns and city centres....

  6. Telecommunications Reform in Nigeria: The Marketing Challenges ...

    African Journals Online (AJOL)

    Telecommunications Reform in Nigeria: The Marketing Challenges. ... Journal of Research in National Development ... This paper discusses the telecommunications reforms process, the role of the regulatory body (Nigeria Commission, the current state of the telecommunication sector and the marketing challenges in ...

  7. Regulatory agencies and regulatory risk

    OpenAIRE

    Knieps, Günter; Weiß, Hans-Jörg

    2008-01-01

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

  8. Addressing the human resource challenge in the electricity industry

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2007-02-15

    The electricity industry is facing significant challenges in terms of its labour forces in the years ahead due to an aging workforce and pending retirements in an industry already challenged by increasing demand, technological change and regulatory instability. A shortage of skilled labour could compromise the electricity sector in a variety of ways including: reduced reliability, increased cost of production, infrastructure projects delays, and decreased safety and productivity due to less experienced employees and worker shortages. This report presented a briefing of recommendations developed by the Canadian Electricity Association (CEA) that offered concrete solutions to addressing the electricity industry's workforce challenges. The recommendations focused around three areas: building Canadian skills base by investing in education, skills training and apprenticeships, particularly in underrepresented communities; ensuring trained, skilled workers are able to work and flourish in their area of expertise by streamlining certification and credential recognition, and facilitating workforce mobility; and attracting and retaining skilled foreign workers by ensuring successful community and workplace integration. Background information on the electricity industry in Canada was also presented. The CEA also proposed a list of policy initiatives to ensure the Canadian electricity industry can maintain and enhance its human and electricity potential. It was concluded that the CEA is prepared to develop detailed implementation plans and programs to operationalize any and all of the recommendations in the briefing. 2 figs.

  9. "Members of the same club": challenges and decisions faced by US IRBs in identifying and managing conflicts of interest.

    Science.gov (United States)

    Klitzman, Robert

    2011-01-01

    Conflicts of interest (COIs) in research have received increasing attention, but many questions arise about how Institutional Review Boards (IRBs) view and approach these. I conducted in-depth interviews of 2 hours each with 46 US IRB chairs, administrators, and members, exploring COI and other issues related to research integrity. I contacted leaders of 60 IRBs (every fourth one among the top 240 institutions by NIH funding), and interviewed IRB leaders from 34 of these institutions (response rate = 55%). Data were analyzed using standard qualitative methods, informed by Grounded Theory. IRBs confront financial and non-financial COIs of PIs, institutions, and IRBs themselves. IRB members may seek to help, or compete with, principal investigators (PIs). Non-financial COI also often appear to be "indirect financial" conflicts based on gain (or loss) not to oneself, but to one's colleagues or larger institution. IRBs faced challenges identifying and managing these COI, and often felt that they could be more effective. IRBs' management of their own potential COI vary, and conflicted members may observe, participate, and/or vote in discussions. Individual IRB members frequently judge for themselves whether to recuse themselves. Challenges arise in addressing these issues, since institutions and PIs need funding, financial information is considered confidential, and COI can be unconscious. This study, the first to explore qualitatively how IRBs confront COIs and probe how IRBs confront non-financial COIs, suggests that IRBs face several types of financial and non-financial COIs, involving themselves, PIs, and institutions, and respond varyingly. These data have critical implications for practice and policy. Disclosure of indirect and non-financial COIs to subjects may not be feasible, partly since IRBs, not PIs, are conflicted. Needs exist to consider guidelines and clarifications concerning when and how, in protocol reviews, IRB members should recuse themselves

  10. New Challenges Facing Small Undergraduate Departments And The Role Of Faculty And Administrators.

    Science.gov (United States)

    El-Shazly, A. K.

    2003-12-01

    Small geoscience departments with 5 faculty members or less in undergraduate institutions are facing serious challenges that will have a profound impact on their future, as well as the future of geoscience education. In addition to past and future budget cuts that affect all departments, small departments are more vulnerable to such problems as (i) decreased enrollments in introductory level classes, (ii) small number of geology majors, (iii) small number of graduates per year (iv) lack or paucity of equipment necessary for faculty and student research, (v) limited opportunities for external funding, (vi) need to offer upper division classes on an alternate year basis, (vii) difficulty in recruiting and retaining students, (viii) high teaching loads for faculty, and (ix) designing rigorous curricula based on 120 credit hours with a significant component of liberal art classes. These problems pose new challenges for faculty, department chairs and administrators. Faculty need to design curricula tailored to the need of the job market, without compromising rigor or the quality of the program. New classes/ concentrations in environmental science, hydrogeology and geographical information systems should be offered, and traditional classes in petrology, geophysics and tectonics should be maintained. Classes in Physics, Chemistry and Math should be core requirements. Student involvement in research should be encouraged at an early stage (sophomore/ junior levels). Department chairs need to assign duties in their department carefully to capitalize on the strengths of their faculty: faculty with strong research backgrounds should be helped in their efforts to pursue external funding opportunities, whereas those with strong teaching abilities should be evaluated primarily on their performance in the classroom. Student credit hour production should not be used as a criterion for evaluating faculty. Administrators should evaluate programs and departments based on the success

  11. Individuating Faces and Common Objects Produces Equal Responses in Putative Face Processing Areas in the Ventral Occipitotemporal Cortex

    Directory of Open Access Journals (Sweden)

    Frank Haist

    2010-10-01

    Full Text Available Controversy surrounds the proposal that specific human cortical regions in the ventral occipitotemporal cortex, commonly called the fusiform face area (FFA and occipital face area (OFA, are specialized for face processing. Here, we present findings from a fMRI study of identity discrimination of faces and objects that demonstrates the FFA and OFA are equally responsive to processing stimuli at the level of individuals (i.e., individuation, be they human faces or non-face objects. The FFA and OFA were defined via a passive viewing task as regions that produced greater activation to faces relative to non-face stimuli within the middle fusiform gyrus and inferior occipital gyrus. In the individuation task, participants judged whether sequentially presented images of faces, diverse objects, or wristwatches depicted the identical or a different exemplar. All three stimulus types produced equivalent BOLD activation within the FFA and OFA; that is, there was no face-specific or face-preferential processing. Critically, individuation processing did not eliminate an object superiority effect relative to faces within a region more closely linked to object processing in the lateral occipital complex (LOC, suggesting that individuation processes are reasonably specific to the FFA and OFA. Taken together, these findings challenge the prevailing view that the FFA and OFA are face-specific processing regions, demonstrating instead that they function to individuate -- i.e., identify specific individuals -- within a category. These findings have significant implications for understanding the function of a brain region widely believed to play an important role in social cognition.

  12. Modular arrangement of regulatory RNA elements.

    Science.gov (United States)

    Roßmanith, Johanna; Narberhaus, Franz

    2017-03-04

    Due to their simple architecture and control mechanism, regulatory RNA modules are attractive building blocks in synthetic biology. This is especially true for riboswitches, which are natural ligand-binding regulators of gene expression. The discovery of various tandem riboswitches inspired the design of combined RNA modules with activities not yet found in nature. Riboswitches were placed in tandem or in combination with a ribozyme or temperature-responsive RNA thermometer resulting in new functionalities. Here, we compare natural examples of tandem riboswitches with recently designed artificial RNA regulators suggesting substantial modularity of regulatory RNA elements. Challenges associated with modular RNA design are discussed.

  13. Analysis of Worldwide Regulatory Framework for On-Line Maintenance

    International Nuclear Information System (INIS)

    Ahn, Sang Kyu; Oh, Kyu Myung; Lee, Chang Ju

    2010-01-01

    With the increasing economic pressures being faced and the potential for shortening outage times under the conditions of deregulated electricity markets in the world, licensees are motivated to get an increasing amount of online maintenance (OLM). OLM means a kind of planned maintenance of nuclear reactor facilities, including structure, systems, and components (SSCs), during power operation. In Korea, a similar situation is made up, so it needs to establish a regulatory framework for OLM. A few years ago, foreign countries' practices related to OLM were surveyed by the Working Group on Inspection Practices (WGIP) of OECD/NEA/CNRA. The survey results and additional new information of countries' status will be helpful to establish our own regulatory framework for OLM, which are analyzed in this paper. From the analysis, some considerable points to be addressed for establishing a regulatory framework for OLM are suggested

  14. Professional development for teachers of students who are deaf or hard of hearing: facing the assessment challenge.

    Science.gov (United States)

    Cawthon, Stephanie

    2009-01-01

    Teachers of students with low-incidence disabilities, such as students who are deaf or hard of hearing, face unique challenges in putting education policy into practice. The present article presents professional development findings from the Third Annual National Survey of Accommodations and Assessment for Students Who Are Deaf or Hard of Hearing (Cawthon, Hersh, Kim, & Online Research Lab, in press). A total of 391 participants described professional development they had experienced related to assessment of students who are deaf or hard of hearing. Teachers reported greater exposure to topics in school/district sessions and discussion with their colleagues than in their preparation programs. Teaching at a school for the deaf or teaching students in high school were significant predictors of an increased prevalence of professional development opportunities on assessment-related topics for students who are deaf or hard of hearing.

  15. Community in Online Higher Education: Challenges and Opportunities

    Science.gov (United States)

    Arasaratnam-Smith, Lily A.; Northcote, Maria

    2017-01-01

    Exploring the challenges and opportunities associated with the concepts of community and communication in online higher education, this paper reconsiders the intention to replicate face-to-face learning and teaching strategies in online learning environments. Rather than beginning with the assumption that face-to-face education is the prototype…

  16. BLENDED LEARNING: STUDENT PERCEPTION OF FACE-TO-FACE AND ONLINE EFL LESSONS

    Directory of Open Access Journals (Sweden)

    Brenda M. Wright

    2017-05-01

    Full Text Available With the ever-increasing development of technology, online teaching is more readily accepted as a viable component in teaching and learning, and blended learning, the combining of online and face-to-face learning, is becoming commonplace in many higher education institutions. Blended learning is, particularly in developing countries, in its early stages and not without its challenges. Asynchronous online lessons are currently still more prevalent in many areas of South-East Asia, perhaps due to potential difficulty in obtaining strong Internet connections, which may deter educators from synchronous options. Technological media have the potential to broaden the scope of resources available in teaching and to enhance the language learning experience. Although research to date shows some focus on blended learning, literature on distance online teaching seems more prevalent. This study exposed 112 Malaysian undergraduate EFL students' responses to an online lesson as part of an English grammar course, and investigates common student perceptions of the online lesson as compared with face-to-face lessons. Questionnaires using qualitative (Likert scale questions and quantitative (open-ended questions approaches provided data for content analysis to determine common student perceptions, with particular reference to motivation and interest. In general, more students associated in-class lessons with higher motivation and more interest, due to better understanding, valued classroom interaction with the lecturer and peers, and input from the lecturer. Students preferring the online lesson cited speed and convenience of study and flexibility of time and place of study as reasons for their choice. Skilful implementation of online lessons can enhance a language course but should not undermine the value of face-to-face instruction with EFL teachers.

  17. Regulatory changes raise troubling questions for genomic testing.

    Science.gov (United States)

    Evans, Barbara J; Dorschner, Michael O; Burke, Wylie; Jarvik, Gail P

    2014-11-01

    By 6 October 2014, many laboratories in the United States must begin honoring new individual data access rights created by recent changes to federal privacy and laboratory regulations. These access rights are more expansive than has been widely understood and pose complex challenges for genomic testing laboratories. This article analyzes regulatory texts and guidances to explore which laboratories are affected. It offers the first published analysis of which parts of the vast trove of data generated during next-generation sequencing will be accessible to patients and research subjects. Persons tested at affected laboratories seemingly will have access, upon request, to uninterpreted gene variant information contained in their stored variant call format, binary alignment/map, and FASTQ files. A defect in the regulations will subject some non-CLIA-regulated research laboratories to these new access requirements unless the Department of Health and Human Services takes swift action to avert this apparently unintended consequence. More broadly, all affected laboratories face a long list of daunting operational, business, compliance, and bioethical issues as they adapt to this change and to the Food and Drug Administration's recently announced plan to publish draft guidance outlining a new oversight framework for lab-developed tests.

  18. Facing Global Challenges with Materials Innovation

    Science.gov (United States)

    Rizzo, Fernando

    2017-10-01

    The path of society evolution has long been associated with a growing demand for natural resources and continuous environmental degradation. During the last decades, this pace has accelerated considerably, despite the general concern with the legacy being left for the next generations. Looking ahead, the predicted growth of the world population, and the improvement of life conditions in most regions, point to an increasing demand for energy generation, resulting in additional pressure on the Earth's sustainability. Materials have had a key role in decreasing the use of natural resources, by either improving efficiency of existing technologies or enabling the development of radical new ones. The greenhouse effect (CO2 emissions) and the energy crisis are global challenges that can benefit from the development of new materials for the successful implementation of promising technologies and for the imperative replacement of fossil fuels by renewable sources.

  19. Challenges in contemporary academic neurosurgery.

    Science.gov (United States)

    Black, Peter M

    2006-03-01

    Traditionally, the ideal academic neurosurgeon has been a "quadruple threat," with excellence in clinical work, teaching, research, and administration. This tradition was best exemplified in Harvey Cushing, who developed the field of neurosurgery 90 years ago. This paradigm will probably have to change as academic neurosurgeons face major challenges. In patient care, these include increasing regulatory control, increasing malpractice costs, consolidation of expensive care in academic centers, and decreasing reimbursement; in resident teaching, work hour limitations and a changing resident culture; in research, the increasing dominance of basic scientists in governmental funding decisions and decreased involvement of neurosurgeons in scientific review committees; and in administration, problems of relationships in the workplace, patient safety, and employment compliance in an increasingly bureaucratic system. To meet these challenges, the new academic neurosurgeon will probably not be a quadruple threat personally but will be part of a quadruple threat in a department and institution. Neurosurgeons in such a setting will have to work with hospital, medical school, and national and international groups to address malpractice, reimbursement, subspecialization, and training problems; find supplemental sources of income through grants, development funds, and hospital support; lead in the development of multidisciplinary centers for neuroscience, brain tumor, spine, and other initiatives; and focus on training leaders for hospital, regional, and national groups to reconfigure neurosurgery. Collaboration, flexibility, and leadership will be characteristic of the academic neurosurgeon in this new era.

  20. Regulatory trends and practices related to nuclear reactor decommissioning

    International Nuclear Information System (INIS)

    Cantor, R.A.

    1984-01-01

    In the next several decades, the electric utility industry will be faced with the retirement of 50,000 megawatts (mW) of nuclear capacity. Responsibility for the financial and technical burdens this activity entails has been delegated to the utilities operating the reactors. However, the operators will have to perform the tasks of reactor decommissioning within the regulatory environment dictated by federal, state and local regulations. The purpose of this paper is to highlight some of the current and likely trends in regulations and regulatory practices that will significantly affect the costs, technical alternatives and financing schemes encountered by the electric utilities and their customers