WorldWideScience

Sample records for regulatory challenges arising

  1. 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)

  2. Regulatory challenges arising from the transition from operation to decommissioning

    International Nuclear Information System (INIS)

    O'Sullivan, P.O.; Pescatore, C.; Duncan, A.

    2008-01-01

    After a nuclear facility is shut down for the final time, the next steps involve reducing the sources of hazard in a systematic and progressive way. At some stage following removal of the bulk of radioactive material, the main process of dismantling down to site clearance may begin. The activities connected with the process of D and D are rather different from the day-today activities on an operating plant in steady-state. Moreover, they vary and change progressively as the D and D process progresses. The NEA Working Party on Dismantling and Decommissioning (WPDD) has long been interested in issues concerned with the regulation of the decommissioning of nuclear facilities. This issue was the subject of a special topical session during the annual WPDD meeting held in October 2006, and also of a subsequent study, the results of which were discussed at the 2007 annual meeting (in November). It is anticipated that the report from this study will be published during 2008. The recent work of the WPDD suggests that a proportionate regulatory response, to accommodate the new work and risk context during D and D, should result eventually in modified emphasis on matters concerned with the handling and use of nuclear materials, such as criticality control, the potential for illegal diversion and emergency preparedness. At the same time, a shift in emphasis towards matters concerned with the various new activities associated with D and D may be expected, particularly in regard to protection of the work force, the public and the environment. Underlying the changes proposed above is the need to have site licence conditions for D and D that reflect more closely the regulatory norms associated with conventional industrial activities rather than those for specifically nuclear activities. In the context of emerging practices, and regardless of the precise regulatory framework, it is evident that the most important issues for licensing of nuclear sites undergoing D and D are those

  3. 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

  4. 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)

  5. Dioxins: diagnostic and prognostic challenges arising from complex mechanisms

    DEFF Research Database (Denmark)

    Rysavy, Noel M.; Maaetoft-Udsen, Kristina; Turner, Helen

    2013-01-01

    Dioxins are ubiquitous environmental challenges to humans, with a pervasiveness that arises from 200?years of rapid industrialization and mechanization of Western societies and which is now extending into the developing world. In spite of their penetrance of the human biota, these compounds...... such as cancer and diabetes, which are already multifactorial and highly complex, creates the context for the current review paper. Here, we summarize dioxin exposure paradigms and the resulting physiological effects that have been documented in animals and humans. Novel insights into potential endogenous end...... exogenous ligands, as well as the mechanisms by which these ligands impact acute and chronic cellular processes, are discussed. We develop the idea that the diagnosis of dioxin exposure, the subtleties of the cellular effects of the compounds and prognosis of the long-term effects of exposure are problems...

  6. 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)

  7. 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)

  8. 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.)

  9. 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.

  10. 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...

  11. 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.

  12. 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.

  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. Security issues of new innovative payments and their regulatory challenges

    NARCIS (Netherlands)

    Kasiyanto, Safari; Gabriella, Gimigliano

    2016-01-01

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

  15. 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)

  16. Regulatory Body of Egypt: Practices and Challenges

    International Nuclear Information System (INIS)

    El-Messiry, A.

    2016-01-01

    In past, Egypt issued the law No. 59 of year 1969 for regulating the use of ionizing radiations inside the country, this law assigns the responsibilities of Egypt Atomic Energy Authority EAEA to control reactors, open sources, and all nuclear and radiation facilities inside its premises, while the ministry of health was responsible for controlling x-ray machine, sealed sources and accelerators. In 1982 EAEA established within its structure a new regulatory body called national centre for Nuclear Safety and radiation Control NC-NSRC as a dependent regulatory body, science EAEA is the operator of reactors and many nuclear and radiation facilities. On 30 March 2010 Egypt issued a nuclear law No 7 of year 2010, followed by its executive regulation in October 2011, the new law replaced the old law 59 of year 1969, in addition, the prime minster issued a decree on march 5td 2012 of establishing an independent regulatory body reported directly to him, it has the name of Egypt Nuclear and Radiological Regulatory Authority ENRRA, it is responsible for regulating all nuclear and radiation facilities and activities inside the country, except X-ray machines and linear accelerators for the medical uses, that still remains under the control of ministry of health. The new nuclear law defines the responsibility of the government to establish, support and determine the authorization and the responsibilities of the independent regulatory body. ENRRA is managed by a board of directors comprises from chairman, vice chairman, head of national security, interior, exterior, customs, export & import, standards, environment, justice organizations, besides two scientific experts from ENRRA. The board of council is the supreme authority of the dominant, and the conduct of ENRRA affairs, and take decisions within the framework of the national plan of Egypt, to achieve the objectives for which the ENRRA was established. ENRRA was organized from the old NC-NSRC staff into three regulatory

  17. 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

  18. 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)

  19. Novel microRNA-like viral small regulatory RNAs arising during human hepatitis A virus infection.

    Science.gov (United States)

    Shi, Jiandong; Sun, Jing; Wang, Bin; Wu, Meini; Zhang, Jing; Duan, Zhiqing; Wang, Haixuan; Hu, Ningzhu; Hu, Yunzhang

    2014-10-01

    MicroRNAs (miRNAs), including host miRNAs and viral miRNAs, play vital roles in regulating host-virus interactions. DNA viruses encode miRNAs that regulate the viral life cycle. However, it is generally believed that cytoplasmic RNA viruses do not encode miRNAs, owing to inaccessible cellular miRNA processing machinery. Here, we provide a comprehensive genome-wide analysis and identification of miRNAs that were derived from hepatitis A virus (HAV; Hu/China/H2/1982), which is a typical cytoplasmic RNA virus. Using deep-sequencing and in silico approaches, we identified 2 novel virally encoded miRNAs, named hav-miR-1-5p and hav-miR-2-5p. Both of the novel virally encoded miRNAs were clearly detected in infected cells. Analysis of Dicer enzyme silencing demonstrated that HAV-derived miRNA biogenesis is Dicer dependent. Furthermore, we confirmed that HAV mature miRNAs were generated from viral miRNA precursors (pre-miRNAs) in host cells. Notably, naturally derived HAV miRNAs were biologically and functionally active and induced post-transcriptional gene silencing (PTGS). Genomic location analysis revealed novel miRNAs located in the coding region of the viral genome. Overall, our results show that HAV naturally generates functional miRNA-like small regulatory RNAs during infection. This is the first report of miRNAs derived from the coding region of genomic RNA of a cytoplasmic RNA virus. These observations demonstrate that a cytoplasmic RNA virus can naturally generate functional miRNAs, as DNA viruses do. These findings also contribute to improved understanding of host-RNA virus interactions mediated by RNA virus-derived miRNAs. © FASEB.

  20. 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.

  1. 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...

  2. 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)

  3. 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

  4. 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)

  5. 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...

  6. 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)

  7. 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.

  8. Navigating the Challenges Arising from University-School Collaborative Action Research

    Science.gov (United States)

    Yuan, Rui; Mak, Pauline

    2016-01-01

    Despite increasing evidence showing the benefits language teachers can reap from university-school collaborative action research (CAR), scant attention has been given to how university researchers collaborate with language teachers, what challenges they might encounter, and how they navigate such challenges in CAR. To fill the gap, this study…

  9. 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)

  10. Regulatory challenges in manufacturing of pancreatic islets.

    Science.gov (United States)

    Linetsky, E; Ricordi, C

    2008-03-01

    At the present time, transplantation of pancreatic islet cells is considered an experimental therapy for a selected cohort of patients with type 1 diabetes, and is conducted under an Investigational New Drug (IND) application. Encouraging results of the Edmonton Protocol published in the year 2000 sparked a renewed interest in clinical transplantation of allogeneic islets, triggering a large number of IND applications for phase I clinical trials. Promising results reported by a number of centers since then prompted the Food and Drug Administration (FDA) to consider the possibility of licensing allogeneic islets as a therapeutic treatment for patients with type 1 diabetes. However, prior to licensure, issues such as safety, purity, efficacy, and potency of the islet product must be addressed. This is complicated by the intricate nature of pancreatic islets and limited characterization prior to transplantation. In this context, control of the manufacturing process plays a critical role in the definition of the final product. Despite significant progress made in standardization of the donor organ preservation methods, reagents used, and characterization assays performed to qualify an islet cell product, control of the isolation process remains a challenge. Within the scope of the FDA regulations, islet cells meet the definition of a biologic product, somatic cell therapy, and a drug. In addition, AABB standards that address cellular therapy products apply to manufacturing facilities accredited by this organization. Control of the source material, isolation process, and final product are critical issues that must be addressed in the context of FDA and other relevant regulations applicable to islet cell products.

  11. Manufacturing a Better Planet: Challenges Arising from the Gap between the Best Intentions and Social Realities

    Directory of Open Access Journals (Sweden)

    Darrin Durant

    2018-05-01

    Full Text Available With rising concerns about the social and environmental impacts of industrial and manufacturing waste, scientists and engineers have sought solutions to the burdens of waste which do not simply involve burying, burning, dumping or diluting. Our purpose here is to sketch how social science perspectives can illuminate aspects of the waste problem which are not routinely grappled with within science and engineering perspectives. We argue that if one is concerned about the burdens of waste, it is crucial to understand the way political and cultural contexts shape what happens (or does not happen in regards to reuse. We sketch some of the challenges facing green manufacturing; challenges that hinge on the gap between the best laid plans and social realities. Rather than imply green manufacturing is simply a post hoc move to hide the excesses of industrial capitalism in the green cloth of sustainability, we hope our discussion can assist those who hope to use green manufacturing as a pre-emptive move to build sustainability into industrial capitalism. We suggest that a socio-political conception of technology can bring greater depth to understandings of the industrial, political and consumer environments into which green manufacturing researchers hope to insert their efforts.

  12. 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...

  13. 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.

  14. Global nuclear industry views: challenges arising from the evolution of the optimisation principle in radiological protection

    International Nuclear Information System (INIS)

    Saint-Pierre, S.

    2012-01-01

    Over the last few decades, the steady progress achieved in reducing planned exposures of both workers and the public has been admirable in the nuclear sector. However, the disproportionate focus on tiny public exposures and radioactive discharges associated with normal operations came at a high price, and the quasi-denial of a risk of major accident and related weaknesses in emergency preparedness and response came at an even higher price. Fukushima has unfortunately taught us that radiological protection (RP) for emergency and post-emergency situations can be much more than a simple evacuation that lasts 24–48 h, with people returning safely to their homes soon afterwards. On optimisation of emergency and post-emergency exposures, the only ‘show in town’ in terms of international RP policy improvements has been the issuance of the 2007 Recommendations of the International Commission on Radiological Protection (ICRP). However, no matter how genuine these improvements are, they have not been ‘road tested’ on the practical reality of severe accidents. Post-Fukushima, there is a compelling case to review the practical adequacy of key RP notions such as optimisation, evacuation, sheltering, and reference levels for workers and the public, and to amend these notions with a view to making the international RP system more useful in the event of a severe accident. On optimisation of planned exposures, the reality is that, nowadays, margins for further reductions of public doses in the nuclear sector are very small, and the smaller the dose, the greater the extra effort needed to reduce the dose further. If sufficient caution is not exercised in the use of RP notions such as dose constraints, there is a real risk of challenging nuclear power technologies beyond safety reasons. For nuclear new build, it is the optimisation of key operational parameters of nuclear power technologies (not RP) that is of paramount importance to improve their overall efficiency. In

  15. Global nuclear industry views: challenges arising from the evolution of the optimisation principle in radiological protection.

    Science.gov (United States)

    Saint-Pierre, S

    2012-01-01

    Over the last few decades, the steady progress achieved in reducing planned exposures of both workers and the public has been admirable in the nuclear sector. However, the disproportionate focus on tiny public exposures and radioactive discharges associated with normal operations came at a high price, and the quasi-denial of a risk of major accident and related weaknesses in emergency preparedness and response came at an even higher price. Fukushima has unfortunately taught us that radiological protection (RP) for emergency and post-emergency situations can be much more than a simple evacuation that lasts 24-48 h, with people returning safely to their homes soon afterwards. On optimisation of emergency and post-emergency exposures, the only 'show in town' in terms of international RP policy improvements has been the issuance of the 2007 Recommendations of the International Commission on Radiological Protection (ICRP). However, no matter how genuine these improvements are, they have not been 'road tested' on the practical reality of severe accidents. Post-Fukushima, there is a compelling case to review the practical adequacy of key RP notions such as optimisation, evacuation, sheltering, and reference levels for workers and the public, and to amend these notions with a view to making the international RP system more useful in the event of a severe accident. On optimisation of planned exposures, the reality is that, nowadays, margins for further reductions of public doses in the nuclear sector are very small, and the smaller the dose, the greater the extra effort needed to reduce the dose further. If sufficient caution is not exercised in the use of RP notions such as dose constraints, there is a real risk of challenging nuclear power technologies beyond safety reasons. For nuclear new build, it is the optimisation of key operational parameters of nuclear power technologies (not RP) that is of paramount importance to improve their overall efficiency. In pursuing

  16. Virtual Currencies – monetary policy dilemmas and regulatory challenges

    Directory of Open Access Journals (Sweden)

    Daj Alexis

    2018-01-01

    Full Text Available Although the topic of virtual currencies is not completely new, the current technological developments and the extent of the globalisation process appear to have changed the scope of the research efforts needed to cover not only the advantages and opportunities, but also the disadvantages and threats that the expansion of virtual currencies can pose for monetary policy and the safety of the financial system. This paper comprises a brief presentation of the different types of virtual currencies and identifies some of the most significant implications of large-scale virtual currency adoption for monetary authorities and regulators, while providing an overview of the main trends in the evolution of virtual currencies. In the end, one conclusion is evident: whatever monetary policy or regulatory issues arise from the use of virtual currencies, their consequences are far from virtual.

  17. 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.

  18. 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.

  19. 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.

  20. Opting out of the commercial use of nuclear power in Germany and challenges arising to nuclear supervision

    International Nuclear Information System (INIS)

    Renneberg, W.

    2001-01-01

    The governing majority in Germany has decided to opt out of the commercial use of nuclear power and to terminate this use in a safe and managed way. In the opinion of the federal government, the reasons for this decision include the potential for severe accidents, which is considered intolerable in the long run even though the probability of occurrence is low. In addition, there are the problems of final storage of radioactive waste, issues associated with the risk of proliferation, and the need to end a deep-seated societal conflict in Germany. In its function as the Top Regulator, the department responsible for nuclear matters of the Federal Ministry for the Environment, Nature Conservation, and Nuclear Safety (BMU) has two important functions: It acts as the federal supervisor of the federal states which execute the Atomic Energy Act on behalf of the federal government, and it exercises the duty of preparing the nuclear policy outlined in the norms established by the federal government. After lengthy discussions with the operators of nuclear power plants an agreement was elaborated in preparation of a solution acceptable to all participants, which essentially defines an electricity quota for nuclear power plant operation and deals with spent fuel and nuclear waste management problems. This implies a number of challenges arising to the BMU as a consequence of the need to further ensure a high safety standard. It also means international efforts as well as the need to counteract the impending loss of competence in the nuclear field. (orig.) [de

  1. Future consequences and challenges for dairy cow production systems arising from climate change in Central Europe - a review.

    Science.gov (United States)

    Gauly, M; Bollwein, H; Breves, G; Brügemann, K; Dänicke, S; Daş, G; Demeler, J; Hansen, H; Isselstein, J; König, S; Lohölter, M; Martinsohn, M; Meyer, U; Potthoff, M; Sanker, C; Schröder, B; Wrage, N; Meibaum, B; von Samson-Himmelstjerna, G; Stinshoff, H; Wrenzycki, C

    2013-05-01

    It is well documented that global warming is unequivocal. Dairy production systems are considered as important sources of greenhouse gas emissions; however, little is known about the sensitivity and vulnerability of these production systems themselves to climate warming. This review brings different aspects of dairy cow production in Central Europe into focus, with a holistic approach to emphasize potential future consequences and challenges arising from climate change. With the current understanding of the effects of climate change, it is expected that yield of forage per hectare will be influenced positively, whereas quality will mainly depend on water availability and soil characteristics. Thus, the botanical composition of future grassland should include species that are able to withstand the changing conditions (e.g. lucerne and bird's foot trefoil). Changes in nutrient concentration of forage plants, elevated heat loads and altered feeding patterns of animals may influence rumen physiology. Several promising nutritional strategies are available to lower potential negative impacts of climate change on dairy cow nutrition and performance. Adjustment of feeding and drinking regimes, diet composition and additive supplementation can contribute to the maintenance of adequate dairy cow nutrition and performance. Provision of adequate shade and cooling will reduce the direct effects of heat stress. As estimated genetic parameters are promising, heat stress tolerance as a functional trait may be included into breeding programmes. Indirect effects of global warming on the health and welfare of animals seem to be more complicated and thus are less predictable. As the epidemiology of certain gastrointestinal nematodes and liver fluke is favourably influenced by increased temperature and humidity, relations between climate change and disease dynamics should be followed closely. Under current conditions, climate change associated economic impacts are estimated to be

  2. 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.

  3. 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.

  4. 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.

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

    Science.gov (United States)

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

    2017-01-01

    Pharmaceutical drug shortages (DSs) are a global problem which presents challenges to countries around the world. Shortages of pharmaceutical products may have a direct detrimental impact on public health and patients' wellbeing by causing delayed, or even lack of, treatment. Moreover, DSs may force both patients and caregivers to use unfamiliar drugs, which could lead to medication errors. The objective of our study was to analyze DSs in Israel during the years 2013-2015, assessing their etiology and exploring the steps taken for their mitigation and prevention. The database of the Israeli Ministry of Health (MoH) on drug shortages contains all the DSs recorded in Israel since 2013, detailing the cause of the DS, its duration, steps taken in its' management and the availability of generic or therapeutic alternatives. Selected examples of DSs from the database are described in this paper in order to identify the causes of DSs, the scope of the problem and possible solutions. Additionally, we have reviewed the recent activities performed by European Medicine Agency (EMA) and the American Food and Drug Administration (FDA) in their efforts to minimize this problem. Several factors contributing towards DSs in Israel were identified, including quality problems in both the final drug product and in the raw materials, upgrades and improvements of the manufacturing process required by the MoH, manufacturing by a sole supplier, dramatic price decrease in off-patent medications causing the manufacturer to discontinue the distribution of the product in Israel, just-in-time inventory control, and others. One of the most important steps in managing drug shortages was identified to be early notification of the shortage by the Marketing Authorization Holder (MAH) to the MoH. In 2013, the Israeli MoH updated the regulation on drug shortages instructing MAHs on their obligation of early notification to the MoH. Furthermore, various steps dealing with marketing withdrawal of drugs

  6. 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)

  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. 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...

  9. 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.

  10. 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...

  11. 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...

  12. 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

  13. 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...

  14. 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)

  15. 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.

  16. 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)

  17. 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.

  18. 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.

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

    Directory of Open Access Journals (Sweden)

    M Venkatesh

    2011-01-01

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

  20. Targeting Interferon Regulatory Factor for Cardiometabolic Diseases: Opportunities and Challenges.

    Science.gov (United States)

    Zhang, Yaxing; Zhang, Xiao-Jing; Li, Hongliang

    2017-01-01

    The pathological activation of innate immune system may contribute to the development of cardiometabolic diseases. The interferon regulatory factor (IRF) family members, which are the major transcription factors in innate immune signaling, are implicated in cardiometabolic diseases. The aim of this review is to summary the current knowledge of the biological functions of IRFs in innate immune responses and immune cell development, and highlight our contemporary understanding of the functions and molecular mechanisms of IRFs in metabolic diseases, cardiovascular remodeling, and stroke. IRFs are the essential regulators of cardiometabolic diseases via immune-dependent and - independent manners. IRFs signaling is the promising target to manage the initiation and progression of cardiometabolic disorders. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  1. Precision genome engineering and agriculture: opportunities and regulatory challenges.

    Science.gov (United States)

    Voytas, Daniel F; Gao, Caixia

    2014-06-01

    Plant agriculture is poised at a technological inflection point. Recent advances in genome engineering make it possible to precisely alter DNA sequences in living cells, providing unprecedented control over a plant's genetic material. Potential future crops derived through genome engineering include those that better withstand pests, that have enhanced nutritional value, and that are able to grow on marginal lands. In many instances, crops with such traits will be created by altering only a few nucleotides among the billions that comprise plant genomes. As such, and with the appropriate regulatory structures in place, crops created through genome engineering might prove to be more acceptable to the public than plants that carry foreign DNA in their genomes. Public perception and the performance of the engineered crop varieties will determine the extent to which this powerful technology contributes towards securing the world's food supply.

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

    Science.gov (United States)

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

    2011-01-01

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

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

    Science.gov (United States)

    Bowman, Diana M; Gatof, Jake

    2015-01-01

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

  4. 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)

  5. Translational and Regulatory Challenges for Exon Skipping Therapies

    NARCIS (Netherlands)

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

    2014-01-01

    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

  6. 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.

  7. 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.

  8. 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.

  9. Female Regulatory Inspectors at Nuclear Power Plants: A Constant Challenge and Opportunities

    International Nuclear Information System (INIS)

    Maree, V.

    2015-01-01

    The South African National Nuclear Regulator (NNR) was established in 1999 to provide for the protection of persons, environment and properties from the harmful effects arising from ionizing radiation produced by radioactive materials. It is the responsibility of the licencee to have in place the necessary safety measures and resources in order to protect the public, workers and the environment against possible harmful effects of ionizing radiation caused by the operations of the Nuclear Power Stations. To fulfill its mission, the NNR employs 61 females with scientific and engineering qualifications to support and perform compliance assurance activities at the Nuclear Power Plant in accordance with the National Nuclear Regulator Act, 1999 (Act No. 47 of 1999). This Act describes the following in terms of duties of an inspector: “An Inspector may carry out inspections and use any applicable equipment during such inspections at any of the nuclear installations, sites or places and conduct such investigations as are necessary for the purpose of monitoring or enforcing compliance with this Act”. The Regulator has two offices, the Head office is located in Pretoria and the Site office is located in Cape Town. Regulatory Inspectors at the Site Office are responsible for performing compliance inspections at Nuclear Power Plant. Women at the Site office play an important role in fulfilling the mandate of the NNR, 3/5 inspectors are women. One is The Chief Inspector responsible for executing the compliance assurance programme and one of the female Inspectors is the South Africa Lead Representative at the International Atomic Energy Agency Waste Safety Standards Committee (IAEA–WASSC). This poster addresses the following challenges: – Plant facilities and personnel protective equipment, • Environment created by historical male domination, • Overcoming conscious and unconscious biases against women (by both genders). (author)

  10. Cosmetic Surgery: Regulatory Challenges in a Global Beauty Market.

    Science.gov (United States)

    Griffiths, Danielle; Mullock, Alex

    2017-02-28

    The market for cosmetic surgery tourism is growing with an increase in people travelling abroad for cosmetic surgery. While the reasons for seeking cosmetic surgery abroad may vary the most common reason is financial, but does cheaper surgery abroad carry greater risks? We explore the risks of poorly regulated cosmetic surgery to society generally before discussing how harm might be magnified in the context of cosmetic tourism, where the demand for cheaper surgery drives the market and makes surgery accessible for increasing numbers of people. This contributes to the normalisation of surgical enhancement, creating unhealthy cultural pressure to undergo invasive and risky procedures in the name of beauty. In addressing the harms of poorly regulated surgery, a number of organisations purport to provide a register of safe and ethical plastic surgeons, yet this arguably achieves little and in the absence of improved regulation the risks are likely to grow as the global market expands to meet demand. While the evidence suggests that global regulation is needed, the paper concludes that since a global regulatory response is unlikely, more robust domestic regulation may be the best approach. While domestic regulation may increase the drive towards foreign providers it may also have a symbolic effect which will reduce this drive by making people more aware of the dangers of surgery, both to society and individual physical wellbeing.

  11. [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.

  12. 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

  13. 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.

  14. 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

  15. 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…

  16. 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

  17. 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

  18. 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.

  19. 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

  20. 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

  1. 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...

  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. Global trade and assisted reproductive technologies: regulatory challenges in international surrogacy.

    Science.gov (United States)

    Nelson, Erin

    2013-01-01

    International surrogacy is an increasingly common phenomenon and an important global health challenge. Legal rules are a key consideration for the participants in international surrogacy arrangements. In some cases the law can help to resolve the complex issues that arise in this context, but it is important to consider the role played by law in contributing to the complex conflicts that such arrangements can generate. © 2013 American Society of Law, Medicine & Ethics, Inc.

  4. 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)

  5. 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.

  6. 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)

  7. 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.

  8. 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.

  9. 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.

  10. 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)

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

    Science.gov (United States)

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

    2014-01-01

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

  12. 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

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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)

  1. 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.

  2. 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.

  3. 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

  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. 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. 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.

  7. 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.

  8. 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.

  9. 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.

  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. 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. 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

  13. 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

  14. 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…

  15. T regulatory cells and related immunoregulatory factors in polymorphic light eruption following ultraviolet A1 challenge.

    Science.gov (United States)

    Gambichler, T; Terras, S; Kampilafkos, P; Kreuter, A; Skrygan, M

    2013-12-01

    Polymorphic light eruption (PLE) is considered to be an autoimmune-mediated skin condition in which the normal ultraviolet (UV)-induced local immunosuppression appears to be absent, leading to recognition of photoinduced autoantigens and subsequent inflammation. To investigate T regulatory cells (Tregs) and related immunoregulatory factors in PLE lesions and controls. Skin biopsies were performed in 13 patients with UVA1-challenged PLE, 12 female patients with chronic discoid lupus erythematosus (CDLE) and 11 healthy controls who had exposure to UVA1. Immunohistochemistry and four-colour immunofluorescence studies were performed. Patients with CDLE and UVA1-exposed controls showed significantly decreased epidermal immunoreactivity for CD1a compared with patients with PLE (P = 0·0001). Four-colour immunofluorescence revealed a median percentage of CD4+CD25+FOXP3+ Tregs of 7·6% (range 3·7-13·6%) in PLE, a median of 11·7% (range 9·5-13·9%) in CDLE and a median of 3·4% (range 0-6·8%) in controls. Compared with UVA1-exposed controls, PLE and CDLE lesions showed significantly decreased transforming growth factor (TGF)-β1 immunoreactivity in the epidermis (P = 0·0003). In PLE lesions, we observed significantly decreased interleukin (IL)-10 expression compared with CDLE (P = 0·022). In the dermis, receptor activator of nuclear factor-κB ligand (RANKL) expression was increased in UVA1-exposed controls compared with PLE and CDLE (P = 0·018). Similar to CDLE lesions, UVA1-challenged PLE lesions display an altered immunoregulatory network, as indicated by decreased epidermal or dermal expression of TGF-β1, IL-10 and RANKL, and a relatively low number of Tregs, particularly when compared with other inflammatory skin conditions reported in the literature. © 2013 British Association of Dermatologists.

  16. 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.

  17. Analytical challenges and regulatory requirements for nasal drug products in europe and the u.s.

    Science.gov (United States)

    Trows, Sabrina; Wuchner, Klaus; Spycher, Rene; Steckel, Hartwig

    2014-04-11

    Nasal drug delivery can be assessed by a variety of means and regulatory agencies, e.g., the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have published a set of guidelines and regulations proposing in vitro test methods for the characterization of nasal drug products. This article gives a summary of the FDA and EMA requirements regarding the determination of droplet size distribution (DSD), plume geometry, spray pattern and shot weights of solution nasal sprays and discusses the analytical challenges that can occur when performing these measurements. In order to support findings from the literature, studies were performed using a standard nasal spray pump and aqueous model formulations. The aim was to identify possible method-, device- and formulation-dependent influencing factors. The literature review, as well as the results from the studies show that DSD, plume geometry and spray pattern are influenced by, e.g., the viscosity of the solution, the design of the device and the actuation parameters, particularly the stroke length, actuation velocity and actuation force. The dominant factor influencing shot weights, however, is the adjustment of the actuation parameters, especially stroke length and actuation velocity. Consequently, for routine measurements assuring, e.g., the quality of a solution nasal spray or, for in vitro bioequivalence studies, the critical parameters, have to be identified and considered in method development in order to obtain reproducible and reliable results.

  18. 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.

  19. 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.

  20. 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.

  1. 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)

  2. 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

  3. 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.

  4. 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.

  5. Clinical investigations of the therapeutic potential of ayahuasca: rationale and regulatory challenges.

    Science.gov (United States)

    McKenna, Dennis J

    2004-05-01

    Ayahuasca is a hallucinogenic beverage that is prominent in the ethnomedicine and shamanism of indigenous Amazonian tribes. Its unique pharmacology depends on the oral activity of the hallucinogen, N,N-dimethyltryptamine (DMT), which results from inhibition of monoamine oxidase (MAO) by beta-carboline alkaloids. MAO is the enzyme that normally degrades DMT in the liver and gut. Ayahuasca has long been integrated into mestizo folk medicine in the northwest Amazon. In Brazil, it is used as a sacrament by several syncretic churches. Some of these organizations have incorporated in the United States. The recreational and religious use of ayahuasca in the United States, as well as "ayahuasca tourism" in the Amazon, is increasing. The current legal status of ayahuasca or its source plants in the United States is unclear, although DMT is a Schedule I controlled substance. One ayahuasca church has received favorable rulings in 2 federal courts in response to its petition to the Department of Justice for the right to use ayahuasca under the Religious Freedom Restoration Act. A biomedical study of one of the churches, the Uñiao do Vegetal (UDV), indicated that ayahuasca may have therapeutic applications for the treatment of alcoholism, substance abuse, and possibly other disorders. Clinical studies conducted in Spain have demonstrated that ayahuasca can be used safely in normal healthy adults, but have done little to clarify its potential therapeutic uses. Because of ayahuasca's ill-defined legal status and variable botanical and chemical composition, clinical investigations in the United States, ideally under an approved Investigational New Drug (IND) protocol, are complicated by both regulatory and methodological issues. This article provides an overview of ayahuasca and discusses some of the challenges that must be overcome before it can be clinically investigated in the United States.

  6. 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

  7. 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

  8. Strengthening of safety and security of radioactive sources: new regulatory challenges

    Energy Technology Data Exchange (ETDEWEB)

    El Messaoudi, M.; Essadki M Lferde, H.; Moutia, Z. [Faculte des Sciences, Dept. de Physique, Rabat (Morocco)

    2006-07-01

    The answer to these new regulatory challenges was given by implementation of divers measures aimed at strengthening of safety and security of radioactive sources and to prevent the malevolent use of radioactive sources. The international basic safety standards for protection against ionizing radiation and for the safety of radiation sources (B.S.S.) require the establishment and implementation of security measures of radioactive sources to ensure that protection and safety requirements are met. The IAEA has engaged in an extensive effort to establish and/or strengthen national radiation protection and radiological safety infrastructure, including legislation and regulation, a regulatory authority empowered to authorize and inspect regulated activities, an adequate number of trained personnel and technical services that are beyond the capabilities required of the authorized legal persons. The Moroccan authority makes steady efforts to strengthen national radiation safety infrastructure by participating in IAEA model project for upgrading radiation protection infrastructure, to implement the revised version of code of conduct on the safety and security of radioactive sources. Indeed, Morocco expressed its adhesion with the technical assistance project of the IAEA in 2001, carrying on the reinforcement of the national infrastructure of regulation and control of the radioactive materials. The control over radioactive sources is an essential element for maintaining high level of security and safety of radioactive sources. The IAEA T.E.C.-D.O.C.-1388 serves as reference document to implement the control culture. The security problems with which the world is confronted showed that the uses of radioactive sources should subject reinforcements of safety, of control and of security of the radioactive sources. For this purpose, the IAEA launched an action plan for the safety and security of radioactive sources. The IAEA guide Security of radioactive sources will help the

  9. Strengthening of safety and security of radioactive sources: new regulatory challenges

    International Nuclear Information System (INIS)

    El Messaoudi, M.; Essadki M Lferde, H.; Moutia, Z.

    2006-01-01

    The answer to these new regulatory challenges was given by implementation of divers measures aimed at strengthening of safety and security of radioactive sources and to prevent the malevolent use of radioactive sources. The international basic safety standards for protection against ionizing radiation and for the safety of radiation sources (B.S.S.) require the establishment and implementation of security measures of radioactive sources to ensure that protection and safety requirements are met. The IAEA has engaged in an extensive effort to establish and/or strengthen national radiation protection and radiological safety infrastructure, including legislation and regulation, a regulatory authority empowered to authorize and inspect regulated activities, an adequate number of trained personnel and technical services that are beyond the capabilities required of the authorized legal persons. The Moroccan authority makes steady efforts to strengthen national radiation safety infrastructure by participating in IAEA model project for upgrading radiation protection infrastructure, to implement the revised version of code of conduct on the safety and security of radioactive sources. Indeed, Morocco expressed its adhesion with the technical assistance project of the IAEA in 2001, carrying on the reinforcement of the national infrastructure of regulation and control of the radioactive materials. The control over radioactive sources is an essential element for maintaining high level of security and safety of radioactive sources. The IAEA T.E.C.-D.O.C.-1388 serves as reference document to implement the control culture. The security problems with which the world is confronted showed that the uses of radioactive sources should subject reinforcements of safety, of control and of security of the radioactive sources. For this purpose, the IAEA launched an action plan for the safety and security of radioactive sources. The IAEA guide Security of radioactive sources will help the

  10. 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.

  11. A New Wave of Vaccines for Non-Communicable Diseases: What Are the Regulatory Challenges?

    Science.gov (United States)

    Darrow, Jonathan J; Kesselheim, Aaron S

    2015-01-01

    Vaccines represent one of the greatest achievements of medicine, dramatically reducing the incidence of serious or life-threatening infectious diseases and allowing people to live longer, healthier lives. As life expectancy has increased, however, the burden of non-communicable diseases (NCDs) such as cancer, hypertension, atherosclerosis, and diabetes has increased. This shifting burden of disease has heightened the already urgent need for therapies that treat or prevent NCDs, a need that is now being met with increased efforts to develop NCD vaccines. Like traditional vaccines, NCD vaccines work by modulating the human immune system, but target cells, proteins or other molecules that are associated with the NCD in question rather than pathogens or pathogen-infected cells. Efforts are underway to develop NCD vaccines to address not only cancer and hypertension, but also addiction, obesity, asthma, arthritis, psoriasis, multiple sclerosis, and Crohn's disease, among others. NCD vaccines present an interesting challenge for the U.S. Food and Drug Administration (FDA), which is tasked with approving new treatments on the basis of efficacy and safety. Should NCD vaccines be evaluated under the same analytic frame as traditional vaccines, or that of biologic drugs? Despite the borrowed nomenclature, NCD vaccines differ in important ways from infectious disease vaccines. Because infectious disease vaccines are generally administered to healthy individuals, often children, tolerance for adverse events is low and willingness to pay is limited. It is important to have infectious disease vaccines even for rare or eradicated disease (e.g., smallpox), in the event of an outbreak. The efficacy of infectious disease vaccines is generally high, and the vaccines convey population level benefits associated with herd immunity and potential eradication. The combination of substantial population-level benefits, low willingness to pay, and low tolerance for adverse events explains the

  12. 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

  13. The Regulatory Review Process in South Africa: Challenges and Opportunities for a New Improved System.

    Science.gov (United States)

    Keyter, Andrea; Gouws, Joey; Salek, Sam; Walker, Stuart

    2018-01-01

    The aims of this study were to assess the regulatory review process in South Africa from 2015 to 2017, identify the key milestones and timelines; evaluate the effectiveness of measures to ensure consistency, transparency, timeliness, and predictability in the review process; and to provide recommendations for enhanced regulatory practices. A questionnaire was completed by the Medicines Control Council (MCC) to describe the organization of the authority, record key milestones and timelines in the review process and to identify good review practices (GRevPs). Currently, the MCC conducts a full assessment of quality, efficacy, and safety data in the review of all applications. The overall regulatory median approval time decreased by 14% in 2017 (1411 calendar days) compared with that of 2016, despite the 27% increase in the number of applications. However, the MCC has no target for overall approval time of new active substance applications and no targets for key review milestones. Guidelines, standard operating procedures, and review templates are in place, while the formal implementation of GRevPs and the application of an electronic document management system are planned for the near future. As the MCC transitions to the newly established South Africa Health Products Regulatory Authority, it would be crucial for the authority to recognize the opportunities for an enhanced regulatory review and should consider models such as abridged assessment, which encompass elements of risk stratification and reliance. It is hoped that resource constraints may then be alleviated and capacity developed to meet target timelines.

  14. Validation of innovative technologies and strategies for regulatory safety assessment methods: challenges and opportunities.

    Science.gov (United States)

    Stokes, William S; Wind, Marilyn

    2010-01-01

    Advances in science and innovative technologies are providing new opportunities to develop test methods and strategies that may improve safety assessments and reduce animal use for safety testing. These include high throughput screening and other approaches that can rapidly measure or predict various molecular, genetic, and cellular perturbations caused by test substances. Integrated testing and decision strategies that consider multiple types of information and data are also being developed. Prior to their use for regulatory decision-making, new methods and strategies must undergo appropriate validation studies to determine the extent that their use can provide equivalent or improved protection compared to existing methods and to determine the extent that reproducible results can be obtained in different laboratories. Comprehensive and optimal validation study designs are expected to expedite the validation and regulatory acceptance of new test methods and strategies that will support improved safety assessments and reduced animal use for regulatory testing.

  15. 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.

  16. Human Genome Editing in the Clinic: New Challenges in Regulatory Benefit-Risk Assessment.

    Science.gov (United States)

    Abou-El-Enein, Mohamed; Cathomen, Toni; Ivics, Zoltán; June, Carl H; Renner, Matthias; Schneider, Christian K; Bauer, Gerhard

    2017-10-05

    As genome editing rapidly progresses toward the realization of its clinical promise, assessing the suitability of current tools and processes used for its benefit-risk assessment is critical. Although current regulations may initially provide an adequate regulatory framework, improvements are recommended to overcome several existing technology-based safety and efficacy issues. Copyright © 2017 Elsevier Inc. All rights reserved.

  17. 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)

  18. HIV testing updates and challenges: when regulatory caution and public health imperatives collide.

    Science.gov (United States)

    Branson, Bernard M

    2015-03-01

    Numerous improvements in HIV testing technology led recently to the first revision of recommendations for diagnostic laboratory testing in the USA in 25 years. Developments in HIV testing continue to produce tests that identify HIV infection earlier with faster turnaround times for test results. These play an important role in identifying HIV infection during the highly infectious acute phase, which has implication for both patient management and public health interventions to control the spread of HIV. Access to these developments, however, is often delayed by the regulatory apparatus for approval and oversight of HIV testing in the USA. This article summarizes recent developments in HIV diagnostic testing technology, outlines their implications for clinical management and public health, describes current systems of regulatory oversight for HIV testing in the USA, and proposes alternatives that could expedite access to improved tests as they become available.

  19. Equivalence of complex drug products: advances in and challenges for current regulatory frameworks.

    Science.gov (United States)

    Hussaarts, Leonie; Mühlebach, Stefan; Shah, Vinod P; McNeil, Scott; Borchard, Gerrit; Flühmann, Beat; Weinstein, Vera; Neervannan, Sesha; Griffiths, Elwyn; Jiang, Wenlei; Wolff-Holz, Elena; Crommelin, Daan J A; de Vlieger, Jon S B

    2017-11-01

    Biotechnology and nanotechnology provide a growing number of innovator-driven complex drug products and their copy versions. Biologics exemplify one category of complex drugs, but there are also nonbiological complex drug products, including many nanomedicines, such as iron-carbohydrate complexes, drug-carrying liposomes or emulsions, and glatiramoids. In this white paper, which stems from a 1-day conference at the New York Academy of Sciences, we discuss regulatory frameworks in use worldwide (e.g., the U.S. Food and Drug Administration, the European Medicines Agency, the World Health Organization) to approve these complex drug products and their follow-on versions. One of the key questions remains how to assess equivalence of these complex products. We identify a number of points for which consensus was found among the stakeholders who were present: scientists from innovator and generic/follow-on companies, academia, and regulatory bodies from different parts of the world. A number of topics requiring follow-up were identified: (1) assessment of critical attributes to establish equivalence for follow-on versions, (2) the need to publish scientific findings in the public domain to further progress in the field, (3) the necessity to develop worldwide consensus regarding nomenclature and labeling of these complex products, and (4) regulatory actions when substandard complex drug products are identified. © 2017 The Authors. Annals of the New York Academy of Sciences published by Wiley Periodicals, Inc. on behalf of New York Academy of Sciences.

  20. 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

  1. Technical and regulatory challenges for digital instrumentation and control and control room systems in nuclear plants

    International Nuclear Information System (INIS)

    Torok, R.; Naser, J.; Harris, T.; Keithline, K.

    2006-01-01

    There are several unsettled technical and licensing issues in the areas of instrumentation and control (I and C), human factors, and updated control room designs that need coordinated, proactive industry attention. Some of these issues are already causing protracted regulatory reviews for existing plants, and left untreated, may cause substantial delays and increased costs for new plant combined construction and operating license approvals. Both industry and the NRC will have roles in resolving the key issues and addressing them in future design efforts and regulatory reviews. Where action is needed, the industry will want to minimize costs and risks by defining industry consensus solutions with corresponding technical bases. NEI has formed a working group to coordinate industry efforts and communications with NRC staff. The working group will also help determine priorities and coordinate both new and existing plant resources. EPRI will provide technical input and guidance for the working group. In order to be able to conduct reviews in a timely fashion, the NRC will likely need to enhance and expand staff resources as existing plants are upgraded and new plant reviews become more active. The industry initiative began with a workshop sponsored by EPRI and NEI on March 28-29, 2006, which led to the creation of the NEI working group. The working group has now identified and prioritized important generic issues, established resolution paths and schedules, and identified the roles of various stakeholders including utility companies, EPRI, NEI, vendors and the NRC. Through the course of this initiative I and C issues for both existing and new plants are being addressed. This paper describes the key I and C related technical and regulatory issues and their implications for new and operating plants, and provides a status report on the efforts to resolve them. (authors)

  2. An Analysis of Malaysia’s Regulatory Framework and Challenges in the Structured Product Market

    OpenAIRE

    Ling, Eu Meng

    2008-01-01

    Structured products are becoming increasingly popular and important to the development of Malaysia’s capital market and had experience impressive growth over the last few years after it was first introduced to the Malaysian market in 2004. Like any industry in its early stage, issues and challenges are expected but for structured products, such challenges require more attention due to the complexity inherent in these instruments. This study uses a qualitative research approach in an attempt t...

  3. Control technologies for soil vapor extraction at petroleum hydrocarbon impacted sites -- Regulatory challenges to system operations

    International Nuclear Information System (INIS)

    Cacossa, K.F.; Campbell, G.E.; Devine, K.

    1995-01-01

    Soil vapor extraction (SVE) is frequently used to remediate soils impacted by petroleum hydrocarbons. Four technologies have proven to be viable methods to control the off-gas emissions from SVE systems, namely, internal combustion, thermal oxidation, catalytic oxidation, and granular activated carbon adsorption. The optimal range of influent vapor concentrations for system operation differs for each of the technologies. Over the past several years the authors have worked proactively with the state regulatory community to develop general, all inclusive air pollution control permits which allow for the potential use of all four technologies over the life of the permit. Private industry has similarly worked with the state regulators to develop a less labor intensive sampling/monitoring procedure. Actual system performances, which were monitored using summa canisters and field equipment, provided the basis for the new procedure. System performance data indicated that field sampling with portable hydrocarbon analyzers, such as flame ionization detectors (FID), was preferable over the use of summa canister sampling. In addition, to reduce the costs associated with the analysis of samples, the new SVE monitoring protocol also reduced the number of system monitoring visits. These reductions equated into a cost effective, yet environmentally sound SVE system monitoring programs. Finally, the authors have worked with the regulatory community to establish permit limitations which allow operational flexibility

  4. Ethical and Regulatory Challenges with Autologous Adult Stem Cells: A Comparative Review of International Regulations.

    Science.gov (United States)

    Lysaght, Tamra; Kerridge, Ian H; Sipp, Douglas; Porter, Gerard; Capps, Benjamin J

    2017-06-01

    Cell and tissue-based products, such as autologous adult stem cells, are being prescribed by physicians across the world for diseases and illnesses that they have neither been approved for or been demonstrated as safe and effective in formal clinical trials. These doctors often form part of informal transnational networks that exploit differences and similarities in the regulatory systems across geographical contexts. In this paper, we examine the regulatory infrastructure of five geographically diverse but socio-economically comparable countries with the aim of identifying similarities and differences in how these products are regulated and governed within clinical contexts. We find that while there are many subtle technical differences in how these regulations are implemented, they are sufficiently similar that it is difficult to explain why these practices appear more prevalent in some countries and not in others. We conclude with suggestions for how international governance frameworks might be improved to discourage the exploitation of vulnerable patient populations while enabling innovation in the clinical application of cellular therapies.

  5. 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.

  6. Proposed Activities to Address Regulatory Gaps and Challenges for Licensing Advanced Reactors Using Seismic Isolation

    Energy Technology Data Exchange (ETDEWEB)

    Coleman, Justin Leigh [Idaho National Lab. (INL), Idaho Falls, ID (United States); Kammerer, Annie M. [Idaho National Lab. (INL), Idaho Falls, ID (United States); Whittaker, Andrew S. [Idaho National Lab. (INL), Idaho Falls, ID (United States)

    2016-12-01

    Over the last decade, particularly since implementation of the certified design regulatory approaches outlined in 10 CFR 52, “Licenses, Certifications, and Approvals for Nuclear Power Plants,” interest has been increasing in the use of seismic isolation (SI) technology to support seismic safety in nuclear facilities. In 2009, the United States (U.S.) Nuclear Regulatory Commission (NRC) initiated research activities to develop new guidance targeted at isolated facilities because SI is being considered for nuclear power plants in the U.S. One product of that research, which was developed around a risk-informed regulatory approach, is a draft NRC NUREG series (NUREG/CR) report that investigates and discusses considerations for use of SI in otherwise traditionally founded large light water reactors (LWRs). A coordinated effort led to new provisions for SI of LWRs in the American Society of Civil Engineers standard ASCE/SEI 4-16, “Seismic Analysis of Safety Related Nuclear Structures.” The risk-informed design philosophy that underpinned development of the technical basis for these documents led to a set of proposed performance objectives and acceptance criteria intended to serve as the foundation for future NRC guidance on the use of SI and related technology. Although the guidance provided in the draft SI NUREG/CR report and ASCE/SEI 4 16 provides a sound basis for further development of nuclear power plant designs incorporating SI, these initial documents were focused on surface-founded or near-surface-founded LWRs and were, necessarily, limited in scope. For example, there is limited information in both the draft NUREG/CR report and ASCE/SEI 4-16 related to nonlinear analysis of soil-structure systems for deeply-embedded reactors, the isolation of components, and the use of vertical isolation systems. Also not included in the draft SI NUREG/CR report are special considerations for licensing of isolated facilities using the certified design approach in 10 CFR

  7. Proposed Activities to Address Regulatory Gaps and Challenges for Licensing Advanced Reactors Using Seismic Isolation

    International Nuclear Information System (INIS)

    Coleman, Justin Leigh; Kammerer, Annie M.; Whittaker, Andrew S.

    2016-01-01

    Over the last decade, particularly since implementation of the certified design regulatory approaches outlined in 10 CFR 52, 'Licenses, Certifications, and Approvals for Nuclear Power Plants,' interest has been increasing in the use of seismic isolation (SI) technology to support seismic safety in nuclear facilities. In 2009, the United States (U.S.) Nuclear Regulatory Commission (NRC) initiated research activities to develop new guidance targeted at isolated facilities because SI is being considered for nuclear power plants in the U.S. One product of that research, which was developed around a risk-informed regulatory approach, is a draft NRC NUREG series (NUREG/CR) report that investigates and discusses considerations for use of SI in otherwise traditionally founded large light water reactors (LWRs). A coordinated effort led to new provisions for SI of LWRs in the American Society of Civil Engineers standard ASCE/SEI 4-16, 'Seismic Analysis of Safety Related Nuclear Structures.' The risk-informed design philosophy that underpinned development of the technical basis for these documents led to a set of proposed performance objectives and acceptance criteria intended to serve as the foundation for future NRC guidance on the use of SI and related technology. Although the guidance provided in the draft SI NUREG/CR report and ASCE/SEI 4 16 provides a sound basis for further development of nuclear power plant designs incorporating SI, these initial documents were focused on surface-founded or near-surface-founded LWRs and were, necessarily, limited in scope. For example, there is limited information in both the draft NUREG/CR report and ASCE/SEI 4-16 related to nonlinear analysis of soil-structure systems for deeply-embedded reactors, the isolation of components, and the use of vertical isolation systems. Also not included in the draft SI NUREG/CR report are special considerations for licensing of isolated facilities using the certified design

  8. Regulatory T cells, maternal-foetal immune tolerance and recurrent miscarriage: new therapeutic challenging opportunities.

    Science.gov (United States)

    Alijotas-Reig, Jaume; Melnychuk, Taisiia; Gris, Josep Maria

    2015-03-15

    Because maternal alloreactive lymphocytes are not depleted during pregnancy, local and/or systemic mechanisms have to play a key role in altering the maternal immune response. Peripheral T regulatory cells (pTregs) at the maternal-foetal interface are necessary in situ to prevent early abortion, but only those pTregs that have been previously exposed to paternal alloantigens. It has been showed that pregnancy selectively stimulates the accumulation of maternal Foxp3(+)CD4(+)CD25(+) (Foxp3Tregs) cells with foetal specificity. Interestingly, after delivery, foetal-specific pTregs persist at elevated levels, maintain tolerance to pre-existing foetal antigen, and rapidly re-accumulate during subsequent pregnancy. pTreg up-regulation could be hypothesized as a possible future therapeutic strategy in humans. Copyright © 2014 Elsevier España, S.L.U. All rights reserved.

  9. Addressing the regulatory and scientific challenges in multiple sclerosis--a statement from the EU regulators.

    Science.gov (United States)

    Balabanov, Pavel; Haas, Manuel; Elferink, Andre; Bakchine, Serge; Broich, Karl

    2014-09-01

    Improving and facilitating the process of making new drugs available to patients with multiple sclerosis (MS) requires cooperation among the regulators and other stakeholders. This cooperation will also positively contribute towards developing guidelines of the highest quality in medical, regulatory and scientific aspects. This would be beneficial both in areas that require further guideline development, but also in fields where existing guidance should be adapted to take into account evolution in science. Considering the input from all stakeholders, the European Medicines Agency confirmed its intention to update the relevant guideline and apply a flexible approach towards new drug development strategies in MS. This article is the first official position from the EU regulators, presenting the main changes to be expected in the guidance document. © The Author(s) 2014.

  10. Overcoming regulatory challenges in the development of companion diagnostics for monitoring and safety.

    Science.gov (United States)

    Shimazawa, Rumiko; Ikeda, Masayuki

    2016-03-01

    Concurrent development and co-approval of a companion diagnostic (CDx) with a corresponding drug is ideal, but often unfeasible. Because of limited exposure to a drug in clinical trials, crucial information on safety is sometimes revealed only after approval. Therefore, a CDx for monitoring/safety is often developed after approval of a corresponding drug. However, regulatory guidance is insufficient if contemporaneous development is not possible, thereby leaving plenty of opportunities for improvement with respect to pharmacovigilance and retrospective validation of the CDx. Furthermore, global harmonization of guidance on how to incorporate new scientific information from retrospective analyses of biomarkers should lead to the establishment of more evidence for the development of CDx for approved drugs.

  11. Regulatory control and challenges in Medical facilities using ionising radiation sources

    International Nuclear Information System (INIS)

    Agarwal, S.P.

    2008-01-01

    Medical facilities utilising ionising radiation sources for diagnostic and treatment of cancer are regulated under the provisions of Atomic Energy (Radiation Protection) Rules, 2004 promulgated under the Atomic Energy Act 1962. The Competent Authority for the enforcement of the rules is Chairman, Atomic Energy Regulatory Board (AERB). Practice specific codes are issued by AERB for medical facilities such as Radiotherapy, Nuclear Medicine and Radiology. Regulatory process for control of medical facilities covers the entire life cycle of the radiation sources in three stages viz pre-Iicensing, during useful life and decommissioning and disposal. Pre-Iicensing requirements include use of type approved sources and equipment, approval of design layout of the facility and installation, exclusive (safe and secure) source storage facility when the equipment is not in use, radiation (area/individual) monitoring devices, qualified, trained and certified manpower, emergency response plans and commitment from the licensee for the safe disposal of disused/decayed sources. Compliance to these requirements makes the applicant eligible to obtain license from AERB for the operation of the medical facility. During the use of radiation sources, specific prior approval of the Competent Authority is required in respect of every source replacement, sale, transfer, transport, import and export. Further, all licensees are required to send the periodic safety Status reports to AERB as well as reporting of any off normal events. AERB conducts inspection of the facilities to ensure compliance with the safety requirements during operation of the facility. Violation of safety norms by licensee attracts enforcement action which includes suspension, modification or withdrawal of licensee for operation of the facility. Upon completion of the useful life of the source, the licensee decommissions the facility and returns the source to the original supplier. For returning the source, prior

  12. 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

  13. 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.

  14. Advanced Therapy Medicinal Products in type I diabetes mellitus: technological and regulatory challenges

    Directory of Open Access Journals (Sweden)

    Camila Leal-Lopes

    2018-02-01

    Full Text Available Introduction: Type 1 Diabetes mellitus (T1DM is an autoimmune disorder which arises from the destruction of insulin-producing pancreatic β-cells. Currently, Brazil’s advanced therapy medicinal products (ATMP, developed for clinical research and therapeutic purposes, take place in the so-called Cellular Technology Centers (CTC, according to the Resolution nº. 9/2011 of the Collegiate Board of Directors (RDC, enacted by the National Health Surveillance Agency (Anvisa. Objective: This study was conducted with the main objective of describing and discussing the development of ATMP for T1DM treatment. Method: A qualitative research, narrative review and critical discussion of the literature were under taken. Results: ATMP promote new therapeutic approaches for Diabetes, holding great potential to restore the patients’ endogenous insulin secretion, improving their life quality, overcoming the chronic complications of Diabetes and reducing the socioeconomic burden. Nowadays, ATMP in T1DM comprise: a cell therapy; b gene therapy products; c tissue engineering and d ATMPassociated to biopharmaceutical products. Conclusions: Further research should contribute to stimulate public and private organizations to effectively act towards reducing the impact of Diabetes on individuals and the society as a whole. It is essential that Brazilian legislation closely follows the biotechnological developments, supporting the scientific progress and benefiting T1DM patients with modern and cutting-edge therapies.

  15. 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)

  16. 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.

  17. Challenges in cryopreservation of regulatory T cells (Tregs) for clinical therapeutic applications.

    Science.gov (United States)

    Golab, Karolina; Leveson-Gower, Dennis; Wang, Xiao-Jun; Grzanka, Jakub; Marek-Trzonkowska, Natalia; Krzystyniak, Adam; Millis, J Michael; Trzonkowski, Piotr; Witkowski, Piotr

    2013-07-01

    Promising results of initial studies applying ex-vivo expanded regulatory T cell (Treg) as a clinical intervention have increased interest in this type of the cellular therapy and several new clinical trials involving Tregs are currently on the way. Methods of isolation and expansion of Tregs have been studied and optimized to the extent that such therapy is feasible, and allows obtaining sufficient numbers of Tregs in the laboratory following Good Manufacturing Practice (GMP) guidelines. Nevertheless, Treg therapy could even more rapidly evolve if Tregs could be efficiently cryopreserved and stored for future infusion or expansions rather than utilization of only freshly isolated and expanded cells as it is preferred now. Currently, our knowledge regarding the impact of cryopreservation on Treg recovery, viability, and functionality is still limited. Based on experience with cryopreserved peripheral blood mononuclear cells (PBMCs), cryopreservation may have a detrimental effect on Tregs, can decrease Treg viability, cause abnormal cytokine secretion, and compromise expression of surface markers essential for proper Treg function and processing. Therefore, optimal strategies and conditions for Treg cryopreservation in conjunction with cell culture, expansion, and processing for clinical application still need to be investigated and defined. Copyright © 2013 Elsevier B.V. All rights reserved.

  18. 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.

  19. Regulatory Anatomy

    DEFF Research Database (Denmark)

    Hoeyer, Klaus

    2015-01-01

    This article proposes the term “safety logics” to understand attempts within the European Union (EU) to harmonize member state legislation to ensure a safe and stable supply of human biological material for transplants and transfusions. With safety logics, I refer to assemblages of discourses, le...... they arise. In short, I expose the regulatory anatomy of the policy landscape....

  20. U.S. Experiences and Regulatory Challenges with New Medical Technologies

    International Nuclear Information System (INIS)

    Elee, J.

    2016-01-01

    There are many challenges in regulating new medical technologies in the United States. In the US, there are fifty different state agencies, several local and city agencies, and eleven federal agencies which all delve into some aspects of regulating the use of radiation. It also can take several years to promulgate new regulations for new technologies. Additionally, some technologies are used outside of their original approved/intended use which causes issues for regulators. Finally, many of our regulating agencies have limited resources to learn and train on the new technologies that are on the market. All of these reasons combine to make regulating new technologies and uses of radiation difficult. (author)

  1. Natural Gas Driven Vehicles Safety and Regulatory Regime - Challenges in Bangladesh

    Directory of Open Access Journals (Sweden)

    Robiul Islam Rubel

    2017-09-01

    Full Text Available Natural gas driven vehicles (NGV is common in Bangladesh first introduced around 1995. Be that as it may, situation has changed because of minimal effort of CNG as fuel. The legislature additionally empowered the change of private vehicles by making a few strategy activities as Bangladesh has natural gas reserve, cost economy, low emission. Now passenger automobile like car, bus, and even agricultural vehicles are utilizing CNG as fuel. Faulty cylinders or other CNG-related kits in NGV not only endanger the lives of the passengers of the vehicles, but also of others somehow remaining close to the accident spots. The safety aspect of CNG runs vehicles are beyond regular and strict monitoring, even out of consideration. The objective of this paper is to find out the present scenario of the NGV of Bangladesh and safety perspective in compare to the CNG safety act of Bangladesh. For this purpose, other CNG safety standard of first world country along with exporter country is under consideration. This paper reviews the options available to policy makers in their efforts to reduce the causalities associated with NGV transport. It provides a summary of the categories of negative impacts targeted together with the specific policy initiatives available. The actions for regulation taken by policy makers and foregoing challenges are underlined. To fight against the challenges a framework has proposed.

  2. 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

  3. 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

  4. Ethical and regulatory challenges of research using pervasive sensing and other emerging technologies: IRB perspectives.

    Science.gov (United States)

    Nebeker, Camille; Harlow, John; Espinoza Giacinto, Rebeca; Orozco-Linares, Rubi; Bloss, Cinnamon S; Weibel, Nadir

    2017-01-01

    Vast quantities of personal health information and private identifiable information are being created through mobile apps, wearable sensors, and social networks. While new strategies and tools for obtaining health data have expanded researchers' abilities to design and test personalized and adaptive health interventions, the deployment of pervasive sensing and computational techniques to gather research data is raising ethical challenges for Institutional Review Boards (IRBs) charged with protecting research participants. To explore experiences with, and perceptions about, technology-enabled research, and identify solutions for promoting responsible conduct of this research we conducted focus groups with human research protection program and IRB affiliates. Our findings outline the need for increased collaboration across stakeholders in terms of: (1) shared and dynamic resources that improve awareness of technologies and decrease potential threats to participant privacy and data confidentiality, and (2) development of appropriate and dynamic standards through collaboration with stakeholders in the research ethics community.

  5. Addressing Emerging Risks: Scientific and Regulatory Challenges Associated with Environmentally Persistent Free Radicals

    Directory of Open Access Journals (Sweden)

    Tammy R. Dugas

    2016-06-01

    Full Text Available Airborne fine and ultrafine particulate matter (PM are often generated through widely-used thermal processes such as the combustion of fuels or the thermal decomposition of waste. Residents near Superfund sites are exposed to PM through the inhalation of windblown dust, ingestion of soil and sediments, and inhalation of emissions from the on-site thermal treatment of contaminated soils. Epidemiological evidence supports a link between exposure to airborne PM and an increased risk of cardiovascular and pulmonary diseases. It is well-known that during combustion processes, incomplete combustion can lead to the production of organic pollutants that can adsorb to the surface of PM. Recent studies have demonstrated that their interaction with metal centers can lead to the generation of a surface stabilized metal-radical complex capable of redox cycling to produce ROS. Moreover, these free radicals can persist in the environment, hence their designation as Environmentally Persistent Free Radicals (EPFR. EPFR has been demonstrated in both ambient air PM2.5 (diameter < 2.5 µm and in PM from a variety of combustion sources. Thus, low-temperature, thermal treatment of soils can potentially increase the concentration of EPFR in areas in and around Superfund sites. In this review, we will outline the evidence to date supporting EPFR formation and its environmental significance. Furthermore, we will address the lack of methodologies for specifically addressing its risk assessment and challenges associated with regulating this new, emerging contaminant.

  6. Seminar on Biogas in France and in Germany: Regulatory framework, potentials and challenges

    International Nuclear Information System (INIS)

    Abadie, Pierre-Marie; Boettcher, Katharina; Stolpp, Sebastian; Vincent, Eric; Chapron, Thibaut; Schuette, Andreas; Paquin, Laurent; Ingremeau, Claire; Moeller, Kurt; Trommler, Marcus; Denysenko, Velina; Bosso, Valerie

    2014-01-01

    The French-German office for Renewable energies (OFAEnR) organised a Seminar on biogas in France and Germany. In the framework of this French-German exchange of experience, about 120 participants exchanged views on the legal framework, the characteristics of this industry, and the opportunities and technical challenges of biogas use in both countries. Differences and similarities were noticed in both countries, for instance regarding the use of energy cultures and digestates. This document brings together the available presentations (slides) made during this event: 1 - The French biogas in the perspective of 2020 (Pierre-Marie Abadie); 2 - Biogas Opportunities in Germany - Status January 2014 (Katharina Boettcher); 3 - Biogas market in Germany (Sebastian Stolpp); 4 - Biogas in France and Germany, Current status and development outlooks in France (Eric Vincent); 5 - Biogas use in France and Germany - a comparison (Thibaut Chapron); 6 - Alternatives to the use of maize in biogas plants - Current research results from Germany (Andreas Schuette); 7 - Inter-crops in France: analysis of the potentials (Laurent Paquin); 8 - Digestates management in France, legislative and technical advances (Claire Ingremeau); 9 - The management of digestates in Germany: Fertilizer application and status of the art (Kurt Moeller); 10 - Status quo of Biomethane in Germany - Development, Technology and Costs (Marcus Trommler); 11 - GrDF's views and actions on biogas. Biomethane injection in France: state-of-the-art and first status (Valerie Bosso)

  7. Addressing Emerging Risks: Scientific and Regulatory Challenges Associated with Environmentally Persistent Free Radicals.

    Science.gov (United States)

    Dugas, Tammy R; Lomnicki, Slawomir; Cormier, Stephania A; Dellinger, Barry; Reams, Margaret

    2016-06-08

    Airborne fine and ultrafine particulate matter (PM) are often generated through widely-used thermal processes such as the combustion of fuels or the thermal decomposition of waste. Residents near Superfund sites are exposed to PM through the inhalation of windblown dust, ingestion of soil and sediments, and inhalation of emissions from the on-site thermal treatment of contaminated soils. Epidemiological evidence supports a link between exposure to airborne PM and an increased risk of cardiovascular and pulmonary diseases. It is well-known that during combustion processes, incomplete combustion can lead to the production of organic pollutants that can adsorb to the surface of PM. Recent studies have demonstrated that their interaction with metal centers can lead to the generation of a surface stabilized metal-radical complex capable of redox cycling to produce ROS. Moreover, these free radicals can persist in the environment, hence their designation as Environmentally Persistent Free Radicals (EPFR). EPFR has been demonstrated in both ambient air PM2.5 (diameter challenges associated with regulating this new, emerging contaminant.

  8. 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

  9. Remediation of Centre Pier, Port Hope, Ontario: Historical, Logistical, Regulatory and Technical Challenges - 13118

    Energy Technology Data Exchange (ETDEWEB)

    Ferguson Jones, Andrea [MMM Group Limited, 100 Commerce Valley Drive West, Thornhill, Ontario, L3T 0A1 (Canada); Case, Glenn [Atomic Energy of Canada Limited, 115 Toronto Road, Port Hope, Ontario, L1A 3S4 (Canada); Lawrence, Dave [Public Works and Government Services Canada, 115 Toronto Road, Port Hope, Ontario, L1A 3S4 (Canada)

    2013-07-01

    Centre Pier is a 3.9 ha property owned by the Commissioners of the Port Hope Harbour in the Municipality of Port Hope, Ontario, Canada. It is centrally located on the Port Hope waterfront and is bounded on the west by the Port Hope Harbour, on the east by the Ganaraska River, on the south by Lake Ontario, and on the north by a railway corridor. The property is currently leased by the Commissioners of the Port Hope Harbour to the Cameco Corporation which owns the four onsite building that are used as warehouse space for their uranium conversion facility located on the western side of the Harbour. Remediation of this site forms part of the Port Hope Project being undertaken by Atomic Energy of Canada Limited (AECL) and Public Works and Government Services Canada (PWGSC) as part of the Port Hope Area Initiative (PHAI). Soil impacts include radiological, metals and petroleum hydrocarbons resulting from long term historical industrial use. Radiological impacts in soil extend across most of the site primarily within the upper metre of fill. Metals-contaminated soil is present across the entire site in the underlying fill material. The metals-contaminated fill extends to a maximum depth of 2.0 m below grade at the north end of the site which is underlain by peat. However, the metals-contaminated soil could extend to the top of the bedrock on the remainder of the site. Based on the elevation of the bedrock in the adjacent river and Harbour Basin, the metals-contaminated soil may extend to a depth of 5.6 m or 6.5 m below existing grade. Petroleum-contaminated soil is present on the southeast side of the site, where a storage tank farm was previously located. Challenges include: - The complex history of the site both relating to site use and Pier construction. Pier development began in the 1800's and was undertaken by many different entities. Modifications and repairs were made over the years resulting in several different types of Pier walls and fill that must be

  10. Remediation of Centre Pier, Port Hope, Ontario: Historical, Logistical, Regulatory and Technical Challenges - 13118

    International Nuclear Information System (INIS)

    Ferguson Jones, Andrea; Case, Glenn; Lawrence, Dave

    2013-01-01

    Centre Pier is a 3.9 ha property owned by the Commissioners of the Port Hope Harbour in the Municipality of Port Hope, Ontario, Canada. It is centrally located on the Port Hope waterfront and is bounded on the west by the Port Hope Harbour, on the east by the Ganaraska River, on the south by Lake Ontario, and on the north by a railway corridor. The property is currently leased by the Commissioners of the Port Hope Harbour to the Cameco Corporation which owns the four onsite building that are used as warehouse space for their uranium conversion facility located on the western side of the Harbour. Remediation of this site forms part of the Port Hope Project being undertaken by Atomic Energy of Canada Limited (AECL) and Public Works and Government Services Canada (PWGSC) as part of the Port Hope Area Initiative (PHAI). Soil impacts include radiological, metals and petroleum hydrocarbons resulting from long term historical industrial use. Radiological impacts in soil extend across most of the site primarily within the upper metre of fill. Metals-contaminated soil is present across the entire site in the underlying fill material. The metals-contaminated fill extends to a maximum depth of 2.0 m below grade at the north end of the site which is underlain by peat. However, the metals-contaminated soil could extend to the top of the bedrock on the remainder of the site. Based on the elevation of the bedrock in the adjacent river and Harbour Basin, the metals-contaminated soil may extend to a depth of 5.6 m or 6.5 m below existing grade. Petroleum-contaminated soil is present on the southeast side of the site, where a storage tank farm was previously located. Challenges include: - The complex history of the site both relating to site use and Pier construction. Pier development began in the 1800's and was undertaken by many different entities. Modifications and repairs were made over the years resulting in several different types of Pier walls and fill that must be considered

  11. Regulatory aspects of oncology drug safety evaluation: Past practice, current issues, and the challenge of new drugs

    International Nuclear Information System (INIS)

    Rosenfeldt, Hans; Kropp, Timothy; Benson, Kimberly; Ricci, M. Stacey; McGuinn, W. David; Verbois, S. Leigh

    2010-01-01

    The drug development of new anti-cancer agents is streamlined in response to the urgency of bringing effective drugs to market for patients with limited life expectancy. FDA's regulation of oncology drugs has evolved from the practices set forth in Arnold Lehman's seminal work published in the 1950s through the current drafting of a new International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) safety guidance for anti-cancer drug nonclinical evaluations. The ICH combines the efforts of the regulatory authorities of Europe, Japan, and the United States and the pharmaceutical industry from these three regions to streamline the scientific and technical aspects of drug development. The recent development of new oncology drug classes with novel mechanisms of action has improved survival rates for some cancers but also brings new challenges for safety evaluation. Here we present the legacy of Lehman and colleagues in the context of past and present oncology drug development practices and focus on some of the current issues at the center of an evolving harmonization process that will generate a new safety guidance for oncology drugs, ICH S9. The purpose of this new guidance will be to facilitate oncology drug development on a global scale by standardizing regional safety requirements.

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

    Science.gov (United States)

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

    2018-06-30

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

  13. Methodological challenges for the evaluation of clinical effectiveness in the context of accelerated regulatory approval: an overview.

    Science.gov (United States)

    Woolacott, Nerys; Corbett, Mark; Jones-Diette, Julie; Hodgson, Robert

    2017-10-01

    Regulatory authorities are approving innovative therapies with limited evidence. Although this level of data is sufficient for the regulator to establish an acceptable risk-benefit balance, it is problematic for downstream health technology assessment, where assessment of cost-effectiveness requires reliable estimates of effectiveness relative to existing clinical practice. Some key issues associated with a limited evidence base include using data, from nonrandomized studies, from small single-arm trials, or from single-center trials; and using surrogate end points. We examined these methodological challenges through a pragmatic review of the available literature. Methods to adjust nonrandomized studies for confounding are imperfect. The relative treatment effect generated from single-arm trials is uncertain and may be optimistic. Single-center trial results may not be generalizable. Surrogate end points, on average, overestimate treatment effects. Current methods for analyzing such data are limited, and effectiveness claims based on these suboptimal forms of evidence are likely to be subject to significant uncertainty. Assessments of cost-effectiveness, based on the modeling of such data, are likely to be subject to considerable uncertainty. This uncertainty must not be underestimated by decision makers: methods for its quantification are required and schemes to protect payers from the cost of uncertainty should be implemented. Crown Copyright © 2017. Published by Elsevier Inc. All rights reserved.

  14. 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)

  15. Transitioning from first- to second-generation biosimilars: An appraisal of regulatory and post-marketing challenges.

    Science.gov (United States)

    Blandizzi, Corrado; Galeazzi, Mauro; Valesini, Guido

    2018-02-01

    Second-generation biosimilars (i.e. monoclonal antibodies or proteins generated by fusion of antibody and receptor moieties) differ in several respects as compared to first-generation ones (e.g. epoetins, bone marrow stimulating factors, somatotropins). In this respect, as second-generation biosimilars are endowed with much greater structural and molecular complexity, which might translate into a number of pharmacological and therapeutic issues, they raise new challenges for manufacturers and regulatory authorities as well as new concerns for clinicians. Based on these arguments, the present article was intended to review information on the main differences between first- and second-generation biosimilars for treatment of immune-mediated inflammatory diseases, as well as their impact on immunogenicity, the design of clinical trials and the critical issue of extrapolation of therapeutic indications. The positions taken by relevant medical associations and the crucial role of pharmacovigilance are also reviewed. According to current knowledge, the initial post-marketing clinical experience with second-generation biosimilars is providing encouraging results, though their long-term safety and efficacy as well as the scientific basis underlying the extrapolation of therapeutic indications are still matter of discussion. There is some consensus that marketing applications should rely on studies supporting the clinical use of biosimilars in their different target diseases and patient populations. In parallel, clinical safety must be ensured by a strict control of the manufacturing processes and a solid pharmacovigilance program. It remains then a responsibility of the physician to drive a proper use of second-generation biosimilars into clinical practice, in accordance with guidelines issued by scientific societies. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  16. Ethical and regulatory issues arising from proteomic research and technology.

    Science.gov (United States)

    Reymond, Marc A; Steinert, Ralf; Eder, Frank; Lippert, Hans

    2003-08-01

    Over the last two decades, medical research has begun to make extensive use of products of human origin in therapeutics, oncology, and most recently, in genetic diseases. This has raised many ethical issues involving patient rights, including issues of consent. Besides informed consent, researchers should address several topics when designing studies using human tissues. Reward for the patient should be kept minimal. Sample transfer should be organized along non-profit lines, at least in Europe. Sampling procedures should be at no risk for human volunteers, and at minimal risk for patients. Biosafety aspects should be addressed, in particular when international collaborations are intended or when collaboration is existing between academia and industry. Regulations on importation and exportation of human tissues should be observed. Data acquisition and storage should be addressed in accordance with national data protection regulations, in particular when using computerized databases. If follow-up information is to be taken, the authorization for such information should be requested. The right for patient's information (or for no information) on the research results should also be addressed. The issues of validation and patenting should be also solved, usually by informing the patient that he/she will have no commercial rights on potential research results. The patient should be told if the samples are transferred to another research laboratory or private company. Samples and related data should be destroyed on request at any time point during the course of the study. If possible, traceability of the donor should be ensured.

  17. Carcinoma arising in thyroglossal remnants

    NARCIS (Netherlands)

    van Vuuren, P. A.; Balm, A. J.; Gregor, R. T.; Hilgers, F. J.; Loftus, B. M.; Delprat, C. C.; Rutgers, E. J.

    1994-01-01

    Three patients with a papillary carcinoma arising in a thyroglossal duct cyst are presented and the literature is reviewed. This rare malignancy is seen mostly in women between the ages of 20 and 50 years. The distribution of carcinoma subtypes differs from that of thyroid carcinomas and

  18. Adenosarcoma arising in hepatic endometriosis

    International Nuclear Information System (INIS)

    N'Senda, P.; Dahan, H.; Tubiana, J.M.; Arrive, L.; Wendum, D.; Balladur, P.

    2000-01-01

    We report a case of adenosarcoma arising in hepatic endometriosis. Both CT and MR scans demontrated a huge heterogeneous mass containing septated, thick-walled cystic lesions. After enlarged right hepatectomy, the patient was asymptomatic with no abnormalities at liver and abdominal CT scan at 2-year follow-up. (orig.)

  19. Endogeneously arising network allocation rules

    NARCIS (Netherlands)

    Slikker, M.

    2006-01-01

    In this paper we study endogenously arising network allocation rules. We focus on three allocation rules: the Myerson value, the position value and the component-wise egalitarian solution. For any of these three rules we provide a characterization based on component efficiency and some balanced

  20. Adenosarcoma arising in hepatic endometriosis

    Energy Technology Data Exchange (ETDEWEB)

    N' Senda, P.; Dahan, H.; Tubiana, J.M.; Arrive, L. [Service de Radiologie, Hopital Saint-Antoine, 75 - Paris (France); Wendum, D. [Service d' Anatomie Pathologie, Hopital Saint-Antoine, 75 - Paris (France); Balladur, P. [Service de Chirurgie Digestive et Generale, Hopital Saint-Antoine, 75 - Paris (France)

    2000-08-01

    We report a case of adenosarcoma arising in hepatic endometriosis. Both CT and MR scans demontrated a huge heterogeneous mass containing septated, thick-walled cystic lesions. After enlarged right hepatectomy, the patient was asymptomatic with no abnormalities at liver and abdominal CT scan at 2-year follow-up. (orig.)

  1. Intervention Research with Youths at Elevated Risk for Suicide: Meeting the Ethical and Regulatory Challenges of Informed Consent and Assent

    Science.gov (United States)

    King, Cheryl A.; Kramer, Anne C.

    2008-01-01

    Intervention research with youths at elevated risk for suicidal behavior and suicide--a vulnerable and high risk population--presents investigators with numerous ethical challenges. This report specifically addresses those challenges involving the informed consent and assent process with parents/guardians and youths. The challenges are delineated…

  2. Regulating Nuclear Reactor Construction and Commissioning, and Preparation for Operation – Challenges for a New Regulatory Body

    International Nuclear Information System (INIS)

    Viktorsson, C.

    2016-01-01

    Following an introduction with a description of the peaceful nuclear energy program in the United Arab Emirates (UAE) and an overview of the regulatory framework for safety, security and safeguards, this paper describes the regulatory approach for oversight of construction and the granting of an Operating Licence for the first nuclear power plant in the UAE. The paper describes the inspection programme set up by the Federal Authority for Nuclear Regulation (FANR) to verify construction and preoperational testing by the licensee. Moreover, it outlines the content of the operating licence application and focus areas for the regulatory review and assessment. Also, the paper describes the basic elements required by FANR for the decision-making regarding the issuance of the Operating Licence including integration of the results of review and assessment and the implementation of a systematic inspection programme to ensure operational readiness to operate and maintain the plant in accordance with FANR regulations. Finally, the paper addresses the preparation for regulatory oversight and the skill-set needed at FANR to ensure an effective and efficient oversight of safety, security of the nuclear energy power in the UAE. (author)

  3. 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

  4. Dealing with uncertainty arising out of probabilistic risk assessment

    International Nuclear Information System (INIS)

    Solomon, K.A.; Kastenberg, W.E.; Nelson, P.F.

    1984-03-01

    In addressing the area of safety goal implementation, the question of uncertainty arises. This report suggests that the Nuclear Regulatory Commission (NRC) should examine how other regulatory organizations have addressed the issue. Several examples are given from the chemical industry, and comparisons are made to nuclear power risks. Recommendations are made as to various considerations that the NRC should require in probabilistic risk assessments in order to properly treat uncertainties in the implementation of the safety goal policy. 40 references, 7 figures, 5 tables

  5. The rate of hypo-osmotic challenge influences regulatory volume decrease (RVD) and mechanical properties of articular chondrocytes.

    Science.gov (United States)

    Wang, Z; Irianto, J; Kazun, S; Wang, W; Knight, M M

    2015-02-01

    Osteoarthritis (OA) is associated with a gradual reduction in the interstitial osmotic pressure within articular cartilage. The aim of this study was to compare the effects of sudden and gradual hypo-osmotic challenge on chondrocyte morphology and biomechanics. Bovine articular chondrocytes were exposed to a reduction in extracellular osmolality from 327 to 153 mOsmol/kg applied either suddenly (osmotic stress, 66% of chondrocytes exhibited an increase in diameter followed by RVD, whilst 25% showed no RVD. By contrast, cells exposed to gradual hypo-osmotic stress exhibited reduced cell swelling without subsequent RVD. There was an increase in the equilibrium modulus for cells exposed to sudden hypo-osmotic stress. However, gradual hypo-osmotic challenge had no effect on cell mechanical properties. This cell stiffening response to sudden hypo-osmotic challenge was abolished when actin organization was disrupted with cytochalasin D or RVD inhibited with REV5901. Both sudden and gradual hypo-osmotic challenge reduced cortical F-actin distribution and caused chromatin decondensation. Sudden hypo-osmotic challenge increases chondrocyte mechanics by activation of RVD and interaction with the actin cytoskeleton. Moreover, the rate of hypo-osmotic challenge is shown to have a profound effect on chondrocyte morphology and biomechanics. This important phenomenon needs to be considered when studying the response of chondrocytes to pathological hypo-osmotic stress. Copyright © 2014 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

  6. 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)

  7. Next steps generation III+/IV - Presentation at ACRS workshop 'Regulatory challenges for future nuclear power plants'

    International Nuclear Information System (INIS)

    Johnson, R. Shane

    2001-01-01

    Near-term actions concerned with deployment of advanced reactors discussed are: to complete report on recommended DOE activities, report will reflect generic and design specific issues, it should be issued by September 30, 2001. Significant activities are expected to include: Development of Regulatory Framework for Gas Reactor Technologies, Early Site Permit Demonstration, Combined Construction/Operating License Demonstration, and Design Certification of Advanced Reactors. Near-term actions concerned with technology road map are: to evaluate the most viable concepts, to compare concept performance to technology goals, to identify technology gaps, to identify R and D needed to close technology gaps and to prepare comprehensive report on most promising concepts including detailed R and D plan

  8. Progress and Updates of Regulatory Challenges and Safety Issues in Korea during Three Years after Fukushima Accident

    International Nuclear Information System (INIS)

    Lee, Young Eal; Kim, Kyun Tae

    2014-01-01

    Before the public fear on radiation risk caused by neighboring country's severe accident disappeared, a series of nuclear safety issues last 3 years made a few reactors shut down and the public trust much lower than before. Because of these scandals such as cover-ups, forged certificated items, corruption of manager of licensee and so on, many efforts made during three year after Fukushima accident on improving the nuclear safety were invalidated and even regulators as well as operators have been sharply criticized for its responsibility and transparency. This paper shares information on the progress and uprates achieved in Korea so far in connection with the safety issues caused during last 3 years and actions taken by the regulatory body. Before the public fear on radiation risk caused by neighboring country's severe accident disappeared, a series of nuclear safety issues last 3 years made a few reactors shut down and the public trust much lower than before. Because of these scandals such as cover-ups, forged certificated items, corruption of manager of licensee and so on, many efforts made during three year after Fukushima accident on improving the nuclear safety were invalidated and even regulators as well as operators have been sharply criticized for its responsibility and transparency

  9. Progress and Updates of Regulatory Challenges and Safety Issues in Korea during Three Years after Fukushima Accident

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Young Eal; Kim, Kyun Tae [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

    2014-10-15

    Before the public fear on radiation risk caused by neighboring country's severe accident disappeared, a series of nuclear safety issues last 3 years made a few reactors shut down and the public trust much lower than before. Because of these scandals such as cover-ups, forged certificated items, corruption of manager of licensee and so on, many efforts made during three year after Fukushima accident on improving the nuclear safety were invalidated and even regulators as well as operators have been sharply criticized for its responsibility and transparency. This paper shares information on the progress and uprates achieved in Korea so far in connection with the safety issues caused during last 3 years and actions taken by the regulatory body. Before the public fear on radiation risk caused by neighboring country's severe accident disappeared, a series of nuclear safety issues last 3 years made a few reactors shut down and the public trust much lower than before. Because of these scandals such as cover-ups, forged certificated items, corruption of manager of licensee and so on, many efforts made during three year after Fukushima accident on improving the nuclear safety were invalidated and even regulators as well as operators have been sharply criticized for its responsibility and transparency.

  10. Hemoglobin-Based Oxygen Carrier (HBOC) Development in Trauma: Previous Regulatory Challenges, Lessons Learned, and a Path Forward.

    Science.gov (United States)

    Keipert, Peter E

    2017-01-01

    Historically, hemoglobin-based oxygen carriers (HBOCs) were being developed as "blood substitutes," despite their transient circulatory half-life (~ 24 h) vs. transfused red blood cells (RBCs). More recently, HBOC commercial development focused on "oxygen therapeutic" indications to provide a temporary oxygenation bridge until medical or surgical interventions (including RBC transfusion, if required) can be initiated. This included the early trauma trials with HemAssist ® (BAXTER), Hemopure ® (BIOPURE) and PolyHeme ® (NORTHFIELD) for resuscitating hypotensive shock. These trials all failed due to safety concerns (e.g., cardiac events, mortality) and certain protocol design limitations. In 2008 the Food and Drug Administration (FDA) put all HBOC trials in the US on clinical hold due to the unfavorable benefit:risk profile demonstrated by various HBOCs in different clinical studies in a meta-analysis published by Natanson et al. (2008). During standard resuscitation in trauma, organ dysfunction and failure can occur due to ischemia in critical tissues, which can be detected by the degree of lactic acidosis. SANGART'S Phase 2 trauma program with MP4OX therefore added lactate >5 mmol/L as an inclusion criterion to enroll patients who had lost sufficient blood to cause a tissue oxygen debt. This was key to the successful conduct of their Phase 2 program (ex-US, from 2009 to 2012) to evaluate MP4OX as an adjunct to standard fluid resuscitation and transfusion of RBCs. In 2013, SANGART shared their Phase 2b results with the FDA, and succeeded in getting the FDA to agree that a planned Phase 2c higher dose comparison study of MP4OX in trauma could include clinical sites in the US. Unfortunately, SANGART failed to secure new funding and was forced to terminate development and operations in Dec 2013, even though a regulatory path forward with FDA approval to proceed in trauma had been achieved.

  11. Synthetic biology between challenges and risks: suggestions for a model of governance and a regulatory framework, based on fundamental rights.

    Science.gov (United States)

    Colussi, Ilaria Anna

    2013-01-01

    This paper deals with the emerging synthetic biology, its challenges and risks, and tries to design a model for the governance and regulation of the field. The model is called of "prudent vigilance" (inspired by the report about synthetic biology, drafted by the U.S. Presidential Commission on Bioethics, 2010), and it entails (a) an ongoing and periodically revised process of assessment and management of all the risks and concerns, and (b) the adoption of policies - taken through "hard law" and "soft law" sources - that are based on the principle of proportionality (among benefits and risks), on a reasonable balancing between different interests and rights at stake, and are oriented by a constitutional frame, which is represented by the protection of fundamental human rights emerging in the field of synthetic biology (right to life, right to health, dignity, freedom of scientific research, right to environment). After the theoretical explanation of the model, its operability is "checked", by considering its application with reference to only one specific risk brought up by synthetic biology - biosecurity risk, i.e. the risk of bioterrorism.

  12. Characteristics of the interferon regulatory factor 5 (IRF5) and its expression in response to LCDV and poly I:C challenges in Japanese flounder, Paralichthys olivaceus.

    Science.gov (United States)

    Hu, Guo-Bin; Lou, Hui-Min; Dong, Xian-Zhi; Liu, Qiu-Ming; Zhang, Shi-Cui

    2012-10-01

    Interferon regulatory factor 5 (IRF5) has been identified as a key transcriptional mediator regulating expression of both type I interferons (IFNs) and proinflammatory cytokines. In this study, the cDNA and genomic sequences of IRF5 were isolated from Japanese flounder, Paralichthys olivaceus. The gene of Japanese flounder (Jf)IRF5 is 7326 bp long, contains 9 exons and 8 introns and encodes a putative protein of 472 amino acids. The predicted protein sequence shares 61.1-81.9% identity to fish IRF5 and possesses a DNA-binding domain (DBD), a middle region (MR), an IRF association domain (IAD), a virus activated domain (VAD) and two nuclear localization signals (NLSs) conserved in all known IRF5s. Phylogenetic analysis clustered it into the teleost IRF5 subgroup within vertebrate IRF5 group. JfIRF5 mRNA was constitutively expressed in all tissues examined, with higher levels observed in the gills and head kidney. Gene expression of JfIRF5 was analyzed over a 7-day time course in the gills, head kidney, spleen and muscle of Japanese flounders challenged with lymphocystis disease virus (LCDV) and polyinosinic:polycytidylic acid (poly I:C). The data showed that JfIRF5 expression was slightly up-regulated by LCDV, but its induction time was clearly moved up; in contrast, the induction upon poly I:C challenge started not earlier than day 2 post-injection and was stronger and more persistent with a later peak time in all four organs. The late and long-lasting inductive expression of JfIRF5 following poly I:C challenge suggests that it might be an interferon stimulated gene (ISG), the induction of which is driven by poly I:C-induced type I IFNs. Copyright © 2012 Elsevier Ltd. All rights reserved.

  13. Scheduling the Remediation of Port Hope: Logistical and Regulatory Challenges of a Multiple Site Urban Remediation Project - 13119

    International Nuclear Information System (INIS)

    Ferguson Jones, Andrea; Lee, Angela; Palmeter, Tim

    2013-01-01

    The Port Hope Project is part of the larger CAN$1.28 billion Port Hope Area Initiative (PHAI), a community-based program for the development and implementation of a safe, local, long-term management solution for historic Low-Level Radioactive Waste (LLRW) in the Municipalities of Port Hope and Clarington, Ontario, Canada. Atomic Energy of Canada (AECL) is the Project Proponent, Public Works and Government Services (PWGSC) is managing the procurement of services and the MMM Group Limited - Conestoga Rovers and Associates Joint Venture (MMM-CRA Joint Venture) is providing detailed design and construction oversight and administration services for the Project. The Port Hope Project includes the construction of a long-term waste management facility (LTWMF) in the Municipality of Port Hope and the remediation of 18 (eighteen) large-scale LLRW, numerous small-scale sites still being identified and industrial sites within the Municipality. The total volume to be remediated is over one million cubic metres and will come from sites that include temporary storage sites, ravines, beaches, parks, private commercial and residential properties and vacant industrial sites all within the urban area of Port Hope. Challenges that will need to be overcome during this 10 year project include: - Requirements stipulated by the Environmental Assessment (EA) that affect Project logistics and schedule. - Coordination of site remediation with the construction schedule at the LTWMF. - Physical constraints on transport routes and at sites affecting production rates. - Despite being an urban undertaking, seasonal constrains for birds and fish (i.e., nesting and spawning seasons). - Municipal considerations. - Site-specific constraints. - Site interdependencies exist requiring consideration in the schedule. Several sites require the use of an adjacent site for staging. (authors)

  14. Scheduling the Remediation of Port Hope: Logistical and Regulatory Challenges of a Multiple Site Urban Remediation Project - 13119

    Energy Technology Data Exchange (ETDEWEB)

    Ferguson Jones, Andrea; Lee, Angela [MMM Group Limited, 100 Commerce Valley Drive West, Thornhill, Ontario, L3T 0A1 (Canada); Palmeter, Tim [Public Works and Government Services Canada, 4900 Yonge Street, Toronto, Ontario, M2N 6A6 (Canada)

    2013-07-01

    The Port Hope Project is part of the larger CAN$1.28 billion Port Hope Area Initiative (PHAI), a community-based program for the development and implementation of a safe, local, long-term management solution for historic Low-Level Radioactive Waste (LLRW) in the Municipalities of Port Hope and Clarington, Ontario, Canada. Atomic Energy of Canada (AECL) is the Project Proponent, Public Works and Government Services (PWGSC) is managing the procurement of services and the MMM Group Limited - Conestoga Rovers and Associates Joint Venture (MMM-CRA Joint Venture) is providing detailed design and construction oversight and administration services for the Project. The Port Hope Project includes the construction of a long-term waste management facility (LTWMF) in the Municipality of Port Hope and the remediation of 18 (eighteen) large-scale LLRW, numerous small-scale sites still being identified and industrial sites within the Municipality. The total volume to be remediated is over one million cubic metres and will come from sites that include temporary storage sites, ravines, beaches, parks, private commercial and residential properties and vacant industrial sites all within the urban area of Port Hope. Challenges that will need to be overcome during this 10 year project include: - Requirements stipulated by the Environmental Assessment (EA) that affect Project logistics and schedule. - Coordination of site remediation with the construction schedule at the LTWMF. - Physical constraints on transport routes and at sites affecting production rates. - Despite being an urban undertaking, seasonal constrains for birds and fish (i.e., nesting and spawning seasons). - Municipal considerations. - Site-specific constraints. - Site interdependencies exist requiring consideration in the schedule. Several sites require the use of an adjacent site for staging. (authors)

  15. Reduction of regulatory risk: a network economic approach

    OpenAIRE

    Knieps, Günter; Weiß, Hans-Jörg

    2007-01-01

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

  16. Primary extradural meningioma arising from the calvarium

    Directory of Open Access Journals (Sweden)

    N Ravi

    2013-06-01

    Full Text Available Meningiomas are the most common intracranial tumours. Meningiomas arising at other locations are termed primary extradural meningiomas (EDM and are rare. Here we report a case of EDM arising from the calvarium – a primary calvarial meningioma (PCM.

  17. Esophageal leiomyoma arising in an epiphrenic diverticulum

    International Nuclear Information System (INIS)

    Hamilton, S.

    1988-01-01

    A 32-year old woman was found at surgery to have an esophageal leiomyoma arising within an epiphrenic diverticulum. These uncommon conditions may rarely occur together, causing difficulty in diagnosis of the leiomyoma. Other neoplasms may also arise in an epiphrenic diverticulum and should be borne in mind in this situation. (orig.)

  18. Apocrine carcinoma arising in a complex fibroadenoma: a case report.

    Science.gov (United States)

    Mele, Marco; Vahl, Pernille; Funder, Jonas Amstrup; Sorensen, Anne Schmidt; Jensen, Vibeke

    2014-01-01

    A carcinoma arising in a fibroadenoma is a rare event, which often entails a diagnostic challenge. The most common type is the lobular carcinoma and secondary a ductal carcinoma. We present an extremely rare case of malignant development of an invasive apocrine carcinoma in a complex fibroadenoma and underline the importance for clinicians to recognize the possibility of benign and malignant co-existence especially in older women.

  19. Issues arising in applying the BSS concepts

    International Nuclear Information System (INIS)

    Linsley, G.

    1997-01-01

    The following issues are discussed arising in applying the basic safety standard concepts: terminology, naturally occurring radionuclides, the exemption and clearance levels, management of very low level wastes, transboundary movements, the waste convention

  20. 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.

  1. Characterization of common carp (Cyprinus carpio L.) interferon regulatory factor 5 (IRF5) and its expression in response to viral and bacterial challenges.

    Science.gov (United States)

    Zhu, Yaoyao; Qi, Chenchen; Shan, Shijuan; Zhang, Fumiao; Li, Hua; An, Liguo; Yang, Guiwen

    2016-06-27

    Common carp (Cyprinus carpio L.), one of the most economically valuable commercial farming fish species in China, is often infected by a variety of viruses. As the first line of defence against microbial pathogens, the innate immune system plays a crucial role in teleost fish, which are lower vertebrates. Interferon (IFN) regulatory factor 5 (IRF5) is a key molecule in antiviral immunity that regulating the expression of IFN and other pro-inflammatory cytokines. It is necessary to gain more insight into the common carp IFN system and the function of fish IRF5 in the antiviral and antibacterial response. In the present study, we characterized the cDNA and genomic sequence of the IRF5 gene in common carp, and analysed tissue distribution and expression profile of this gene in response to polyinosinic:polycytidylic acid (poly I:C) and lipopolysaccharides (LPS) treatment. The common carp IRF5 (ccIRF5) gene is 5790 bp in length and is composed of 9 exons and 8 introns. The open reading frame (ORF) of ccIRF5 is 1554 bp, and encodes 517 amino acid protein. The putative ccIRF5 protein shares identity (65.4-90.0 %) with other fish IRF5s and contains a DNA binding domain (DBD), a middle region (MR), an IRF-associated domain (IAD), a virus activated domain (VAD) and two nuclear localization signals (NLSs) similar to those found in vertebrate IRF5. Phylogenetic analysis clustered ccIRF5 into the IRF5 subfamily with other vertebrate IRF5 and IRF6 genes. Real-time PCR analysis revealed that ccIRF5 mRNA was expressed in all examined tissues of healthy carps, with high levels observed in the gills and the brain. After poly I:C challenge, expression levels of ccIRF5, tumour-necrosis factor α (ccTNFα) and two IFN stimulated genes [ISGs (ccISG5 and ccPKR)] were up-regulated in seven immune-related tissues (liver, spleen, head kidney, foregut, hindgut, skin and gills). Furthermore, all four genes were up-regulated in vitro upon poly I:C and LPS challenges. Our findings suggest

  2. 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...

  3. Pharma Opportunities and Risks Multiply as Regulatory Reform Remakes APAC: Expanded Accelerated Pathways Challenge Developer Value Story, Evidence Collection, and Market Access Strategies.

    Science.gov (United States)

    Grignolo, Alberto; Mingping, Zhang

    2018-01-01

    Sweeping reforms in the largest markets of the Asia-Pacific region are transforming the regulatory and commercial landscape for foreign pharmaceutical companies. Japan, South Korea, and China are leading the charge, establishing mechanisms and infrastructure that both reflect and help drive international regulatory convergence and accelerate delivery of needed, innovative products to patients. In this rapidly evolving regulatory and commercial environment, drug developers can benefit from reforms and proliferating accelerated pathway (AP) frameworks, but only with regulatory and evidence-generation strategies tailored to the region. Otherwise, they will confront significant pricing and reimbursement headwinds. Although APAC economies are at different stages of development, they share a common imperative: to balance pharmaceutical innovation with affordability. Despite the complexity of meeting these sometimes conflicting demands, companies that focus on demonstrating and delivering value for money, and that price new treatments reasonably and sustainably, can succeed both for their shareholders and the region's patient population.

  4. Cutaneous osteosarcoma arising from a burn scar

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Min A.; Yi, Jaehyuck [Kyungpook National University, Department of Radiology, College of Medicine, Daegu (Korea, Republic of); Kyungpook National University Hospital, Department of Radiology, Daegu (Korea, Republic of); Chae, Jong Min [Kyungpook National University, Department of Pathology, College of Medicine, Daegu (Korea, Republic of)

    2017-04-15

    Tumors that develop in old burn scars are usually squamous cell carcinomas. Sarcomas have also been reported, albeit rarely. To our knowledge, there has been only one case report of an extraskeletal osteosarcoma arising in a prior burn scar reported in the English-language literature, mainly discussing the clinicopathological features. Herein, we present a case of cutaneous osteosarcoma visualized as a mineralized soft-tissue mass arising from the scar associated with a previous skin burn over the back. This seems to be the first report describing the imaging features of a cutaneous osteosarcoma from an old burn scar. (orig.)

  5. Cellular schwannoma arising from sigmoid mesocolon presenting ...

    African Journals Online (AJOL)

    Schwannomas are a type of peripheral nerve sheath tumors with clinically indolent behavior. Though, they can occur anywhere in body, the incidence in retroperitoneum, mediastinum, and pelvis is exceedingly rare. We present a case of a 58‑year‑old female with a massive twisted tumor arising from sigmoid mesocolon.

  6. Cellular Schwannoma Arising from Sigmoid Mesocolon Presenting ...

    African Journals Online (AJOL)

    Schwannomas are a type of peripheral nerve sheath tumors with clinically indolent behavior. Though, they can occur anywhere in body, the incidence in retroperitoneum, mediastinum, and pelvis is exceedingly rare. We present a case of a 58‑year‑old female with a massive twisted tumor arising from sigmoid mesocolon.

  7. ARISE: American renaissance in science education

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1998-09-14

    The national standards and state derivatives must be reinforced by models of curricular reform. In this paper, ARISE presents one model based on a set of principles--coherence, integration of the sciences, movement from concrete ideas to abstract ones, inquiry, connection and application, sequencing that is responsive to how people learn.

  8. Occupancy statistics arising from weighted particle rearrangements

    International Nuclear Information System (INIS)

    Huillet, Thierry

    2007-01-01

    The box-occupancy distributions arising from weighted rearrangements of a particle system are investigated. In the grand-canonical ensemble, they are characterized by determinantal joint probability generating functions. For doubly non-negative weight matrices, fractional occupancy statistics, generalizing Fermi-Dirac and Bose-Einstein statistics, can be defined. A spatially extended version of these balls-in-boxes problems is investigated

  9. Security risks arising from portable storage devices

    CSIR Research Space (South Africa)

    Molotsi, K

    2012-10-01

    Full Text Available of the security risks arising from the use of PSDs, and further provides possible security countermeasures to help organisations and users to protect their digital assets. APPROACH Literature review: ? To investigate security risks posed by PSDs... technology in the workplace. International Journal of Electronic Security and Digital Forensics. 3(1): 73?81 [3] Kim, K., Kim, E. & Hong S. (2009). Privacy information protection in portable device. Proceedings of International Conference on Convergence...

  10. Conjunctival lymphoma arising from reactive lymphoid hyperplasia

    Directory of Open Access Journals (Sweden)

    Fukuhara Junichi

    2012-09-01

    Full Text Available Abstract Extra nodal marginal zone B-cell lymphoma (EMZL of the conjunctiva typically arises in the marginal zone of mucosa-associated lymphoid tissue. The pathogenesis of conjunctival EMZL remains unknown. We describe an unusual case of EMZL arising from reactive lymphoid hyperplasia (RLH of the conjunctiva. A 35-year-old woman had fleshy salmon-pink conjunctival tumors in both eyes, oculus uterque (OU. Specimens from conjunctival tumors in the right eye, oculus dexter (OD, revealed a collection of small lymphoid cells in the stroma. Immunohistochemically, immunoglobulin (Ig light chain restriction was not detected. In contrast, diffuse atypical lymphoid cell infiltration was noted in the left eye, oculus sinister (OS, and positive for CD20, a marker for B cells OS. The tumors were histologically diagnosed as RLH OD, and EMZL OS. PCR analysis detected IgH gene rearrangement in the joining region (JH region OU. After 11 months, a re-biopsy specimen demonstrated EMZL based on compatible pathological and genetic findings OD, arising from RLH. This case suggests that even if the diagnosis of the conjunctival lymphoproliferative lesions is histologically benign, confirmation of the B-cell clonality by checking IgH gene rearrangement should be useful to predict the incidence of malignancy.

  11. Application of Regulation for recycling metals arising from Decommissioning of an Italian Nuclear Facility - Application of national regulations for metallic materials' recycling from the decommissioning of an Italian nuclear facility

    International Nuclear Information System (INIS)

    Varasano, Giovanni; Baldassarre, Leonardo; Petagna, Edoardo

    2014-01-01

    The start of the decommissioning of nuclear Italian sites requires proper management of clearance for large volumes of metallic materials. This paper describes the current legal framework relating to the Italian regulatory system of reference for the verification of the conditions of unconditional release of materials from nuclear installations, with particular reference to the recycling of metals. The definition of clearance levels, whether general or specific, ensures the clearance of materials arising from nuclear sites without further examinations. The Italian legislation on radiation protection requires that the removal of materials from authorized practices be subject to special requirements included in the authorization provisions. These requirements provide clearance levels that take account of the recommendations and technical guidelines supplied by the European Commission. The regulatory framework requires compliance with current technical and managerial requirements, issued by the National Regulatory Authority and annexed to the Ministerial Authorization, in which are shown the levels of surface activity and specific activity established for the unconditional release of metals from nuclear sites. The real challenge for the nuclear operator is the management of large amounts of waste materials arising from decommissioning activities. For the Italian operator SOGIN SpA is of extreme importance the correct application of national regulatory framework, in order to allow the most effective reduction of the amount of radioactive waste during decommissioning activities. (authors)

  12. Regulatory activities

    International Nuclear Information System (INIS)

    2001-01-01

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

  13. Kapteyn series arising in radiation problems

    International Nuclear Information System (INIS)

    Lerche, I; Tautz, R C

    2008-01-01

    In discussing radiation from multiple point charges or magnetic dipoles, moving in circles or ellipses, a variety of Kapteyn series of the second kind arises. Some of the series have been known in closed form for a hundred years or more, others appear not to be available to analytic persuasion. This paper shows how 12 such generic series can be developed to produce either closed analytic expressions or integrals that are not analytically tractable. In addition, the method presented here may be of benefit when one has other Kapteyn series of the second kind to consider, thereby providing an additional reason to consider such series anew

  14. Activation of Salmonella Typhi-specific regulatory T cells in typhoid disease in a wild-type S. Typhi challenge model.

    OpenAIRE

    Monica A McArthur; Stephanie Fresnay; Laurence S Magder; Thomas C Darton; Claire Jones; Claire S Waddington; Christoph J Blohmke; Gordon Dougan; Brian Angus; Myron M Levine; Andrew J Pollard; Marcelo B Sztein

    2015-01-01

    Salmonella Typhi (S. Typhi), the causative agent of typhoid fever, causes significant morbidity and mortality worldwide. Currently available vaccines are moderately efficacious, and identification of immunological responses associated with protection or disease will facilitate the development of improved vaccines. We investigated S. Typhi-specific modulation of activation and homing potential of circulating regulatory T cells (Treg) by flow and mass cytometry using specimens obtained from a h...

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

    Science.gov (United States)

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

    2007-04-11

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

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

    International Nuclear Information System (INIS)

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

    2007-01-01

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

  17. Regulatory control of the use of contractors by operating organizations. Peer discussions on regulatory practices

    International Nuclear Information System (INIS)

    2000-09-01

    This report arises from the eighth series of peer discussions on regulatory practices entitled 'Regulatory control of the use of contractors by operating organizations'. Senior regulators from 19 Member States participated in two peer group discussions in March 2000 and May 2000. This report gives an account of the outcomes of these meetings and of practical suggestions put forward by senior regulators. These suggestions do not necessarily reflect the views of the governments of the nominating Member States, the organizations they belong to, or the International Atomic Energy Agency. The objective of this document is to share experience between regulatory bodies and provide practical suggestions for controlling the use of contractors and subcontractors by the operating organizations during all stages, especially operation, of a nuclear power plant, so as to ensure that the quality of work and services delivered is commensurate with the safety importance of the activities and that these are carried out in a manner that will not adversely affect the safe or reliable operation of the facility. These documented practical suggestions and experiences are the result of a series of peer discussions at the IAEA in 2000. It is considered that the manner in which control is exercised, and the various challenges connected to this control, are highly dependent upon the legislative framework, maturity of the nuclear programme, the size of the national nuclear industry and the culture in each country. The report is structured so that it covers the subject matter under the following main headings: Legal Provisions, Regulatory Strategy and Requirements; Regulatory Approaches for Controlling the Use of Contractors; Types of Contracts; Practical Suggestions

  18. Spinal cord injury arising in anaesthesia practice.

    Science.gov (United States)

    Hewson, D W; Bedforth, N M; Hardman, J G

    2018-01-01

    Spinal cord injury arising during anaesthetic practice is a rare event, but one that carries a significant burden in terms of morbidity and mortality. In this article, we will review the pathophysiology of spinal cord injury. We will then discuss injuries relating to patient position, spinal cord hypoperfusion and neuraxial techniques. The most serious causes of spinal cord injury - vertebral canal haematoma, spinal epidural abscess, meningitis and adhesive arachnoiditis - will be discussed in turn. For each condition, we draw attention to practical, evidence-based measures clinicians can undertake to reduce their incidence, or mitigate their severity. Finally, we will discuss transient neurological symptoms. Some cases of spinal cord injury during anaesthesia can be ascribed to anaesthesia itself, arising as a direct consequence of its conduct. The injury to a spinal nerve root by inaccurate and/or incautious needling during spinal anaesthesia is an obvious example. But in many cases, spinal cord injury during anaesthesia is not caused by, related to, or even associated with, the conduct of the anaesthetic. Surgical factors, whether direct (e.g. spinal nerve root damage due to incorrect pedicle screw placement) or indirect (e.g. cord ischaemia following aortic surgery) are responsible for a significant proportion of spinal cord injuries that occur concurrently with the delivery of regional or general anaesthesia. © 2018 The Association of Anaesthetists of Great Britain and Ireland.

  19. Assessment of regulatory effectiveness. Peer discussions on regulatory practices

    International Nuclear Information System (INIS)

    1999-09-01

    This report arises from the seventh series of peer discussions on regulatory practices entitled 'Assessment of Regulatory Effectiveness'. The term 'regulatory effectiveness' covers the quality of the work and level of performance of a regulatory body. In this sense, regulatory effectiveness applies to regulatory body activities aimed at preventing safety degradation and ensuring that an acceptable level of safety is being maintained by the regulated operating organizations. In addition, regulatory effectiveness encompasses the promotion of safety improvements, the timely and cost effective performance of regulatory functions in a manner which ensures the confidence of the operating organizations, the general public and the government, and striving for continuous improvements to performance. Senior regulators from 22 Member States participated in two peer group discussions during March and May 1999. The discussions were focused on the elements of an effective regulatory body, possible indicators of regulatory effectiveness and its assessment. This report presents the outcome of these meetings and recommendations of good practices identified by senior regulators, which do not necessarily reflect those of the governments of the nominating Member States, the organizations they belong to, or the International Atomic Energy Agency. In order to protect people and the environment from hazards associated with nuclear facilities, the main objective of a nuclear regulatory body is to ensure that a high level of safety in the nuclear activities under its jurisdiction is achieved, maintained and within the control of operating organizations. Even if it is possible to directly judge objective safety levels at nuclear facilities, such safety levels would not provide an exclusive indicator of regulatory effectiveness. The way the regulatory body ensures the safety of workers and the public and the way it discharges its responsibilities also determine its effectiveness. Hence the

  20. Adenocarcinoma arising in female urethral diverticulum

    International Nuclear Information System (INIS)

    Patanaphan, V.; Prempree, T.; Sewchand, W.; Hafiz, M.A.; Jaiwatana, J.

    1983-01-01

    Cancer arising from a female urethral diverticulum is rare, and because of its rarity, a review of the medical literature reveals significant nonuniformity in its management. We report an additional 2 cases of this disease, one of which has an even rarer feature of being mucin-producing. The management of our 2 cases is presented in detail and in line with the management of female urethral cancer. From our extensive literature search, diverticulectomy alone showed poor results with the highest rate of recurrence (67%). Extensive surgery, either in the form of cystourethrectomy or anterior exenteration, offered results comparable with those of combined therapy (diverticulectomy and full course of irradiation for early cases; preoperative irradiation followed by cystourethrectomy for late cases). Individualization of radiation treatment and cooperative effort between urologist and radiation oncologist are essential if best results are to be achieved

  1. Microbial diversity arising from thermodynamic constraints

    Science.gov (United States)

    Großkopf, Tobias; Soyer, Orkun S

    2016-01-01

    The microbial world displays an immense taxonomic diversity. This diversity is manifested also in a multitude of metabolic pathways that can utilise different substrates and produce different products. Here, we propose that these observations directly link to thermodynamic constraints that inherently arise from the metabolic basis of microbial growth. We show that thermodynamic constraints can enable coexistence of microbes that utilise the same substrate but produce different end products. We find that this thermodynamics-driven emergence of diversity is most relevant for metabolic conversions with low free energy as seen for example under anaerobic conditions, where population dynamics is governed by thermodynamic effects rather than kinetic factors such as substrate uptake rates. These findings provide a general understanding of the microbial diversity based on the first principles of thermodynamics. As such they provide a thermodynamics-based framework for explaining the observed microbial diversity in different natural and synthetic environments. PMID:27035705

  2. Microbial diversity arising from thermodynamic constraints.

    Science.gov (United States)

    Großkopf, Tobias; Soyer, Orkun S

    2016-11-01

    The microbial world displays an immense taxonomic diversity. This diversity is manifested also in a multitude of metabolic pathways that can utilise different substrates and produce different products. Here, we propose that these observations directly link to thermodynamic constraints that inherently arise from the metabolic basis of microbial growth. We show that thermodynamic constraints can enable coexistence of microbes that utilise the same substrate but produce different end products. We find that this thermodynamics-driven emergence of diversity is most relevant for metabolic conversions with low free energy as seen for example under anaerobic conditions, where population dynamics is governed by thermodynamic effects rather than kinetic factors such as substrate uptake rates. These findings provide a general understanding of the microbial diversity based on the first principles of thermodynamics. As such they provide a thermodynamics-based framework for explaining the observed microbial diversity in different natural and synthetic environments.

  3. Radioisotopes: problems of responsibility arising from medicine

    International Nuclear Information System (INIS)

    Dupon, Michel.

    1978-09-01

    Radioisotopes have brought about great progress in the battle against illnesses of mainly tumoral origin, whether in diagnosis (nuclear medicine) or in treatment (medical radiotherapy). They are important enough therefore to warrant investigation. Such a study is attempted here, with special emphasis, at a time when medical responsibility proceedings are being taken more and more often on the medicolegal problems arising from their medical use. It is hoped that this study on medical responsibility in the use of radioisotopes will have shown: that the use of radioisotopes for either diagnosis or therapy constitutes a major banch of medicine; that this importance implies an awareness by the practitioner of a vast responsibility, especially in law where legislation to ensure protection as strict as in the field of ionizing radiations is lacking. The civil responsibility of doctors who use radioisotopes remains to be defined, since for want of adequate jurisprudence we are reduced to hypotheses based on general principles [fr

  4. High grade angiosarcoma arising in fibroadenoma

    Science.gov (United States)

    2011-01-01

    Primary angiosarcoma of the breast is a rare tumour that account for fewer than 0.05% of all malignant mammary tumours. Angiosarcoma may have an perfidious clinical onset. Radiologic findings are often nonspecific and may appear completely normal in one-third of cases with primary angiosarcoma. The prognosis is usually poor because of the high rates of local recurrence and early development of metastases. Aggressive surgical resection is the mainstay of treatment. The role of adjuvant therapy has not yet been well established. Here we present a case of a 53 year old, postmenopausal women with primary angiosarcoma arising in fibroadenoma. To our knowledge, this is the first case described in the literature to date. PMID:22185665

  5. Periorbital nodular fasciitis arising during pregnancy

    Directory of Open Access Journals (Sweden)

    Brandon N Phillips

    2014-01-01

    Full Text Available Nodular fasciitis (NF is a benign proliferation of fibroblasts and myofibroblasts that rarely occurs in the periorbital region. We report what we believe to be the first case of periorbital NF associated with pregnancy. A case of intravascular fasciitis, a NF variant, has been reported during pregnancy, but it was not located in the periorbital region. A weak presence of estrogen receptors has been reported in NF. This may make it more susceptible to the hormone-related changes during pregnancy and contribute to the development of the lesion by stimulating fibroblasts and smooth muscle cell types. Although rare, NF should be considered in the differential diagnosis of periorbital soft-tissue masses arising during pregnancy.

  6. Airborne iodine-125 arising from surface contamination

    International Nuclear Information System (INIS)

    Kwok, C.S.; Hilditch, T.E.

    1982-01-01

    Measurements of airborne 125 I were made during the subdivision of 740 MBq stocks of 125 I iodide solution in a hospital dispensary. Within the fume cupboard the mean airborne 125 I concentration was 3.5 +- 2.9 kBqm -3 . No airborne concentration contamination was found outside the fume cupboard during these dispensing sessions. The airborne 125 I concentration arising from deliberate surface contamination (50 μl, 3.7-6.3 MBq) of the top of a lead pot was measured at a height simulating face level at an open work bench. There was a progressive fall in airborne concentration over seven days but even then the level was still significantly above background. Measurements made with the extraction system of the fume cupboard in operation were 2-3 times lower. (U.K.)

  7. Survival of mutations arising during invasions.

    Science.gov (United States)

    Miller, Judith R

    2010-03-01

    When a neutral mutation arises in an invading population, it quickly either dies out or 'surfs', i.e. it comes to occupy almost all the habitat available at its time of origin. Beneficial mutations can also surf, as can deleterious mutations over finite time spans. We develop descriptive statistical models that quantify the relationship between the probability that a mutation will surf and demographic parameters for a cellular automaton model of surfing. We also provide a simple analytic model that performs well at predicting the probability of surfing for neutral and beneficial mutations in one dimension. The results suggest that factors - possibly including even abiotic factors - that promote invasion success may also increase the probability of surfing and associated adaptive genetic change, conditioned on such success.

  8. Environmental challenges and opportunities of the evolving North American electricity market : European electricity generating facilities: an overview of European regulatory requirements and standardization efforts

    International Nuclear Information System (INIS)

    Nichols, L.

    2002-06-01

    Several factors are affecting power generating facilities, such as the opening of both electricity and gas markets, and the pressure applied on generators and governments to ensure a steady energy supply for consumers. An additional factor is the pressure for the closing of nuclear power facilities. European siting and emissions requirements for coal-fired and natural gas generating facilities were presented in this background paper. In addition, the author provided an overview of the standardization process in place in Europe. The European Union and its functioning were briefly described, as well as a listing of relevant organizations. The current trends were examined. The document first introduced the European Union, and the next section dealt with Regulatory regime: the internal energy market. The third section examined the issue of Regulatory regime: generation and environmental regulations. Section four presented environmental management systems, followed by a section on standardization. Section six discussed European organizations involved in electricity issues, while the following section dealt with European commission programs. The last section briefly looked at the trends in the electricity sector, broaching topics such as compliance, electricity generation, and emissions trading. 52 refs., 2 tabs

  9. 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

  10. 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...

  11. [Chemical hazards arising from shale gas extraction].

    Science.gov (United States)

    Pakulska, Daria

    2015-01-01

    The development of the shale industry is gaining momentum and hence the analysis of chemical hazards to the environment and health of the local population is extreiely timely and important. Chemical hazards are created during the exploitation of all minerals, but in the case of shale gas production, there is much more uncertainty as regards to the effects of new technologies application. American experience suggests the increasing risk of environmental contamination, mainly groundwater. The greatest, concern is the incomplete knowledge of the composition of fluids used for fracturing shale rock and unpredictability of long-term effects of hydraulic fracturing for the environment and health of residents. High population density in the old continent causes the problem of chemical hazards which is much larger than in the USA. Despite the growing public discontent data on this subject are limited. First of all, there is no epidemiological studies to assess the relationship between risk factors, such as air and water pollution, and health effects in populations living in close proximity to gas wells. The aim of this article is to identify and discuss existing concepts on the sources of environmental contamination, an indication of the environment elements under pressure and potential health risks arising from shale gas extraction.

  12. Chemical hazards arising from shale gas extraction

    Directory of Open Access Journals (Sweden)

    Daria Pakulska

    2015-02-01

    Full Text Available The development of the shale industry is gaining momentum and hence the analysis of chemical hazards to the environment and health of the local population is extremely timely and important. Chemical hazards are created during the exploitation of all minerals, but in the case of shale gas production, there is much more uncertainty as regards to the effects of new technologies application. American experience suggests the increasing risk of environmental contamination, mainly groundwater. The greatest concern is the incomplete knowledge of the composition of fluids used for fracturing shale rock and unpredictability of long-term effects of hydraulic fracturing for the environment and health of residents. High population density in the old continent causes the problem of chemical hazards which is much larger than in the USA. Despite the growing public discontent data on this subject are limited. First of all, there is no epidemiological studies to assess the relationship between risk factors, such as air and water pollution, and health effects in populations living in close proximity to gas wells. The aim of this article is to identify and discuss existing concepts on the sources of environmental contamination, an indication of the environment elements under pressure and potential health risks arising from shale gas extraction. Med Pr 2015;66(1:99–117

  13. Cutaneous leiomyosarcoma arising in a smallpox scar.

    Science.gov (United States)

    Pol, Robert A; Dannenberg, Hilde; Robertus, Jan-Lukas; van Ginkel, Robert J

    2012-07-16

    Cutaneous leiomyosarcoma (CLM) is a very rare smooth muscle tumour that accounts for about 2-3% of all superficial soft tissue sarcomas. Although the development of various malignancies in scar tissue is well known, we report the first case of a CLM developing in a small pox scar. A 66-year-old man presented with a painless, slow-growing lump in a small pox scar on his left shoulder. Histological biopsies showed the lesion to be a primary, well-differentiated cutaneous leiomyosarcoma. A CT scan of the thorax was conducted, which showed no signs of metastases. The complete lesion was then surgically excised, and histopathological examination revealed a radically excised cutaneous type leiomyosarcoma After 13 months' review the patient was doing well with no evidence of tumour recurrence. This is the first report of a CLM arising in a small pox scar. Although the extended time interval between scarring and malignant changes makes it difficult to advise strict follow-up for patients with small pox scars, one should be aware that atypical changes and/or symptoms occurring in a small pox scar could potentially mean malignant transformation.

  14. Cutaneous leiomyosarcoma arising in a smallpox scar

    Directory of Open Access Journals (Sweden)

    Pol Robert A

    2012-07-01

    Full Text Available Abstract Background Cutaneous leiomyosarcoma (CLM is a very rare smooth muscle tumour that accounts for about 2–3% of all superficial soft tissue sarcomas. Although the development of various malignancies in scar tissue is well known, we report the first case of a CLM developing in a small pox scar. Case presentation A 66-year-old man presented with a painless, slow-growing lump in a small pox scar on his left shoulder. Histological biopsies showed the lesion to be a primary, well-differentiated cutaneous leiomyosarcoma. A CT scan of the thorax was conducted, which showed no signs of metastases. The complete lesion was then surgically excised, and histopathological examination revealed a radically excised cutaneous type leiomyosarcoma After 13 months’ review the patient was doing well with no evidence of tumour recurrence. Conclusions This is the first report of a CLM arising in a small pox scar. Although the extended time interval between scarring and malignant changes makes it difficult to advise strict follow-up for patients with small pox scars, one should be aware that atypical changes and/or symptoms occurring in a small pox scar could potentially mean malignant transformation.

  15. Chemodectomas arising in temporal bone structures

    International Nuclear Information System (INIS)

    Dickens, W.J.; Million, R.R.; Cassisi, N.J.; Singleton, G.T.

    1982-01-01

    Eighteen patients with chemodectomas arising in temporal bone structures were evaluated and treated at the University of Florida. Seventeen patients have each been followed a minimum of 3 years. Patients were retrospectively staged as having ''local'' or ''advanced'' disease, depending on the presence or absence of bone destruction and/or cranial nerve involvement. Fourteen of the patients received radiation therapy as all or part of their therapy; 6 patients were treated with radiation therapy alone, 3 patients were irradiated immediately postoperatively for residual disease, and 5 patients had radiation therapy for recurrence after operation. They were treated with cobalt-60 radiation with doses ranging from 3760 to 5640 rad. All irradiated patients demonstrated evidence of tumor regression, and none have had tumor recurrence with followup of 3-12 years. Of the 8 patients with cranial nerve paralysis prior to therapy, 5 had return of function of 1 or more cranial nerves. One of 6 patients treated initially with radiation therapy had a complication, while 6 of 8 patients irradiated postoperatively had complications. None of the complications were fatal. Three patients treated by operation for early disease limited to the hypotympanum had the disease controlled for 11-12 years. Guidelines for the selection of initial therapy are discussed

  16. Radiological emergencies arising from accidents in Italy

    International Nuclear Information System (INIS)

    Bazzan, A.

    1986-01-01

    The Nuclear Safety and Health Protection Directorate (DISP) of ENEA has organized a structure of officers and technicians on call whenever an accident related to the activity of ENEA-DISP should occur. The most frequent events arise from natural misfortunes, crime, and deficiencies in public services. As regards technical operations such as measurements, removals, decontaminations and transport, DISP requests utilization of the different structures and equipment available to ENEA research centres and, in particular and most frequently, of the Safety and Radioprotection Division of the main ENEA centre: the Casaccia Research Centre. The technicians of this division are always available via telephone or radio, with the firm duty to be present within one hour from the call. The co-operation between these two structures enables timely and efficient intervention in many circumstances so that population and environmental risks can be avoided. Typical accidental situations are earthquakes, adverse atmospheric events, landslides, collapses, railway and road accidents, lost sources discovery, and seizure of illegally detained sources by judicial power. The paper briefly describes some of the situations which have occurred, and the actions carried out to recover sources and to re-establish safe environmental conditions. (author)

  17. Nuclear security regulatory framework analysis for small modular reactors in Canada and abroad

    Energy Technology Data Exchange (ETDEWEB)

    Farah, A., E-mail: amjad.farah@uoit.ca [University of Ontario Institute of Technology, Oshawa, ON (Canada)

    2015-07-01

    Small Modular Reactors (SMRs) are gaining global attention as a potential solution for future power plants due to claims of flexibility and cost effectiveness, while maintaining or increasing safety and security. With the change of design and the potential deployment in remote areas, however, challenges arise from a regulatory standpoint, to meet the safety and security regulations while maintaining economic feasibility. This work comprises of a review of the nuclear security regulatory frameworks in place for SMRs in Canada, USA and the IAEA; how they compare to each other, and to those of large reactors. The goal is to gauge what needs to be adjusted in order to address the changes in design between the two reactor sizes. Some key challenges concern the type of reactor, transportation of reactor components and fuel to remote areas, reduced security staff, and increased complexity of emergency planning and evacuation procedures. (author)

  18. Nuclear security regulatory framework analysis for small modular reactors in Canada and abroad

    International Nuclear Information System (INIS)

    Farah, A.

    2015-01-01

    Small Modular Reactors (SMRs) are gaining global attention as a potential solution for future power plants due to claims of flexibility and cost effectiveness, while maintaining or increasing safety and security. With the change of design and the potential deployment in remote areas, however, challenges arise from a regulatory standpoint, to meet the safety and security regulations while maintaining economic feasibility. This work comprises of a review of the nuclear security regulatory frameworks in place for SMRs in Canada, USA and the IAEA; how they compare to each other, and to those of large reactors. The goal is to gauge what needs to be adjusted in order to address the changes in design between the two reactor sizes. Some key challenges concern the type of reactor, transportation of reactor components and fuel to remote areas, reduced security staff, and increased complexity of emergency planning and evacuation procedures. (author)

  19. Emerging Resistance, New Antimicrobial Agents  …  but No Tests! The Challenge of Antimicrobial Susceptibility Testing in the Current US Regulatory Landscape.

    Science.gov (United States)

    Humphries, R M; Hindler, J A

    2016-07-01

    Accurate and timely performance of antimicrobial susceptibility testing (AST) by the clinical laboratory is paramount to combating antimicrobial resistance. The ability of laboratories in the United States to effectively perform ASTs is challenged by several factors. Some, such as new resistance mechanisms and the associated evolution of testing recommendations and breakpoints, are inevitable. Others are entirely man-made. These include unnecessarily strict US Food and Drug Administration (FDA) limitations on how commercial AST systems can be used for diagnostic testing, the absence of up-to-date performance data on these systems, and the lack of commercially available FDA-cleared tests for newer antimicrobial agents or for older agents with updated breakpoints. This viewpoint will highlight contemporary AST challenges faced by the clinical laboratory, and propose some solutions. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

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

    Energy Technology Data Exchange (ETDEWEB)

    Kielland, Jens Jacob; Ruud, Audun

    2012-07-01

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

  1. Boundary Value Problems Arising in Kalman Filtering

    Directory of Open Access Journals (Sweden)

    Sinem Ertürk

    2009-01-01

    Full Text Available The classic Kalman filtering equations for independent and correlated white noises are ordinary differential equations (deterministic or stochastic with the respective initial conditions. Changing the noise processes by taking them to be more realistic wide band noises or delayed white noises creates challenging partial differential equations with initial and boundary conditions. In this paper, we are aimed to give a survey of this connection between Kalman filtering and boundary value problems, bringing them into the attention of mathematicians as well as engineers dealing with Kalman filtering and boundary value problems.

  2. Boundary Value Problems Arising in Kalman Filtering

    Directory of Open Access Journals (Sweden)

    Bashirov Agamirza

    2008-01-01

    Full Text Available The classic Kalman filtering equations for independent and correlated white noises are ordinary differential equations (deterministic or stochastic with the respective initial conditions. Changing the noise processes by taking them to be more realistic wide band noises or delayed white noises creates challenging partial differential equations with initial and boundary conditions. In this paper, we are aimed to give a survey of this connection between Kalman filtering and boundary value problems, bringing them into the attention of mathematicians as well as engineers dealing with Kalman filtering and boundary value problems.

  3. Scientific, economic, regulatory, and ethical challenges of bringing science-based pediatric nutrition products to the U.S. market and ensuring their availability for patients.

    Science.gov (United States)

    Merritt, Russell J; Goldsmith, Arthur H

    2014-11-01

    Many nutrition products and related drugs are unavailable or not consistently available to clinicians despite a body of clinical data and experience supporting their use. Many of these can be related to drug shortages that have increased since 2009. In addition, there are potentially useful products that are not approved for a specific use or are no longer being manufactured. This review broadly examines the product availability gap from the perspectives of a clinician/former nutrition industry medical director and an economist. The process of pediatric nutrition product and related drug innovation, as well as its drivers and the steps involved in bringing a product to market, is first described. This is followed by an assessment of factors influencing product availability beyond the innovation process, including regulatory issues, manufacturing compliance, purchasing practices, and other factors related to drug and nutrition product pricing and reimbursement. Three pediatric case examples are reviewed and placed in the context of the prior review. Last, recent and future possible steps toward closing the product availability gap are discussed. © 2014 American Society for Parenteral and Enteral Nutrition.

  4. Primary extradural meningioma arising from the calvarium | Ravi ...

    African Journals Online (AJOL)

    Meningiomas are the most common intracranial tumours. Meningiomas arising at other locations are termed primary extradural meningiomas (EDMs) and are rare. Here we report a case of EDM arising from the calvarium – a primary calvarial meningioma (PCM).

  5. Squamous cell carcinoma arising in an odontogenic cyst

    International Nuclear Information System (INIS)

    Yu, Jae Jung; Hwang, Eui Hwan; Lee, Sang Rae; Choi, Jeong Hee

    2003-01-01

    Squamous cell carcinoma arising in an odontogenic cyst is uncommon. The diagnosis of carcinoma arising in a cyst requires that there must be an area of microscopic transition from the benign epithelial cyst lining to the invasive squamous cell carcinoma. We report a histopathologically proven case of squamous cell carcinoma arising in a residual mandibular cyst in a 54-year-old woman.

  6. Regulatory Governance

    DEFF Research Database (Denmark)

    Kjær, Poul F.; Vetterlein, Antje

    2018-01-01

    Regulatory governance frameworks have become essential building blocks of world society. From supply chains to the regimes surrounding international organizations, extensive governance frameworks have emerged which structure and channel a variety of social exchanges, including economic, political...... by the International Transitional Administrations (ITAs) in Kosovo and Iraq as well as global supply chains and their impact on the garment industry in Bangladesh....

  7. Giant lipoma arising from deep lobe of the parotid gland

    Directory of Open Access Journals (Sweden)

    Hsu Ying-Che

    2006-06-01

    Full Text Available Abstract Background Lipomas are common benign soft tissue neoplasms but they are found very rarely in the deep lobe of parotid gland. Surgical intervention in these tumors is challenging because of the proximity of the facial nerve, and thus knowledge of the anatomy and meticulous surgical technique are essential. Case presentation A 71-year-old female presented with a large asymptomatic mass, which had occupied the left facial area for over the past fifteen years, and she requested surgical excision for a cosmetically better facial appearance. The computed tomography (CT scan showed a well-defined giant lipoma arising from the left deep parotid gland. The lipoma was successfully enucleated after full exposure and mobilization of the overlying facial nerve branches. The surgical specimen measured 9 × 6 cm in size, and histopathology revealed fibrolipoma. The patient experienced an uneventful recovery, with a satisfying facial contour and intact facial nerve function. Conclusion Giant lipomas involving the deep parotid lobe are extremely rare. The high-resolution CT scan provides an accurate and cost-effective preoperative investigative method. Surgical management of deep lobe lipoma should be performed by experienced surgeons due to the need for meticulous dissection of the facial nerve branches. Superficial parotidectomy before deep lobe lipoma removal may be unnecessary in selected cases because preservation of the superficial lobe may contribute to a better aesthetic and functional result.

  8. Utilizing national and international registries to enhance pre-market medical device regulatory evaluation.

    Science.gov (United States)

    Yue, Lilly Q; Campbell, Gregory; Lu, Nelson; Xu, Yunling; Zuckerman, Bram

    2016-01-01

    Regulatory decisions are made based on the assessment of risk and benefit of medical devices at the time of pre-market approval and subsequently, when post-market risk-benefit balance needs reevaluation. Such assessments depend on scientific evidence obtained from pre-market studies, post-approval studies, post-market surveillance studies, patient perspective information, as well as other real world data such as national and international registries. Such registries provide real world evidence and are playing a more and more important role in enhancing the safety and effectiveness evaluation of medical devices. While these registries provide large quantities of data reflecting real world practice and can potentially reduce the cost of clinical trials, challenges arise concerning (1) data quality adequate for regulatory decision-making, (2) bias introduced at every stage and aspect of study, (3) scientific validity of study designs, and (4) reliability and interpretability of study results. This article will discuss related statistical and regulatory challenges and opportunities with examples encountered in medical device regulatory reviews.

  9. Wilms tumor arising in extracoelomic paravertebral soft tissues.

    LENUS (Irish Health Repository)

    Mulligan, Linda

    2012-02-01

    Extrarenal Wilms tumor (ERWT) is a well-established entity which most commonly arises within the genitourinary tract, including intracoelomic paranephric soft tissue. Rarely, ERWT arises within teratoma, and it tends to occur predominantly in distinct settings, such as females with spinal defects and males with testicular teratomas. We report a unique ERWT arising within an extracoelomic teratoma of the paraspinal musculature, thereby expanding the range of reported locations for this unusual tumor.

  10. Solitary Fibrous Tumor Arising from Stomach: CT Findings

    Science.gov (United States)

    Park, Sung Hee; Kwon, Jieun; Park, Jong-pil; Park, Mi-Suk; Lim, Joon Seok; Kim, Joo Hee; Kim, Ki Whang

    2007-01-01

    Solitary fibrous tumors are spindle-cell neoplasms that usually develop in the pleura and peritoneum, and rarely arise in the stomach. To our knowledge, there is only one case reporting a solitary fibrous tumor arising from stomach in the English literature. Here we report the case of a 26-year-old man with a large solitary fibrous tumor arising from the stomach which involved the submucosa and muscular layer and resembled a gastrointestinal stromal tumor in the stomach, based on what was seen during abdominal computed tomography. A solitary fibrous tumor arising from the stomach, although rare, could be considered as a diagnostic possibility for gastric submucosal tumors. PMID:18159603

  11. Squamous Cell Carcinoma Arising in Mature Teratoma of the Ovary Masquerading as Abdominal Tuberculosis

    Directory of Open Access Journals (Sweden)

    Shreeya Taresh Indulkar

    2018-01-01

    Full Text Available Pure squamous cell carcinoma (SCC of the ovary is rare. SCC can arise in a mature teratoma (MT, ovarian endometriosis or in a Brenner tumor. SCC is the most common malignant transformation arising in MT and comprises 80% of all cases. Such neoplastic transformations are extremely difficult either to predict or detect early. The mechanism of malignant transformation has not been completely understood. Due to the rarity and the aggressive course, diagnosis and treatment constitute a big challenge. We report a case of SCC arising in MT presenting with a huge abdominopelvic mass and abundant peritoneal collections clinically masquerading as abdominal tuberculosis. A review of literature with special emphasis on prognosis and treatment modalities is also presented.

  12. 32 CFR 537.19 - Demands arising from maritime claims.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 3 2010-07-01 2010-07-01 true Demands arising from maritime claims. 537.19 Section 537.19 National Defense Department of Defense (Continued) DEPARTMENT OF THE ARMY CLAIMS AND ACCOUNTS CLAIMS ON BEHALF OF THE UNITED STATES § 537.19 Demands arising from maritime claims. (a) It is...

  13. Biopharmaceuticals as Challenges to the Regulatory System

    NARCIS (Netherlands)

    Ebbers, H.C.

    2012-01-01

    Biopharmaceuticals differ from small molecules in terms of structure and pharmacology. Furthermore, they are also prescribed for different patient populations. The protein nature of biopharmaceuticals makes them especially prone for immunological reactions and their safety profile may be affected by

  14. 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

  15. Solitary Fibrous Tumor Arising from Stomach: CT Findings

    OpenAIRE

    Park, Sung Hee; Kim, Myeong-Jin; Kwon, Jieun; Park, Jong-pil; Park, Mi-Suk; Lim, Joon Seok; Kim, Joo Hee; Kim, Ki Whang

    2007-01-01

    Solitary fibrous tumors are spindle-cell neoplasms that usually develop in the pleura and peritoneum, and rarely arise in the stomach. To our knowledge, there is only one case reporting a solitary fibrous tumor arising from stomach in the English literature. Here we report the case of a 26-year-old man with a large solitary fibrous tumor arising from the stomach which involved the submucosa and muscular layer and resembled a gastrointestinal stromal tumor in the stomach, based on what was see...

  16. Regulatory Physiology

    Science.gov (United States)

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

    1999-01-01

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

  17. Regulatory Benchmarking

    DEFF Research Database (Denmark)

    Agrell, Per J.; Bogetoft, Peter

    2017-01-01

    Benchmarking methods, and in particular Data Envelopment Analysis (DEA), have become well-established and informative tools for economic regulation. DEA is now routinely used by European regulators to set reasonable revenue caps for energy transmission and distribution system operators. The appli......Benchmarking methods, and in particular Data Envelopment Analysis (DEA), have become well-established and informative tools for economic regulation. DEA is now routinely used by European regulators to set reasonable revenue caps for energy transmission and distribution system operators....... The application of bench-marking in regulation, however, requires specific steps in terms of data validation, model specification and outlier detection that are not systematically documented in open publications, leading to discussions about regulatory stability and economic feasibility of these techniques...

  18. Regulatory Benchmarking

    DEFF Research Database (Denmark)

    Agrell, Per J.; Bogetoft, Peter

    2017-01-01

    Benchmarking methods, and in particular Data Envelopment Analysis (DEA), have become well-established and informative tools for economic regulation. DEA is now routinely used by European regulators to set reasonable revenue caps for energy transmission and distribution system operators. The appli......Benchmarking methods, and in particular Data Envelopment Analysis (DEA), have become well-established and informative tools for economic regulation. DEA is now routinely used by European regulators to set reasonable revenue caps for energy transmission and distribution system operators....... The application of benchmarking in regulation, however, requires specific steps in terms of data validation, model specification and outlier detection that are not systematically documented in open publications, leading to discussions about regulatory stability and economic feasibility of these techniques...

  19. Squamous cell carcinoma arising in mature cystic teratoma of ovary

    Directory of Open Access Journals (Sweden)

    Ranu Patni

    2014-01-01

    Full Text Available Squamous cell carcinoma of the ovary is a rare condition and usually arises in mature cystic teratoma (MCT or dermoid cyst of the ovary. The reported incidence of malignant transformation in MCT is approximately 2%. A case of squamous cell carcinoma arising in a dermoid cyst of the ovary presenting at an early stage is presented here. A 53-year-old postmenopausal lady, presented with the complaint of pain in right lower abdomen since one month and a large complex abdomino-pelvic mass on examination and investigations. Final histopathology was reported as squamous cell carcinoma of left ovary arising from dermoid cyst and a benign dermoid cyst in the right ovary. The patient was assigned to squamous cell carcinoma of the ovary arising in a mature cystic teratoma, surgical stage Ic2. In view of the poor prognosis, adjuvant chemotherapy was started.

  20. Convex solutions of systems arising from Monge-Ampere equations

    Directory of Open Access Journals (Sweden)

    Haiyan Wang

    2009-10-01

    Full Text Available We establish two criteria for the existence of convex solutions to a boundary value problem for weakly coupled systems arising from the Monge-Ampère equations. We shall use fixed point theorems in a cone.

  1. Empiricism Verses Rationalism: Matters Arising in Medical Practice ...

    African Journals Online (AJOL)

    Empiricism Verses Rationalism: Matters Arising in Medical Practice. ... AFRREV STECH: An International Journal of Science and Technology ... entirely antagonistic to one another, one favoring the senses and the other favoring the mind.

  2. Multi-objective convex programming problem arising in multivariate ...

    African Journals Online (AJOL)

    user

    Multi-objective convex programming problem arising in ... However, although the consideration of multiple objectives may seem a novel concept, virtually any nontrivial ..... Solving multiobjective programming problems by discrete optimization.

  3. MYC Amplification in Angiosarcoma Arising from an Arteriovenous Graft Site

    Directory of Open Access Journals (Sweden)

    Kristen M. Paral

    2015-01-01

    Full Text Available Angiosarcoma arising in association with an arteriovenous graft (AVG or fistula is a unique clinicopathologic scenario that appears to be gaining recognition in the literature. Among reported cases, none has described high-level MYC gene amplification, a genetic aberration that is increasingly unifying the various clinicopathologic subdivisions of angiosarcoma. We therefore report the MYC gene status in a case of angiosarcoma arising at an AVG site.

  4. Electric reaction arising in bone subjected to mechanical loadings

    Science.gov (United States)

    Murasawa, Go; Cho, Hideo; Ogawa, Kazuma

    2006-03-01

    The aim of present study is the investigation of the electric reaction arising in bone subjected to mechanical loadings. Firstly, specimen was fabricated from femur of cow, and ultrasonic propagation in bone was measured by ultrasonic technique. Secondary, 4-point bending test was conducted up to fracture, and electric reaction arising in bone was measured during loading. Thirdly, cyclic 4-point bending test was conducted to investigate the effect of applied displacement speed on electric reaction.

  5. Removal of regulatory controls for materials and sites

    International Nuclear Information System (INIS)

    2004-01-01

    Issues with the removal of regulatory controls are very important on the agenda of the regulatory authorities dealing with radioactive waste management (RWM). These issues arise prominently in decommissioning and in site remediation, and decisions can be very wide ranging having potentially important economic impacts and reaching outside the RWM area. The RWMC Regulators Forum started to address these issues by holding a topical discussion at its meeting in March 2003. Ths present document collates the national regulatory positions in the area of removal of regulatory controls. A summary of the national positions is also provided. The document is up to date to April 2004. (authors)

  6. Four Different Tumors Arising in a Nevus Sebaceous

    Directory of Open Access Journals (Sweden)

    Takeshi Namiki

    2016-04-01

    Full Text Available Nevus sebaceous is known by its association with one or more secondary tumors, but more than three multiple tumors arising from a nevus sebaceous is extremely rare. A 67-year-old female presented with a light brown plaque on the back of her head that contained a dome-shaped black node and an erosive lesion. Histopathological examination showed atypical basaloid cells in the black node. At the periphery of that node, structures resembling follicular germs extruded from interlacing cords in the upper portion and tumor nests with sebocytes were in the lower portion. In the erosive lesion, papillated structures with an apocrine epithelium were observed. In the light brown plaque, enlargement of sebaceous lobules was noted. From those histopathological features, a diagnosis of syringocystadenoma papilliferum, sebaceoma, trichoblastoma and basal cell carcinoma arising from a nevus sebaceous was made. We discuss the rarity of multiple tumors arising from a nevus sebaceous.

  7. Anomalous Posterior Intercostal Arterial Trunk Arising From the Abdominal Aorta

    Energy Technology Data Exchange (ETDEWEB)

    Jie, Bing, E-mail: jbshh@163.com; Yu, Dong, E-mail: yudong-mail@126.com; Jiang, Sen, E-mail: jasfly77@vip.163.com [Tongji University School of Medicine, Department of Radiology, Shanghai Pulmonary Hospital (China)

    2016-04-15

    A common trunk of the ipsilateral posterior intercostal artery (PIA) arising from the thoracic aorta is usually an anatomical variation. However, a common trunk of bilateral posterior intercostal arterial trunk (PIAT) arising from the abdominal aorta is rare. It is important to recognize this anatomical variation of PIA when performing interventional radiological procedures. We present a rare case of an anomalous PIAT that originated from the abdominal aorta in a patient with hemoptysis caused by tuberculosis sequelae. Bilateral 4th to 11th PIAs arose from a common trunk and the trunk arising from the posterior aspect of the abdominal aorta at the level of T12/L1 intervertebral space. The pathological right 4th and 5th PIAs and bronchial arteries were embolized. Hemoptysis has been controlled for 3 months.

  8. Mitigating the Impacts from the Challenges that Arise in IT Outsourcing Relationships

    DEFF Research Database (Denmark)

    M.A. Juel, Elisabeth; Hedman, Jonas

    In modern business world, Information Technology (IT) outsourcing is a major trend, with an annual growth rate of over 20%. The current literature on IT outsourcing show benefits, but also evidence that many of those involved in outsourcing are not satisfied with the results. One approach to solve...... issues is to develop guidelines, policies, and management practices. There are some guidelines in the literature that propose ways to improve the outsourcing process and hopefully the outcome. The current guidelines are formulated at a strategic level and do not address the individual interaction between...... outsourcing parties. Thus, the purpose of this paper is to propose guidelines to aid individuals who are in regular contact with those at the outsourced unit. A case study was conducted with a multinational firm to develop and test a set of IT Outsourcing Guidelines. The guidelines were developed...

  9. Extraskeletal Ewing’s Sarcoma Arising from the Sciatic Nerve: A Diagnostic Challenge

    Directory of Open Access Journals (Sweden)

    Aadhar Sharma

    2015-01-01

    Full Text Available Ewing’s sarcoma is a common bone tumour of childhood but is a rare occurrence in individuals over 20 years of age. Few cases are reported as originating from peripheral nerves. We present an unusual case of extraosseous Ewing’s sarcoma originating from the sciatic nerve in a 66-year-old patient which had the clinical hallmarks of a benign nerve sheath tumour. Following discussion at a multidisciplinary meeting, excision biopsy of the suspected benign nerve sheath tumour was planned. At operation, the mass had malignant features. Histology confirmed the presence of Ewing’s sarcoma. Due to the morbidity of nerve resection, radiotherapy and chemotherapy were commenced. Ewing’s sarcoma is known to mimic benign pathologies. In this case there were subtle signs of a malignant process in the form of unremitting pain. It is vital to keep in mind the less common tumours that can affect the peripheral nervous system in such cases.

  10. Climate is the real challenge, not shortage. New problems arising for global energy supply

    Energy Technology Data Exchange (ETDEWEB)

    Pestel, E.

    1988-11-01

    The author of the article is Professor E. Pestel who, as an executive member of the Club of Rome, belongs to the group of experts who first gave impetus to start thinking about the global problems of mankind. In his publications on the problems linked with CO/sub 2/ emission he explains the unavoidable dilemma created by the growing world population and the growing demand for energy on the one hand, and the resulting hazards to the global climate on the other. His analyses take away the soft cushion of hopeful make-believe still widespread in the Western World, and in his capacity as an expert and realist he decidedly calls for decisions and measures to tackle the problem.

  11. Malignant melanoma arising in congenital melanocytic nevi: clinical and dermoscopic challenges

    Directory of Open Access Journals (Sweden)

    Fatma Pelin Cengiz

    2017-01-01

    Full Text Available Congenital melanocytic nevi (CMN are visible pigmented lesions in the skin that are present at birth. CMN are benign malformations resulting from defective development of melanocyte precursors in the embryo. Six MMs from six patients were analyzed by clinical and dermoscopic examination. Of the patients, 33.3% were female (N = 2 and 66.6% were male (N = 4. Of the MMs, four (66.6% were superficial spreading MM and two (33.3 % were in situ MM. A reticular pattern was present in the MMs of three patients (50%, a homogeneous pattern was present in the other patients (50% at the base of the MMs. Superficial spreading melanomas and in situ melanomas with atypical dots and globules and a blue-white veil were the most common dermoscopic features of MMs found in CMN.

  12. 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.

  13. Simulating Arctic clouds during Arctic Radiation- IceBridge Sea and Ice Experiment (ARISE)

    Science.gov (United States)

    Bromwich, D. H.; Hines, K. M.; Wang, S. H.

    2015-12-01

    The representation within global and regional models of the extensive low-level cloud cover over polar oceans remains a critical challenge for quantitative studies and forecasts of polar climate. In response, the polar-optimized version of the Weather Research and Forecasting model (Polar WRF) is used to simulate the meteorology, boundary layer, and Arctic clouds during the September-October 2014 Arctic Radiation- IceBridge Sea and Ice Experiment (ARISE) project. Polar WRF was developed with several adjustments to the sea ice thermodynamics in WRF. ARISE was based out of Eielson Air Force Base near Fairbanks, Alaska and included multiple instrumented C-130 aircraft flights over open water and sea ice of the Beaufort Sea. Arctic boundary layer clouds were frequently observed within cold northeasterly flow over the open ocean and ice. Preliminary results indicate these clouds were primarily liquid water, with characteristics differing between open water and sea ice surfaces. Simulated clouds are compared to ARISE observations. Furthermore, Polar WRF simulations are run for the August-September 2008 Arctic Summer Cloud Ocean Study (ASCOS) for comparison to the ARISE. Preliminary analysis shows that simulated low-level water clouds over the sea ice are too extensive during the the second half of the ASCOS field program. Alternatives and improvements to the Polar WRF cloud schemes are considered. The goal is to use the ARISE and ASCOS observations to achieve an improved polar supplement to the WRF code for open water and sea ice that can be provided to the Polar WRF community.

  14. Guidance notes for the protection of persons against ionising radiations arising from medical and dental use

    International Nuclear Information System (INIS)

    1988-01-01

    Guidance notes have been prepared by the NRPB, the Health Departments and the Health and Safety Executive for the protection of all persons against ionising radiations arising from medical and dental use. The guidance notes are a guide to good radiation protection practice consistent with regulatory requirements. The areas covered include medical and dental radiology, diagnostic X-ray equipment for medical and dental radiography, beam therapy and remotely controlled after-loading, brachytherapy, diagnostic and therapeutic uses of unsealed radioactive substances, diagnostic uses of sealed or other solid radioactive sources, patients leaving hospital after administration of radioactive substances, precautions after death of a patient whom radioactive substances have been administered, storage and movement of radioactive substances, disposal of radioactive waste and contingency planning and emergency procedures. (U.K.)

  15. 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)

  16. Role of partnership in enhancing the performance of radiation regulatory authority in Zambia

    International Nuclear Information System (INIS)

    Banda, S.C.

    2003-01-01

    The National Radiation Infrastructure includes legislation, human resource, technical capacity to execute responsibilities of the regulatory (1). In cases of developing countries like Zambia, special challenges arise in view of the constraints both in terms of human resource and funding. This paper will highlight same measures that may be undertaken to improve the operations of nation radiation protection infrastructure. The measures include collaboration with Science and Technology organisations that have technical capacity, delegation of responsible to key institutions that may have competence and generation of funds through training and provision of reliable quality service. (2). In Zambia, some achievements in this line have been registered by Radiation Protection Board working with the University of Zambia and National Institute for Scientific and Industrial Research (3). Some measures of generation of funds have been done though utilization of the generated remains to be the limiting factor to exploit fully benefits that may arise from the use of the monies generated from services. Partnerships with private sector may be used as regulatory authorities for support to its programme in particular the public awareness campaign. Sponsorship by a Private Cellar Phone Company (Telecel Zambia) and Rotary Club of Lusaka for Radiation Week to Radiation Protection Service under Theme 'Safe Radiation Use' is one such an example. The other opportunity is the technical cooperation with regional and international organisations such as SADC, IAEA, WHO, Interpol, EU and WCO for technical capacity building, human resource development and information access. (author)

  17. Lower Limb Injuries Arising From Motorcycle Crashes | Kortor ...

    African Journals Online (AJOL)

    Background: Motorcycle accidents are the second most common cause of road traffic accidents in both developing and developed countries. In this study we aim to look at the pattern and characteristics of lower limb injuries arising from motorcycle accidents and evaluate early outcome of treatment. Methods: All the patients ...

  18. Squamous cell carcinoma arising in a mature cystic teratoma

    Directory of Open Access Journals (Sweden)

    Gupta Vishwanath

    2009-04-01

    Full Text Available Two cases of squamous cell carcinoma (SCC arising in a mature cystic teratoma (MCT are being discussed for their rarity and pattern of infiltration of tumor cells in the stroma (alpha mode, beta mode and gamma mode, which is a key factor in deciding the prognosis and patient survival.

  19. Ecknomic benefits arising from the Canadian nuclear industry

    International Nuclear Information System (INIS)

    1982-03-01

    This document is a collection of surveys of the Canadian nuclear industry, with forecasts covering a number of possible scenarios. Topics covered include uranium mining and processing; economic benefits arising from the design, manufacture and construction of CANDU generating stations; employment and economic activity in the Canadian nqclear industry; and an overview of the remainder of the industry

  20. Testicular artery arising from an aberrant right renal artery | Suluba ...

    African Journals Online (AJOL)

    This case report we discovered the rare variation of the origin of the right testicular artery arising from the right aberrant renal artery with double renal artery irrigating both left and right kidneys. These variations in the testicular arteries and renal arteries have implication to surgical procedures such as orchidopexy repair for ...

  1. Sound radiation quantities arising from a resilient circular radiator

    NARCIS (Netherlands)

    Aarts, R.M.; Janssen, A.J.E.M.

    2009-01-01

    Power series expansions in ka are derived for the pressure at the edge of a radiator, the reaction force on the radiator, and the total radiated power arising from a harmonically excited, resilient, flat, circular radiator of radius a in an infinite baffle. The velocity profiles on the radiator are

  2. 32 CFR 536.111 - Investigation of claims arising under international agreements (for those claims arising in the...

    Science.gov (United States)

    2010-07-01

    ... under international agreements (for those claims arising in the United States). Responsibility for... civilian component is attached, including the legal office of another armed force, to carry out the responsibility to investigate. The investigation will comply with the responsible Service's implementing claims...

  3. 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...

  4. Arthroscopic Resection of Wrist Ganglion Arising from the Lunotriquetral Joint

    OpenAIRE

    Mak, Michael C. K.; Ho, Pak-cheong; Tse, W. L.; Wong, Clara W. Y.

    2013-01-01

    The dorsal wrist ganglion is the most common wrist mass, and previous studies have shown that it arises from the scapholunate interval in the vast majority of cases. Treatment has traditionally been open excision, and more recently arthroscopic resection has been established as an effective and less invasive treatment method. However, application of this technique to ganglia in atypical locations has not been reported, where open excision is the usual practice. This report describes two cases...

  5. Hausdorff dimension of certain sets arising in Engel expansions

    Science.gov (United States)

    Fang, Lulu; Wu, Min

    2018-05-01

    The present paper is concerned with the Hausdorff dimension of certain sets arising in Engel expansions. In particular, the Hausdorff dimension of the set is completely determined, where A n (x) can stand for the digit, gap and ratio between two consecutive digits in the Engel expansion of x and ϕ is a positive function defined on natural numbers. These results significantly extend the existing results of Galambos’ open problems on the Hausdorff dimension of sets related to the growth rate of digits.

  6. Radiation-induced squamous carcinoma arising within a seborrhoeic keratosis

    Energy Technology Data Exchange (ETDEWEB)

    Suvarna, S.K.; Bagary, M.; Glazer, G. (Saint Mary' s Hospital, London (United Kingdom))

    1993-04-01

    Seborrhoeic keratoses (SK) are common skin tumours. They are benign, and present little difficulty in management. However, rare malignant transformation is recognized. The authors report a case of a squamous cell carcinoma arising from dysplastic changes within a long-standing SK on the chest wall of a 75-year-old retired radiologist, and consider the role of radiation in inducing malignant change within SKs. (author).

  7. Radiation-induced squamous carcinoma arising within a seborrhoeic keratosis

    International Nuclear Information System (INIS)

    Suvarna, S.K.; Bagary, M.; Glazer, G.

    1993-01-01

    Seborrhoeic keratoses (SK) are common skin tumours. They are benign, and present little difficulty in management. However, rare malignant transformation is recognized. The authors report a case of a squamous cell carcinoma arising from dysplastic changes within a long-standing SK on the chest wall of a 75-year-old retired radiologist, and consider the role of radiation in inducing malignant change within SKs. (author)

  8. Squamous neoplasms arising within tattoos: clinical presentation, histopathology and management.

    Science.gov (United States)

    Junqueira, A L; Wanat, K A; Farah, R S

    2017-08-01

    Tattooing, which involves the placement of ink into the skin, is an ancient decorative technique that has remained popular in modern society. Tattoos have long been known to cause cutaneous reactions, which include the emergence of neoplasms such as keratoacanthoma (KA) and squamous cell carcinoma (SCC) in tattooed areas of the skin. We review the clinical presentations, histology and treatment options for squamous neoplasms, primarily KA and SCC, arising in tattoos. © 2017 British Association of Dermatologists.

  9. Basal Cell Carcinoma Arising in a Tattooed Eyebrow

    Science.gov (United States)

    Lee, Jong-Sun; Park, Jin; Kim, Seong-Min; Kim, Han-Uk

    2009-01-01

    Malignant skin tumors, including squamous cell carcinoma and malignant melanoma, have occurred in tattoos. Seven documented cases of basal cell carcinoma associated with tattoos have also been reported in the medical literature. We encountered a patient with basal cell carcinoma in a tattooed eyebrow. We report on this case as the eighth reported case of a patient with basal cell carcinoma arising in a tattooed area. PMID:20523804

  10. Entanglement witnesses arising from exposed positive linear maps

    OpenAIRE

    Ha, Kil-Chan; Kye, Seung-Hyeok

    2011-01-01

    We consider entanglement witnesses arising from positive linear maps which generate exposed extremal rays. We show that every entanglement can be detected by one of these witnesses, and this witness detects a unique set of entanglement among those. Therefore, they provide a minimal set of witnesses to detect all entanglement in a sense. Furthermore, if those maps are indecomposable then they detect large classes of entanglement with positive partial transposes which have nonempty relative int...

  11. 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.

  12. Squamous cell carcinoma arising in previously burned or irradiated skin

    International Nuclear Information System (INIS)

    Edwards, M.J.; Hirsch, R.M.; Broadwater, J.R.; Netscher, D.T.; Ames, F.C.

    1989-01-01

    Squamous cell carcinoma (SCC) arising in previously burned or irradiated skin was reviewed in 66 patients treated between 1944 and 1986. Healing of the initial injury was complicated in 70% of patients. Mean interval from initial injury to diagnosis of SCC was 37 years. The overwhelming majority of patients presented with a chronic intractable ulcer in previously injured skin. The regional relapse rate after surgical excision was very high, 58% of all patients. Predominant patterns of recurrence were in local skin and regional lymph nodes (93% of recurrences). Survival rates at 5, 10, and 20 years were 52%, 34%, and 23%, respectively. Five-year survival rates in previously burned and irradiated patients were not significantly different (53% and 50%, respectively). This review, one of the largest reported series, better defines SCC arising in previously burned or irradiated skin as a locally aggressive disease that is distinct from SCC arising in sunlight-damaged skin. An increased awareness of the significance of chronic ulceration in scar tissue may allow earlier diagnosis. Regional disease control and survival depend on surgical resection of all known disease and may require radical lymph node dissection or amputation

  13. Transoral videolaryngoscopic surgery for papillary carcinoma arising in lingual thyroid.

    Science.gov (United States)

    Mogi, Chisato; Shinomiya, Hirotaka; Fujii, Natsumi; Tsuruta, Tomoyuki; Morita, Naruhiko; Furukawa, Tatsuya; Teshima, Masanori; Kanzawa, Maki; Hirokawa, Mitsuyoshi; Otsuki, Naoki; Nibu, Ken-Ichi

    2018-05-15

    Carcinoma arising in lingual thyroid is an extremely rare entity accounting for only 1% of all reported ectopic thyroids. Here, we report a case of carcinoma arising in lingual thyroid, which has been successfully managed by transoral resection and bilateral neck dissections. A lingual mass 4-cm in diameter with calcification was incidentally detected by computed tomography at medical check-up. No thyroid tissue was observed in normal position. Ultrasound examination showed bilateral multiple lymphadenopathies. Fine needle aspiration biopsy from lymph node in his right neck was diagnosed as Class III and thyroglobulin level of the specimen was 459ng/ml. Due to the difficulty in performing FNA of the lingual masses, right neck dissection was performed in advance for diagnostic purpose. Pathological examination showed existence of large and small follicular thyroid tissues in several lymph nodes, suggesting lymph node metastasis from thyroid carcinoma. Two months after the initial surgery, video-assisted transoral resection of lingual thyroid with simultaneous left neck dissection was performed. Postoperative course was uneventful. Papillary carcinoma was found in the lingual thyroid and thyroid tissues were also found in left cervical lymph nodes. Video-assisted transoral resection was useful for the treatment of thyroid cancer arising in lingual thyroid. Copyright © 2018 Elsevier B.V. All rights reserved.

  14. 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...

  15. Dynamics of the middle atmosphere as observed by the ARISE project

    Science.gov (United States)

    Blanc, E.

    2015-12-01

    It has been strongly demonstrated that variations in the circulation of the middle atmosphere influence weather and climate all the way to the Earth's surface. A key part of this coupling occurs through the propagation and breaking of planetary and gravity waves. However, limited observations prevent to faithfully reproduce the dynamics of the middle atmosphere in numerical weather prediction and climate models. The main challenge of the ARISE (Atmospheric dynamics InfraStructure in Europe) project is to combine existing national and international observation networks including: the International infrasound monitoring system developed for the CTBT (Comprehensive nuclear-Test-Ban Treaty) verification, the NDACC (Network for the Detection of Atmospheric Composition Changes) lidar network, European observation infrastructures at mid latitudes (OHP observatory), tropics (Maïdo observatory), high latitudes (ALOMAR and EISCAT), infrasound stations which form a dense European network and satellites. The ARISE network is unique by its coverage (polar to equatorial regions in the European longitude sector), its altitude range (from troposphere to mesosphere and ionosphere) and the involved scales both in time (from seconds to tens of years) and space (from tens of meters to thousands of kilometers). Advanced data products are produced with the scope to assimilate data in the Weather Prediction models to improve future forecasts over weeks and seasonal time scales. ARISE observations are especially relevant for the monitoring of extreme events such as thunderstorms, volcanoes, meteors and at larger scales, deep convection and stratospheric warming events for physical processes description and study of long term evolution with climate change. Among the applications, ARISE fosters integration of innovative methods for remote detection of non-instrumented volcanoes including distant eruption characterization to provide notifications with reliable confidence indices to the

  16. Professional and Regulatory Search

    Science.gov (United States)

    Professional and Regulatory search are designed for people who use EPA web resources to do their job. You will be searching collections where information that is not relevant to Environmental and Regulatory professionals.

  17. The CANDU-PHW generating system waste arisings

    International Nuclear Information System (INIS)

    Simmons, G.R.

    1979-03-01

    In this report, the volume of material and level of contained radioactive nuclides are tabulated for wastes arising from four fuel cycles which might be operated in CANDU-PHW (CANada Deuterium Uranium - Pressurized Heavy Water) reactors. The data presented, based on Canadian experience and/or studies, cover the range of conditioned waste volumes which could be expected from steady-state (no growth), CANDU-PHW-powered electrical generating systems. The wastes arising from operation and decommissioning of facilities in each phase of each fuel cycle are estimated. Each fuel cycle is considered to operate in isolation with the data given in terms of quantities per gigawatt-year of electricity produced. Three of the fuel cycles for which data are presented, the natural uranium once-through cycle, the plutonium-enriched uranium cycle (plutonium recycle) and the low-burnup uranium-enriched thorium cycle (thorium and uranium recycle), were studied by INFCE WG.7 (the International Nuclear Fuel Cycle Evaluation, Working Group 7) as fuel cycles 4, 5 and 6. The high-burnup uranium-enriched thorium cycle is included for comparison. INFCE WG.7 selected many common reference parameters which are applied uniformly to all seven INFCE WG.7 reference fuel cycles in determining waste arisings. Where these parameters differ from the data of Canadian origin given in the body of this report, the INFCE WG.7 data are given in an appendix. The waste management costs associated with operation of each INFCE WG.7 reference fuel cycle were calculated and compared by the working group. An arbitrary set of costing parameters and disposal technologies was selected by the working group for application to each of the reference fuel cycles. The waste management and disposal costs for the PHW reactor fuel cycles based on these arbitrary cost parameters are given in an appendix. (author)

  18. Knowledge Protection and Input Complexity Arising from Open Innovation

    DEFF Research Database (Denmark)

    Peeters, Thijs; Sofka, Wolfgang

    Controlling unique knowledge is of increasing importance to firms. Therefore, firms use knowledge protection mechanisms to prevent competitors from imitating their knowledge. We study the effects of the complexity of knowledge inputs that arises from open innovation on the importance of two widely...... used protection mechanisms: patents and trademarks. We argue that this complexity makes the threat of imitation less predictable, and thus makes knowledge protection more important. By analyzing survey data of 938 German firms, we find that patents are more important for firms in industries with higher...... knowledge input complexity. Furthermore, we show that the dynamics and not the level of knowledge input complexity positively affect the importance of trademarks....

  19. Solitary fibrous tumor arising in an intrathoracic goiter

    DEFF Research Database (Denmark)

    Larsen, Stine Rosenkilde; Godballe, Christian; Krogdahl, Annelise

    2010-01-01

    . CONCLUSION: The histological appearance and immunohistochemical reaction pattern of SFT is characteristic. The entity should be considered when dealing with a spindle cell lesion in the thyroid gland. All cases of this site of origin reported have had a benign clinical course. As only a small number of cases......BACKGROUND: Solitary fibrous tumor (SFT) is a rare spindle cell tumor most often found in the mediastinal pleura. Nineteen cases of SFT arising in the thyroid gland have been reported. We report a case of SFT of the thyroid gland with immunohistochemical and cytogenetic investigation. SUMMARY: A 58...

  20. Facial Cellulitis Arising from Dens Evaginatus: A Case Report

    Directory of Open Access Journals (Sweden)

    Chun-Ming Chen

    2005-07-01

    Full Text Available Dens evaginatus is a developmental anomaly that produces a tubercle on the occlusal surface of a tooth. It is found most frequently in the mandibular premolars. The occlusal tubercle easily causes occlusal interferences. Attrition or fracture of the tubercle can lead to pulpitis, pulp necrosis, periapical pathosis, and periapical infection. This case report illustrates the treatment of facial cellulitis arising from dens evaginatus with open apex. Calcium hydroxide was used for the apexification procedure. One year after canal obturation, radiography revealed no apical pathosis and the apical seal was evident.

  1. Management of radioactive solid waste arisings from PFR reprocessing

    International Nuclear Information System (INIS)

    Allardice, R.H.; Hackney, S.; Bailey, G.; Bremner, W.; Lillyman, E.; Pugh, O.; Reekie, J.

    1982-01-01

    A description is given of the solid radioactive waste management facilities for dealing with the arisings from PFR reprocessing at the Dounreay Nuclear Power Development Establishment. Four major categories of solid waste are identified. The 'La Calhene' posting system for the transfer of active wastes which has been installed is discussed. The three new retrievable stores for high α#betta##betta#, high α low #betta##betta# and low α high #betta##betta# are described. The methods of waste categorisation by non-destructive assay techniques are outlined. Finally a review of operating experience with the facilities is presented. (U.K.)

  2. Radiologic findings of malignant tumors arising from ovarian endometriosis

    International Nuclear Information System (INIS)

    Lee, Eun Ju; Joo, Hee Jae; Kim, Bo Hyun

    1999-01-01

    To determine the radiologic characteristics of malignant tumors arising from ovarian endometriosis. The radiologic findings of eleven patients with pelvic masses histologically confirmed as malignant ovarian tumors arising from endometriosis were retrospectively reviewed. All patients underwent MR, and six underwent ultrasonography. The findings were evaluated with regard to tumor size and shape, locularity, thickness and enhancement of the wall and septa, the presence of papillary nodule or solid portion, signal intensity of the locule, the presence of mass in contralateral ovary, ascites, local invasion, distant metastases, and the Pathologic diagnosis included clear cell carcinoma in six cases, endometrioid carcinoma in three, and mucinous cystadenocarcinoma of borderline malignancy and endometrial stromal sarcoma in one case each. Tumor size ranged from 8 to 20 (mean, 12.7)cm. The tumors were mixed in four cases, entirely cystic in three, predominantly cystic in three, and predominantly solid in one. Six cases were unilocular and five were multilocular. The wall and septa varied in thickness and regularity and were well enhanced in all but one case. In all cases papillary nodules or solid portions with similar enhancement to uterine myometrium were seen. On T1WI, the signal intensity of fluid was seen to be high in eight cases, low or intermediate in two, and of differing intensity in one. Ten cases showed high signal intensity on T2WI, whereas in one case in which high signal intensity was seen on T1WI, there was low signal intensity(shading). In three cases the contralateral ovary contained an endometrioma. Other features included ascites in seven cases and peritoneal seeding in one. Malignant ovarian tumors arising from endometriosis showed radiologic features of malignancy:they were larger than 10cm, there was enhancement of the wall and septa, and a papillary nodule or solid portion was present. However, the presence of hyperintense fluid, as seen on T1WI

  3. Radiologic findings of malignant tumors arising from ovarian endometriosis

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Eun Ju; Joo, Hee Jae [Ajou Univ. College of Medicine, Suwon (Korea, Republic of); Kim, Bo Hyun [SungkyunKwan Univ. College of Medicine, Seoul (Korea, Republic of)

    1999-11-01

    To determine the radiologic characteristics of malignant tumors arising from ovarian endometriosis. The radiologic findings of eleven patients with pelvic masses histologically confirmed as malignant ovarian tumors arising from endometriosis were retrospectively reviewed. All patients underwent MR, and six underwent ultrasonography. The findings were evaluated with regard to tumor size and shape, locularity, thickness and enhancement of the wall and septa, the presence of papillary nodule or solid portion, signal intensity of the locule, the presence of mass in contralateral ovary, ascites, local invasion, distant metastases, and the Pathologic diagnosis included clear cell carcinoma in six cases, endometrioid carcinoma in three, and mucinous cystadenocarcinoma of borderline malignancy and endometrial stromal sarcoma in one case each. Tumor size ranged from 8 to 20 (mean, 12.7)cm. The tumors were mixed in four cases, entirely cystic in three, predominantly cystic in three, and predominantly solid in one. Six cases were unilocular and five were multilocular. The wall and septa varied in thickness and regularity and were well enhanced in all but one case. In all cases papillary nodules or solid portions with similar enhancement to uterine myometrium were seen. On T1WI, the signal intensity of fluid was seen to be high in eight cases, low or intermediate in two, and of differing intensity in one. Ten cases showed high signal intensity on T2WI, whereas in one case in which high signal intensity was seen on T1WI, there was low signal intensity(shading). In three cases the contralateral ovary contained an endometrioma. Other features included ascites in seven cases and peritoneal seeding in one. Malignant ovarian tumors arising from endometriosis showed radiologic features of malignancy:they were larger than 10cm, there was enhancement of the wall and septa, and a papillary nodule or solid portion was present. However, the presence of hyperintense fluid, as seen on T1WI

  4. Digital holographic reconstruction detection of localized corrosion arising from scratches

    Directory of Open Access Journals (Sweden)

    LIANG WANG

    2010-04-01

    Full Text Available In this study, electrochemical methods and the digital holographic reconstruction technique were combined to detect the localized scratch-induced corrosion process of Alloy 690 in 0.50 mol dm-3 H2SO4 containing 0.10 mol dm-3 NaCl. The numerical reconstruction method has been proved to be an effective technique to detect changes of solution concentration. One can obtain direct information from the reconstructed images and capture subtle more revealing changes. It provides a method to detect localized corrosion arising from scratches.

  5. Regulatory Powers in Public Procurement Law of Peruvian Administrative Agencies

    Directory of Open Access Journals (Sweden)

    Juan Carlos Morón Urbina

    2017-12-01

    Full Text Available Peruvian law has explicitly recognized regulatory powers to administrative agencies, which allows them to have a preponderant role in the production of rules in public procurement. Although these delegations of legislative authority are positively defined, distortions in the system of legal sources arise when agencies exceed delegated powers or when measures issued by administrative entities are mistaken for regulations. This paper aims to identify regulatory powers of Peruvian administrative agencies, as well as the regulatory measures they issue, and their relation with other sources of law.

  6. Boundaries of regulatory fit: Is it the thought that counts?

    DEFF Research Database (Denmark)

    Leikas, S.; Lindeman, M.; Roininen, K.

    2009-01-01

    The feeling of regulatory fit is thought to arise from the right kind of goal pursuit, but some studies imply that it may be evoked even by lesser involvement in the right kind of strategies. The present experiment explored the minimum of involvement necessary to evoke regulatory fit. Participants...... the same information. Participants in promotion focus reported more positive attitudes in the rich information condition, whereas prevention-focused participants reported more positive attitudes in the accurate information condition. The results showed that regulatory fit can be evoked through mere thought...

  7. Hybrid incompatibility arises in a sequence-based bioenergetic model of transcription factor binding.

    Science.gov (United States)

    Tulchinsky, Alexander Y; Johnson, Norman A; Watt, Ward B; Porter, Adam H

    2014-11-01

    Postzygotic isolation between incipient species results from the accumulation of incompatibilities that arise as a consequence of genetic divergence. When phenotypes are determined by regulatory interactions, hybrid incompatibility can evolve even as a consequence of parallel adaptation in parental populations because interacting genes can produce the same phenotype through incompatible allelic combinations. We explore the evolutionary conditions that promote and constrain hybrid incompatibility in regulatory networks using a bioenergetic model (combining thermodynamics and kinetics) of transcriptional regulation, considering the bioenergetic basis of molecular interactions between transcription factors (TFs) and their binding sites. The bioenergetic parameters consider the free energy of formation of the bond between the TF and its binding site and the availability of TFs in the intracellular environment. Together these determine fractional occupancy of the TF on the promoter site, the degree of subsequent gene expression and in diploids, and the degree of dominance among allelic interactions. This results in a sigmoid genotype-phenotype map and fitness landscape, with the details of the shape determining the degree of bioenergetic evolutionary constraint on hybrid incompatibility. Using individual-based simulations, we subjected two allopatric populations to parallel directional or stabilizing selection. Misregulation of hybrid gene expression occurred under either type of selection, although it evolved faster under directional selection. Under directional selection, the extent of hybrid incompatibility increased with the slope of the genotype-phenotype map near the derived parental expression level. Under stabilizing selection, hybrid incompatibility arose from compensatory mutations and was greater when the bioenergetic properties of the interaction caused the space of nearly neutral genotypes around the stable expression level to be wide. F2's showed higher

  8. Multiple Ectopic Hepatocellular Carcinomas Arising in the Abdominal Cavity

    Directory of Open Access Journals (Sweden)

    Toru Miyake

    2012-09-01

    Full Text Available Ectopic hepatocellular carcinoma (HCC is a very rare clinical entity that is defined as HCC arising from extrahepatic liver tissue. This report presents a case of ectopic multiple HCC arising in the abdominal cavity. A 42-year-old otherwise healthy male presented with liver dysfunction at a general health checkup. Both HCV antibody and hepatitis B surface antigen were negative. Laboratory examination showed elevations in serum alpha-fetoprotein and PIVKA-II. Ultrasonography and computed tomography revealed multiple nodular lesions in the abdominal cavity with ascites without a possible primary tumor. Exploratory laparoscopy was performed, which revealed bloody ascites and multiple brown nodular tumors measuring approximately 10 mm in size that were disseminated on the perineum and mesentery. A postoperative PET-CT scan was performed but it did not reveal any evidence of a tumor in the liver. The tumors resected from the peritoneum were diagnosed as HCC. The present case of HCC was thought to have possibly developed from ectopic liver on the peritoneum or mesentery.

  9. Basal Cell Carcinoma Arising in a Breast Augmentation Scar.

    Science.gov (United States)

    Edwards, Lisa R; Cresce, Nicole D; Russell, Mark A

    2017-04-01

    We report a case of a 46-year-old female who presented with a persistent lesion on the inferior right breast. The lesion was located within the scar from a breast augmentation procedure 12 years ago. The lesion had been treated as several conditions with no improvement. Biopsy revealed a superficial and nodular basal cell carcinoma, and the lesion was successfully removed with Mohs micrographic surgery. Basal cell carcinoma arising in a surgical scar is exceedingly rare with only 13 reported cases to date. This is the first reported case of basal cell carcinoma arising in a breast augmentation scar. We emphasize the importance of biopsy for suspicious lesions or those refractory to treatment, particularly those lesions that form within a scar. Level of Evidence V This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

  10. High-Grade Leiomyosarcoma Arising in a Previously Replanted Limb

    Directory of Open Access Journals (Sweden)

    Tiffany J. Pan

    2015-01-01

    Full Text Available Sarcoma development has been associated with genetics, irradiation, viral infections, and immunodeficiency. Reports of sarcomas arising in the setting of prior trauma, as in burn scars or fracture sites, are rare. We report a case of a leiomyosarcoma arising in an arm that had previously been replanted at the level of the elbow joint following traumatic amputation when the patient was eight years old. He presented twenty-four years later with a 10.8 cm mass in the replanted arm located on the volar forearm. The tumor was completely resected and pathology examination showed a high-grade, subfascial spindle cell sarcoma diagnosed as a grade 3 leiomyosarcoma with stage pT2bNxMx. The patient underwent treatment with brachytherapy, reconstruction with a free flap, and subsequently chemotherapy. To the best of our knowledge, this is the first case report of leiomyosarcoma developing in a replanted extremity. Development of leiomyosarcoma in this case could be related to revascularization, scar formation, or chronic injury after replantation. The patient remains healthy without signs of recurrence at three-year follow-up.

  11. Poorly Differentiated Squamous Cell Carcinoma Arising in Tattooed Skin

    Science.gov (United States)

    Sarma, Deba P.; Dentlinger, Renee B.; Forystek, Amanda M.; Stevens, Todd; Huerter, Christopher

    2010-01-01

    Introduction. Tattoos have increasingly become accepted by mainstream Western society. As a result, the incidence of tattoo-associated dermatoses is on the rise. The presence of a poorly differentiated squamous cell carcinoma in an old tattooed skin is of interest as it has not been previously documented. Case Presentation. A 79-year-old white homeless man of European descent presented to the dermatology clinic with a painless raised nodule on his left forearm arising in a tattooed area. A biopsy of the lesion revealed a poorly differentiated squamous cell carcinoma infiltrating into a tattoo. The lesion was completely excised and the patient remains disease-free one year later. Conclusion. All previous reports of squamous cell carcinomas arising in tattoos have been well-differentiated low-grade type or keratoacanthoma-type and are considered to be coincidental rather than related to any carcinogenic effect of the tattoo pigments. Tattoo-associated poorly differentiated invasive carcinoma appears to be extremely rare. PMID:21274289

  12. Poorly Differentiated Squamous Cell Carcinoma Arising in Tattooed Skin

    Directory of Open Access Journals (Sweden)

    Deba P. Sarma

    2010-01-01

    Full Text Available Introduction. Tattoos have increasingly become accepted by mainstream Western society. As a result, the incidence of tattoo-associated dermatoses is on the rise. The presence of a poorly differentiated squamous cell carcinoma in an old tattooed skin is of interest as it has not been previously documented. Case Presentation. A 79-year-old white homeless man of European descent presented to the dermatology clinic with a painless raised nodule on his left forearm arising in a tattooed area. A biopsy of the lesion revealed a poorly differentiated squamous cell carcinoma infiltrating into a tattoo. The lesion was completely excised and the patient remains disease-free one year later. Conclusion. All previous reports of squamous cell carcinomas arising in tattoos have been well-differentiated low-grade type or keratoacanthoma-type and are considered to be coincidental rather than related to any carcinogenic effect of the tattoo pigments. Tattoo-associated poorly differentiated invasive carcinoma appears to be extremely rare.

  13. Nipple adenoma arising from axillary accessory breast: a case report

    Directory of Open Access Journals (Sweden)

    Shioi Yoshihiro

    2012-11-01

    Full Text Available Abstract Nipple adenoma is a relatively rare benign breast neoplasm, and cases of the disease arising from the axillary accessory breast have very seldom been reported in the English literature. We report a case of nipple adenoma arising from axillary accessory breast including clinical and pathological findings. An 82-year-old woman presented with the complaint of a small painful mass in the right axilla. Physical examination confirmed a well-defined eczematous crusted mass that was 8 mm in size. The diagnosis of nipple adenoma was made from an excisional specimen on the basis of characteristic histological findings. Microscopic structural features included a compact proliferation of small tubules lined by epithelial and myoepithelial cells, and the merging of glandular epithelial cells of the adenoma into squamous epithelial cells in the superficial epidermal layer. Because clinically nipple adenoma may resemble Paget’s disease and pathologically can be misinterpreted as tubular carcinoma, the correct identification of nipple adenoma is an important factor in the differential diagnosis for axillary tumor neoplasms. Virtual slides The virtual slide(s for this article can be found here: http://www.diagnosticpathology.diagnomx.eu/vs/1186821489769063

  14. 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

  15. Regulatory activities; Actividades regulatorias

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2001-07-01

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

  16. Challenges for nuclear regulators

    International Nuclear Information System (INIS)

    Allen, M.R.

    1994-01-01

    The paper discusses issues that will present particular challenges to the nuclear industry, during the next decade, that should be addressed in order to achieve increased public acceptance of the industry. The issues of safety culture, peer review of safety, severe accidents, transport accidents and public communication are suggest as meriting special consideration. The need for nuclear regulatory agencies to establish credibility and for operating organisations to demonstrate accountability is emphasised, and the Australian experiences are reviewed. Increased collaboration by nuclear regulatory agencies in the Asian-pacific region is suggested, in order to encourage consistency of regulatory safety standards for the nuclear safety issues identified. Methods whereby this could be achieved within the framework of existing agreements and arrangements are suggested. 2 refs

  17. Evaluation of NORM in facility Venezuelan oil industry to establish regulatory criteria

    International Nuclear Information System (INIS)

    Acevedo Lozada, D. J.; Rivas, I.; Davila, L.; Flores, Y.

    2013-01-01

    The present work shows the need to identify, in the Venezuelan oil industry, the existence of exposure to natural sources of radiation should be considered as occupational. As Regulatory Authority in the area of ionizing radiation the need for regulatory processes and ensure radiation protection of personnel involved in these practices arises, as well as personal and environmental monitoring. NORM identifying an installation of the Venezuelan oil industry to establish regulatory processes and take steps to ensure occupational radiation protection. (Author)

  18. Optimal control of switched systems arising in fermentation processes

    CERN Document Server

    Liu, Chongyang

    2014-01-01

    The book presents, in a systematic manner, the optimal controls under different mathematical models in fermentation processes. Variant mathematical models – i.e., those for multistage systems; switched autonomous systems; time-dependent and state-dependent switched systems; multistage time-delay systems and switched time-delay systems – for fed-batch fermentation processes are proposed and the theories and algorithms of their optimal control problems are studied and discussed. By putting forward novel methods and innovative tools, the book provides a state-of-the-art and comprehensive systematic treatment of optimal control problems arising in fermentation processes. It not only develops nonlinear dynamical system, optimal control theory and optimization algorithms, but can also help to increase productivity and provide valuable reference material on commercial fermentation processes.

  19. Clear Cell Adenocarcinoma Arising from Abdominal Wall Endometriosis

    Directory of Open Access Journals (Sweden)

    Thouraya Achach

    2008-01-01

    Full Text Available Endometriosis is a frequent benign disorder. Malignancy arising in extraovarian endometriosis is a rare event. A 49-year-old woman is presented with a large painful abdominal wall mass. She underwent a myomectomy, 20 years before, for uterus leiomyoma. Computed tomography suggested that this was a desmoid tumor and she underwent surgery. Histological examination showed a clear cell adenocarcinoma associated with endometriosis foci. Pelvic ultrasound, computed tomography, and endometrial curettage did not show any malignancy or endometriosis in the uterus and ovaries. Adjuvant chemotherapy was recommended, but the patient was lost to follow up. Six months later, she returned with a recurrence of the abdominal wall mass. She was given chemotherapy and then she was reoperated.

  20. Primary extraskeletal mesenchymal chondrosarcoma arising from the iliac vein

    Directory of Open Access Journals (Sweden)

    Hua Zhang

    2017-10-01

    Full Text Available The iliac vein is an extremely rare site for mesenchymal chondrosarcoma, and patients with primary extraskeletal mesenchymal chondrosarcoma arising from a vein always suffer a very poor prognosis. We report a case of a 45-year-old female who presented with a 5-month history of left leg edema in 2015. Contrast-enhanced computed tomography showed a large mass in the left iliac vein with scattered calcifications. Wide-margin resection was performed, and histopathologic and immunohistochemical analyses confirmed the presence of intraluminal mesenchymal chondrosarcoma with local invasion out of the vein wall. Due to poor patient compliance, postoperative neoadjuvant chemotherapy and radiotherapy were not started, and a bone scan performed 16 weeks postoperatively showed multiple bone metastases. The patient died on the twenty-fourth postoperative week.

  1. [Gender stereotypes arising in a state of gender awareness].

    Science.gov (United States)

    Ito, Y

    2001-12-01

    This study examined the structure of gender stereotypes which might arise in the state of gender awareness that was triggered by social situations where people perceived their gender differences strongly. Out of 1,500 residents in Tokyo aged between 20-60, 342 females and 313 males were randomly chosen and answered the questions about gender consciousness in the state of gender awareness. A factor analysis revealed that "maternity" and "trustworthiness" were the dominant dimensions of gender stereotypes in the state of gender awareness, and that trustworthiness particularly formed the basis of gender stereotypes. Generation differences in gender stereotypes were also revealed between women in their 40 s and 50 s, and between men in their 30 s and 40 s. Generally, power for men and nurture for women were more likely to be perceived in a state of gender awareness.

  2. Nuclear waste management and problems arising from constitutional law

    International Nuclear Information System (INIS)

    Rauschning, D.

    1983-01-01

    The author discusses the problems arising in the field of nuclear waste management on account of the constitutional law. Especially the difficulties emanating from the conflict between the provisions of section 9a of the Atomic Energy Act and the provisions of constitutional law are dealt with in detail, referring to the monography of H. Hofmann, 'legal aspects of nuclear waste management'. The author comes to the conclusion that the reqquirements laid down in section 9a-9c of the Atomic Energy Act are in agreement with the Basic law. There is, he says, no unreasonable risk for future generations, as the provisions of the nuclear law provide for sufficient safety of sites and equipment selected for the final storage of nuclear waste, ensuring that radioactive leakage is excluded over long periods of time. In the second part of his lecture, the author discusses the problem of competency and delegation of authority with regard to the reprocessing of radioactive waste. (BW) [de

  3. Source terms for airborne radioactivity arising from uranium mill wastes

    International Nuclear Information System (INIS)

    O'Riordan, M.C.; Downing, A.L.

    1978-01-01

    One of the problems in assessing the radiological impact of uranium milling is to determine the rates of release to the air of material from the various sources of radioactivity. Such source terms are required for modelling the transport of radioactive material in the atmosphere. Activity arises from various point and area sources in the mill itself and from the mill tailings. The state of the tailings changes in time from slurry to solid. A layer of water may be maintained over the solids during the life of the mine, and the tailings may be covered with inert material on abandonment. Releases may be both gaseous and particulate. This paper indicates ways in which radon emanation and the suspension of long-lived particulate activity might be quantified, and areas requiring further exploration are identified

  4. Irregular activity arises as a natural consequence of synaptic inhibition

    International Nuclear Information System (INIS)

    Terman, D.; Rubin, J. E.; Diekman, C. O.

    2013-01-01

    Irregular neuronal activity is observed in a variety of brain regions and states. This work illustrates a novel mechanism by which irregular activity naturally emerges in two-cell neuronal networks featuring coupling by synaptic inhibition. We introduce a one-dimensional map that captures the irregular activity occurring in our simulations of conductance-based differential equations and mathematically analyze the instability of fixed points corresponding to synchronous and antiphase spiking for this map. We find that the irregular solutions that arise exhibit expansion, contraction, and folding in phase space, as expected in chaotic dynamics. Our analysis shows that these features are produced from the interplay of synaptic inhibition with sodium, potassium, and leak currents in a conductance-based framework and provides precise conditions on parameters that ensure that irregular activity will occur. In particular, the temporal details of spiking dynamics must be present for a model to exhibit this irregularity mechanism and must be considered analytically to capture these effects

  5. Irregular activity arises as a natural consequence of synaptic inhibition

    Energy Technology Data Exchange (ETDEWEB)

    Terman, D., E-mail: terman@math.ohio-state.edu [Department of Mathematics, The Ohio State University, Columbus, Ohio 43210 (United States); Rubin, J. E., E-mail: jonrubin@pitt.edu [Department of Mathematics, University of Pittsburgh, Pittsburgh, Pennsylvania 15260 (United States); Diekman, C. O., E-mail: diekman@njit.edu [Department of Mathematical Sciences, New Jersey Institute of Technology, Newark, New Jersey 07102 (United States)

    2013-12-15

    Irregular neuronal activity is observed in a variety of brain regions and states. This work illustrates a novel mechanism by which irregular activity naturally emerges in two-cell neuronal networks featuring coupling by synaptic inhibition. We introduce a one-dimensional map that captures the irregular activity occurring in our simulations of conductance-based differential equations and mathematically analyze the instability of fixed points corresponding to synchronous and antiphase spiking for this map. We find that the irregular solutions that arise exhibit expansion, contraction, and folding in phase space, as expected in chaotic dynamics. Our analysis shows that these features are produced from the interplay of synaptic inhibition with sodium, potassium, and leak currents in a conductance-based framework and provides precise conditions on parameters that ensure that irregular activity will occur. In particular, the temporal details of spiking dynamics must be present for a model to exhibit this irregularity mechanism and must be considered analytically to capture these effects.

  6. Surprises and pitfalls arising from (pseudo)symmetry

    International Nuclear Information System (INIS)

    Zwart, Peter H.; Grosse-Kunstleve, Ralf W.; Lebedev, Andrey A.; Murshudov, Garib N.; Adams, Paul D.

    2008-01-01

    The presence of pseudosymmetry can cause problems in structure determination and refinement. The relevant background and representative examples are presented. It is not uncommon for protein crystals to crystallize with more than a single molecule per asymmetric unit. When more than a single molecule is present in the asymmetric unit, various pathological situations such as twinning, modulated crystals and pseudo translational or rotational symmetry can arise. The presence of pseudosymmetry can lead to uncertainties about the correct space group, especially in the presence of twinning. The background to certain common pathologies is presented and a new notation for space groups in unusual settings is introduced. The main concepts are illustrated with several examples from the literature and the Protein Data Bank

  7. Unilateral Eye Blinking Arising From the Ictal Ipsilateral Occipital Area.

    Science.gov (United States)

    Falsaperla, Raffaele; Perciavalle, Valentina; Pavone, Piero; Praticò, Andrea Domenico; Elia, Maurizio; Ruggieri, Martino; Caraballo, Roberto; Striano, Pasquale

    2016-07-01

    We report on an 18-month-old boy with unilateral left eye blinking as a single ictal manifestation without facial twitching. The clinical onset of this phenomenon was first recorded (as an occasional event) at age 3 months, and it was overlooked. By age 6 months, the child's blinking increased to almost daily occurrence in clusters: during blinking the infant showed intact awareness and occasional jerks in the upper limbs and right leg. A video-electroencephalography (video-EEG) documented clinical correlation with a focal pattern arising from the left occipital region, and brain magnetic resonance imaging (MRI) revealed severe brain damage, consisting in poroencephalic hollows and increased spaces in the convexities involving a large area of the left cerebral hemisphere. The boy was prescribed sodium valproate (30 mg/kg/d), resulting in drastic reduction of his clinical seizures. Follow-up to his current age documented good general status, with persistent partial right hemilateral seizures. The blinking progressively disappeared, and is no longer recorded. The pathogenic hypotheses of the unilateral ictal blinking include involvement of the ipsilateral cerebral hemisphere and/or the cerebellar pathways. Review of previous reports of unilateral eye blinking, arising from the ictal ipsilateral brain, revealed that different damaged regions may give rise to blinking ictal phenomena, likely via the trigeminal fibres innervating the subdural intracranial structures and the pial vessels in the ipsilateral affected brain. The eye blinking in the present child represents a further example of an ictal phenomenon, which is predictive of the damaged brain region. © EEG and Clinical Neuroscience Society (ECNS) 2014.

  8. 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.

  9. Challenges of atomic energy regulation in Indian context

    International Nuclear Information System (INIS)

    Bajaj, S.S.

    2010-01-01

    applications; -Developing competence in wide variety of technologies and different reactor designs; - Developing adequate human resource ready for safety supervision of this huge nuclear and radiation programme; - Approach to regulatory research related to new technologies. Apart from the above mentioned issues regulatory challenges may arise from policies to make all energy sectors competitive. With growing competition, it is becoming increasingly important to reconcile commercial interests with safety requirements. For AERB, the first challenge will be to ensure that economic pressures do not erode nuclear safety. To maintain highest level of safety culture, AERB will also need to adapt to an increasingly market-oriented environment and new working relationships with utilities. Although it is a difficult task, the Board has also evolved systematically over the years and now has an efficient structure, which is capable of facing the current challenges. (author)

  10. A safe transoral surgical approach to parapharyngeal tumor arising from deep lobe of parotid gland

    Directory of Open Access Journals (Sweden)

    Manuele Casale

    2016-12-01

    Full Text Available The management of parapharyngeal tumor is surgical, but the approach remains a challenge. Attention should be paid to avoidance intra-operative bleeding or cranial nerves damage. We report a case of a 67-year-old male complaining of left-ear fullness. A submucosal mass arising from the lateral wall of oropharynx on the left side was observed. Magnetic resonance imaging detected a mass arising from the parotid gland, in particular from the deep lobe, and a fine needle biopsy was compatible with “Warthin tumor.” We performed a mini-invasive transoral approach under magnification, previous isolation of homolateral vessels. The decision on which surgical approach to be used is determined by site, size vascularity, and histology of the tumor. A literature review of the main surgical approaches was performed. We performed a combined transoral dissection under magnification with cervicotomic exposure of the neck vascular bundle allowing to dissect the tumor and manage any intra-operative complications.

  11. 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...

  12. Managing liabilities which arise out of radioactive waste

    International Nuclear Information System (INIS)

    Hall, R.M. Jr.

    1986-01-01

    The Atomic Energy Act has established a comprehensive regulatory program which governs the management of most radioactive wastes. There are substantial civil and criminal penalties for violations. In addition, environmental statutes such as the Resource Conservation and Recovery Act and the Superfund law impose liabilities on managers of ''non-nuclear'' hazardous wastes. The availability of common law remedies by private parties subjects companies and their officers and employees, and in some cases the government, to liability for personal injuries or property damage. An environmental manager at any facility where radioactive materials are being handled must be aware of these potential liabilities and should engage in a regular program of environmental auditing to ensure compliance

  13. Massive contribution of transposable elements to mammalian regulatory sequences.

    Science.gov (United States)

    Rayan, Nirmala Arul; Del Rosario, Ricardo C H; Prabhakar, Shyam

    2016-09-01

    Barbara McClintock discovered the existence of transposable elements (TEs) in the late 1940s and initially proposed that they contributed to the gene regulatory program of higher organisms. This controversial idea gained acceptance only much later in the 1990s, when the first examples of TE-derived promoter sequences were uncovered. It is now known that half of the human genome is recognizably derived from TEs. It is thus important to understand the scope and nature of their contribution to gene regulation. Here, we provide a timeline of major discoveries in this area and discuss how transposons have revolutionized our understanding of mammalian genomes, with a special emphasis on the massive contribution of TEs to primate evolution. Our analysis of primate-specific functional elements supports a simple model for the rate at which new functional elements arise in unique and TE-derived DNA. Finally, we discuss some of the challenges and unresolved questions in the field, which need to be addressed in order to fully characterize the impact of TEs on gene regulation, evolution and disease processes. Copyright © 2016 Elsevier Ltd. All rights reserved.

  14. Squamous Cell Carcinoma of the Larynx Arising in Multifocal Pharyngolaryngeal Oncocytic Papillary Cystadenoma

    Science.gov (United States)

    Stenner, Markus; Müller, Klaus-Michael; Koopmann, Mario; Rudack, Claudia

    2014-01-01

    Abstract We report on a rare case of a laryngeal carcinoma arising in a multifocal pharyngolaryngeal oncocytic papillary cystadenoma (OPC). The disease of a 63-year-old man is well documented by computed and positron emission tomography, histology, and electron microscopy. We could show that an OPC can even develop in the pharynx. The coexistence of both tumors makes this a challenging diagnosis for pathologists. Treated by surgery and radiotherapy, both lesions dissolved. Based on the literature available, we discuss the theory that the laryngeal carcinoma might be the result of a true metaplasia facilitated by chronic irritation and recommend a regular follow-up for OPC too. As in benign oncocytic lesions, we could show that the detection of numerous mitochondria is a diagnostic indicator for malignant variants as well. PMID:25211046

  15. Quenching rate for a nonlocal problem arising in the micro-electro mechanical system

    Science.gov (United States)

    Guo, Jong-Shenq; Hu, Bei

    2018-03-01

    In this paper, we study the quenching rate of the solution for a nonlocal parabolic problem which arises in the study of the micro-electro mechanical system. This question is equivalent to the stabilization of the solution to the transformed problem in self-similar variables. First, some a priori estimates are provided. In order to construct a Lyapunov function, due to the lack of time monotonicity property, we then derive some very useful and challenging estimates by a delicate analysis. Finally, with this Lyapunov function, we prove that the quenching rate is self-similar which is the same as the problem without the nonlocal term, except the constant limit depends on the solution itself.

  16. Using Inequality Measures to Incorporate Environmental Justice into Regulatory Analyses

    Science.gov (United States)

    Abstract: Formally evaluating how specific policy measures influence environmental justice is challenging, especially in the context of regulatory analyses in which quantitative comparisons are the norm. However, there is a large literature on developing and applying quantitative...

  17. Small finance banks: Challenges

    Directory of Open Access Journals (Sweden)

    Jayadev M

    2017-12-01

    Full Text Available A recent innovation in the Indian banking structure has been the formation of a new banking institution—small finance banks (SFBs. These banks are expected to penetrate into financial inclusion by providing basic banking and credit services with a differentiated banking model to the larger population. In this context the new SFBs have multiple challenges in coming out with a new, differentiated business model. The challenges include building low cost liability portfolio, technology management, and balancing the regulatory compliances. This paper also presents the top of mind views of three senior executives of new small finance banks.

  18. Research and regulatory review

    International Nuclear Information System (INIS)

    Macleod, J.S.; Fryer, D.R.H.

    1979-01-01

    To enable the regulatory review to be effectively undertaken by the regulatory body, there is a need for it to have ready access to information generated by research activities. Certain advantages have been seen to be gained by the regulatory body itself directly allocating and controlling some portion of these activities. The princial reasons for reaching this conclusion are summarised and a brief description of the Inspectorates directly sponsored programme outlined. (author)

  19. The impact of alternate weekly collections on waste arisings

    Energy Technology Data Exchange (ETDEWEB)

    Williams, I.D., E-mail: idw@soton.ac.uk [Waste Management Research Group, Faculty of Engineering and the Environment, Lanchester Building, University of Southampton, University Rd, Highfield, SOUTHAMPTON, Hampshire, SO17 1BJ (United Kingdom); Cole, C. [Centre for Innovative and Collaborative Construction Engineering, School of Civil and Building Engineering, Loughborough University, Epinal Way, Loughborough, LE11 3TU (United Kingdom)

    2013-02-15

    Residual waste is commonly collected separately from recyclable and organic materials. Different forms of collection and disposal are used internationally since regional or municipal authorities have to adapt to their own circumstances. Many authorities have adopted an alternate weekly collection (AWC) of residual waste and recyclables to force/encourage householders to recycle; however, the degree to which they achieve waste reduction has yet to be reliably quantified. This study reports on how the introduction of AWCs affects household waste arisings. The paper evaluates single and dual stream collection methods and compares their performance with the previous system. Household waste collection trials were conducted between March and June 2009 in England (Lichfield). The trials examined changes to frequency of collection, type of container issued, amounts of sorting required of residents, household participation and productivity levels. A survey of households was completed before any changes were implemented. The quantity of recyclates collected was examined for 2008/2009 and 2009/2010. The study showed that the AWC scheme positively impacted on recycling rates and household behaviour, with no adverse impacts on public participation, household waste arisings or the local environment. No public health problems were reported. Both trials saw an increase in the quantities of recyclates collected per household during the trial period compared to the same period of time in the previous year. The dual stream performed better than the single stream, collecting an average of 5.94 kg/hh/week compared to an average of 5.63 kg/hh/week. The single stream system showed a greater increase in the weight of material collected (0.53 kg/hh/week vs. 0.48 kg/hh/week). Participation and set-out rates showed an increase during the trial period. The single stream option (comingled materials in one container) outperformed the dual stream service. The reduction in costs and improved

  20. Variational problems arising in classical mechanics and nonlinear elasticity

    International Nuclear Information System (INIS)

    Spencer, P.

    1999-01-01

    In this thesis we consider two different classes of variational problems. First, one-dimensional problems arising from classical mechanics where the problem is to determine whether there is a unique function η 0 (x) which minimises the energy functional of the form I(η) = ∫ a b L(x,η(x), η'(x)) dx. We will investigate uniqueness by making a change of dependent and independent variables and showing that for a class of integrands L with a particular kind of scaling invariance the resulting integrand is completely convex. The change of variables arises by applying results from Lie group theory as applied in the study of differential equations and this work is motivated by [60] and [68]. Second, the problem of minimising energy functionals of the form E(u) = ∫ A W(∇u(x)) dx in the case of a nonlinear elastic body occupying an annular region A contains R 2 with u : A-bar → A-bar. This work is motivated by [57] (in particular the example of paragraph 4). We will consider rotationally symmetric deformations satisfying prescribed boundary conditions. We will show the existence of minimisers for stored energy functions of the form W(F) = g-tilde(vertical bar-F-vertical bar, det(F)) in a class of general rotationally symmetric deformations of a compressible annulus and for stored energy functions of the form W(F) = g-bar(vertical bar-F-vertical bar) in a class of rotationally symmetric deformations of an incompressible annulus. We will also show that in each case the minimisers are solutions of the full equilibrium equations. A model problem will be considered where the energy functional is the Dirichlet integral and it will be shown that the rotationally symmetric solution obtained is a minimiser among admissible non-rotationally symmetric deformations. In the case of an incompressible annulus, we will consider the Dirichlet integral as the energy functional and show that the rotationally symmetric equilibrium solutions in this case are weak local minimisers in

  1. The impact of alternate weekly collections on waste arisings

    International Nuclear Information System (INIS)

    Williams, I.D.; Cole, C.

    2013-01-01

    Residual waste is commonly collected separately from recyclable and organic materials. Different forms of collection and disposal are used internationally since regional or municipal authorities have to adapt to their own circumstances. Many authorities have adopted an alternate weekly collection (AWC) of residual waste and recyclables to force/encourage householders to recycle; however, the degree to which they achieve waste reduction has yet to be reliably quantified. This study reports on how the introduction of AWCs affects household waste arisings. The paper evaluates single and dual stream collection methods and compares their performance with the previous system. Household waste collection trials were conducted between March and June 2009 in England (Lichfield). The trials examined changes to frequency of collection, type of container issued, amounts of sorting required of residents, household participation and productivity levels. A survey of households was completed before any changes were implemented. The quantity of recyclates collected was examined for 2008/2009 and 2009/2010. The study showed that the AWC scheme positively impacted on recycling rates and household behaviour, with no adverse impacts on public participation, household waste arisings or the local environment. No public health problems were reported. Both trials saw an increase in the quantities of recyclates collected per household during the trial period compared to the same period of time in the previous year. The dual stream performed better than the single stream, collecting an average of 5.94 kg/hh/week compared to an average of 5.63 kg/hh/week. The single stream system showed a greater increase in the weight of material collected (0.53 kg/hh/week vs. 0.48 kg/hh/week). Participation and set-out rates showed an increase during the trial period. The single stream option (comingled materials in one container) outperformed the dual stream service. The reduction in costs and improved

  2. Regulatory Commission of Alaska

    Science.gov (United States)

    Map Help Regulatory Commission of Alaska Login Forgot Password Arrow Image Forgot password? View Cart login Procedures for Requesting Login For Consumers General Information Telephone Electric Natural Gas

  3. 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

  4. Problems arising in the evaluation of collective dose commitment

    International Nuclear Information System (INIS)

    Coulon, R.; Beau, P.

    1979-01-01

    In order to apply the concept of optimization it is necessary to evaluate the collective dose commitment for the population as a whole. This is found by summing the dose commitments for the different population groups involved, including persons occupationally exposed and members of the public both locally and globally. The average dose received by each of these groups can vary considerably: for occupational exposure it is about one order of magnitude below the limits, whereas for the general public it is far below, although certain local groups may be subjected to a much higher exposure than the overall average. The question arises, therefore, whether certain groups should not be weighted differently in order to take into account the heterogeneity of the distribution of exposure. As far as the validity of forecast evaluations is concerned, one may assume that for occupational exposure the dose commitment over the whole period of operation of a facility can be estimated fairly accurately. The overall collective dose commitment for the public is relatively insensitive to local variations in the environment and in the public itself but is strongly dependent on long-term developments which cannot at present be forecast. For the evaluation of dose equivalent to the critical group, local variations are of considerable importance and need to be foreseen, which is not always possible. By taking into account a period which includes the annual maximum collective dose equivalent one can make some of these difficulties less severe. (author)

  5. Novel ethical dilemmas arising in geriatric clinical practice.

    Science.gov (United States)

    Calleja-Sordo, Elisa Constanza; de Hoyos, Adalberto; Méndez-Jiménez, Jorge; Altamirano-Bustamante, Nelly F; Islas-Andrade, Sergio; Valderrama, Alejandro; García-Peña, Carmen; Altamirano-Bustamante, Myriam M

    2015-05-01

    The purpose of this study is to determine empirically the state of the art of the medical care, when healthcare personal is confronted with ethical dilemmas related with the care they give to the geriatric population. An observational, longitudinal, prospective and qualitative study was conducted by analyzing the correlation between healthcare personnel-patient relationship, and ethical judgments regarding dilemmas that arise in daily clinical practice with geriatric patients. Mexican healthcare personnel with current active practices were asked to write up an ethical dilemma that arose frequently or that had impacted their medical practice. From the narrative input, we were able to draw up a database with 421 dilemmas, and those corresponding to patients 60 years and older were selected (n = 54, 12.8 %). The axiological analysis of the narrative dilemmas of geriatric patients was made using dialectical empiricism. The axiological analysis values found most frequently were classified into three groups: the impact of healthcare, the roles of the physician, and refusal of therapy; the healthcare role of educator, caring for the patients' life and the risk of imminent death where the values found more often. The persistence and universality of certain dilemmas in geriatrics calls for awareness and requires a good training in the ethical discernment of these dilemmas. This would help to improve substantially the care and the life quality of this population.

  6. Primary Extraskeletal Mesenchymal Chondrosarcoma Arising from the Pancreas

    Energy Technology Data Exchange (ETDEWEB)

    Oh, Bae Geun; Han, Yoon Hee; Lee, Byung Hoon; Kim, Su Young; Hwang, Yoon Joon; Seo, Jung Wook; Kim, Yong Hoon; Cha, Soon Joo; Hur, Gham; Joo, Mee [Inje University, School of Medicine, Goyang (Korea, Republic of)

    2007-12-15

    The CT scans showed a heterogeneously enhancing necrotic mass with numerous areas of coarse calcification, and this was located in the left side of the retroperitoneal space and involved the body and tail of the pancreas. Portal venography via the celiac axis also showed invasion of the splenic vein. It represents approximately 1% of all chondrosarcomas and it carries a poor prognosis. It can occur in extraskeletal locations and mainly in the soft tissues of the orbit, the cranial and spinal meningeal coverings and the lower limbs. To the best of our knowledge, there has been no reported case of primary extraskeletal mesenchymal chondrosarcoma of the pancreas. Only two instances of metastatic chondrosarcomas in the pancreas have been reported in the literature. We report here on a case of primary mesenchymal chondrosarcoma arising from the pancreas in a 41-year-old man. In summary, we present here a case of primary extraskeletal mesenchymal chondrosarcoma that arose from the pancreas. Radiologically, it manifested as a necrotic soft tissue mass with chondroid calcifications.

  7. Esophageal Adenocarcinoma Arising from Barrett's Epithelium in Taiwan

    Directory of Open Access Journals (Sweden)

    Chia-Hung Tu

    2007-08-01

    Full Text Available The prevalence of Barrett's esophagus (BE in Eastern countries is rising to match the prevalence in the West. However, a corresponding trend of BE-associated adenocarcinoma has yet to be observed in Asia. Historically, adenocarcinoma complicating BE has been considered a rare event in Taiwan. In the present report, we collected three Taiwanese cases of esophageal adenocarcinoma arising from BE. The first case was a 37-year-old man with an advanced cancer that developed on pre-existing BE after a 3-year interval without endoscopic surveillance. The second case was a 63-year-old man who presented with odynophagia and was found to have an ulcerative tumor centered on the characteristic Barrett's mucosa. The final case was a 44-year-old man who presented with gradual-onset dysphagia and weight loss, without typical reflux symptom. Our report emphasizes the need for an updated epidemiologic study to determine the incidence of BE-associated adenocarcinoma in Taiwan.

  8. Exposures to asbestos arising from bandsawing gasket material.

    Science.gov (United States)

    Fowler, D P

    2000-05-01

    A simulation of bandsawing sheet asbestos gasket material was performed as part of a retrospective exposure evaluation undertaken to assist in determining causation of a case of mesothelioma. The work was performed by bandsawing a chrysotile asbestos (80%)/neoprene gasket sheet with a conventional 16-inch woodworking bandsaw inside a chamber. Measurements of airborne asbestos were made using conventional area and personal sampling methods, with analysis of collected samples by transmission electron microscopy (TEM) and phase contrast microscopy (PCM). These were supplemented by qualitative scanning electron microscopy (SEM) examinations of some of the airborne particles collected on the filters. In contrast with findings from studies examining manual handling (installation and removal) of gaskets, airborne asbestos concentrations from this operation were found to be well above current Occupational Safety and Health Administration (OSHA) permissible exposure limit (PEL) (eight-hour time-weighted average [TWA]) and excursion limit (30-minute) standards. Although some "encapsulation" effect of the neoprene matrix was seen on the particles in the airborne dust, unencapsulated individual fiber bundles were also seen. Suggestions for the implications of the work are given. In summary, the airborne asbestos concentrations arising from this work were quite high, and point to the need for careful observation of common sense precautions when manipulation of asbestos-containing materials (even those believed to have limited emissions potential) may involved machining operations.

  9. Risk analysis for renewable energy projects due to constraints arising

    Science.gov (United States)

    Prostean, G.; Vasar, C.; Prostean, O.; Vartosu, A.

    2016-02-01

    Starting from the target of the European Union (EU) to use renewable energy in the area that aims a binding target of 20% renewable energy in final energy consumption by 2020, this article illustrates the identification of risks for implementation of wind energy projects in Romania, which could lead to complex technical implications, social and administrative. In specific projects analyzed in this paper were identified critical bottlenecks in the future wind power supply chain and reasonable time periods that may arise. Renewable energy technologies have to face a number of constraints that delayed scaling-up their production process, their transport process, the equipment reliability, etc. so implementing these types of projects requiring complex specialized team, the coordination of which also involve specific risks. The research team applied an analytical risk approach to identify major risks encountered within a wind farm project developed in Romania in isolated regions with different particularities, configured for different geographical areas (hill and mountain locations in Romania). Identification of major risks was based on the conceptual model set up for the entire project implementation process. Throughout this conceptual model there were identified specific constraints of such process. Integration risks were examined by an empirical study based on the method HAZOP (Hazard and Operability). The discussion describes the analysis of our results implementation context of renewable energy projects in Romania and creates a framework for assessing energy supply to any entity from renewable sources.

  10. Malignant tumors arising in the maxillary region after radiation therapy

    International Nuclear Information System (INIS)

    Shimizu, Sawamichi; Shirahata, Yuichi; Uchida, Yutaka

    1984-01-01

    Although radiotherapy has proven of great therapeutic value in the treatment of malignant tumors, it should also be borne in mind that radiation has a serious potential risk of giving rise to a secondary malignancy. We recently experienced 2 cases each of carcinoma and sarcoma arising in the irradiated areas long after radiation therapy for malignant tumors. In these 4 cases, 2 males and 2 females, the primary neoplastic diseases were squamous cell carcinoma, epidermoid carcinoma, carcinoma of unknown pathology and malignant lymphoma, and the secondary tumors were epidermoid carcinoma, squamous cell carcinoma, osteosarcoma and chondrosarcoma, respectively. The sites of occurrence of these malignancies were invariably in the maxillary region; the mean latent period was 15 years, aside from an infantile case with a latent period of 5 years. In view of the primary diseases being malignant tumors the following criteria were set up for the diagnosis of radiation-induced malignancies: (1) the site of occurrence is within the confines of a previously irradiated area, (2) the latent period is prolonged and (3) the malignancy occurs as a double tumor. Therapy was primarily by operation. The prognosis was exceedingly ominous, the average survival time being 22 months. This was probably and mainly because of rapidity of tumor growth. Thus, the secondary tumors had already spread back to inward by the time they were first discovered. This should be kept in mind during a long-term follow-up of patients receiving radiotherapy for malignancy. (author)

  11. Metaplastic Carcinoma with Chondroid Differentiation Arising in Microglandular Adenosis

    Directory of Open Access Journals (Sweden)

    Ga-Eon Kim

    2017-07-01

    Full Text Available Microglandular adenosis (MGA of the breast is a rare, benign proliferative lesion but with a significant rate of associated carcinoma. Herein, we report an unusual case of metaplastic carcinoma with chondroid differentiation associated with typical MGA. Histologically, MGA showed a direct transition to metaplastic carcinoma without an intervening atypical MGA or ductal carcinoma in situ component. The immunohistochemical profile of the metaplastic carcinoma was mostly similar to that of MGA. In both areas, all the epithelial cells were positive for S-100 protein, but negative for estrogen receptor, progesterone receptor, HER2/neu, and epidermal growth factor receptor. An increase in the Ki-67 and p53 labelling index was observed from MGA to invasive carcinoma. To the best of our knowledge, this is the first case of metaplastic carcinoma with chondroid differentiation arising in MGA in Korea. This case supports the hypothesis that a subset of MGA may be a non-obligate morphologic precursor of breast carcinoma, especially the triple-negative subtype.

  12. Obesity, the endocannabinoid system, and bias arising from pharmaceutical sponsorship.

    Science.gov (United States)

    McPartland, John M

    2009-01-01

    Previous research has shown that academic physicians conflicted by funding from the pharmaceutical industry have corrupted evidence based medicine and helped enlarge the market for drugs. Physicians made pharmaceutical-friendly statements, engaged in disease mongering, and signed biased review articles ghost-authored by corporate employees. This paper tested the hypothesis that bias affects review articles regarding rimonabant, an anti-obesity drug that blocks the central cannabinoid receptor. A MEDLINE search was performed for rimonabant review articles, limited to articles authored by USA physicians who served as consultants for the company that manufactures rimonabant. Extracted articles were examined for industry-friendly bias, identified by three methods: analysis with a validated instrument for monitoring bias in continuing medical education (CME); analysis for bias defined as statements that ran contrary to external evidence; and a tally of misrepresentations about the endocannabinoid system. Eight review articles were identified, but only three disclosed authors' financial conflicts of interest, despite easily accessible information to the contrary. The Takhar CME bias instrument demonstrated statistically significant bias in all the review articles. Biased statements that were nearly identical reappeared in the articles, including disease mongering, exaggerating rimonabant's efficacy and safety, lack of criticisms regarding rimonabant clinical trials, and speculations about surrogate markers stated as facts. Distinctive and identical misrepresentations regarding the endocannabinoid system also reappeared in articles by different authors. The findings are characteristic of bias that arises from financial conflicts of interest, and suggestive of ghostwriting by a common author. Resolutions for this scenario are proposed.

  13. Sound radiation quantities arising from a resilient circular radiator.

    Science.gov (United States)

    Aarts, Ronald M; Janssen, Augustus J E M

    2009-10-01

    Power series expansions in ka are derived for the pressure at the edge of a radiator, the reaction force on the radiator, and the total radiated power arising from a harmonically excited, resilient, flat, circular radiator of radius a in an infinite baffle. The velocity profiles on the radiator are either Stenzel functions (1-(sigma/a)2)n, with sigma the radial coordinate on the radiator, or linear combinations of Zernike functions Pn(2(sigma/a)2-1), with Pn the Legendre polynomial of degree n. Both sets of functions give rise, via King's integral for the pressure, to integrals for the quantities of interest involving the product of two Bessel functions. These integrals have a power series expansion and allow an expression in terms of Bessel functions of the first kind and Struve functions. Consequently, many of the results in [M. Greenspan, J. Acoust. Soc. Am. 65, 608-621 (1979)] are generalized and treated in a unified manner. A foreseen application is for loudspeakers. The relation between the radiated power in the near-field on one hand and in the far field on the other is highlighted.

  14. The Challenges of Digital Leadership

    Science.gov (United States)

    McLeod, Scott

    2015-01-01

    Because digital devices and online environments can simultaneously be transformatively empowering and maddeningly disruptive, the work of integrating digital learning tools into schools is usually difficult and complex. Common challenges arise, however, and can be thoughtfully addressed by proactive leadership. In the end, technology change in…

  15. 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

  16. NRC Regulatory Agenda

    International Nuclear Information System (INIS)

    1991-10-01

    The NRC Regulatory Agenda is a compilation of all rules on which the NRC has recently completed action, or has proposed action, or is considering action, and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter

  17. NRC regulatory agenda

    International Nuclear Information System (INIS)

    1993-04-01

    The NRC Regulatory Agenda is a compilation of all rules on which the NRC has recently completed action, or has proposed action, or is considering action, and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter

  18. NRC regulatory agenda

    International Nuclear Information System (INIS)

    1990-01-01

    The NRC Regulatory Agenda is a compilation of all rules on which the NRC has proposed or is considering action and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter

  19. NRC regulatory agenda

    International Nuclear Information System (INIS)

    1991-04-01

    The NRC Regulatory Agenda is a compilation of all rules on which the NRC has recently completed action or has proposed, or is considering action and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter

  20. NRC Regulatory Agenda

    International Nuclear Information System (INIS)

    1991-08-01

    The NRC Regulatory Agenda is a compilation of all rules on which the NRC has recently completed action or has proposed, or is considering action and all petitions for rulemaking which have been received by the commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter

  1. Trust in regulatory regimes

    NARCIS (Netherlands)

    Six, Frédérique; Verhoest, Koen

    2017-01-01

    Within political and administrative sciences generally, trust as a concept is contested, especially in the field of regulatory governance. This groundbreaking book is the first to systematically explore the role and dynamics of trust within regulatory regimes. Conceptualizing, mapping and analyzing

  2. Nuclear Regulatory legislation

    International Nuclear Information System (INIS)

    1984-06-01

    This compilation of statutes and material pertaining to nuclear regulatory legislation through the 97th Congress, 2nd Session, has been prepared by the Office of the Executive Legal Director, U.S. Nuclear Regulatory Commission, with the assistance of staff, for use as an internal resource document

  3. Sewage sludge - arisings, composition, disposal capacities; Klaerschlamm - Mengen, Zusammensetzung, Entsorgungskapazitaeten

    Energy Technology Data Exchange (ETDEWEB)

    Faulstich, M.; Rabus, J. [Technische Univ. Muenchen, Garching (Germany). Lehrstuhl fuer Wasserguete- und Abfallwirtschaft; Urban, A.I.; Friedel, M. [Kassel Univ. (Gesamthochschule) (Germany). Fachgebiet Abfalltechnik

    1998-09-01

    One of the main disposal paths for sewage sludge in the past was landfilling. This option was severely restricted by the issue of the Technical Code on Household Waste in 1993. In its agricultural applications sewage sludge serves as a fertiliser and a soil improvement agent. Estimates on potential thermal treatment capacities have shown that there are enough public power plants to accommodate and provide thermal treatment for the total of sewage sludge arisings in Germany. As can be seen from the estimates presented in this paper, it would not even be necessary to restrict oneself to public power plant capacities. The paper points out possibilities of using plant capacities already existing in industrial firing plants and certain production sectors. It uses a comparison to show that sewage sludge would have to be dried in order to permit its thermal treatment in these private facilities. Aside from this, there are a number of new techniques entering the market which from the technical viewpoint also appear to be well suited for thermal sewage sludge treatment. [Deutsch] Ein wesentlicher Entsorgungsweg von Klaerschlamm war in der Vergangenheit die Verbringung auf eine Deponie. Diese Moeglichkeit ist durch die TA Siedlungsabfall von 1993 stark eingeschraenkt. Bei der landwirtschaftlichen Verwertung wird durch den Klaerschlamm eine Duengewirkung sowie eine Bodenverbesserung erreicht. Eine Abschaetzung der potentiellen thermischen Behandlungskapazitaeten zeigt, dass die gesamte bundesdeutsche Klaerschlammenge in oeffentlichen Kraftwerken unterzubringen und thermisch zu behandeln waere. Wie die hier dargestellten Abschaetzungen gezeigt haben, ist man durchaus nicht allein auf die Nutzung oeffentlicher Kraftwerkskapazitaeten angewiesen. Es wurden Moeglichkeiten zur Nutzung vorhandener Anlagenkapazitaeten in industriellen Feuerungsanlagen und in Produktionsbereichen aufgezeigt. Wie aus einem Vergleich erkennbar wird, ist allerdings eine Trocknung der Klaerschlaemme

  4. Fast multipole preconditioners for sparse matrices arising from elliptic equations

    KAUST Repository

    Ibeid, Huda

    2017-11-09

    Among optimal hierarchical algorithms for the computational solution of elliptic problems, the fast multipole method (FMM) stands out for its adaptability to emerging architectures, having high arithmetic intensity, tunable accuracy, and relaxable global synchronization requirements. We demonstrate that, beyond its traditional use as a solver in problems for which explicit free-space kernel representations are available, the FMM has applicability as a preconditioner in finite domain elliptic boundary value problems, by equipping it with boundary integral capability for satisfying conditions at finite boundaries and by wrapping it in a Krylov method for extensibility to more general operators. Here, we do not discuss the well developed applications of FMM to implement matrix-vector multiplications within Krylov solvers of boundary element methods. Instead, we propose using FMM for the volume-to-volume contribution of inhomogeneous Poisson-like problems, where the boundary integral is a small part of the overall computation. Our method may be used to precondition sparse matrices arising from finite difference/element discretizations, and can handle a broader range of scientific applications. It is capable of algebraic convergence rates down to the truncation error of the discretized PDE comparable to those of multigrid methods, and it offers potentially superior multicore and distributed memory scalability properties on commodity architecture supercomputers. Compared with other methods exploiting the low-rank character of off-diagonal blocks of the dense resolvent operator, FMM-preconditioned Krylov iteration may reduce the amount of communication because it is matrix-free and exploits the tree structure of FMM. We describe our tests in reproducible detail with freely available codes and outline directions for further extensibility.

  5. Qualia could arise from information processing in local cortical networks.

    Science.gov (United States)

    Orpwood, Roger

    2013-01-01

    Re-entrant feedback, either within sensory cortex or arising from prefrontal areas, has been strongly linked to the emergence of consciousness, both in theoretical and experimental work. This idea, together with evidence for local micro-consciousness, suggests the generation of qualia could in some way result from local network activity under re-entrant activation. This paper explores the possibility by examining the processing of information by local cortical networks. It highlights the difference between the information structure (how the information is physically embodied), and the information message (what the information is about). It focuses on the network's ability to recognize information structures amongst its inputs under conditions of extensive local feedback, and to then assign information messages to those structures. It is shown that if the re-entrant feedback enables the network to achieve an attractor state, then the message assigned in any given pass of information through the network is a representation of the message assigned in the previous pass-through of information. Based on this ability the paper argues that as information is repeatedly cycled through the network, the information message that is assigned evolves from a recognition of what the input structure is, to what it is like, to how it appears, to how it seems. It could enable individual networks to be the site of qualia generation. The paper goes on to show networks in cortical layers 2/3 and 5a have the connectivity required for the behavior proposed, and reviews some evidence for a link between such local cortical cyclic activity and conscious percepts. It concludes with some predictions based on the theory discussed.

  6. Obesity, the endocannabinoid system, and bias arising from pharmaceutical sponsorship.

    Directory of Open Access Journals (Sweden)

    John M McPartland

    Full Text Available Previous research has shown that academic physicians conflicted by funding from the pharmaceutical industry have corrupted evidence based medicine and helped enlarge the market for drugs. Physicians made pharmaceutical-friendly statements, engaged in disease mongering, and signed biased review articles ghost-authored by corporate employees. This paper tested the hypothesis that bias affects review articles regarding rimonabant, an anti-obesity drug that blocks the central cannabinoid receptor.A MEDLINE search was performed for rimonabant review articles, limited to articles authored by USA physicians who served as consultants for the company that manufactures rimonabant. Extracted articles were examined for industry-friendly bias, identified by three methods: analysis with a validated instrument for monitoring bias in continuing medical education (CME; analysis for bias defined as statements that ran contrary to external evidence; and a tally of misrepresentations about the endocannabinoid system. Eight review articles were identified, but only three disclosed authors' financial conflicts of interest, despite easily accessible information to the contrary. The Takhar CME bias instrument demonstrated statistically significant bias in all the review articles. Biased statements that were nearly identical reappeared in the articles, including disease mongering, exaggerating rimonabant's efficacy and safety, lack of criticisms regarding rimonabant clinical trials, and speculations about surrogate markers stated as facts. Distinctive and identical misrepresentations regarding the endocannabinoid system also reappeared in articles by different authors.The findings are characteristic of bias that arises from financial conflicts of interest, and suggestive of ghostwriting by a common author. Resolutions for this scenario are proposed.

  7. Fast multipole preconditioners for sparse matrices arising from elliptic equations

    KAUST Repository

    Ibeid, Huda; Yokota, Rio; Pestana, Jennifer; Keyes, David E.

    2017-01-01

    Among optimal hierarchical algorithms for the computational solution of elliptic problems, the fast multipole method (FMM) stands out for its adaptability to emerging architectures, having high arithmetic intensity, tunable accuracy, and relaxable global synchronization requirements. We demonstrate that, beyond its traditional use as a solver in problems for which explicit free-space kernel representations are available, the FMM has applicability as a preconditioner in finite domain elliptic boundary value problems, by equipping it with boundary integral capability for satisfying conditions at finite boundaries and by wrapping it in a Krylov method for extensibility to more general operators. Here, we do not discuss the well developed applications of FMM to implement matrix-vector multiplications within Krylov solvers of boundary element methods. Instead, we propose using FMM for the volume-to-volume contribution of inhomogeneous Poisson-like problems, where the boundary integral is a small part of the overall computation. Our method may be used to precondition sparse matrices arising from finite difference/element discretizations, and can handle a broader range of scientific applications. It is capable of algebraic convergence rates down to the truncation error of the discretized PDE comparable to those of multigrid methods, and it offers potentially superior multicore and distributed memory scalability properties on commodity architecture supercomputers. Compared with other methods exploiting the low-rank character of off-diagonal blocks of the dense resolvent operator, FMM-preconditioned Krylov iteration may reduce the amount of communication because it is matrix-free and exploits the tree structure of FMM. We describe our tests in reproducible detail with freely available codes and outline directions for further extensibility.

  8. Calculation of forces arising from impacting projectiles upon yielding structures

    International Nuclear Information System (INIS)

    Drittler, K.; Gruner, P.; Krivy, J.

    1977-01-01

    Calculations concerning the impact of airplanes upon nuclear power plant buildings usually imply that the building 'acts' as a rigid target. This assumption is justified for considerations concerning the structural integrity of the building being hit. However, for investigating induced vibrations of components within the structure, this approach might -in general- be too conservative. It is expected, that yielding of the structure during impact reduces the peak values of the loads and changes the temporal behavior of the load function which is obtained for a rigid target. To calculate the changes of the load function which are due to deformations of the structure, Riera's method is extended for the case of a yielding target. In view of the applications of the calculations to the impact of airplanes upon buildings which are constructed to withstand loads of this kind without serious damage and without large deformations, it is possible to simplify the calculations to some extent. That is, the investigations need not take into account in detail the behavior of the target during impact. The calculations are performed with a one-dimensional model for the projectile. The direction of impact is perpendicular to the target surface; direction of impact and projectile axis coincide. The calculations were performed for several initial velocities of the projectiles simulating a fast flying military airplane. Variations of the peak values of the load functions as compared to corresponding values for a rigid target do not exceed about 10%. The overall temporal behavior of the load curves turns out to be not very sensitive to the yielding of the target, though, in some cases displacements in time of the peak positions within a single load curve do arise

  9. Improving nuclear regulatory effectiveness

    International Nuclear Information System (INIS)

    2001-01-01

    Ensuring that nuclear installations are operated and maintained in such a way that their impact on public health and safety is as low as reasonably practicable has been and will continue to be the cornerstone of nuclear regulation. In the past, nuclear incidents provided the main impetus for regulatory change. Today, economic factors, deregulation, technological advancements, government oversight and the general requirements for openness and accountability are leading regulatory bodies to review their effectiveness. In addition, seeking to enhance the present level of nuclear safety by continuously improving the effectiveness of regulatory bodies is seen as one of the ways to strengthen public confidence in the regulatory systems. This report covers the basic concepts underlying nuclear regulatory effectiveness, advances being made and future requirements. The intended audience is primarily nuclear safety regulators, but government authorities, nuclear power plant operators and the general public may also be interested. (author)

  10. 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.

  11. 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.

  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. Cognitive Challenges

    Science.gov (United States)

    ... Privacy Policy Sitemap Learn Engage Donate About TSC Cognitive Challenges Approximately 45% to 60% of individuals with TSC develop cognitive challenges (intellectual disabilities), although the degree of intellectual ...

  14. 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...

  15. Diversity and plasticity of Th cell types predicted from regulatory network modelling.

    Directory of Open Access Journals (Sweden)

    Aurélien Naldi

    Full Text Available Alternative cell differentiation pathways are believed to arise from the concerted action of signalling pathways and transcriptional regulatory networks. However, the prediction of mammalian cell differentiation from the knowledge of the presence of specific signals and transcriptional factors is still a daunting challenge. In this respect, the vertebrate hematopoietic system, with its many branching differentiation pathways and cell types, is a compelling case study. In this paper, we propose an integrated, comprehensive model of the regulatory network and signalling pathways controlling Th cell differentiation. As most available data are qualitative, we rely on a logical formalism to perform extensive dynamical analyses. To cope with the size and complexity of the resulting network, we use an original model reduction approach together with a stable state identification algorithm. To assess the effects of heterogeneous environments on Th cell differentiation, we have performed a systematic series of simulations considering various prototypic environments. Consequently, we have identified stable states corresponding to canonical Th1, Th2, Th17 and Treg subtypes, but these were found to coexist with other transient hybrid cell types that co-express combinations of Th1, Th2, Treg and Th17 markers in an environment-dependent fashion. In the process, our logical analysis highlights the nature of these cell types and their relationships with canonical Th subtypes. Finally, our logical model can be used to explore novel differentiation pathways in silico.

  16. Resilient Prosumer Scenario in a Changing Regulatory Environment—The UniRCon Solution

    Directory of Open Access Journals (Sweden)

    Mihai Sanduleac

    2017-11-01

    Full Text Available Technological developments are pushing for new solutions based upon massive integration of renewable electricity generation in networks already facing many challenges. This paper presents a novel approach to managing the energy transfer towards prosumers making use of smart management of local energy storage. The proposed design (including storage dimensioning is based on several operating scenarios in which the prosumer might operate as: (i a “load only” entity (from a grid perspective, thus exhibiting investment resiliency against regulatory changes and high energy efficiency; or (ii a prosumer, in case regulatory opportunistic profit might be available. This can be realized within a newly proposed Uni-directional Resilient Consumer (UniRCon architecture. The major aim of the proposed architecture is to achieve optimal self-consumption while avoiding curtailment even in a changing regulatory environment like, for example, the total lack of incentives for generation based on renewable energy sources (RES. One of the major advantages of the proposed architecture consists in the adaptability to changes in the regulatory and market environment. The term resilience is used with multiple meanings: (a the prosumer’s financial resilience against regulatory changes when investment calculations assume no-grid injections; (b the prosumer’s technical resilience, with electrical design based on standalone operation; (c the resilience of clusters of interconnected end-user installations with enabled community-level electricity exchange, independent of the existing main grid supply; (d the contribution to grid resilience, by enabling AC microgrid (MG operation in island mode when large portions of the grid are formed by clusters of UniRCon prosumers (the ease of islanding segmentation of the local grid in case of emergencies. For proof of concept, three use-cases are detailed: (i photovoltaic (PV installations connected behind the meter; (ii PV and

  17. Multimodality Imaging Approach towards Primary Aortic Sarcomas Arising after Endovascular Abdominal Aortic Aneurysm Repair: Case Series Report

    Energy Technology Data Exchange (ETDEWEB)

    Kamran, Mudassar, E-mail: kamranm@mir.wustl.edu; Fowler, Kathryn J., E-mail: fowlerk@mir.wustl.edu; Mellnick, Vincent M., E-mail: mellnickv@mir.wustl.edu [Washington University School of Medicine, Mallinckrodt Institute of Radiology (United States); Sicard, Gregorio A., E-mail: sicard@wudosis.wustl.edu [Washington University School of Medicine, Department of Surgery (United States); Narra, Vamsi R., E-mail: narrav@mir.wustl.edu [Washington University School of Medicine, Mallinckrodt Institute of Radiology (United States)

    2016-06-15

    Primary aortic neoplasms are rare. Aortic sarcoma arising after endovascular aneurysm repair (EVAR) is a scarce subset of primary aortic malignancies, reports of which are infrequent in the published literature. The diagnosis of aortic sarcoma is challenging due to its non-specific clinical presentation, and the prognosis is poor due to delayed diagnosis, rapid proliferation, and propensity for metastasis. Post-EVAR, aortic sarcomas may mimic other more common aortic processes on surveillance imaging. Radiologists are rarely knowledgeable about this rare entity for which multimodality imaging and awareness are invaluable in early diagnosis. A series of three pathologically confirmed cases are presented to display the multimodality imaging features and clinical presentations of aortic sarcoma arising after EVAR.

  18. Mucinous adenocarcinoma arising at the anastomotic site after operation for hirschsprung's disease: case report

    International Nuclear Information System (INIS)

    Kim, Hyung Soo; Yoon, Kwon Ha

    2004-01-01

    To our knowledge, rectal cancer arising at the anastomotic site after surgery for Hirschsprung's disease has not been reported. We report a case of mucinous adenocarcinoma arising at the anastomotic site after Soave operation 26 years ago

  19. 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

  20. Regulatory guidance document

    International Nuclear Information System (INIS)

    1994-05-01

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

  1. Managing Regulatory Body Competence

    International Nuclear Information System (INIS)

    2013-01-01

    In 2001, the IAEA published TECDOC 1254, which examined the way in which the recognized functions of a regulatory body for nuclear facilities results in competence needs. Using the systematic approach to training (SAT), TECDOC 1254 provided a framework for regulatory bodies for managing training and developing and their maintaining their competence. It has been successfully used by many regulators. The IAEA has also introduced a methodology and an assessment tool - Guidelines for Systematic Assessment of Regulatory Competence Needs (SARCoN) - which provides practical guidance on analysing the training and development needs of a regulatory body and, through a gap analysis, guidance on establishing competence needs and how to meet them. In 2009, the IAEA established a steering committee (supported by a bureau) with the mission to advise the IAEA on how it could best assist Member States to develop suitable competence management systems for their regulatory bodies. The committee recommended the development of a safety report on managing staff competence as an integral part of a regulatory body's management system. This Safety Report was developed in response to this request. It supersedes TECDOC 1254, broadens its application to regulatory bodies for all facilities and activities, and builds upon the experience gained through the application of TECDOC 1254 and SARCoN and the feedback received from Member States. This Safety Report applies to the management of adequate competence as needs change, and as such is equally applicable to the needs of States 'embarking' on a nuclear power programme. It also deals with the special case of building up the competence of regulatory bodies as part of the overall process of establishing an 'embarking' State's regulatory system

  2. Pleiotropy constrains the evolution of protein but not regulatory sequences in a transcription regulatory network influencing complex social behaviours

    Directory of Open Access Journals (Sweden)

    Daria eMolodtsova

    2014-12-01

    Full Text Available It is increasingly apparent that genes and networks that influence complex behaviour are evolutionary conserved, which is paradoxical considering that behaviour is labile over evolutionary timescales. How does adaptive change in behaviour arise if behaviour is controlled by conserved, pleiotropic, and likely evolutionary constrained genes? Pleiotropy and connectedness are known to constrain the general rate of protein evolution, prompting some to suggest that the evolution of complex traits, including behaviour, is fuelled by regulatory sequence evolution. However, we seldom have data on the strength of selection on mutations in coding and regulatory sequences, and this hinders our ability to study how pleiotropy influences coding and regulatory sequence evolution. Here we use population genomics to estimate the strength of selection on coding and regulatory mutations for a transcriptional regulatory network that influences complex behaviour of honey bees. We found that replacement mutations in highly connected transcription factors and target genes experience significantly stronger negative selection relative to weakly connected transcription factors and targets. Adaptively evolving proteins were significantly more likely to reside at the periphery of the regulatory network, while proteins with signs of negative selection were near the core of the network. Interestingly, connectedness and network structure had minimal influence on the strength of selection on putative regulatory sequences for both transcription factors and their targets. Our study indicates that adaptive evolution of complex behaviour can arise because of positive selection on protein-coding mutations in peripheral genes, and on regulatory sequence mutations in both transcription factors and their targets throughout the network.

  3. Transcription regulatory networks analysis using CAGE

    KAUST Repository

    Tegnér, Jesper N.

    2009-10-01

    Mapping out cellular networks in general and transcriptional networks in particular has proved to be a bottle-neck hampering our understanding of biological processes. Integrative approaches fusing computational and experimental technologies for decoding transcriptional networks at a high level of resolution is therefore of uttermost importance. Yet, this is challenging since the control of gene expression in eukaryotes is a complex multi-level process influenced by several epigenetic factors and the fine interplay between regulatory proteins and the promoter structure governing the combinatorial regulation of gene expression. In this chapter we review how the CAGE data can be integrated with other measurements such as expression, physical interactions and computational prediction of regulatory motifs, which together can provide a genome-wide picture of eukaryotic transcriptional regulatory networks at a new level of resolution. © 2010 by Pan Stanford Publishing Pte. Ltd. All rights reserved.

  4. 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...

  5. NRC regulatory agenda

    International Nuclear Information System (INIS)

    1990-10-01

    The Regulatory Agenda is a quarterly compilation of all rules on which the NRC has recently completed action or has proposed, or is considering action and of all petitions for rulemaking that the NRC has received that are pending disposition

  6. NRC regulatory agenda

    International Nuclear Information System (INIS)

    1990-04-01

    The Regulatory Agenda is a quarterly compilation of all rules on which the NRC has recently completed action or has proposed, or is considering action and of all petitions for rulemaking that the NRC has received that are pending disposition

  7. Through the regulatory hoop

    International Nuclear Information System (INIS)

    Kirner, N.P.

    1985-01-01

    There are many regulatory hoops through which waste generators, brokers, and disposal site operators must jump to dispose of waste safely. As the proposed exclusionary date of January 1, 1986, approaches, these regulatory hoops have the distinct possibility of multiplying or at least changing shape. The state of Washington, in its role as an Agreement State with the US Nuclear Regulatory Commission, licenses and inspects the commercial operator of the Northwest Compact's low-level radioactive waste disposal site on the Hanford Reservation. Washington has received as much as 53%, or 1.4 million cubic feet per year, of the nation's total volume of waste disposed. To control such a large volume of waste, a regulatory program involving six agencies has developed over the years in Washington

  8. Cryptocurrencies & the Challenge of Global Governance

    Directory of Open Access Journals (Sweden)

    Garry Jacbs

    2018-05-01

    Full Text Available The recent explosive development of new forms of digital currency opens up unprecedented opportunities and poses significant regulatory challenges. This new form of digital currency lowers the costs and other barriers to the global movement of money, international trade, foreign investment and speculation, while simultaneously enhancing the anonymity on which tax evasion, money-laundering and other illegal activities thrive. It also liberates the creation of money and regulation of economic activities from the political control of national governments and central banks. Since the value of a currency is related to the size of the population, strength of the economy and value of transactions that utilize it, a basket of cryptocurrencies could emerge as the first prototype of a world currency whose value is backed by the total productive capacity of the entire human community. Moreover, the triad of Internet, distributed ledger technologies and cryptocurrencies could serve as the basis for the development of new global economic potentials in a manner similar and a degree far exceeding the economic impact of the World Wide Web over the past two decades. At the same time, the rapid deployment of cryptocurrencies could have profound impact on the capacity of governments to tax transactions, income and wealth, one of the main pillars of the modern nation state. The development of autonomous global cryptocurrencies could dramatically reduce the control and effectiveness of existing regulatory mechanisms at the national level and generate considerable pressure for the evolution of more effective institutions for global governance. They could provide compelling incentives for national governments to enhance international cooperation and strengthen the functioning of international institutions to fill the regulatory void. International organizations will play an important role in harnessing the potentials and minimizing the risks arising from the growing

  9. 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.

  10. Cross-border issues that arise in conjunction with the execution of U.S.-Canadian natural gas contracts

    International Nuclear Information System (INIS)

    Martin, J. G.

    1999-01-01

    Development of the U.S.-Canadian natural gas market as it is today and the issues that may arise in cross-border transactions involving natural gas contracts between the two countries are reviewed. In this context, the paper reviews recent history of U.S.-Canadian trade relations culminating in the development of NAFTA, the U.S. regulatory and legislative framework surrounding cross-border natural gas transactions, and general U.S. foreign trade policy that may come into play at the U.S.- Canada border. The paper also examines certain issues arising in the U.S. commercial context that may be of interest to Canadian corporations, specifically the U.S. Uniform Commercial Code, state jurisdiction on the U.S. side of the border, state and federal tax concerns, and the mechanics and potential benefits for a Canadian parent company in forming a U.S.-based subsidiary to handle U.S.-Canada natural gas transactions. 71 refs

  11. 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.

  12. Overcoming challenges

    Medline Plus

    Full Text Available ... breastfeeding Overcoming challenges Common questions about breastfeeding and pain Breastfeeding checklist: How to get a good latch Finding ... myths Overcoming challenges Common questions about breastfeeding and pain Breastfeeding checklist: How to get a good latch Finding ...

  13. Overcoming challenges

    Medline Plus

    Full Text Available ... section Back to section menu It's Only Natural Planning ahead Breastfeeding and baby basics Making breastfeeding work ... It's Only Natural Overcoming challenges It's Only Natural Planning ahead Addressing breastfeeding myths Overcoming challenges Common questions ...

  14. The global conduct of cancer clinical trials: challenges and opportunities.

    Science.gov (United States)

    Barrios, Carlos H; Werutsky, Gustavo; Martinez-Mesa, Jeovany

    2015-01-01

    The nature of clinical research has changed substantially over the last 2 decades, evolving from being centered almost exclusively in developed countries to a more global scenario that is increasingly involving less developed regions of the world. Pharmaceutical companies and some academic cooperative groups have been conducting challenging, large pivotal registration studies with multinational participation. The much more needed globalization of academic research demands particular attention and represents a worthwhile subject for a more profound discussion. The requirement of large sample sizes and the potential for fast recruitment leading to a speedy completion of clinical studies are probably the most important factors that have fueled globalization of studies. Reduced operational costs and the ability to expedite the regulatory approval of drugs in various countries or regions are also important drivers. Globalization of research should be seen as having a much wider effect in the societies involved, in particular, when we consider public health, economic, social, and ethical implications. Most importantly, the process of expanding the network of clinical research sites also fosters the integration and the development of closer relationships among investigators at a global level. We consider this an essential element that should remain a prominent element in the discussion. In this article, we address the underlying reasons for globalization and we highlight some of the scientific and ethical concerns arising as a consequence. Finally, some strategies to address and mitigate the challenges of conducting multinational clinical research are proposed.

  15. Strategies to Address Common Challenges When Teaching in an Active Learning Classroom

    Science.gov (United States)

    Petersen, Christina I.; Gorman, Kristen S.

    2014-01-01

    This chapter provides practical strategies for addressing common challenges that arise for teachers in active learning classrooms. Our strategies come from instructors with experience teaching in these environments.

  16. Nuclear regulatory decision making

    International Nuclear Information System (INIS)

    2005-01-01

    The fundamental objective of all nuclear safety regulatory bodies is to ensure that nuclear utilities operate their plants at all times in an acceptably safe manner. In meeting this objective, the regulatory body should strive to ensure that its regulatory decisions are technically sound, consistent from case to case, and timely. In addition, the regulator must be aware that its decisions and the circumstances surrounding those decisions can affect how its stakeholders, such as government policy makers, the industry it regulates, and the public, view it as an effective and credible regulator. In order to maintain the confidence of those stakeholders, the regulator should make sure that its decisions are transparent, have a clear basis in law and regulations, and are seen by impartial observers to be fair to all parties. Based on the work of a Nuclear Energy Agency (NEA) expert group, this report discusses some of the basic principles and criteria that a regulatory body should consider in making decisions and describes the elements of an integrated framework for regulatory decision making. (author)

  17. 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.

  18. 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 ...

  19. The Feasibility and Acceptability of "Arise": An Online Substance Abuse Relapse Prevention Program.

    Science.gov (United States)

    Sanchez, Rebecca Polley; Bartel, Chelsea M

    2015-04-01

    The purpose of this study was to test the feasibility and acceptability of a novel online adolescent substance abuse relapse prevention tool, "Arise" (3C Institute, Cary, NC). The program uses an innovative platform including interactive instructional segments and skill-building games to help adolescents learn and practice coping skills training strategies. We conducted a pilot test with nine adolescents in substance abuse treatment (44 percent female) and a feasibility test with treatment providers (n=8; 50 percent female). Adolescents interacted with the program via a secure Web site for approximately 30 minutes for each of two instructional units. Treatment providers reviewed the same material at their own pace. All participants completed a questionnaire with items assessing usability, acceptability, understanding, and subjective experience of the program. Regarding feasibility, recruitment of this population within the study constraints proved challenging, but participant retention in the trial was high (no attrition). Adolescents and treatment providers completed the program with no reported problems, and overall we were able to collect data as planned. Regarding acceptability, the program received strong ratings from both adolescents and providers, who found the prototype informative, engaging, and appealing. Both groups strongly recommended continuing development. We were able to deliver the intervention as intended, and acceptability ratings were high, demonstrating the feasibility and acceptability of online delivery of engaging interactive interventions. This study contributes to our understanding of how interactive technologies, including games, can be used to modify behavior in substance abuse treatment and other health areas.

  20. Nuclear Regulatory Legislation

    International Nuclear Information System (INIS)

    1989-08-01

    This compilation of statutes and material pertaining to nuclear regulatory legislation through the 100th Congress, 2nd Session, has been prepared by the Office of the General Counsel, US Nuclear Regulatory Commission, with the assistance of staff, for use as an internal resource document. Persons using this document are placed on notice that it may not be used as an authoritative citation in lieu of the primary legislative sources. Furthermore, while every effort has been made to ensure the completeness and accuracy of this material, neither the United States Government, the Nuclear Regulatory Commission, nor any of their employees makes any expressed or implied warranty or assumes liability for the accuracy or completeness of the material presented in this compilation

  1. 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)

  2. Regulatory and licensee surveys

    International Nuclear Information System (INIS)

    2009-01-01

    Prior to the workshop two CSNI/WGHOF surveys were distributed. One survey was directed at regulatory bodies and the other was directed at plant licensees. The surveys were: 1 - Regulatory Expectations of Licensees' Arrangements to Ensure Suitable Organisational Structure, Resources and Competencies to Manage Safety (sent to WGHOF regulatory members). The survey requested that the respondents provide a brief overview of the situation related to plant organisations in their country, their regulatory expectations and their formal requirements. The survey addressed three subjects: the demonstration and documentation of organisational structures, resources and competencies, organisational changes, issues for improvement (for both current and new plants). Responses were received from eleven regulatory bodies. 2 - Approaches to Justify Organisational Suitability (sent to selected licensees). The purpose of the survey to was to gain an understanding of how licensees ensure organisational suitability, resources and competencies. This information was used to assist in the development of the issues and subjects that were addressed at the group discussion sessions. Responses were received from over fifteen licensees from nine countries. The survey requested that the licensees provide information on how they ensure effective organisational structures at their plants. The survey grouped the questions into the following four categories: organisational safety functions, resource and competence, decision-making and communication, good examples and improvement needs. The findings from these surveys were used in conjunction with other factors to identify the key issues for the workshop discussion sessions. The responses from these two surveys are discussed briefly in Sections 4 and 5 of this report. More extensive reviews of the regulatory and licensee responses are provided in Appendix 1

  3. 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...

  4. Rationales for regulatory activity

    Energy Technology Data Exchange (ETDEWEB)

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

    1997-02-01

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

  5. 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...

  6. 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)

  7. Integration of Bacterial Small RNAs in Regulatory Networks.

    Science.gov (United States)

    Nitzan, Mor; Rehani, Rotem; Margalit, Hanah

    2017-05-22

    Small RNAs (sRNAs) are central regulators of gene expression in bacteria, controlling target genes posttranscriptionally by base pairing with their mRNAs. sRNAs are involved in many cellular processes and have unique regulatory characteristics. In this review, we discuss the properties of regulation by sRNAs and how it differs from and combines with transcriptional regulation. We describe the global characteristics of the sRNA-target networks in bacteria using graph-theoretic approaches and review the local integration of sRNAs in mixed regulatory circuits, including feed-forward loops and their combinations, feedback loops, and circuits made of an sRNA and another regulator, both derived from the same transcript. Finally, we discuss the competition effects in posttranscriptional regulatory networks that may arise over shared targets, shared regulators, and shared resources and how they may lead to signal propagation across the network.

  8. Radiological protection issues arising during and after the Fukushima nuclear reactor accident

    International Nuclear Information System (INIS)

    González, Abel J; Akashi, Makoto; Sakai, Kazuo; Yonekura, Yoshiharu; Boice Jr, John D; Chino, Masamichi; Homma, Toshimitsu; Ishigure, Nobuhito; Kai, Michiaki; Kusumi, Shizuyo; Lee, Jai-Ki; Menzel, Hans-Georg; Niwa, Ohtsura; Yamashita, Shunichi; Weiss, Wolfgang

    2013-01-01

    Following the Fukushima accident, the International Commission on Radiological Protection (ICRP) convened a task group to compile lessons learned from the nuclear reactor accident at the Fukushima Daiichi nuclear power plant in Japan, with respect to the ICRP system of radiological protection. In this memorandum the members of the task group express their personal views on issues arising during and after the accident, without explicit endorsement of or approval by the ICRP. While the affected people were largely protected against radiation exposure and no one incurred a lethal dose of radiation (or a dose sufficiently large to cause radiation sickness), many radiological protection questions were raised. The following issues were identified: inferring radiation risks (and the misunderstanding of nominal risk coefficients); attributing radiation effects from low dose exposures; quantifying radiation exposure; assessing the importance of internal exposures; managing emergency crises; protecting rescuers and volunteers; responding with medical aid; justifying necessary but disruptive protective actions; transiting from an emergency to an existing situation; rehabilitating evacuated areas; restricting individual doses of members of the public; caring for infants and children; categorising public exposures due to an accident; considering pregnant women and their foetuses and embryos; monitoring public protection; dealing with ‘contamination’ of territories, rubble and residues and consumer products; recognising the importance of psychological consequences; and fostering the sharing of information. Relevant ICRP Recommendations were scrutinised, lessons were collected and suggestions were compiled. It was concluded that the radiological protection community has an ethical duty to learn from the lessons of Fukushima and resolve any identified challenges. Before another large accident occurs, it should be ensured that inter alia: radiation risk coefficients of

  9. Radiological protection issues arising during and after the Fukushima nuclear reactor accident.

    Science.gov (United States)

    González, Abel J; Akashi, Makoto; Boice, John D; Chino, Masamichi; Homma, Toshimitsu; Ishigure, Nobuhito; Kai, Michiaki; Kusumi, Shizuyo; Lee, Jai-Ki; Menzel, Hans-Georg; Niwa, Ohtsura; Sakai, Kazuo; Weiss, Wolfgang; Yamashita, Shunichi; Yonekura, Yoshiharu

    2013-09-01

    Following the Fukushima accident, the International Commission on Radiological Protection (ICRP) convened a task group to compile lessons learned from the nuclear reactor accident at the Fukushima Daiichi nuclear power plant in Japan, with respect to the ICRP system of radiological protection. In this memorandum the members of the task group express their personal views on issues arising during and after the accident, without explicit endorsement of or approval by the ICRP. While the affected people were largely protected against radiation exposure and no one incurred a lethal dose of radiation (or a dose sufficiently large to cause radiation sickness), many radiological protection questions were raised. The following issues were identified: inferring radiation risks (and the misunderstanding of nominal risk coefficients); attributing radiation effects from low dose exposures; quantifying radiation exposure; assessing the importance of internal exposures; managing emergency crises; protecting rescuers and volunteers; responding with medical aid; justifying necessary but disruptive protective actions; transiting from an emergency to an existing situation; rehabilitating evacuated areas; restricting individual doses of members of the public; caring for infants and children; categorising public exposures due to an accident; considering pregnant women and their foetuses and embryos; monitoring public protection; dealing with 'contamination' of territories, rubble and residues and consumer products; recognising the importance of psychological consequences; and fostering the sharing of information. Relevant ICRP Recommendations were scrutinised, lessons were collected and suggestions were compiled. It was concluded that the radiological protection community has an ethical duty to learn from the lessons of Fukushima and resolve any identified challenges. Before another large accident occurs, it should be ensured that inter alia: radiation risk coefficients of potential

  10. Educational Game as Supplemental Learning Tool: Benefits, Challenges, and Tensions Arising from Use in an Elementary School Classroom

    Science.gov (United States)

    Warren, Scott; Dondlinger, Mary Jo; Stein, Richard; Barab, Sasha

    2009-01-01

    This article examines the qualitative findings from a mixed-methods comparison study of the use of an online multi-user virtual environment called Anytown which supplemented face-to-face writing instruction in a fourth grade classroom to determine implications for the design of such environments and the reported impact of this design on students…

  11. Neglected Australian Arboviruses and Undifferentiated Febrile Illness: Addressing Public Health Challenges Arising From the 'Developing Northern Australia' Government Policy.

    Science.gov (United States)

    Gyawali, Narayan; Bradbury, Richard S; Aaskov, John G; Taylor-Robinson, Andrew W

    2017-01-01

    The Australian Government is currently promoting the development of Northern Australia, with an associated increase in the local population. Consequent to this is the public health threat posed by heightened human exposure to many previously neglected arboviruses that are indigenous to the region. This initiative to support economic activity in the tropical north of the continent is leading to the accelerated expansion of an infection-naïve human population into hitherto un-encountered ecosystems inhabited by reservoir animals and vectors for these arboviruses. Combined with an apparent rise in the number and impact of dramatic climate events, such as tropical cyclones and floods caused by torrential monsoonal rainfall, this heightens the potential for viral transmission to humans. More than 75 arboviruses have been identified in Australia, some of which are associated with human disease but for which routine tests are not available to diagnose infection. Here, we describe briefly the neglected Australian arboviruses that are most likely to emerge as significant agents of human disease in the coming decades. We also advocate the establishment of a thorough surveillance and diagnostic protocol, including developing new pan-viral rapid tests for primary care use to assist in the early diagnosis and correct treatment of affected patients. We propose that the implementation of these activities will enhance our understanding of the geographical range, prevalence, identification and control of neglected Australian arboviruses. This would minimise and limit the possibility of large-scale outbreaks with these agents as population and economic growth expands further into Australia's tropical north.

  12. Unintended changes in cognition, mood, and behavior arising from cell-based interventions for neurological conditions: ethical challenges.

    Science.gov (United States)

    Duggan, P S; Siegel, A W; Blass, D M; Bok, H; Coyle, J T; Faden, R; Finkel, J; Gearhart, J D; Greely, H T; Hillis, A; Hoke, A; Johnson, R; Johnston, M; Kahn, J; Kerr, D; King, P; Kurtzberg, J; Liao, S M; McDonald, J W; McKhann, G; Nelson, K B; Rao, M; Regenberg, A; Smith, K; Solter, D; Song, H; Sugarman, J; Traystman, R J; Vescovi, A; Yanofski, J; Young, W; Mathews, D J H

    2009-05-01

    The prospect of using cell-based interventions (CBIs) to treat neurological conditions raises several important ethical and policy questions. In this target article, we focus on issues related to the unique constellation of traits that characterize CBIs targeted at the central nervous system. In particular, there is at least a theoretical prospect that these cells will alter the recipients' cognition, mood, and behavior-brain functions that are central to our concept of the self. The potential for such changes, although perhaps remote, is cause for concern and careful ethical analysis. Both to enable better informed consent in the future and as an end in itself, we argue that early human trials of CBIs for neurological conditions must monitor subjects for changes in cognition, mood, and behavior; further, we recommend concrete steps for that monitoring. Such steps will help better characterize the potential risks and benefits of CBIs as they are tested and potentially used for treatment.

  13. Introducing E-Learning in a South African Higher Education Institution: Challenges Arising from an Intervention and Possible Responses

    Science.gov (United States)

    Bharuthram, Sharita; Kies, Carolynn

    2013-01-01

    This article draws on research conducted at a tertiary institution in South Africa as part of the redesigning of an English for Educational Development (EED) course to include an e-learning online discussion component. The subject material used was based on HIV/AIDS topics that students had to debate within an online discussion forum. Framed by…

  14. Ethical challenges that arise at the community interface of health research: village reporters' experiences in Western Kenya.

    Science.gov (United States)

    Chantler, Tracey; Otewa, Faith; Onyango, Peter; Okoth, Ben; Odhiambo, Frank; Parker, Michael; Geissler, Paul Wenzel

    2013-04-01

    Community Engagement (CE) has been presented by bio-ethicists and scientists as a straightforward and unequivocal good which can minimize the risks of exploitation and ensure a fair distribution of research benefits in developing countries. By means of ethnographic fieldwork undertaken in Kenya between 2007 and 2009 we explored how CE is understood and enacted in paediatric vaccine trials conducted by the Kenyan Medical Research Institute and the US Centers for Disease Control (KEMRI/CDC). In this paper we focus on the role of paid volunteers who act as an interface between villagers KEMRI/CDC. Village Reporters' (VRs) position of being both with the community and with KEMRI/CDC is advantageous for the conduct of trials. However it is also problematic in terms of exercising trust, balancing allegiances and representing community views. VRs role is shaped by ambiguities related to their employment status and their dual accountability to researchers and their villages. VRs are understandably careful to stress their commitment to self-less community service since it augments their respectability at community level and opens up opportunities for financial gain and self-development. Simultaneously VRs association with KEMRI/CDC and proximity to trial participants requires them to negotiate implicit and explicit expectations for material and medical assistance in a cultural setting in which much importance is placed on sharing and mutuality. To ensure continuity of productive interactions between VRs, and similar community intermediaries, and researchers, open discussion is needed about the problematic aspects of relational ethics, issues concerning undue influence, power relations and negotiating expectations. © 2013 Blackwell Publishing Ltd.

  15. Developing regulatory approaches

    International Nuclear Information System (INIS)

    Axelsson, Lars

    2012-01-01

    Lars Axelsson presented SSM progress on oversight of LMfS/SC since the Chester 1 Workshop in 2007. Current SSM approaches for safety culture oversight include targeted safety management and safety culture inspections, compliance inspections which cover aspects of safety management/safety culture and multi-disciplinary team inspections. Examples of themes for targeted inspections include management of ambiguous operational situations or other weak signals, understanding of and attitudes to Human Performance tools, the Safety Department's role and authority and Leadership for safety. All regulatory activities provide inputs for the SSM yearly safety evaluation of each licensee. A form has been developed to capture safety culture observations from inspections and other interactions with licensees. Analysis will be performed to identify patterns and provide information to support planning of specific Safety Culture activities. Training has been developed for regulatory staff to enhance the quality of regulatory interventions on safety culture. This includes a half-day seminar to provide an overview of safety culture, and a workshop which provides more in-depth discussion on cultural issues and how to capture those during regulatory activities. Future plans include guidance for inspectors, and informal seminars on safety culture with licensees

  16. NRC Regulatory Agenda

    International Nuclear Information System (INIS)

    1992-07-01

    This document compilation of all rules on which the NRC has recently completed action, or has proposed action, or is considering action, and all petitions for rule making which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter

  17. NRC regulatory agenda

    International Nuclear Information System (INIS)

    1993-02-01

    This document is a compilation of all rules on which the NRC has recently completed action, or has proposed action, or is considered action, and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter

  18. NRC Regulatory Agenda

    International Nuclear Information System (INIS)

    1989-07-01

    This document is a compilation of all rules on which the NRC has proposed or is considering action and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter

  19. NRC regulatory agenda

    International Nuclear Information System (INIS)

    1992-11-01

    This document provides a compilation of all rules on which the NRC has recently completed action, or has proposed action, or is considering action, and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter

  20. Comments on regulatory reform

    International Nuclear Information System (INIS)

    Hendrie, J.M.

    1982-01-01

    Nuclear regulatory reform is divided into two parts. The first part contains all those matters for which new legislation is required. The second part concerns all those matters that are within the power of the Commission under existing statutes. Recommendations are presented

  1. Comments on regulatory reform

    Energy Technology Data Exchange (ETDEWEB)

    Hendrie, J.M.

    1982-01-01

    Nuclear regulatory reform is divided into two parts. The first part contains all those matters for which new legislation is required. The second part concerns all those matters that are within the power of the Commission under existing statutes. Recommendations are presented.

  2. 3 CFR - Regulatory Review

    Science.gov (United States)

    2010-01-01

    ... as a means of promoting regulatory goals. The fundamental principles and structures governing... review. In this time of fundamental transformation, that process—and the principles governing regulation... the Office of Management and Budget (OMB) has reviewed Federal regulations. The purposes of such...

  3. Intraosseous verrucous carcinoma arising from an orthokeratinized odontogenic keratocyst: A report of a rarest entity

    Directory of Open Access Journals (Sweden)

    Nagaraju Kamarthi

    2016-01-01

    Full Text Available Intraosseous verrucous carcinomas (VCs arising from odontogenic cysts are a rare entity. An unusual case of a VC arising from the orthokeratinized odontogenic cyst is described for the first time. The microscopic features of the lesion are presented.

  4. Law of the Energy Regulatory Commission

    International Nuclear Information System (INIS)

    1995-01-01

    This Decree-Law consist of three chapters each on divided in articles and subsections and came into force in November 1 st., 1995. Chapter I, with the heading 'Nature and Powers', defines the Energy Regulatory Commission as a decentralized organ of the Energy Secretariat with technical and operative autonomy in terms of the law, and establish the conditions for the sell, generation, exportation and importation of electricity with destination to particular and public services. The sell transport, storage and distribution of natural gas, as well as the gas liquefied from petroleum are also considered. Chapter II with the heading 'Organization and duties' establish that the Commission is integrated by five Committee, the President included. The Committee members will deliberate in collegiate manner and the decisions are by majority, having the President a vote of quality. Chapter III for 'General provisions' is related to the lawsuits arises between the Commission and the users of services. (Author)

  5. Emotion: The Self-regulatory Sense.

    Science.gov (United States)

    Peil, Katherine T

    2014-03-01

    While emotion is a central component of human health and well-being, traditional approaches to understanding its biological function have been wanting. A dynamic systems model, however, broadly redefines and recasts emotion as a primary sensory system-perhaps the first sensory system to have emerged, serving the ancient autopoietic function of "self-regulation." Drawing upon molecular biology and revelations from the field of epigenetics, the model suggests that human emotional perceptions provide an ongoing stream of "self-relevant" sensory information concerning optimally adaptive states between the organism and its immediate environment, along with coupled behavioral corrections that honor a universal self-regulatory logic, one still encoded within cellular signaling and immune functions. Exemplified by the fundamental molecular circuitry of sensorimotor control in the E coli bacterium, the model suggests that the hedonic (affective) categories emerge directly from positive and negative feedback processes, their good/bad binary appraisals relating to dual self-regulatory behavioral regimes-evolutionary purposes, through which organisms actively participate in natural selection, and through which humans can interpret optimal or deficit states of balanced being and becoming. The self-regulatory sensory paradigm transcends anthropomorphism, unites divergent theoretical perspectives and isolated bodies of literature, while challenging time-honored assumptions. While suppressive regulatory strategies abound, it suggests that emotions are better understood as regulating us, providing a service crucial to all semantic language, learning systems, evaluative decision-making, and fundamental to optimal physical, mental, and social health.

  6. Emotion: The Self-regulatory Sense

    Science.gov (United States)

    2014-01-01

    While emotion is a central component of human health and well-being, traditional approaches to understanding its biological function have been wanting. A dynamic systems model, however, broadly redefines and recasts emotion as a primary sensory system—perhaps the first sensory system to have emerged, serving the ancient autopoietic function of “self-regulation.” Drawing upon molecular biology and revelations from the field of epigenetics, the model suggests that human emotional perceptions provide an ongoing stream of “self-relevant” sensory information concerning optimally adaptive states between the organism and its immediate environment, along with coupled behavioral corrections that honor a universal self-regulatory logic, one still encoded within cellular signaling and immune functions. Exemplified by the fundamental molecular circuitry of sensorimotor control in the E coli bacterium, the model suggests that the hedonic (affective) categories emerge directly from positive and negative feedback processes, their good/bad binary appraisals relating to dual self-regulatory behavioral regimes—evolutionary purposes, through which organisms actively participate in natural selection, and through which humans can interpret optimal or deficit states of balanced being and becoming. The self-regulatory sensory paradigm transcends anthropomorphism, unites divergent theoretical perspectives and isolated bodies of literature, while challenging time-honored assumptions. While suppressive regulatory strategies abound, it suggests that emotions are better understood as regulating us, providing a service crucial to all semantic language, learning systems, evaluative decision-making, and fundamental to optimal physical, mental, and social health. PMID:24808986

  7. Systematic identification of regulatory variants associated with cancer risk.

    Science.gov (United States)

    Liu, Song; Liu, Yuwen; Zhang, Qin; Wu, Jiayu; Liang, Junbo; Yu, Shan; Wei, Gong-Hong; White, Kevin P; Wang, Xiaoyue

    2017-10-23

    Most cancer risk-associated single nucleotide polymorphisms (SNPs) identified by genome-wide association studies (GWAS) are noncoding and it is challenging to assess their functional impacts. To systematically identify the SNPs that affect gene expression by modulating activities of distal regulatory elements, we adapt the self-transcribing active regulatory region sequencing (STARR-seq) strategy, a high-throughput technique to functionally quantify enhancer activities. From 10,673 SNPs linked with 996 cancer risk-associated SNPs identified in previous GWAS studies, we identify 575 SNPs in the fragments that positively regulate gene expression, and 758 SNPs in the fragments with negative regulatory activities. Among them, 70 variants are regulatory variants for which the two alleles confer different regulatory activities. We analyze in depth two regulatory variants-breast cancer risk SNP rs11055880 and leukemia risk-associated SNP rs12142375-and demonstrate their endogenous regulatory activities on expression of ATF7IP and PDE4B genes, respectively, using a CRISPR-Cas9 approach. By identifying regulatory variants associated with cancer susceptibility and studying their molecular functions, we hope to help the interpretation of GWAS results and provide improved information for cancer risk assessment.

  8. Nuclear Regulatory Commission information digest

    International Nuclear Information System (INIS)

    1990-03-01

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

  9. Characteristics of regulatory regimes

    Directory of Open Access Journals (Sweden)

    Noralv Veggeland

    2013-03-01

    Full Text Available The overarching theme of this paper is institutional analysis of basic characteristics of regulatory regimes. The concepts of path dependence and administrative traditions are used throughout. Self-reinforcing or positive feedback processes in political systems represent a basic framework. The empirical point of departure is the EU public procurement directive linked to OECD data concerning use of outsourcing among member states. The question is asked: What has caused the Nordic countries, traditionally not belonging to the Anglo-Saxon market-centred administrative tradition, to be placed so high on the ranking as users of the Market-Type Mechanism (MTM of outsourcing in the public sector vs. in-house provision of services? A thesis is that the reason may be complex, but might be found in an innovative Scandinavian regulatory approach rooted in the Nordic model.

  10. NRC regulatory agenda

    International Nuclear Information System (INIS)

    1993-07-01

    The NRC Regulatory Agenda is a compilation of all rules on which the NRC has recently completed action, or has proposed action, or is considering action, and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter. The rules on which final action has been taken since March 31, 1993 are: Repeal of NRC standards of conduct; Fitness-for-duty requirements for licensees who possess, use, or transport Category I material; Training and qualification of nuclear power plant personnel; Monitoring the effectiveness of maintenance at nuclear power plants; Licensing requirements for land disposal of radioactive wastes; and Licensees' announcements of safeguards inspections

  11. A flexible regulatory framework

    International Nuclear Information System (INIS)

    Silvennoinen, T.

    2000-01-01

    Regulatory reform of the Finnish electricity market meant opening up potentially competitive parts of the electricity sector to competition and eliminating all unnecessary forms of regulation covering generation, wholesale supply, retail supply, and foreign trade in electricity. New types of control and regulatory mechanisms and institutions were set up for those parts of the electricity industry that were excluded from competition, such as network operations. Network activities now have to be licensed, whereas no licence is needed for generation or supply. A new sector-specific regulatory authority was established in 1995 to coincide with the implementation of the Electricity Market Act, known as the Electricity Market Authority. This is responsible for regulating network activities and retail supply to captive customers. The core function of the authority, which employs some 14 people, is to promote the smooth operation of the Finnish electricity market and to oversee the implementation of the Electricity Market Act and its provisions. Its most important duties are linked to overseeing the process by which network companies price their electricity. As price regulation no longer exists, all the companies in the electricity sector set their tariffs independently, even network companies. The job of controlling the pricing of network services is handed by the Electricity Market Authority, following the principles of competition control. Pricing control takes place ex post - after a pricing system has been adopted by a company and concentrates on individual cases and companies. There is no ex ante system of setting or approving prices and tariffs by the regulator. The tariffs and pricing of network services can be evaluated, however, by both the Electricity Market Authority and the Finnish Competition Authority, which have overlapping powers as regards the pricing of network activities. The Finnish regulatory framework can be described as a system of light

  12. Engineered Nanoscale Materials and Derivative Products: Regulatory Challenges

    National Research Council Canada - National Science Library

    Schierow, Linda-Jo

    2008-01-01

    .... government has invested billions of dollars to ensure that American industry remains a global leader in the field, because the products of nanotechnology are seen to have great economic potential...

  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. ENEN'S challenges in response to the industry and regulatory needs

    International Nuclear Information System (INIS)

    Safieh, Joseph; De Regge, Peter Paul; Kusumi, Ryoko

    2011-01-01

    The European Nuclear Education Network (ENEN) Association is a non-profit organization established in 2003. Its main objective is the preservation and further development of expertise in the nuclear fields by higher education and training. As of December 2010, the ENEN has 56 members in 18 European countries, South Africa, Russian Federation, Ukraine and Japan. The ENEN has provided support to its Members for the organization of and participation to selected E&T courses in nuclear disciplines and developed the European Master of Science in Nuclear Engineering. Since 2009 the ENEN has been involved in three FP7 European Fission Training Scheme (EFTS) projects, i.e. ENEN III on nuclear engineering, PETRUS II on waste management and ENETRAP II on radiation protection. The ultimate objective of each EFTS is to develop a European passport for training, using the European Credit system for Vocational Education and Training (ECVET) approach, which is in fact a portfolio of learning outcomes. Once established, this concept will be applied to all ENEN and other appropriate training courses for achieving the harmonization of professional training over Europe. In December 2008 the European Council welcomed the existence within the EU of coordinated teaching and training leading to qualifications in the nuclear field, provided notably by the ENEN, and expressed its hope that, with assistance of the EU, the ENEN and its members will continue to develop the coordination of nuclear education and training in Europe. The ENEN endeavours to respond to their expectations in the years to come. (author)

  15. Demand response in Germany: Technical potential, benefits and regulatory challenges

    OpenAIRE

    Stede, Jan

    2016-01-01

    An increased flexibility of the electricity demand side through demand response (DR) is an opportunity to support the integration of renewable energies. By optimising the use of the generation, transmission and distribution infrastructure, DR reduces the need for costly investments and contributes to system security. There is a significant technical DR potential for load reduction from industrial production processes in Germany, as well as from cross-cutting technologies in industry and the t...

  16. Introduction: Contemporary Food Regulatory Regimes and the Challenges Ahead

    NARCIS (Netherlands)

    A. Arcuri (Alessandra)

    2010-01-01

    textabstractFood is one of the fundamental elements of human life: it guarantees survival, it can dispense death and, above all, as Marcel Proust reminds us, it is deeply connected to our own ‘essence’, having the power of blessing men with ‘exquisite pleasure’ and ‘all-powerful joy’. Given the

  17. Tools for regulatory assessment of occupational exposure: Development and challenges

    NARCIS (Netherlands)

    Tielemans, E.; Warren, N.; Schneider, T.; Tischer, M.; Ritchie, P.; Goede, H.; Kromhout, H.; Hemmen, J. van; Cherrie, J.W.

    2007-01-01

    REACH (Registration, Evaluation and Authorization of CHemicals) requires improved exposure models that can be incorporated into screening tools and refined assessment tools. These are referred to as tier 1 and 2 models, respectively. There are a number of candidate in tier 1 models that could be

  18. ENEN's challenges in response to the industry and regulatory needs

    International Nuclear Information System (INIS)

    Safieh, J.; De Regge, P. P.; Kusumi, R.

    2011-01-01

    The European Nuclear Education Network (ENEN) Association is a non-profit organization established by the consortium of the EU 5. Framework Programme (FP) ENEN project in 2003. Its main objective is the preservation and further development of expertise in the nuclear fields by higher education and training. As of April 2011, the ENEN has 60 members in 18 European countries, South Africa, Russian Federation, Ukraine and Japan. Based on the mutual recognition and adoption of the European Credit Transfer and Accumulation System (ECTS) within the EU, the ENEN has provided support to its members and European students/young professionals by organising selected Education and Training (E and T) courses in the nuclear field. The ENEN also developed a reference curriculum in nuclear engineering, consisting of a core package of courses and optional substitute courses in nuclear disciplines, to be realised in order to obtain the 'European Master of Science in Nuclear Engineering (EMSNE)', the ENEN Certificate, which has been implemented from 2005. In December 2008 the European Council welcomed the existence within the EU of coordinated teaching and training leading to qualifications in the nuclear field, provided notably by the ENEN. Since 2009 the ENEN is involved in four FP7 European Fission Training Scheme (EFTS) projects in order to establish a common certificate for professionals at European level. ENEN launched also since 2009 the EUJEP project for exchange of Master students with Japan, the ECNET 7. FP project for E and T cooperation with China in March 2011 and one with Russian Federation is to be launched in May 2011. (authors)

  19. Non-inferiority trials: methodological and regulatory challenges

    NARCIS (Netherlands)

    Wangge, G.

    2012-01-01

    A randomized clinical trial (RCT) is the gold standard to evaluate the intended effects of drugs. In such trials a drug can be compared with a placebo or with another active compound for the same indication. RCTs can be used to demonstrate that a drug is superior to placebo or an active comparator

  20. The changing regulatory environment

    International Nuclear Information System (INIS)

    Caron, G.

    1999-01-01

    The role and value of regulation in the energy sector was discussed, demonstrating how, despite common perception, regulation is an essential part of Canada's strategy to find and develop new opportunities. The future vision of regulation for industry participants was presented with particular focus on issues related to streamlining the regulatory process. As far as pipelines are concerned, regulatory actions are necessary to facilitate capacity increases and to ensure the line's integrity, safety and environmental record. Furthermore, regulation provides economic solutions where market forces cannot provide them, as for example where business has elements of monopoly. It arbitrates interests of landowners, business, consumers, and environmental groups. It looks for ways to ensure conditions under which competition can flourish. It acts as the guardian of citizens' rights in a democratic society by providing citizens with an opportunity to be heard on the building or expansion of pipelines and associated facilities. As citizens become more and more concerned about their property and the land that surrounds them, citizen involvement in decision making about how industry activity affects their quality of life will become correspondingly more important. Regulatory agencies are committed to facilitate this engagement by flexible hearing procedures and by making use of evolving communication and information technology

  1. Regulatory aspects of radiopharmaceuticals

    International Nuclear Information System (INIS)

    Kristensen, K.

    1985-01-01

    Regulatory systems in the field of radiopharmaceuticals have two main purposes: efficacy and safety. Efficacy expresses the quality of the diagnostic and therapeutic process for the patient. Safety involves the patient, the staff, and the environment. The world situation regarding regulations for radiopharmaceuticals is reviewed on the basis of a survey in WHO Member States. The main content of such regulations is discussed. The special properties of radiopharmaceuticals compared with ordinary drugs may call for modified regulations. Several countries are preparing such regulations. Close co-operation and good understanding among scientists working in hospital research, industry and regulatory bodies will be of great importance for the fast and safe introduction of new radiopharmaceuticals for the benefit of the patient. Before introducing new legislation in this field, a radiopharmaceutical expert should analyse the situation in the country and the relationship to the existing regulations. It is expected that the most important factor in promoting the fast introduction of new, safe and effective radiopharmaceuticals will be the training of people working within the regulatory bodies. It is foreseen that the IAEA and WHO will have an important role to play by providing expert advice and training in this area. (author)

  2. Overcoming challenges

    Medline Plus

    Full Text Available ... Disease and Stroke HIV and AIDS Mental Health Pain Pregnancy Reproductive Health Sexual Health Sexually Transmitted Infections ... breastfeeding Overcoming challenges Common questions about breastfeeding and pain Breastfeeding checklist: How to get a good latch ...

  3. Overcoming challenges

    Medline Plus

    Full Text Available ... menu It's Only Natural Planning ahead Breastfeeding and baby basics Making breastfeeding work for you Addressing breastfeeding ... in the African-American community Incredible facts about babies, breastmilk, and breastfeeding Overcoming challenges Common questions about ...

  4. Overcoming challenges

    Medline Plus

    Full Text Available ... facts about babies, breastmilk, and breastfeeding Overcoming challenges Common questions about breastfeeding and pain Breastfeeding checklist: How to get a good latch Finding support It takes a village: Building ...

  5. Cognitive Challenges

    Science.gov (United States)

    ... Alliance Our Story Our Vision Our Team Our Leadership Our Results Our Corporate Policies FAQs Careers Contact Us Media Store Privacy Policy Sitemap Learn Engage Donate About TSC Cognitive Challenges Approximately 45% to 60% of individuals with TSC ...

  6. Overcoming challenges

    Medline Plus

    Full Text Available ... breastfeeding means to them. Subscribe To receive Breastfeeding email updates Enter email Submit Overcoming challenges Breastfeeding has a long list ... breastfeeding means to them. Subscribe To receive Breastfeeding email updates Enter email Submit All material contained on ...

  7. Overcoming challenges

    Medline Plus

    Full Text Available ... into your life Breastfeeding in daily life: At home and in public Laws that support breastfeeding 10 ... and jobs View all pages in this section Home It's Only Natural Overcoming challenges It's Only Natural ...

  8. Doing Qualitative Comparative Research on Teaching: Challenges and Benefits of Working with Grounded Theory

    Science.gov (United States)

    Rupp, Claudia

    2016-01-01

    The last decades have seen the completion of an increasing number of qualitative comparative research projects on teaching. Challenges and benefits which might arise from a qualitative international comparative research design have been considered. However, very little has been published on challenges and benefits which may arise from using…

  9. ITER safety challenges and opportunities

    International Nuclear Information System (INIS)

    Piet, S.J.

    1992-01-01

    This paper reports on results of the Conceptual Design Activity (CDA) for the International Thermonuclear Experimental Reactor (ITER) suggest challenges and opportunities. ITER is capable of meeting anticipated regulatory dose limits, but proof is difficult because of large radioactive inventories needing stringent radioactivity confinement. Much research and development (R ampersand D) and design analysis is needed to establish that ITER meets regulatory requirements. There is a further oportunity to do more to prove more of fusion's potential safety and environmental advantages and maximize the amount of ITER technology on the path toward fusion power plants. To fulfill these tasks, three programmatic challenges and three technical challenges must be overcome. The first step is to fund a comprehensive safety and environmental ITER R ampersand D plan. Second is to strengthen safety and environment work and personnel in the international team. Third is to establish an external consultant group to advise the ITER Joint Team on designing ITER to meet safety requirements for siting by any of the Parties. The first of three key technical challenges is plasma engineering - burn control, plasma shutdown, disruptions, tritium burn fraction, and steady state operation. The second is the divertor, including tritium inventory, activation hazards, chemical reactions, and coolant disturbances. The third technical challenge is optimization of design requirements considering safety risk, technical risk, and cost

  10. Information transmission in genetic regulatory networks: a review

    International Nuclear Information System (INIS)

    Tkacik, Gasper; Walczak, Aleksandra M

    2011-01-01

    Genetic regulatory networks enable cells to respond to changes in internal and external conditions by dynamically coordinating their gene expression profiles. Our ability to make quantitative measurements in these biochemical circuits has deepened our understanding of what kinds of computations genetic regulatory networks can perform, and with what reliability. These advances have motivated researchers to look for connections between the architecture and function of genetic regulatory networks. Transmitting information between a network's inputs and outputs has been proposed as one such possible measure of function, relevant in certain biological contexts. Here we summarize recent developments in the application of information theory to gene regulatory networks. We first review basic concepts in information theory necessary for understanding recent work. We then discuss the functional complexity of gene regulation, which arises from the molecular nature of the regulatory interactions. We end by reviewing some experiments that support the view that genetic networks responsible for early development of multicellular organisms might be maximizing transmitted 'positional information'. (topical review)

  11. Endometrial Stromal Sarcoma Arising in Colorectal Endometriosis: A Case Report and Review of the Literature

    Directory of Open Access Journals (Sweden)

    Qiao Wang

    2015-01-01

    Full Text Available Extrauterine endometrial stromal sarcoma (ESS arising in endometriosis is extremely rare, particularly in the colorectum. It should always be included in the differential diagnosis of primary tumors originating from gastrointestinal tract in females, given that preoperative endoscopical biopsy may reveal no specific changes. We reported a case of ESS arising in colorectal endometriosis and reviewed the previous 7 cases reported in the English literature. Our patient, who was unavailable for tumor resection and refused further adjuvant therapy, played a role in representing the natural history of low-grade extragenital ESS. This case was the only death from ESS arising in colorectal endometriosis.

  12. Primary chondroid chordoma arising from the petrous temporal bone: a case report

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Young Uk; Youn, Eun Kyung [Koryo General Hospital, Seoul (Korea, Republic of)

    1991-01-15

    Chordomas are uncommon tumors which arise from remnants of the primitive notochord. They are situated chiefly in the anterior spinal axis with a predilection for the sacrococcygeal region and the basiocciput. About 50% of chordomas are sacrococcygeal, 35% are intracranial, and 15% arise from a vertebral body. As a histologic variant of chordoma, /chondroid chordoma' was first described by Heffelfinger et al. We present a rare case of primary chondroid chordoma arising from the petrous temporal bone. To our knowledge, only two other cases of this type have been reported earlier.

  13. Primary chondroid chordoma arising from the petrous temporal bone: a case report

    International Nuclear Information System (INIS)

    Lee, Young Uk; Youn, Eun Kyung

    1991-01-01

    Chordomas are uncommon tumors which arise from remnants of the primitive notochord. They are situated chiefly in the anterior spinal axis with a predilection for the sacrococcygeal region and the basiocciput. About 50% of chordomas are sacrococcygeal, 35% are intracranial, and 15% arise from a vertebral body. As a histologic variant of chordoma, /chondroid chordoma' was first described by Heffelfinger et al. We present a rare case of primary chondroid chordoma arising from the petrous temporal bone. To our knowledge, only two other cases of this type have been reported earlier

  14. Protection of people and environment from radiation risk through good regulatory practice

    Science.gov (United States)

    Jais, Azlina Mohammad; Hassan, Najwa

    2017-01-01

    The term "good regulatory practice" has seen growing frequency of usage worldwide, especially since the 2011 Fukushima nuclear incident. However, the term appears quite ambiguous as it may mean differently to different people. This leads us to the first important question: what does "good regulatory practice" actually mean? When used in conjunction with the Fukushima incident, do we imply that there is an absence of "good regulatory practice" in the Japanese' Nuclear and Industry Safety Agency (NISA)? This is quite troubling. It is clear that the term should be defined formally so that our understanding of "good regulatory practice" can be standardized. There is still another important question beyond agreeing on what "good regulatory practice" is: is "good regulatory practice" specific to a region, or is it global? And is it applicable only to nuclear regulators, or to all types of regulators per se? This paper aims to deliberate on the above mentioned questions. Specifically, we hope to discuss the "good regulatory practice" for atomic energy activities in order to protect the people and the environment from radiation risk of such activities. By understanding what "good regulatory practice" truly means, a newcomer country such as Malaysia can quickly learn and adopt these practices so as to assure a competent national nuclear regulatory authority who will be responsible in ensuring the safety, security and safeguards of peaceful atomic energy activities in the country including nuclear liability. In understanding this concept, a holistic approach will be taken by looking into example of advanced and newcomer countries of various nuclear regulatory authorities all around the world. Then the paper will focus on the challenges that the current nuclear regulatory authority in Malaysia which is Atomic Energy Licensing Board has, its challenges to follow the concept of "good regulatory practice" and its ways to overcome it. This study explore the initiatives could be

  15. Regulatory Safety Requirements for Operating Nuclear Installations

    International Nuclear Information System (INIS)

    Gubela, W.

    2017-01-01

    The National Nuclear Regulator (NNR) is established in terms of the National Nuclear Regulator Act (Act No 47 of 1999) and its mandate and authority are conferred through sections 5 and 7 of this Act, setting out the NNR's objectives and functions, which include exercising regulatory control over siting, design, construction etc of nuclear installations through the granting of nuclear authorisations. The NNR's responsibilities embrace all those actions aimed at providing the public with confidence and assurance that the risks arising from the production of nuclear energy remain within acceptable safety limits -> Therefore: Set fundamental safety standards, conducting pro-active safety assessments, determining licence conditions and obtaining assurance of compliance. The promotional aspects of nuclear activities in South Africa are legislated by the Nuclear Energy Act (Act No 46 of 1999). The NNR approach to regulations of nuclear safety and security take into consideration, amongst others, the potential hazards associated with the facility or activity, safety related programmes, the importance of the authorisation holder's safety related processes as well as the need to exercise regulatory control over the technical aspects such as of the design and operation of a nuclear facility in ensuring nuclear safety and security. South Africa does not have national nuclear industry codes and standards. The NNR is therefore non-prescriptive as it comes to the use of industry codes and standards. Regulatory framework (current) provide for the protection of persons, property, and environment against nuclear damage, through Licensing Process: Safety standards; Safety assessment; Authorisation and conditions of authorisation; Public participation process; Compliance assurance; Enforcement

  16. Applications of liquid phase chromatographies for the analysis of streams arising at the back end of nuclear fuel cycle

    International Nuclear Information System (INIS)

    Deshingkar, D.S.; Yalmali, Vrunda S.; Wattal, P.K.

    2000-06-01

    India has opted for a closed fuel cycle comprising of reprocessing and recycling technology. The back end of such nuclear fuel cycle involves the reprocessing of spent nuclear fuels for recovery of plutonium and depleted uranium by Purex technology. Wastes arising from the reprocessing plant are classified as high, intermediate and low level wastes (HLW, ILW, LLW). HLW is mixture of over 50 elements present in different chemical forms. The accurate analyses of dissolver solution and HLW are the most challenging but essential tasks for reprocessing plant operations and also for further development of treatment methods. Inductively coupled plasma - atomic emission spectroscopy and atomic absorption spectroscopy techniques are suitable for analysis of metallic anions. Ion chromatography has proven capability to analyse number of cations or anions at ppm or even ppb level in single run. The report reviews the literature regarding the title subject. To assess the technical feasibility of ion chromatography for waste analysis, a simulated PHWR-HLW analogue was prepared. The PHWR-HLW analogue and ground water samples were analysed on DIONEX-DX 500 and Metrohm IC. Results obtained clearly demonstrated the usefulness of ion chromatography as vital analytical tool. HLW and other process or waste streams arising at the back end of nuclear fuel cycle can be analysed for alkali, alkaline earth, rare earth and transition metal cations and important anions. Use of fraction collector along with ion chromatography can enhance it's sensitivity to few Bq/ml for radioactive samples. (author)

  17. Evaluation of NORM in facility Venezuelan oil industry to establish regulatory criteria; Evaluacion de NORM en una instalacion de la industria petrolera venezolana para establecer los criterios reguladores

    Energy Technology Data Exchange (ETDEWEB)

    Acevedo Lozada, D. J.; Rivas, I.; Davila, L.; Flores, Y.

    2013-07-01

    The present work shows the need to identify, in the Venezuelan oil industry, the existence of exposure to natural sources of radiation should be considered as occupational. As Regulatory Authority in the area of ionizing radiation the need for regulatory processes and ensure radiation protection of personnel involved in these practices arises, as well as personal and environmental monitoring. NORM identifying an installation of the Venezuelan oil industry to establish regulatory processes and take steps to ensure occupational radiation protection. (Author)

  18. An Ethics Challenge for School Counselors

    Science.gov (United States)

    Froeschle, Janet G.; Crews, Charles

    2010-01-01

    Ethical issues arise more often for school counselors than for those who work in other settings (Remley, 2002). The challenge of working not only with minors but also with other stakeholders including parents, teachers, school administrators, and community members sets the stage for potential legal and ethical dilemmas. Awareness and adherence to…

  19. 78 FR 67344 - American Energy Data Challenge

    Science.gov (United States)

    2013-11-12

    ... in cases of willful misconduct, for any injury, death, damage, or loss of personal property, revenue... Challenge competition, whether the injury, death, damage, or loss arises through negligence or otherwise. F... Government is without any warranty or representation whatsoever, including but not limited to its suitability...

  20. Squamous cell carcinoma arising within a maxillary odontogenic keratocyst: A rare occurrence

    Energy Technology Data Exchange (ETDEWEB)

    Jalali, Elnaz [Eliray Oral and Maxillofacial Radiology Consulting Services, Miami (United States); Tadinada, Aditya; Rengasamy, Kandasamy; Ferneini, Elie M. [University of Connecticut, School of Dental Medicine, Farmington (United States)

    2017-06-15

    Squamous cell carcinoma (SCC) arising within the lining of an odontogenic keratocyst (OKC) is a rare occurrence. Although potentially locally destructive, OKC is a benign odontogenic process that typically presents with clinical and radiographic features characteristic of a benign intraosseous neoplasm. We present the clinical and radiographic features of a maxillary mass that demonstrated SCC arising from the lining of an OKC. Although the initial clinical and radiographic presentation suggested an infection or malignant neoplasm, biopsies revealed an infiltrative well-differentiated SCC contiguous with and arising from the focus of a pre-existing OKC. The patient subsequently underwent a type II hemi-maxillectomy with neoadjuvant chemoradiation. This report discusses the clinical and radiographic features associated with intraosseous malignancies, especially those arising from an otherwise benign odontogenic lesion. While the majority of OKCs are benign, the current report illustrates the potential for carcinomatous transformation within the lining of an OKC.

  1. Squamous cell carcinoma arising within a maxillary odontogenic keratocyst: A rare occurrence

    International Nuclear Information System (INIS)

    Jalali, Elnaz; Tadinada, Aditya; Rengasamy, Kandasamy; Ferneini, Elie M.

    2017-01-01

    Squamous cell carcinoma (SCC) arising within the lining of an odontogenic keratocyst (OKC) is a rare occurrence. Although potentially locally destructive, OKC is a benign odontogenic process that typically presents with clinical and radiographic features characteristic of a benign intraosseous neoplasm. We present the clinical and radiographic features of a maxillary mass that demonstrated SCC arising from the lining of an OKC. Although the initial clinical and radiographic presentation suggested an infection or malignant neoplasm, biopsies revealed an infiltrative well-differentiated SCC contiguous with and arising from the focus of a pre-existing OKC. The patient subsequently underwent a type II hemi-maxillectomy with neoadjuvant chemoradiation. This report discusses the clinical and radiographic features associated with intraosseous malignancies, especially those arising from an otherwise benign odontogenic lesion. While the majority of OKCs are benign, the current report illustrates the potential for carcinomatous transformation within the lining of an OKC

  2. On the numerical solution of coupled eigenvalue differential equations arising in molecular spectroscopy

    International Nuclear Information System (INIS)

    Friedman, R.S.; Jamieson, M.J.; Preston, S.C.

    1990-01-01

    A method for solving coupled eigenvalue differential equations is given and its relation to an existing technique is shown. Use of the Gram-Schmidt process to overcome the severe instabilities arising in molecular problems is described in detail. (orig.)

  3. On a Linear Equation Arising in Isometric Embedding of Torus-like Surface

    Institute of Scientific and Technical Information of China (English)

    Chunhe LI

    2009-01-01

    The solvability of a linear equation and the regularity of the solution are discussed.The equation is arising in a geometric problem which is concerned with the realization of Alexandroff's positive annul in R3.

  4. Using packaged software for solving two differential equation problems that arise in plasma physics

    International Nuclear Information System (INIS)

    Gaffney, P.W.

    1980-01-01

    Experience in using packaged numerical software for solving two related problems that arise in Plasma physics is described. These problems are (i) the solution of the reduced resistive MHD equations and (ii) the solution of the Grad-Shafranov equation

  5. Understanding how to maintain compliance in the current regulatory climate

    International Nuclear Information System (INIS)

    Bignell, D.T.; Burns, R.

    1995-01-01

    High level radioactive waste facilities must maintain compliance with all regulatory requirements, even those requirements that have been promulgated after the facility was placed into operation. Facilities must aggressively pursue compliance because environmental laws often impose strict liability for violations; therefore, an honest mistake is no defense. Radioactive waste management is constantly under the public microscope, particularly those facilities that handle high-level radioactive waste. The Savannah River Site has effectively met the challenges of regulatory compliance in its HLRW facilities and plans are being formulated to meet future regulatory requirements as well. Understanding, aggressively achieving, and clearly demonstrating compliance is essential for the continued operations of radioactive waste management facilities. This paper examines how HLRW facilities are impacted by regulatory requirements and how compliance in this difficult area is achieved and maintained

  6. Schedules for Regulatory Regimes

    International Nuclear Information System (INIS)

    Austvik, Ole Gunnar

    2003-01-01

    The idea of regulating transporters' terms of operations is that if the market itself does not produce optimal outcomes, then it can be mimicked to do so through regulatory and other public instruments. The first-best solution could be a subsidized (publicly owned) enterprise that sets tariffs according to marginal costs. This has been the tradition in many European countries in the aftermath of WW2. Due to lack of innovative pressure on and x-inefficiency in these companies, this solution is today viewed as inferior to the system of regulating independent (privately owned) firms. When the European gas market becomes liberalized, part of the process in many countries is to (partially) privatise the transport utilities. Privatised or not, in a liberalized market, the transport utilities should face an independent authority that overviews their operations not only in technical, but also in economic terms. Under regulation, a ''visible hand'' is introduced to correct the imperfect market's ''invisible hand''. By regulating the framework and conditions for how firms may operate, public authorities seek to achieve what is considered optimal for the society. The incentives and disincentives given for pricing and production should create mechanisms leading to an efficient allocation of resources and ''acceptable'' distribution of income. As part of intervening into firms' behavior, regulation may be introduced to direct the firm to behave in certain ways. The framework and regulatory mechanisms for the market must then be constructed in a way that companies voluntarily produce an amount at a price that gives maximal profits and simultaneously satisfies social goals. The regulations should lead to consistency between the company's desire to maximize profits and the society's desire for maximizing welfare, as in a perfectly competitive market. This is the core of regulatory economics

  7. Post-transplant Lymphoproliferative Disorder Arising from Renal Allograft Parenchyma: A Case Report

    Energy Technology Data Exchange (ETDEWEB)

    Park, Byung Kwan; Kim, Chan Kyo; Kwon, Ghee Young [Samsung Medical Center, Sungkyunkwan University College of Medicine, Seoul (Korea, Republic of)

    2010-06-15

    Post-transplant lymphoproliferative disorder (PTLD) is a rare but serious complication that occurs in patients undergoing kidney transplantation. PTLD usually manifests as a renal hilar mass comprised of histologically B-lymphocytes. We report our experience of managing a patient with PTLD arising from renal parenchyma. Ultrasonographic and MR imaging features of this unusual PTLD suggested differentiated renal cell carcinoma arising from the renal allograft

  8. Two cases of basal cell carcinoma arising from chronic radiation dermatitis

    International Nuclear Information System (INIS)

    Wakamori, Takeshi; Takenaka, Hideya; Ueda, Eiichiro; Katoh, Norito; Kishimoto, Saburo

    2003-01-01

    A 48-year-old female and a 51-year-old male with basal cell carcinoma (BCC) arising from chronic radiation dermatitis are reviewed. They are treated with radiotherapy for hemangioma on their right cheek in their childhood. Review in the literature showed high incidence of the histological diagnosis of malignant skin tumors arising from chronic radiation dermatitis are follows: squamous cell carcinoma (SCC), BCC, sarcoma, and Bowen's disease. (author)

  9. Clinical outcomes of patients with clear cell and endometrioid ovarian cancer arising from endometriosis.

    Science.gov (United States)

    Paik, E Sun; Kim, Tae Joong; Choi, Chel Hun; Kim, Byoung Gie; Bae, Duk Soo; Lee, Jeong Won

    2018-03-01

    The aim of this investigation is to compare outcomes of patients according to the presence of cancer arising from endometriosis in ovarian clear cell carcinoma (CCC) and endometrioid carcinoma (EC). This study retrospectively investigated 224 CCC and EC patients treated in Samsung Medical Center from 2001 to 2015 to identify cancer arising from endometriosis according to Sampson and Scott criteria. Propensity score matching was performed to compare patients arising from endometriosis to patients without endometriosis (ratio 1:1) according to stage, age, lymph node metastasis (LNM), cancer antigen (CA)-125 level, and residual status after debulking surgery. Forty-five cases arising from endometriosis were compared with 179 cases without endometriosis. CCC and EC arising from endometriosis tended to present with early age (mean, 45.2 vs. 49.2 years; p=0.003), early-stage (stages I and II, 92.7% vs. 62.3%; p<0.001), lower CA-125 level (mean, 307.1 vs. 556.7; p=0.041), higher percentages of no gross residual disease after surgery (87.8% vs.56.8%; p=0.001), and higher percentages of negative LNM (82.9% vs. 59.0%; p=0.008) compared to cases without endometriosis. Kaplan-Meier curves for progression-free survival (PFS) and overall survival (OS) showed better outcomes for groups with cancer arising from endometriosis (p=0.014 for PFS; and p=0.010 for OS). However, the association with endometriosis was not significant in multivariate analysis. Also, after propensity score matching, survival differences between the 2 groups were not significant. CCC and EC arising from endometriosis are diagnosed at an earlier age and stage. However, cancer arising from endometriosis was not a significant prognostic factor. Copyright © 2018. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic Oncology

  10. Multi-focal lobular carcinoma in situ arising in benign phylodes tumor: A case report

    International Nuclear Information System (INIS)

    Lee, Taeg Ki; Choi, Chang Hwan; Kim, Youn Jeong; Kim, Mi Young; Lee, Kyung Hee; Cho, Soon Gu

    2015-01-01

    Coexistent breast malignancy arising in phyllodes tumor is extremely rare, and most of them are incidental reports after surgical excision. Coexistent malignancy in phyllodes tumor can vary from in-situ to invasive carcinoma. Lobular neoplasia is separated into atypical lobular hyperplasia and lobular carcinoma in situ (LCIS). LCIS is known to have a higher risk of developing invasive cancer. We reported imaging findings of multifocal LCIS arising in benign phyllodes tumor

  11. Multi-focal lobular carcinoma in situ arising in benign phylodes tumor: A case report

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Taeg Ki; Choi, Chang Hwan; Kim, Youn Jeong; Kim, Mi Young; Lee, Kyung Hee; Cho, Soon Gu [Inha University Hospital, Incheon (Korea, Republic of)

    2015-08-15

    Coexistent breast malignancy arising in phyllodes tumor is extremely rare, and most of them are incidental reports after surgical excision. Coexistent malignancy in phyllodes tumor can vary from in-situ to invasive carcinoma. Lobular neoplasia is separated into atypical lobular hyperplasia and lobular carcinoma in situ (LCIS). LCIS is known to have a higher risk of developing invasive cancer. We reported imaging findings of multifocal LCIS arising in benign phyllodes tumor.

  12. MAINTAINING LONG-TERM MANAGEMENT: Herbicide-resistant weeds challenge some signature cropping systems

    Directory of Open Access Journals (Sweden)

    Bradley D. Hanson

    2014-10-01

    Full Text Available Invasive and endemic weeds pose recurring challenges for California land managers. The evolution of herbicide resistance in several species has imposed new challenges in some cropping systems, and these issues are being addressed by UC Cooperative Extension farm advisors, specialists and faculty. There are currently 24 unique herbicide-resistant weed biotypes in the state, dominated by grasses and sedges in flooded rice systems and, more recently, glyphosate-resistant broadleaf and grass weeds in tree and vine systems, roadsides and glyphosate-tolerant field crops. Weed scientists address these complex issues using approaches ranging from basic physiology and genetics research to applied research and extension efforts in grower fields throughout the state. Although solutions to herbicide resistance are not simple and are affected by many biological, economic, regulatory and social factors, California stakeholders need information, training and solutions to address new weed management problems as they arise. Coordinated efforts conducted under the Endemic and Invasive Pests and Disease Strategic Initiative directly address weed management challenges in California's agricultural industries.

  13. International regulatory activities

    International Nuclear Information System (INIS)

    Anon.

    2009-01-01

    In this last part is reviewed international regulatory activities and bilateral agreements including two parts: concerning European atomic energy community with European commission proposal for a council directive setting up a community framework for nuclear safety, update of the nuclear illustrative programme in the context of the second strategic energy review, european commission recommendation on criteria for the export of radioactive waste and spent fuel to third countries and a communication on nuclear non-proliferation and the second part in relation with international atomic energy agency with a joint convention on the safety of spent fuel management and on safety of radioactive waste management (third review meeting). (N.C.)

  14. International regulatory activities

    International Nuclear Information System (INIS)

    Anon.

    2002-01-01

    Different international regulatory activities are presented: recommendation on the protection of the public against exposure to radon in drinking water supplies, amendment to the legislation implementing the regulation on imports of agricultural products originating in third countries following the Chernobyl accident, resolution on the commission green paper towards a European strategy for the security of energy supply, declaration of mandatory nature of the international code for the safe carriage of packaged irradiated nuclear fuel, plutonium and high level radioactive wastes on board ships, adoption of action plan against nuclear terrorism. (N.C.)

  15. The core to regulatory reform

    International Nuclear Information System (INIS)

    Partridge, J.W. Jr.

    1993-01-01

    Federal Energy Regulatory Commission (FERC) Orders 436, 500, and 636, the Clean Air Act Amendments of 1990, Public Utility Holding Company Act reform, and the 1992 Energy Policy Act all can have significant effects on an LDC's operations. Such changes in an LDC's environments must be balanced by changes within the utility, its marketplace, and its state regulatory environment. The question is where to start. For Columbia Gas Distribution Cos., based in Columbus, OH, the new operating foundation begins with each employee. Internal strength is critical in designing initiatives that meet the needs of the marketplace and are well-received by regulators. Employees must understand not only the regulatory environment in which the LDC operates, but also how their work contributes to a positive regulatory relationship. To achieve this, Columbia initiated the COntinuing Regulatory Education program, or CORE, in 1991. CORE is a regulatory-focused, information-initiative program coordinated by Columbia's Regulatory Policy, Planning, and Government Affairs Department. The CORE programs can take many forms, such as emerging issue discussions, dialogues with regulators and key parties, updates on regulatory fillings, regulatory policy meetings, and formal training classes. The speakers and discussion facilitators can range from human resource department trainers to senior officers, from regulatory department staff members to external experts, or from state commissioners to executives from other LDCs. The goals of CORE initiatives are to: Support a professional level of regulatory expertise through employee participation in well-developed regulatory programs presented by credible experts. Encourage a constructive state regulatory environment founded on communication and cooperation. CORE achieves these goals via five program levels: introductory basics, advanced learning, professional expertise, crossfunctional dialogues, and external idea exchanges

  16. 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)

  17. Politically Induced Regulatory Risk and Independent Regulatory Agencies

    OpenAIRE

    Strausz, Roland

    2015-01-01

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

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

    OpenAIRE

    Kerber, Wolfgang; Wendel, Julia

    2016-01-01

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

  19. 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.

  20. Nuclear regulatory challenges of who should we train and why - a regulatory perspective

    International Nuclear Information System (INIS)

    Furness, J.

    2000-01-01

    The understanding by the staff who design, construct, commission, operate and decommission our nuclear installations of the safety cases for the plants is crucial to nuclear safety. The lack of such understanding has been a major contributor to accidents at Windscale, Three Mile Island and Chernobyl, and may also have played a role in the recent criticality accident at Tokai-Mura. Competence is not only a matter of knowledge, but also of behaviour at the level of the individual and the organisation. It is also important for those in Government departments who sponsor or regulate nuclear power. The right competence is an essential ingredient in achieving a health safety culture at all levels. Staff turnover will be high over the next 5-10 years and the long experience of those who will be retiring must somehow be transferred to those who remain and who will be recruited. Competitive pressures may accelerate this process, increasing the stresses on the staff concerned. Plants are ageing and work-loads increasing, making safety culture all the more important. 'Soft skills' are as important as technical knowledge and should be included in training programmes at all levels. (author)

  1. Malignancy arising within cutaneous tattoos: case of dermatofibrosarcoma protuberans and review of literature.

    Science.gov (United States)

    Reddy, Kavitha K; Hanke, C William; Tierney, Emily P

    2011-08-01

    Dermatofibrosarcoma protuberans (DFSP) is an uncommon tumor of the skin with high rates of local recurrence. Several reports describe a frequent history of local trauma. In one prior case, a DFSP arising in a tattoo site has been reported. Mohs micrographic surgery (MMS) has been used successfully for treatment. To present a case of dermatofibrosarcoma protuberans arising in the site of a prior and current tattoo, and treated with Mohs micrographic surgery. We present findings of a case of a DFSP arising in a tattoo and a review of Medline literature on the association between tattoos and cutaneous malignancy, and treatment of DFSP with MMS. Review of the literature confirms multiple reports of DFSP arising in sites of local trauma, as well as malignancies arising in sites of tattoos. The recurrence rate for MMS treatment of DFSP (0-6.6%) was found to be significantly lower than that for patients treated with wide local excision (13% to 95%). DFSP should be considered in the differential diagnosis of neoplasms arising within areas of tattoos. Sites of local trauma and tattoos may show predilection for benign and malignant changes and should be evaluated during regular skin exams. Review of the literature confirms MMS is an ideal treatment modality for DFSP as the tumor often extends far beyond clinical margins.

  2. 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

  3. 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

  4. Semi-supervised prediction of gene regulatory networks using ...

    Indian Academy of Sciences (India)

    2015-09-28

    Sep 28, 2015 ... Use of computational methods to predict gene regulatory networks (GRNs) from gene expression data is a challenging ... two types of methods differ primarily based on whether ..... negligible, allowing us to draw the qualitative conclusions .... research will be conducted to develop additional biologically.

  5. Regulatory control analysis and design for sewer systems

    DEFF Research Database (Denmark)

    Mollerup, Ane Loft; Mikkelsen, Peter Steen; Thornberg, Dines

    2015-01-01

    A systematic methodology for regulatory control analysis and design is adapted for sewer system operation and evaluated. The main challenge with adapting the methodology is the handling of the stochastic and transient nature of the rainfall disturbances, inherent to sewer system operation...

  6. Breeding and regulatory opportunities and constraints for developing broccoli cultivars adapted to organic agriculture

    NARCIS (Netherlands)

    Renaud, E.N.C.

    2014-01-01

    This thesis is about the regulatory and technical challenges to the organic seed and breeding sector. This study specifically explored the mutual influence of the regulatory environment for organic seed sector development in the United States (US), Europe Union (EU) and Mexico, and the extent to

  7. Visions of regulatory renewal

    International Nuclear Information System (INIS)

    Edgeworth, A.

    1998-01-01

    The economic contribution of the CEPA (Canadian Energy Pipeline Association) member companies to Canada's trade balance was discussed. CEPA member companies transport 95 per cent of the crude oil and natural gas produced in Canada to domestic and export markets. This represents a total of 5.6 Tcf of gas annually. Half of Canada's natural gas and oil production is exported to U.S. markets. All of these exports are transported by pipeline. CEPA member companies operate 90,000 km of pipeline from British Columbia to Quebec. Expansions are needed as a result of a significant increase in demand for natural gas and crude oil since 1990. Several issues exist for regulatory renewal. They include the need to create a level playing field, the overseeing of tolls and contract renewal terms, changing risk/reward trade-offs, the right to confidentiality of information and price discovery mechanism. The drivers for regulatory reform at Westcoast Energy are the need for pricing flexibility, customers desire for toll certainty, decontracting and opposition to rolled-in expansions for gathering and processing. An overview of Westcoast Energy's negotiated toll settlement, its implications, and the components of Westcoast Energy's 'light handed regulation' (LHR) was presented

  8. The regulatory dynamic

    International Nuclear Information System (INIS)

    Dybwad, C.

    2001-01-01

    An outline of the activities and efforts expanded by the National Energy Board to adjust to the changing natural gas market was provided in this presentation. The author began by defining the role of the National Energy Board in energy markets. It must ensure the adoption of rules and procedures that result in a more competitive and efficient market. Light-handed regulatory techniques are the norm, and the National Energy Board is now committed to facilitating the availability and flow of information so that all parties know where opportunities exist, the terms offered to buy or sell goods and services, their quality and costs. It will specialize in providing new participants with information on the workings of the market, who the players are, the regulatory processes in place, and how, when and where the market can be accessed. The manner in which the Board deals with information was reviewed, providing examples along the way to clarify some points. Some of the documents produced by the National Energy Board are being reviewed with the intent of making them easier to read and understand. Audio streaming over the Internet is another avenue being pursued to ensure individuals can listen in real time to hearings without having to be present in the room. The National Energy Board is also exploring alternative dispute resolution techniques. Consultation with energy market participants represents another facet of these efforts to be more accessible and responsive

  9. Governing Nanomedicine: Lessons from within, and for the EU medical technology regulatory framework.

    NARCIS (Netherlands)

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

    2010-01-01

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

  10. Post engineered nanomaterials lifespan: nanowastes classification, legislative development/implementation challenges, and proactive approaches

    CSIR Research Space (South Africa)

    Musee, N

    2012-05-01

    Full Text Available -1 NANOLCA Symposium, "Safety issues and regulatory challenges of nanomaterials", San Sebastian, Spain, 3-4 May 2012 Post engineered nanomaterials lifespan: nanowastes classification, legislative development/implementation challenges, and proactive...

  11. The European Medicines Agency's strategies to meet the challenges of Alzheimer disease.

    Science.gov (United States)

    Haas, Manuel; Mantua, Valentina; Haberkamp, Marion; Pani, Luca; Isaac, Maria; Butlen-Ducuing, Florence; Vamvakas, Spiros; Broich, Karl

    2015-04-01

    Regulatory agencies have a key role in facilitating the development of new drugs for Alzheimer disease, particularly given the challenges associated with early intervention. Here, we highlight the strategies of the European Medicines Agency to help address such challenges.

  12. Environmental challenge

    International Nuclear Information System (INIS)

    Conable, B.; Warford, J.; Partow, Z.; Lutz, E.; Munasinghe, M.

    1991-09-01

    The contents include the following: Development and the Environment: A Global Balance; Evolution of the World Bank's Environmental Policy; Accounting for the Environment; Public Policy and the Environment; Managing Drylands; Environmental Action Plans in Africa; Agroforestry in Sub-Saharan Africa; Irrigation and the Environmental Challenge; Curbing Pollution in Developing Countries; Global Warming and the Developing World; and The Global Environment Facility

  13. Challenging Identities

    DEFF Research Database (Denmark)

    depends on the conceptual or ideological constellation in which it takes part. This volume on one hand demonstrates the role of notions of identity in a variety of European contexts, and on the other hand highlights how there may be reasons to challenge the use of the term and corresponding social...

  14. Overcoming challenges

    Medline Plus

    Full Text Available ... Contact Us Blog Popular topics Vision and mission Leadership Programs and activities In your community Funding opportunities Internships and jobs View all pages in this section Home It's Only Natural Overcoming challenges It's Only Natural Planning ahead Addressing breastfeeding myths ...

  15. Overcoming challenges

    Medline Plus

    Full Text Available ... we are What we do Programs and activities Work with us Contact Us Blog Popular topics Vision and mission Leadership Programs and activities In your community Funding opportunities Internships and jobs View all pages in this section Home It's Only Natural Overcoming challenges It's Only Natural ...

  16. Regulatory inspection of BARC facilities

    International Nuclear Information System (INIS)

    Rajdeep; Jayarajan, K.

    2017-01-01

    Nuclear and radiation facilities are sited, constructed, commissioned, operated and decommissioned, in conformity with the current safety standards and codes. Regulatory bodies follow different means to ensure compliance of the standards for the safety of the personnel, the public and the environment. Regulatory Inspection (RI) is one of the important measures employed by regulatory bodies to obtain the safety status of a facility or project and to verify the fulfilment of the conditions stipulated in the consent

  17. Steering healthcare service delivery: a regulatory perspective.

    Science.gov (United States)

    Prakash, Gyan

    2015-01-01

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

  18. Opening Address [International Conference on Effective Nuclear Regulatory Systems: Further Enhancing the Global Nuclear Safety and Security Regime, Cape Town (South Africa), 14-18 December 2009

    International Nuclear Information System (INIS)

    Peters, Elizabeth Dipuo

    2010-01-01

    Nuclear energy is seen by many countries as providing a sustainable solution to energy security challenges. In this context, many developing countries are considering the establishment of nuclear power build programmes, while countries with mature nuclear programmes are considering the possibility of further expansion. The challenges facing countries that are embarking on this new venture include, inter alia, the development of policies, legislation as well as the establishment of appropriate institutions such as regulatory bodies with effective independence to take regulatory decisions. Regional and international cooperation and coordination are therefore of critical importance. Accordingly, the establishment of the Forum of Regulatory Bodies in Africa is a welcome initiative. We are pleased that the national nuclear programme in post-apartheid South Africa places us in a position to become active global participants in the safe use of nuclear energy for peaceful purposes. However, we all have an obligation to ensure that the presence of a plethora of cooperation mechanisms such as this body are as inclusive and as supportive as possible. This will help the global community of nations in reaping maximum benefits that surely should arise from these initiatives to ensure security of energy supply. We do not have the luxury to duplicate such bodies. The role of the International Atomic Energy Agency in nuclear safety and security cannot be over-emphasized. That alone is the reason that drove the liberation movement of the people of our country, and now the ruling party, fully to conform to all the treaties and conventions that have been drafted by this reputable institution of the peoples of the world. The same goes for the facilitation of cooperation and the sharing of knowledge and experience. The IAEA is invariably trusted to provide independent views and advice in order to strengthen safety and security while preserving the sovereignty, authority and

  19. Energy challenges in Asia

    International Nuclear Information System (INIS)

    Niquet, V.

    2007-01-01

    Energy challenges represent one of the most important security paradigms in the Asia Pacific region where you have a mixture of growing energy dependency, fuelled by high economic growth, the emergence of new major players like China and India, and a quasi-complete absence of regional regulatory mechanisms to tackle the challenges in a multilateral way. These challenges mostly concern Japan and China, where crucial energy issues are aggravated by power rivalry, historical and ideological issues, and a lack of both economic and political harmony between them. Neither countries are self sufficient in terms of energy needs. This can lead to a shared analysis and common approaches regarding Japan and China concerning this issue. Their cases are. however very different and the solutions applied are related to different world views that are not easily reconcilable. Both countries share common objectives: both want security and stable supply. But there are also big divergences and these divergences could be new sources of conflict and misunderstanding between Tokyo and Beijing. One of the main differences is history related. Both China and Japan are uneasy regarding outside energy dependency. In Japan, memories of the pre-war oil embargo have not disappeared. The oil shocks of the 70's renewed this uneasiness. However, Japan's outside dependency is not new. Tokyo has learned to live with it, finding a system to alleviate this vulnerability in cooperation with its partners, multilateral institutions like the International Energy Agency (IEA). China's outside dependency is new. The country's dependency on oil, which began in 1993, is particularly challenging since the principles of independence, non interference and military autonomy, principles at the core of Maoist foreign strategy, did not completely disappear in spite of China's new policy of reform and opening up. China's leadership, even the fourth generation, did not forget its isolation during the 60's and 70's

  20. National legislative and regulatory activities

    International Nuclear Information System (INIS)

    2012-01-01

    This section gathers the following national legislative and regulatory activities sorted by country: Bulgaria: General legislation; Czech Republic: General legislation; France: General legislation, Regulatory infrastructure and activity; Germany: General legislation; India: Liability and compensation, Organisation and structure; Ireland: Radiation protection, General legislation; Korea (Republic of): Organisation and structure; Lithuania: Regulatory infrastructure and activity, Radioactive waste management, Radiation protection, international cooperation, Nuclear safety; Poland: General legislation; Romania: Environmental protection; Russian Federation: Radioactive waste management; Slovenia: Nuclear safety; Spain: Liability and compensation, Nuclear security; Sweden: Nuclear safety; Turkey: Radiation protection, Regulatory infrastructure and activity, Nuclear safety, Liability and compensation; United States: General legislation