WorldWideScience

Sample records for regulatory challenges facing

  1. 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.

  2. 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)

  3. 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.

  4. 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)

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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)

  10. 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.

  11. Challenges facing production grids

    Energy Technology Data Exchange (ETDEWEB)

    Pordes, Ruth; /Fermilab

    2007-06-01

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

  12. Facing the Challenges

    DEFF Research Database (Denmark)

    He, Kai

    2014-01-01

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

  13. 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.

  14. Grand Challenges facing Storage Systems

    CERN Multimedia

    CERN. Geneva

    2004-01-01

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

  15. Facing Tomorrow's Challenges - An Overview

    Science.gov (United States)

    ,

    2008-01-01

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

  16. Sponge systematics facing new challenges.

    Science.gov (United States)

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

    2012-01-01

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

  17. Regulatory Challenges for Cartilage Repair Technologies.

    Science.gov (United States)

    McGowan, Kevin B; Stiegman, Glenn

    2013-01-01

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

  18. Challenges Facing Group Work Online

    Science.gov (United States)

    Chang, Bo; Kang, Haijun

    2016-01-01

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

  19. Homeland Security. Management Challenges Facing Federal Leadership

    Science.gov (United States)

    2002-12-01

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

  20. Interpretative challenges in face analysis

    DEFF Research Database (Denmark)

    de Oliveira, Sandi Michele; Hernández-Flores, Nieves

    2015-01-01

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

  1. 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)

  2. 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)

  3. Gender-Specific Health Challenges Facing Women

    Science.gov (United States)

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

  4. Exploring the challenges faced by polytechnic students

    Science.gov (United States)

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

    2015-02-01

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

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

    Science.gov (United States)

    MacNeil, James D

    2012-08-01

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

  6. Fiber quality challenges facing the cotton industry

    Science.gov (United States)

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

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

    African Journals Online (AJOL)

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

  8. Facing the challenges of a competitive market

    International Nuclear Information System (INIS)

    Hollins, P.

    2001-01-01

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

  9. 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.

  10. 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)

  11. Regulatory Body of Egypt: Practices and Challenges

    International Nuclear Information System (INIS)

    El-Messiry, A.

    2016-01-01

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

  12. Air toxics regulatory issues facing urban settings

    Energy Technology Data Exchange (ETDEWEB)

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

    1996-10-01

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

  13. Challenges facing water management in China

    International Nuclear Information System (INIS)

    Varis, O.; Vakkilainen, P.

    2000-01-01

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

  14. 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...

  15. 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.

  16. The Face Management Challenges of Sport Celebrity

    Directory of Open Access Journals (Sweden)

    Diana-Luiza DUMITRIU

    2015-03-01

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

  17. Innovation in the face of future challenges

    International Nuclear Information System (INIS)

    Albistur, F. X.

    2006-01-01

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

  18. Four Challenges That Global Health Networks Face

    Directory of Open Access Journals (Sweden)

    Jeremy Shiffman

    2017-04-01

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

  19. Medical physics and challenges faced in Africa

    International Nuclear Information System (INIS)

    Nakatudde, R.

    2010-01-01

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

  20. TELECOMMUTING: Overview of Challenges Facing Federal Agencies

    National Research Council Canada - National Science Library

    RObertson, Robert

    2001-01-01

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

  1. Compulsive exercise: links, risks and challenges faced

    Directory of Open Access Journals (Sweden)

    Lichtenstein MB

    2017-03-01

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

  2. Oil producers facing a common challenge

    International Nuclear Information System (INIS)

    Galal, E.E.

    1992-01-01

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

  3. 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.

  4. What are the challenges facing our industry

    International Nuclear Information System (INIS)

    1998-01-01

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

  5. What are the challenges facing our industry

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1998-12-01

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

  6. 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

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

    Science.gov (United States)

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

    2015-09-01

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

  8. Psychosocial challenges facing physicians of today.

    Science.gov (United States)

    Arnetz, B B

    2001-01-01

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

  9. 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)

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

    African Journals Online (AJOL)

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

  11. Ethics committees in India: Facing the challenges!

    Science.gov (United States)

    Kadam, Rashmi; Karandikar, Shashikant

    2012-04-01

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

  12. Ethics committees in India: Facing the challenges!

    Directory of Open Access Journals (Sweden)

    Rashmi Kadam

    2012-01-01

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

  13. 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

  14. The challenges facing sustainable and adaptive groundwater ...

    African Journals Online (AJOL)

    These are: the undervaluation of groundwater importance and significance; the need for expertise and information at all scales; the centralisation of power; and the disregard of ecosystems and the associated goods and services. As a means to tackle these challenges, it has been assumed that the concept of adaptive water ...

  15. 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.

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

    African Journals Online (AJOL)

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

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

    African Journals Online (AJOL)

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

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

    African Journals Online (AJOL)

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

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

    Science.gov (United States)

    Neugebauer, Roger

    2011-01-01

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

  20. Facing Global Challenges with Materials Innovation

    Science.gov (United States)

    Rizzo, Fernando

    2017-10-01

    The path of society evolution has long been associated with a growing demand for natural resources and continuous environmental degradation. During the last decades, this pace has accelerated considerably, despite the general concern with the legacy being left for the next generations. Looking ahead, the predicted growth of the world population, and the improvement of life conditions in most regions, point to an increasing demand for energy generation, resulting in additional pressure on the Earth's sustainability. Materials have had a key role in decreasing the use of natural resources, by either improving efficiency of existing technologies or enabling the development of radical new ones. The greenhouse effect (CO2 emissions) and the energy crisis are global challenges that can benefit from the development of new materials for the successful implementation of promising technologies and for the imperative replacement of fossil fuels by renewable sources.

  1. 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)

  2. Challenges facing the marketing of scientific and research institutes

    OpenAIRE

    Bogdan Sojkin

    2015-01-01

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

  3. Challenges facing the marketing of scientific and research institutes

    Directory of Open Access Journals (Sweden)

    Bogdan Sojkin

    2015-12-01

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

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

    Science.gov (United States)

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

    2014-01-01

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

  5. NEW CHALLENGES FACED BY EUROPEAN COMPANIES AND THEIR STAKEHOLDERS

    Directory of Open Access Journals (Sweden)

    BOBE Claudia-Maria

    2010-07-01

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

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

    Directory of Open Access Journals (Sweden)

    M. J. Naude

    2006-12-01

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

  7. 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...

  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. 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)

  10. Challenges and Opportunities Facing Technology Education in Taiwan

    Science.gov (United States)

    Lee, Lung-Sheng Steven

    2009-01-01

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

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

    Indian Academy of Sciences (India)

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

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

    African Journals Online (AJOL)

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

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

    African Journals Online (AJOL)

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

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

    African Journals Online (AJOL)

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

  15. The Challenges Facing Catholic Education in France Today

    Science.gov (United States)

    Moog, François

    2016-01-01

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

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

    African Journals Online (AJOL)

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

  17. 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

  18. 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)

  19. 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)

  20. 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...

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

    Science.gov (United States)

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

    2016-01-01

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

  2. Challenges when electricity markets face the investment phase

    International Nuclear Information System (INIS)

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

    2004-01-01

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

  3. 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.

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

    International Nuclear Information System (INIS)

    Brister, J.

    2012-01-01

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

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

    OpenAIRE

    Islam, Nurul; Beer, Martin; Slack, Frances

    2015-01-01

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

  6. 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)

  7. 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.)

  8. Power distribution faced with the challenges posed by competition

    International Nuclear Information System (INIS)

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

    2009-01-01

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

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

    Science.gov (United States)

    Carter, Pam; Martin, Graham

    2016-01-21

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

  10. Higher education in the face of social challenges

    Directory of Open Access Journals (Sweden)

    Adrián Cuevas Jiménez

    2016-08-01

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

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

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1996-10-01

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

  12. 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.

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

    Science.gov (United States)

    Dey, Eric L.

    2008-10-01

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

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

    Directory of Open Access Journals (Sweden)

    Hashim A

    2017-06-01

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

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

    Science.gov (United States)

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

    1998-01-01

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

  16. The challenges that parents of children with epilepsy face

    DEFF Research Database (Denmark)

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

    2017-01-01

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

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

    Science.gov (United States)

    Madas, E; North, N

    2000-01-01

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

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

    Science.gov (United States)

    Alsharari, Salman

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

  19. Challenges faced when identifying patients for combination immunotherapy.

    Science.gov (United States)

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

    2017-08-01

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

  20. Faces

    DEFF Research Database (Denmark)

    Mortensen, Kristine Køhler; Brotherton, Chloe

    2018-01-01

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

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

    CERN Document Server

    Schmidt, Reiner

    1999-01-01

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

  2. 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...

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

    International Nuclear Information System (INIS)

    Florini, Ann; Sovacool, Benjamin K.

    2009-01-01

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

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

    International Nuclear Information System (INIS)

    Howes, H.

    1999-01-01

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

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

    Science.gov (United States)

    Raff, D.

    2017-12-01

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

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

    Science.gov (United States)

    Agno, Christina Farala; Guo, Kristina L

    2013-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Marian Tukuta

    2015-04-01

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

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2008-07-01

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

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

    Science.gov (United States)

    Schnable, P. S.

    2017-12-01

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

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2016-11-01

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

  11. The challenges facing today's operators

    Energy Technology Data Exchange (ETDEWEB)

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

    2004-07-01

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

  12. Challenges facing air management for fuel cell systems

    Energy Technology Data Exchange (ETDEWEB)

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

    2000-07-01

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

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2009-12-15

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

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

    International Nuclear Information System (INIS)

    Linke, J; Pintsuk, G.; Rödig, M.

    2013-01-01

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

  15. 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.

  16. 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.

  17. Challenges faced by nuclear research centres in Indonesia

    International Nuclear Information System (INIS)

    Subki, I.R.; Soentono, S.

    2001-01-01

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

  18. A personal perspective on challenges that face women scientists

    Science.gov (United States)

    Cashman, Katharine

    2016-04-01

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

  19. 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.

  20. 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.

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

    Science.gov (United States)

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

    2007-01-01

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

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

    Science.gov (United States)

    Sandford, Adam; Burton, A Mike

    2014-09-01

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

  4. Assessment of dietary challenges faced by Sub-Saharan immigrants ...

    African Journals Online (AJOL)

    Data relating to socio-demographic characteristics, such as continuity with ethnic food culture and the problems faced by Sub-Saharan immigrants with regard to them retaining their traditional food culture was collected. All the respondents indicated that they treasured and maintained their traditional food culture, albeit to ...

  5. The mighty oak faces challenges in the Pacific West

    Science.gov (United States)

    Gail Wells

    2010-01-01

    In popular imagination, the oak tree stands for strength, endurance, and longevity. But in the coastal lowlands and central valleys of British Columbia, Washington, Oregon, and California, oaks face a battery of natural and human-induced threats. Sudden oak death, caused by a virulent pathogen identified in 2000, has killed millions of tanoaks, California black oaks,...

  6. Challenges Faced by Adult Learners Enrolled in Blended Distance ...

    African Journals Online (AJOL)

    This research attempted to provide an insight into major barriers facing adult learners pursuing a diploma in adult and continuing education programme through Blended Distance Learning. Participants included the adult learners, staff from the Department of Open and Distance Learning who are also the facilitators of the ...

  7. Top Ten Challenges Facing the Next Secretary of Homeland Security

    National Research Council Canada - National Science Library

    2008-01-01

    In an effort to assist with the first Presidential administration transition of the Department of Homeland Security, the Homeland Security Advisory Council has identified ten key challenges that will...

  8. A Challenging Giant Dermatofibrosarcoma Protuberans on the Face

    Directory of Open Access Journals (Sweden)

    Gimena Castro Pérez

    2016-01-01

    Full Text Available Dermatofibrosarcoma protuberans (DFSP is a malignant fibrohistiocytic tumor that appears exclusively on the skin. It is a low-grade malignant soft tissue tumor of subcutaneous tissues that has a propensity for local recurrence but seldom metastasizes. It may rarely occur on the head and neck accounting for less than one percent of total head and neck malignancies. We present a man with a giant DFSP on the face. Oncological, functional, and aesthetic aspects are set forth.

  9. 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.

  10. 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.

  11. 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.

  12. Challenges facing the development of the Arabic chatbot

    Science.gov (United States)

    AlHagbani, Eman Saad; Khan, Muhammad Badruddin

    2016-07-01

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

  13. Wise reasoning in the face of everyday life challenges

    NARCIS (Netherlands)

    Grossmann, Igor; Gerlach, Tanja M.; Denissen, J.J.A.

    2016-01-01

    How stable vs. dynamic is wisdom in daily life? We conducted a daily diary study of wise reasoning (WR) by recording people's reflections on daily challenges in terms of three facets: intellectual humility, self-transcendence, and consideration of others' perspectives/compromise. We observed

  14. Confronting the Challenges Facing the Nigerian Nation State: Using ...

    African Journals Online (AJOL)

    This paper explains the concept of nation-state and sports. It critically examines some of the challenges characterizing Nigerian nation state such as ethnicity, corruption, politics of godfatherisms, tribalism, language differences, and religious crises among others. It emphasizes the use of sports for creating of friendship ...

  15. Issues and Challenges Facing the Minority Woman Dentist.

    Science.gov (United States)

    Sinkford, Jeanne C.

    1992-01-01

    The status of minority women dentists is reviewed, and initiatives to improve it are noted. Issues and challenges for African-American female dentists are outlined, including negative racial/gender stereotypes, lack of advancement opportunities, difficulties in starting practices and securing professional and social support systems, lack of…

  16. Facing the Issues: Challenges, Censorship, and Reflection through Dialogue

    Science.gov (United States)

    Lent, ReLeah Cossett

    2008-01-01

    ReLeah Cossett Lent provides practical advice for ensuring that books are kept on shelves and in classrooms for students to read. She outlines steps for creating professional learning communities that engage with censorship issues and prepare schools to deal with book challenges in thoughtful, supportive ways. (Contains 4 figures.)

  17. THE CHALLENGES POLITICAL LEADERSHIP FACES IN THE MODERN WORLD

    Directory of Open Access Journals (Sweden)

    T. N. Samsonova

    2016-01-01

    Full Text Available Political leadership is a concept central to understanding political processes and outcomes, yet its definition is elusive. The study of political leadership has a long history. Many disciplines have contributed to this study, including history, philosophy, political theory, psychology etc. Leadership is a process in which leaders and followers interact dynamically in a particular situation or context. Leaders must be able to connect with followers to understand their mood and their initiative. There are essential and operational differences between a leader and a manager. Managerial effectiveness is related to an emphasis on rationality and organizational structure. Leadership effectiveness is linked to symbols and culture. The interactive nature of leader-followers-situation can help us better understand the changing nature of the leaderfollower relationship and the increasingly greater complexity of situations leaders and followers face in contemporary world. Good leadership makes a difference, and it can be enhanced through greater awareness of the important factors influencing the leadership process. The changes we are facing in today’s world demand a new breed of political leaders, new forms and mechanisms of leader-follower interaction that provide effective leadership. 

  18. 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.

  19. Adequately Addressing Pediatric Obesity: Challenges Faced by Primary Care Providers.

    Science.gov (United States)

    Shreve, Marilou; Scott, Allison; Vowell Johnson, Kelly

    2017-07-01

    To assess the challenges primary care providers encounter when providing counseling for pediatric patients identified as obese. A survey assessed the current challenges and barriers to the screening and treatment of pediatric obesity for providers in northwest Arkansas who provide care to families. The survey consisted of 15 Likert scale questions and 4 open-ended questions. Time, resources, comfort, and cultural issues were reported by providers as the biggest barriers in screening and the treatment of pediatric obesity. All providers reported lack of time as a barrier to providing the care needed for obese children. Cultural barriers of both the provider and client were identified as factors, which negatively affect the care and treatment of obese children. Primary care providers continue to experience challenges when addressing pediatric obesity. In this study, a lack of adequate time to address obesity was identified as the most significant current barrier and may likely be tied to physician resources. Although reimbursement for obesity is increasing, the level of reimbursement does not support the time or the resources needed to treat patients. Many providers reported their patients' cultural view of obesity influenced how they counsel their patients. Increasing providers' knowledge concerning differences in how weight is viewed or valued may assist them in the assessment and care of obese pediatric patients. The challenges identified in previous research continue to limit providers when addressing obesity. Although progress has been made regarding knowledge of guidelines, continuing effort is needed to tackle the remaining challenges. This will allow for earlier identification and intervention, resulting in improved outcomes in pediatric obesity.

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

    International Nuclear Information System (INIS)

    2007-01-01

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

  1. IT Project Portfolio Management; Challenges faced by Danish municipalities

    DEFF Research Database (Denmark)

    Hansen, Lars Kristian

    2010-01-01

    Abstract. Increasing the organizational benefits from IT projects is a key concern in most organizations. The use of Project Portfolio Management (PPM) is generally recommended by consultants (e.g. Kaplan 2005) and researchers (e.g. De Reyck et al 2005) as one way of increasing the organizational...... benefits from IT investments. This article reports from an action research project aiming at understanding and improving IT PPM practices in Danish municipalities, thereby contributing to the general body of knowledge concerning PPM of IT projects. Our findings suggest that the participating organizations...... might benefit from a structured approach as suggested by the literature (e.g. Kaplan 2005), but also that the prescriptive PPM literature in some areas is too simplistic when compared to the reality faced by the participating practitioners. Especially, our research suggests that different PPM elements...

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

    African Journals Online (AJOL)

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

  3. Spent Fuel Challenges Facing Small and New Nuclear Programmes

    International Nuclear Information System (INIS)

    McCombie, C.

    2015-01-01

    In order to ensure that the radioactive wastes in any country are managed safely, it is necessary to have an established legislative and regulatory framework and also to create the necessary organizations for implementation and for oversight of waste management operations and facility development. Guidance on these issues is given in the Joint Convention and a number of other IAEA documents. The IAEA, and also the EC, have in addition published key overarching strategic advisory documents for new nuclear programmes. These tend to imply that all nuclear programmes, however large or small, should be pressing ahead urgently towards early implementation of geological repositories. In practice, however, in small programmes there are neither economic nor technical drivers for early implementation of deep geological repositories; constructing simpler facilities for the disposal of the larger volume of low-level waste has higher priority. Nevertheless, in all countries political decisions have to be taken and policies set in place to ensure that geological disposal will implemented without unjustified delay. This paper distils out a set of key messages for small programmes. Amongst the most critical are the following. Even if disposal is far off, planning and organization should begin at the initiation of the programme; this can help with technical and economic optimization and (importantly) also with public and political acceptance. Important lessons can be learned from advanced programmes — but these must be adapted to allow for the different boundary conditions of new and small programmes. The key differences relate to the timescales involved, and the resources available. There is a range of waste management and waste disposal options open to new programmes. It is not necessary to choose definitive solutions at the outset; options can be kept open, but a minimum level of engagement is required for all open options. (author)

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

    Science.gov (United States)

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

    2017-01-01

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

  5. Issue and challenges facing rechargeable thin film lithium batteries

    International Nuclear Information System (INIS)

    Patil, Arun; Patil, Vaishali; Shin, Dong Wook; Choi, Ji-Won; Paik, Dong-Soo; Yoon, Seok-Jin

    2008-01-01

    New materials hold the key to fundamental advances in energy conversion and storage, both of which are vital in order to meet the challenge of global warming and the finite nature of fossil fuels. Nanomaterials in particular offer unique properties or combinations of properties as electrodes and electrolytes in a range of energy devices. Technological improvements in rechargeable solid-state batteries are being driven by an ever-increasing demand for portable electronic devices. Lithium batteries are the systems of choice, offering high energy density, flexible, lightweight design and longer lifespan than comparable battery technologies. We present a brief historical review of the development of lithium-based thin film rechargeable batteries highlight ongoing research strategies and discuss the challenges that remain regarding the discovery of nanomaterials as electrolytes and electrodes for lithium batteries also this article describes the possible evolution of lithium technology and evaluates the expected improvements, arising from new materials to cell technology. New active materials under investigation and electrode process improvements may allow an ultimate final energy density of more than 500 Wh/L and 200 Wh/kg, in the next 5-6 years, while maintaining sufficient power densities. A new rechargeable battery technology cannot be foreseen today that surpasses this. This report will provide key performance results for thin film batteries and highlight recent advances in their development

  6. Challenges faced by public health nursing leaders in hyperturbulent times.

    Science.gov (United States)

    Reyes, David J; Bekemeier, Betty; Issel, L Michele

    2014-01-01

    This study discusses the challenges and characteristics of effective public health nursing leaders in local health departments and barriers to effective leadership during the hyperturbulent conditions of 2008-2010. Participants were drawn from a purposive sample of seven directors of nursing (DON) in six county LHDs in two states for this qualitative study using inductive methods. Semistructured telephone interviews were conducted, using open-ended questions. Data analysis consisted of coding, pattern identification, and theme development, assisted by the use of ATLAS.ti™. Credibility was achieved through intercoder agreement and resonance of the findings with participants. Two underlying challenges emerged: leadership dissonance and leading through ambiguity. Three key effective leadership attributes identified were as follows: collaborative change management, life-long learning, and being visionary. DONs identified extrinsic and intrinsic barriers to leadership effectiveness and leading change in public health systems and PHN practice. Results suggest ways to support PHN leaders in order to overcome barriers to effective leadership such as defined leadership competencies, continuing education, and mentorship opportunities. © 2013 Wiley Periodicals, Inc.

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

    Science.gov (United States)

    Moon, Sidney M.

    2009-01-01

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

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

    Science.gov (United States)

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

    2014-01-01

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

  9. Generation Y facing the challenge of employability: facts against stereotypes

    Directory of Open Access Journals (Sweden)

    Alberto Vallejo Peña

    2017-07-01

    Full Text Available Young people Spain classed as belonging Generation Y are facing the transition to employment under even more adverse conditions than the previous generation (X, as a result of the economic crisis (2008-2015 prevailing as they reach working age. This paper aims to address the generational traits that are attributed to these young people in Spain, and contrast them with the data offered (Labour Force Survey, LFS, and Organization for Economic Co-operation and Development, OECD, mainly. This aims to achieve a better understanding of the phenomenon to distinguish their true features and generational experiences from the testimony of somewhat unreliable sources. To this end, we analyse the main social types attributed to this generation (Not in Education, Employment, or Training, NEETs, mileuristas and boomerangs, technological changes that determine their profile (digital society, new migration trends, the influence of social stratification and the contribution of the family. The conclusions look in particular at the influence of certain factors (education, social class to improve their employability, and the prevalence of the family as a key institution in supporting these young people, given the lack of other social actors.

  10. Recent Challenges Facing US Government Climate Science Access and Application

    Science.gov (United States)

    Goldman, G. T.; Carter, J. M.; Licker, R.

    2017-12-01

    Climate scientists have long faced politicization of their work, especially those working within the US federal government. However, political interference in federal government climate change science has escalated in the current political era with efforts by political actors to undermine and disrupt infrastructure supporting climate science. This has included funding changes, decreased access to climate science information on federal agency websites, restrictions on media access to scientific experts within the government, and rolling back of science-based policies designed to incorporate and respond to climate science findings. What are the impacts of such changes for both the climate science community and the broader public? What can be done to ensure that access to and application of climate change-related research to policy decisions continues? We will summarize and analyze the state of climate change research and application in the US government. The impacts of political interference in climate change science as well as opportunities the scientific community has to support climate science in the US government, will be discussed.

  11. Facing technological challenges of Solar Updraft Power Plants

    Science.gov (United States)

    Lupi, F.; Borri, C.; Harte, R.; Krätzig, W. B.; Niemann, H.-J.

    2015-01-01

    The Solar Updraft Power Plant technology addresses a very challenging idea of combining two kinds of renewable energy: wind and solar. The working principle is simple: a Solar Updraft Power Plant (SUPP) consists of a collector area to heat the air due to the wide-banded ultra-violet solar radiation, the high-rise solar tower to updraft the heated air to the atmosphere, and in between the power conversion unit, where a system of coupled turbines and generators transforms the stream of heated air into electric power. A good efficiency of the power plant can only be reached with extra-large dimensions of the tower and/or the collector area. The paper presents an up-to-date review of the SUPP technology, focusing on the multi-physics modeling of the power plant, on the structural behavior of the tower and, last but not least, on the modeling of the stochastic wind loading process.

  12. The environmental challenges facing a Chinese oil company in Chad

    International Nuclear Information System (INIS)

    Van Vliet, Geert; Magrin, Geraud; Dittgen, Romain; Tavares, Marie-Adeline; Doudjidingao, Antoine; Maoundonodji, Gilbert; Liang, Guohuang; Wang, Fan; Yang, Weiyong; Lin, Yiran

    2012-11-01

    This book analyses the factors that influence environmental management in the CNPC when operating outside of China, in the outer margins of the world oil system, specifically in Chad, a Least Developed Country. Within a sector marked by the regulations inherited from the Exxon project in Doba (implemented since 2000 with initial World Bank support), the 2007 CNPC Ronier project aims at refining part of the extracted oil and exporting the remainder, most probably through the pipeline built under the Exxon Doba project. The question of the compatibility between the systems of reference and practices in both firms thus arises. Through the prism of social and environmental responsibility, this text analyses the challenges in the interaction between Chinese oil firms, host countries and OCDE-based firms. (authors)

  13. [China faces a challenge of breast cancer prevention and control].

    Science.gov (United States)

    Zhang, B N; Chen, W Q; Zhang, X; Qiao, Y L

    2016-10-23

    The incidence and mortality of breast cancer is in an increasing trend. In contrast to the global breast cancer situation, the prevention and control is challenging in China. Some suggestions are presented to the project of breast cancer prevention and control in China. Combining the global screening experiences with the epidemiological features of Chinese female breast cancer, aims to improve the population screening and early detection rate. Standardizing clinical diagnosis and treatment practice, aims to increase the efficacy and decrease the mortality. Intervening lifestyle and dietary behaviors, and intends to reduce risk exposure and incidence. Building national breast cancer registry provides preventive strategies. Great efforts should be made to carry out large sample multicenter clinical trails and translational research on the prevention and cotrol of breast cancer coordiated by health care service and science and technology administrations. Breast cancer prevention and control has a long way to go in China.

  14. Facing Domestic Violence Against Women in Brazil: Advances and Challenges

    Directory of Open Access Journals (Sweden)

    Thiago Pierobom de Avila

    2018-03-01

    Full Text Available This article aims to offer a critical overview of the Brazilian legal framework for confronting domestic violence against women. Intimate partner homicides are epidemic in Brazil: there are four deaths of women per day. In 2006, the Maria da Penha Law (MPL introduced integrated polices and transformed criminal procedures to deal with the complexities of gender violence. Reforms included the establishment of The House of Brazilian Women, women-only police stations, specialised courts, intervention orders, interdisciplinary experts, and perpetrator programs. In 2015, a new law created the crime of femicide, designed to prevent ‘honor killings’ defenses in cases of intimate partner homicide and to avoid impunity. Despite law reform, structuring and articulating the network of services remains a challenge. The MPL led to great social change in Brazil regarding awareness of the violence against women, facilitating a broader discussion about gender equality.

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

    Science.gov (United States)

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

    2014-01-01

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

  16. The challenges facing the European Union Centres of Excellence

    International Nuclear Information System (INIS)

    Dupre, Bruno; )

    2012-10-01

    On 19 April 2012, the United Nation Security Council congratulated the European Union for its initiative on centres of excellence in the nuclear, radiological, biological, and chemical fields. The time for glowing reports is over. Three years after its creation, the support of EU Member Sates, the Security Council, the G8, the IEAE, the WHO, the USA, Interpol, the ICRC, has been obtained. Other diplomatic, organisational, and communicative challenges have now arisen regarding implementation. The manifest challenges include: 1/Political exploitation of the centres. Following a recent round table in Algiers, the Algerian press ran headlines such as 'terrorism, the Malian crisis arrives in Algiers' CBRN centres of excellence' and 'Bouteflika, the centres of excellence slight'. 2/Communication errors. A unanimously approved expert in South East Asia became a persona non grata over the last six months despite not making any fundamental mistake, aside from his inability to evaluate the degree of a country's sensitivity and pride. The countries in the region went so far as to threaten to pull out of the Manila centre as a result of this ultimately minor error in communication. 3/The scope of the centres' role complicates the grasp of its objectives. To date, the focus has essentially been on non-proliferation and the fight against CBRN terrorism, under the well-established theme of Resolution 1540. The shift of CBRN focus, at the behest of certain regions, on to real natural risks (pandemics) or industrial risks (protection of crucial infrastructure following an earthquake, flooding, or a tsunami) fundamentally changes the teams' make-up and the mobilization of resources. The emergency services culture is different to that of nonproliferation. However, they both very much address CBRN risks and threats. 4/The limits of the 'bottom-up' approach. To date, the centres' success has been due to the lack of restrictive rules. The policy is to enlist willing third-party States

  17. Sustainable Digital Environments: What Major Challenges Is Humankind Facing?

    Directory of Open Access Journals (Sweden)

    Roland W. Scholz

    2016-07-01

    Full Text Available This paper identifies and discusses the benefits, threats, and vulnerabilities related to the digital revolution. It aims to motivate research and its funding regarding digital threats and vulnerabilities related, in particular, to anticipating unintended, undesirable rebound effects, tipping points, critically fast evolutionary change rates, trade-offs, etc. A brief analysis of the history of the mind and technology reveals slow technological development over tens of thousands of years (including the invention of a place-value digital number system. Then, a small series of groundbreaking ideas (e.g., binary logic, Shannon’s symbolic analysis of relay and switching circuits, architectures of computing enabled the industry-driven invention of programmable computing machines. Ultimately, the mastery of electron and semiconductor physics allowed for economical and seemingly unlimited storage capacity that made digital tools available to all domains of society. Based on the historical analysis, a coupled human-environment systems perspective (that includes a hierarchy assumption ranging from the human cell to the human species enables the identification of several potential challenges to society and science. First, digital nano-engineering promotes genetic modifications (i.e., directed evolution, and synthetic biology enables a new level of the appropriation of nature. The understanding of cell-based biocomputers may call for new forms of logic. These and other challenges require thorough sustainability research in order to anticipate major changes on all levels of human systems. Second, the human individual is exposed to new forms of vulnerability. In particular, the potential epigenetic effects resulting from the excessive use of digital information of historically unknown speed, density, and contents and the loss of (the Western common-law right to privacy resulting from big data (whose ownership is often unknown should become subjects of

  18. Representative Delay Measurements (RDM: Facing the Challenge of Modern Networks

    Directory of Open Access Journals (Sweden)

    Joachim Fabini

    2015-02-01

    Full Text Available Network access technologies have evolved significantly in the last years. They deploy novel mechanisms like reactive capacity allocation and time-slotted operation to optimize overall network capacity. From a single node's perspective, such optimizations decrease network determinism and measurement repeatability. Evolving application fields like machine to machine (M2M communications or real-time gaming often have strict real-time requirements to operate correctly. Highly accurate delay measurements are necessary to monitor network compliance with application demands or to detect deviations of normal network behavior, which may be caused by network failures, misconfigurations or attacks. This paper analyzes factors that challenge active delay measurements in modern networks. It introduces the Representative Delay Measurement tool (RDM that addresses these factors and proposes solutions that conform to requirements of the recently published RFC7312. Delay measurement results acquired using RDM in live networks confirm that advanced measurement methods can significantly improve the quality of measurement samples by isolating systematic network behavior. The resulting high-quality samples are one prerequisite for accurate statistics that support proper operation of subsequent algorithms and applications.

  19. Challenges Faced in Field Application of Phosphate-Solubilizing Bacteria

    KAUST Repository

    Eida, Abdul Aziz

    2017-08-01

    The general inaccessibility of soil phosphorous (P) to plants in combination with the depletion of global P reserves provides an incentive for researchers to find sustainable solutions to sustain food security for the ever-increasing world population. Bio-fertilizers based on bacteria and fungi able to solubilize endogenous P in soils have a high potential for increasing nutrient availability in agriculture. However, the inconsistency of bio-fertilizer performance in the field poses a major challenge for farmers. This discrepancy is thought to stem from the complexity of the interactions between crop plants, microbes, and their soil environments, as well as our lack of understanding of the processes involved. For farmers, a clear beneficial effect across different soil types, crop species, environmental conditions, and microbial communities will be required to make it worth to adopt bio-fertilizer technology based on phosphate-solubilizing microbes (PSMs). Here, we attempt to review the current knowledge of the complexity of the P-solubilization mechanisms used by PSMs and how they may be affected by interactions in the field. We also identify possible explanations for the inconsistent performance of P-solubilizing bacteria in the field and ways to solve these obstacles.

  20. Reentry challenges facing women with mental health problems.

    Science.gov (United States)

    Visher, Christy A; Bakken, Nicholas W

    2014-01-01

    Women entering the correctional system represent a population at high risk for mental health and the body of research on the mental health needs of women offenders is growing. These mental health problems pose challenges for women at every stage of the criminal justice process, from arrest to incarceration to community reentry and reintegration. In this article, we examined mental health status among a sample of 142 women leaving confinement and the role that mental health problems played in shaping their reentry outcomes using data collected between 2002 and 2005 in Houston, Texas. In the year after leaving prison, women with mental health problems reported poorer health, more hospitalizations, more suicidal thoughts, greater difficulties securing housing and employment, more involvement in criminal behavior, and less financial support from family than women with no indication of mental health problems. However, mental health status did not increase the likelihood of substance use relapse or reincarceration. The article concludes with a discussion of recommendations for improved policy and practice.

  1. U.S. drilling contractors could face stiff challenges

    International Nuclear Information System (INIS)

    Simmons, M.R.

    1993-01-01

    Although the outlook for most segments of the contract drilling business is now more optimistic than in the past decade, the increased activity has brought several problems: the availability of fully trained crews, the need for new capital, and the limited number of quality drillstrings. These problems will grow in importance if natural gas deliverability begins to decline visibly and once the scramble to correct this decline begins. As the drilling recovery unfolds, the most important lesson to remember, based on worldwide activity in the past year, is how rapidly conditions can change and how quickly excess capacity can turn into chronic shortages. The various segments of the world wide contract drilling industry's prospects have changed dramatically during the past 12 months, and oddly, some market sectors have improved while others have become worse. These quick changes highlight the unpredictable and volatile nature of the markets for contract drilling and other services needed to drill and complete oil and gas wells. The paper describes the business of well drilling onshore and offshore in the US, drilling activities in Canada, international markets, capacity, the supplies of natural gas, Gulf of Mexico activities, drill pipe shortages, manpower shortages, and challenges offshore

  2. Challenges Faced in Field Application of Phosphate-Solubilizing Bacteria

    KAUST Repository

    Eida, Abdul Aziz; Hirt, Heribert; Saad, Maged

    2017-01-01

    The general inaccessibility of soil phosphorous (P) to plants in combination with the depletion of global P reserves provides an incentive for researchers to find sustainable solutions to sustain food security for the ever-increasing world population. Bio-fertilizers based on bacteria and fungi able to solubilize endogenous P in soils have a high potential for increasing nutrient availability in agriculture. However, the inconsistency of bio-fertilizer performance in the field poses a major challenge for farmers. This discrepancy is thought to stem from the complexity of the interactions between crop plants, microbes, and their soil environments, as well as our lack of understanding of the processes involved. For farmers, a clear beneficial effect across different soil types, crop species, environmental conditions, and microbial communities will be required to make it worth to adopt bio-fertilizer technology based on phosphate-solubilizing microbes (PSMs). Here, we attempt to review the current knowledge of the complexity of the P-solubilization mechanisms used by PSMs and how they may be affected by interactions in the field. We also identify possible explanations for the inconsistent performance of P-solubilizing bacteria in the field and ways to solve these obstacles.

  3. Towards Lead-Free Piezoceramics: Facing a Synthesis Challenge

    Directory of Open Access Journals (Sweden)

    María Elena Villafuerte-Castrejón

    2016-01-01

    Full Text Available The search for electroceramic materials with enhanced ferro-pyro-piezoelectric properties and revealing the perovskite type structure has been the objective of a significant number of manuscripts reported in the literature. This has been usually carried out by proposing the synthesis and processing of new compounds and solid solution series. In this work, several methods to obtain ferro-pyro-piezoelectric families of materials featuring the well-known ABO3 perovskite structure (or related such as BaTiO3, Ba1–xCaxTi1–yZryO3, (Bi0.5Na0.5TiO3, (K0.5Na0.5NbO3 and their solid solutions with different cations either in the A or B positions, are presented. For this kind of materials, the challenge for obtaining a single phase compound with a specific grain size and morphology and, most importantly, with the adequate stoichiometry, will also be discussed. The results reviewed herein will be discussed in terms of the tendency of working with softer conditions, i.e., lower temperature and shorter reaction times, also referred to as soft-chemistry.

  4. 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

  5. UK community health visiting: challenges faced during lean implementation

    Directory of Open Access Journals (Sweden)

    Carr SM

    2012-01-01

    Full Text Available Susan M Carr1,2, Pauline Pearson1, Lesley Young-Murphy3, Barbara Cleghorn41Centre for Community Health & Education Studies Research & Enterprise, Northumbria University, Newcastle upon Tyne, UK; 2School of Health, University of New England, Armidale, New South Wales, Australia; 3NHS North of Tyne, Newcastle upon Tyne, UK, 4Newcastle PCT, Newcastle upon Tyne, UKAbstract: This paper presents an overview of the challenges and potential of lean implementation for the health visiting service in England and examines the rhetoric and the reality of the situation. It is coauthored by academic researchers and senior service providers so as to embrace the multidimensional issues impacting on this subject. If lean thinking is to be implemented in relation to health visiting, it is important to understand how it is likely to be viewed by practitioners and line managers in settings where it is used. In order to contextualize the discussion, an introduction to the roles, systems, and structures of health visiting are provided. The literature on what lean implementation is, what it means, and in particular the application and potential of the approach to primary care and public health services is reviewed. The process and findings from a focus group convened within a large primary care organization in the National Health Service during their lean implementation is reported. The paper concludes that it is important for staff at all levels to see a clear link between strategic aims and objectives and the planning processes operated by providers and commissioners. It appears that the successful introduction of lean thinking should focus more on productive working and thereby reducing waste. This has the potential to refresh workforce models to ensure that health visiting and other practitioners liberate the use of their specialist knowledge and skills. In a context of enhanced partnership working, the stage is then set for providers to add value to the whole

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

    Science.gov (United States)

    Kozikoglu, Ishak

    2017-01-01

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

  7. Romanian spatial planning research facing the challenges of globalizing sciences

    Directory of Open Access Journals (Sweden)

    Alexandru-Ionuţ Petrişor

    2018-03-01

    competitiveness, measured in terms of scientific yield and citations, primarily affects fields where articles and citations are not the traditional outputs, such as the humanities and social sciences in general and planning-related disciplines in particular. When discussing planning, it has to be stressed out that research has a merely societal value and is not aimed at developing products that can foster economic growth or delivering scientific articles that profoundly change the theoretical perspectives. Simply put, research in planning aims at increasing the safety and welfare of people. As a consequence, planning research topics have shifted from providing scientific grounds to regional development policies, to addressing research quality and social responsibility or producing research guidelines. This article looks at the particular case of Romanian planning research based on SCImago data, in an attempt to assess whether this field is able to meet these global challenges, especially after the consistent, albeit uneven, in terms of goal and pace, application of new research policies designed after joining the European Union, which were aimed at increasing its article output and its international visibility. The findings indicate that the numerical growth of articles and publications is spectacular in Romania for most fields, and even more so within the humanities, the social sciences and planning. However, the question remains whether this impressive growth is supported by an increase in quality. We have therefore left aside matters such as the globalization of authors, topics or citations. These aspects require a more in-depth research effort.

  8. 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)

  9. 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.

  10. 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...

  11. 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.

  12. 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...

  13. 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...

  14. 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...

  15. 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)

  16. 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.

  17. 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

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

    Science.gov (United States)

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

    2018-03-15

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

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

    OpenAIRE

    Raden Aswin Rahadi

    2016-01-01

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

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

    OpenAIRE

    Al Ajlouni, Ahmed

    2004-01-01

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

  1. 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.

  2. 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.

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

    Science.gov (United States)

    Spicer, Andrew; Molnar, Attila

    2018-03-06

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

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

    Science.gov (United States)

    Subramanyam, K.; Haridharan, M. K.

    2017-07-01

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

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

    Science.gov (United States)

    Enugu, Ramya; Hokayem, Hayat

    2017-01-01

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

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

    Science.gov (United States)

    Morojele, Pholoho

    2013-01-01

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

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

    African Journals Online (AJOL)

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

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

    Science.gov (United States)

    Alias, Aliza

    2014-01-01

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

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

    Science.gov (United States)

    de Lange, Paul; Watty, Kim

    2011-01-01

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

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

    Science.gov (United States)

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

    2010-05-01

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

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

    Science.gov (United States)

    Mahfoodh, Omer Hassan Ali

    2014-01-01

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

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

    Science.gov (United States)

    Rajasingham, Lalita

    2011-01-01

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

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

    Science.gov (United States)

    Al-Jaradat, Mahmoud Khaled Mohammad

    2014-01-01

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

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

    Science.gov (United States)

    Gudgel, Mark

    2013-01-01

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

  15. 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.

  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. 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.

  18. 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.

  19. 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

  20. 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.

  1. 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)

  2. 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

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

    Science.gov (United States)

    Bernardes, Margarida Maria Rocha; Lopes, Gertrudes Teixeira

    2007-01-01

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

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

    International Nuclear Information System (INIS)

    2018-01-01

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

  5. 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

  6. 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.

  7. [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.

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

    Directory of Open Access Journals (Sweden)

    BUCIU Ioan

    2014-05-01

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

  9. 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

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

    Directory of Open Access Journals (Sweden)

    Tim Scott J

    2001-11-01

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

  11. Different perspectives on the key challenges facing rural health: The challenges of power and knowledge.

    Science.gov (United States)

    Malatzky, Christina; Bourke, Lisa

    2018-05-25

    To examine the effects of dominant knowledge in rural health, including how they shape issues central to rural health. In particular, this article examines the roles of: (i) deficit knowledge of rural health workforce; (ii) dominant portrayals of generalism; and (iii) perceptions of inferiority about rural communities in maintaining health disparities between rural- and metropolitan-based Australians. A Foucauldian framework is applied to literature, evidence, case studies and key messages in rural health. Three scenarios are used to provide practical examples of specific knowledge that is prioritised or marginalised. The analysis of three areas in rural health identifies how deficit knowledge is privileged despite it undermining the purpose of rural health. First, deficit knowledge highlights the workforce shortage rather than the type of work in rural practice or the oversupply of workforce in metropolitan areas. Second, the construction of generalist practice as less skilled and more monotonous undermines other knowledge that it is diverse and challenging. Third, dominant negative stereotypes of rural communities discourage rural careers and highlight undesirable aspects of rural practice. The privileging of deficit knowledge pertaining to rural health workforce, broader dominant discourses of generalism and the nature of rural Australian communities reproduces many of the key challenges in rural health today, including persisting health disparities between rural- and metropolitan-based Australians. To disrupt the operations of power that highlight deficit knowledge and undermine other knowledge, we need to change the way in which rural health is currently constructed and understood. © 2018 National Rural Health Alliance Ltd.

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

    Science.gov (United States)

    Taderera, Clever; Hall, Herna

    2017-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Tanja Komarac

    2014-12-01

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

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

    OpenAIRE

    Elizabeth Chinomona; Eugine Tafadzwa Maziriri

    2015-01-01

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

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

    OpenAIRE

    Fridah Muriungi Mwobobia

    2012-01-01

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

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

    Science.gov (United States)

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

    2012-05-01

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

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

    Science.gov (United States)

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

    2018-05-15

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

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

    Science.gov (United States)

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

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

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

    OpenAIRE

    Chung, Hoyoon

    2017-01-01

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

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

    Science.gov (United States)

    Evans, S

    1985-04-01

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

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

    Science.gov (United States)

    2010-05-01

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

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

    Czech Academy of Sciences Publication Activity Database

    Kolejka, Jaromír

    2010-01-01

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

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

    Science.gov (United States)

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

    2013-06-01

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

  4. 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.

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

    Directory of Open Access Journals (Sweden)

    Kole Legodi

    2015-12-01

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

  6. 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

  7. 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…

  8. 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

  9. 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

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

    Directory of Open Access Journals (Sweden)

    C.C. Ifeanyi-Obi

    2017-01-01

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

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

    Science.gov (United States)

    Mattsson, Mats-Olof; Simkó, Myrtill

    2017-03-01

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

  12. 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.

  13. 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

  14. 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

  15. 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...

  16. 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

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

    Directory of Open Access Journals (Sweden)

    Elena Maydell

    2009-08-01

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

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

    Science.gov (United States)

    Davis, Sheila P; Davis, Danyetta D

    2010-01-01

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

  19. 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.

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

    Science.gov (United States)

    Pung, L-X; Goh, Y-S

    2017-03-01

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

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

    International Nuclear Information System (INIS)

    Zhang Lisheng

    2004-01-01

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

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

    Science.gov (United States)

    Simard, Paule

    2007-01-01

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

  3. 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)

  4. 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.

  5. 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)

  6. 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.

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2010-08-05

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

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

    Directory of Open Access Journals (Sweden)

    Raden Aswin Rahadi

    2016-03-01

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

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

    Science.gov (United States)

    Spendlove, Zoey

    2018-05-01

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

  10. 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.

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

    Science.gov (United States)

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

    2012-05-01

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

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

    Directory of Open Access Journals (Sweden)

    Julie O'Connor

    2009-05-01

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

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

    Directory of Open Access Journals (Sweden)

    Roosta-G., Manigeh

    2015-08-01

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

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

    Science.gov (United States)

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

    2013-01-01

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

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

    Science.gov (United States)

    Dickey, Lore M; Singh, Anneliese A

    2017-08-01

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

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

    International Nuclear Information System (INIS)

    Corathers, L.A.

    1992-03-01

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

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

    International Nuclear Information System (INIS)

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

    2016-01-01

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

  18. 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)

  19. 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

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

    International Nuclear Information System (INIS)

    Maillard, D.

    1999-01-01

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

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

    International Nuclear Information System (INIS)

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

    2016-06-01

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

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

    Directory of Open Access Journals (Sweden)

    Bhaskara P Shelley

    2018-01-01

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

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

    Science.gov (United States)

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

    2018-05-05

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

  4. Anti-racist pedagogy: challenges faced by faculty of color in predominantly white schools of nursing.

    Science.gov (United States)

    Hassouneh, Dena

    2006-07-01

    Despite the significant effects of systems of oppression on health, nursing education tends not to include anti-racist pedagogy in its curricula, preferring instead to focus more narrowly on culture. This narrow focus allows nurses to depoliticize discussions of race and other social differences, largely ignoring the influence that systems of oppression, imperialism, and historical trauma have had on health in marginalized populations. In contrast, anti-racist pedagogy educates students in ways that make racialized power relations explicit, deconstruct the social construction of race, and analyze interlocking systems of oppression that serve to marginalize and exclude some groups while privileging others. This article describes anti-racist pedagogy from the perspective of a faculty member of color, drawing on personal experience and a review of the anti-racist pedagogical literature. Specifically, this article highlights some of the personal and professional challenges faced by faculty of color when engaged in anti-racist pedagogy in predominantly white schools of nursing.

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

    Science.gov (United States)

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

    2015-01-01

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

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

    International Nuclear Information System (INIS)

    Borsato, J.

    2010-01-01

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

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

    Science.gov (United States)

    Kakyo, T A; Xiao, L D

    2018-04-19

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

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

    Science.gov (United States)

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

    2013-10-01

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

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

    Directory of Open Access Journals (Sweden)

    Ingrid L. Potgieter

    2017-02-01

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

  10. 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.

  11. 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.

  12. 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.

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

    Science.gov (United States)

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

    2013-01-01

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

  14. 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.

  15. 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.

  16. 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.

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

    Science.gov (United States)

    Bear, Daniel

    2017-04-01

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

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

    Directory of Open Access Journals (Sweden)

    Conceição de Maria Pinheiro Barros

    2011-10-01

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

  19. Challenges facing the insurance industry since the modernisation of the international nuclear third party liability regime

    International Nuclear Information System (INIS)

    Quere, Alain

    2014-01-01

    events illustrate some of the challenges facing the world of insurance following the modernisation of the international nuclear third party liability regime: - Will the insurance industry be able to find funds corresponding to the new amounts that have been set? - Do the additional damages covered by the revised conventions provide adequate cover for existing risks and will private insurance be able and willing to cover such risks? Nevertheless, the insurance world has changed a great deal since 2004 and there are many additional issues that have arisen since that time. For example, the economic crisis and the introduction of the European Solvency II Directive require insurers to take a more stringent line with their commitments. Moreover, after the Fukushima Daiichi accident, a number of questions have resurfaced: are the new insurance amounts sufficient? The age of 'nuclear renaissance' has long gone and some countries are distancing themselves from nuclear power in light of its questionable costs; are operators paying a fair price in light of the risks incurred? Finally, Europe is keen to play its part and impose its own rules; what will be the consequences of this development? This article reconsiders these challenges in light of the 2004 Protocol (which has not entered into force), by focusing in particular on the situation in Europe. Section I looks back at the history behind the conventions and the key principles they set down. Section II highlights the changes made to the Paris Convention as amended by the 2004 Protocol and the problems facing the insurance industry. Section III provides an overview of the various actors involved in the insurance industry and redefines the necessary insurance foundations to cover the challenges described in Section IV. Finally, Section IV covers all the challenges facing the insurance industry since the modernisation of the international nuclear third party liability regime. (author)

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

    Directory of Open Access Journals (Sweden)

    Morten Tryland

    2013-03-01

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

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

    Science.gov (United States)

    Lorenzino, Martina; Caminati, Martina; Caudek, Corrado

    2018-05-25

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

  2. Regime complexity and expertise in transnational governance: Strategizing in the face of regulatory uncertainty

    Directory of Open Access Journals (Sweden)

    Sigrid Quack

    2013-01-01

    Full Text Available The rise and spread of transnational governance arrangements has added to the legal indeterminacy of existing regime complexes. The combined regulatory uncertainty resulting from international regime complexes and transnational polycentric governance heightens the role of expertise in managing this institutional complexity. The rising importance of knowledgeable actors with claims to policy-relevant expertise, according to many scholars, is expected further to advantage well-resourced and powerful actors. However, attention to recent developments in accounting and copyright, as two transnational governance fields that have been dominated by a small group of powerful actors for more than three decades, sheds doubt on the generalizability of such arguments. Although representing least likely cases for change, the empirical evidence presented in this paper shows how apparently weak or marginalized actors – whether they are part of public bureaucracies or civil society – developed expertise-based strategies to claim greater involvement and influence in rule and standard-setting. Their strategizing on regime complexity opened up previously shielded policy spaces to broader audiences, thereby transforming actor constellations, preferences and problem definitions in the two policy fields. These findings suggest that under conditions of complexity, indeterminacy and uncertainty, claims to expertise-based rule are becoming increasingly contested – even in transnational governance fields that have a long-established trajectory of rule-setting and rule-implementation monopolized by small groups of professionals, industrialists or technical diplomats. El surgimiento y la difusión de las disposiciones de gobierno transnacional ha contribuido a la indeterminación jurídica de los complejos regímenes existentes. La incertidumbre regulatoria resultante de los complejos regímenes internacionales y del gobierno policéntrico transnacional realza el

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

    OpenAIRE

    Rajanbir Kaur; Kanwaljit Kaur; Rajinder Kaur

    2018-01-01

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

  4. 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)

  5. 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.

  6. 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.

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2014-05-01

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

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

    Science.gov (United States)

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

    2017-06-01

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

  9. New Challenges Facing Small Undergraduate Departments And The Role Of Faculty And Administrators.

    Science.gov (United States)

    El-Shazly, A. K.

    2003-12-01

    Small geoscience departments with 5 faculty members or less in undergraduate institutions are facing serious challenges that will have a profound impact on their future, as well as the future of geoscience education. In addition to past and future budget cuts that affect all departments, small departments are more vulnerable to such problems as (i) decreased enrollments in introductory level classes, (ii) small number of geology majors, (iii) small number of graduates per year (iv) lack or paucity of equipment necessary for faculty and student research, (v) limited opportunities for external funding, (vi) need to offer upper division classes on an alternate year basis, (vii) difficulty in recruiting and retaining students, (viii) high teaching loads for faculty, and (ix) designing rigorous curricula based on 120 credit hours with a significant component of liberal art classes. These problems pose new challenges for faculty, department chairs and administrators. Faculty need to design curricula tailored to the need of the job market, without compromising rigor or the quality of the program. New classes/ concentrations in environmental science, hydrogeology and geographical information systems should be offered, and traditional classes in petrology, geophysics and tectonics should be maintained. Classes in Physics, Chemistry and Math should be core requirements. Student involvement in research should be encouraged at an early stage (sophomore/ junior levels). Department chairs need to assign duties in their department carefully to capitalize on the strengths of their faculty: faculty with strong research backgrounds should be helped in their efforts to pursue external funding opportunities, whereas those with strong teaching abilities should be evaluated primarily on their performance in the classroom. Student credit hour production should not be used as a criterion for evaluating faculty. Administrators should evaluate programs and departments based on the success

  10. Is sustainable development attainable? Challenges facing forestry and the forest products industry

    International Nuclear Information System (INIS)

    Wrist, P.E.

    1991-01-01

    The challenges that face the forest industry in achieving sustainable development are reviewed. Sustainable development is not the same as sustained yield forest management. While sustained yield limits harvesting to an estimate of a forest's incremental annual growth, it is a policy which neither takes into account how improved forest management practices can increase future growth rates nor gives guidance on how multiple uses for the forest resource can be made compatible with periodic harvesting of that resource. Forests, in addition to meeting demands for timber production, must also meet demands for watershed management, recreation, preservation of wildlife and genetic diversity, moderation of climates, carbon sequestration, and land reclamation. Information is lacking from which to develop improved forest management programs that take these demands into account. Questions remain about such matters as the role of plantations in sustainable forestry and the maintenance of natural diversity. Some recent research being undertaken to generate better information for future forestry decision making is outlined, including work on gene pool maintenance, the interdependence of forest ecology and climate, the symbiotic role of mycorrhiza, forest fertilization, and the interdependence of sustainable forestry and sustainable fisheries. In the forest products industry, engineered wood products have been developed that meet tight specifications and require less raw material, and process changes have been introduced that greatly reduce pollutants from pulp manufacture

  11. Polycentrism in Global Health Governance Scholarship Comment on "Four Challenges That Global Health Networks Face".

    Science.gov (United States)

    Tosun, Jale

    2017-05-23

    Drawing on an in-depth analysis of eight global health networks, a recent essay in this journal argued that global health networks face four challenges to their effectiveness: problem definition, positioning, coalition-building, and governance. While sharing the argument of the essay concerned, in this commentary, we argue that these analytical concepts can be used to explicate a concept that has implicitly been used in global health governance scholarship for quite a few years. While already prominent in the discussion of climate change governance, for instance, global health governance scholarship could make progress by looking at global health governance as being polycentric. Concisely, polycentric forms of governance mix scales, mechanisms, and actors. Drawing on the essay, we propose a polycentric approach to the study of global health governance that incorporates coalitionbuilding tactics, internal governance and global political priority as explanatory factors. © 2018 The Author(s); Published by Kerman University of Medical Sciences. This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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

    Directory of Open Access Journals (Sweden)

    Jamal Mohammadi

    2015-12-01

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

  13. Challenges faced in the treatment of acute lymphoblastic leukemia in adolescents and young adults

    Directory of Open Access Journals (Sweden)

    Levine SR

    2016-02-01

    Full Text Available Selena R Levine,1 Jennifer L McNeer,2 Michael S Isakoff1 1Center for Cancer and Blood Disorders, Connecticut Children’s Medical Center and University of Connecticut School of Medicine, Hartford, CT, 2Section of Pediatric Hematology/Oncology, University of Chicago Comer Children's Hospital, Chicago, IL, USA Abstract: The survival rate for children with acute lymphoblastic leukemia (ALL has dramatically improved over the last 50 years. However, for those in the adolescent and young adult (AYA age-group of 15–30 years with ALL, there has not been the same degree of improvement. Historically, pediatric and adult providers have utilized different treatment approaches based on clinical trials. However, studies that have compared the outcome of AYA patients with ALL treated on pediatric or adult clinical trials have generally shown substantially better outcomes for this patient population treated with the pediatric trials. Additionally, hematopoietic stem cell transplantation has been considered as part of intensified therapy for AYA patients with ALL. Herein, we review the outcomes with chemotherapy alone and with hematopoietic stem cell transplantation, and explore the challenges faced in determining the ideal therapy for the AYA population of patients. Keywords: adolescent young adult oncology, leukemia, hematopoietic stem cell transplantation

  14. 'Shedding light' on the challenges faced by Palestinian maternal health-care providers.

    Science.gov (United States)

    Hassan-Bitar, Sahar; Narrainen, Sheila

    2011-04-01

    to explore the challenges and barriers faced by Palestinian maternal health-care providers (HCPs) to the provision of quality maternal health-care services through a case study of a Palestinian public referral hospital in the Occupied Palestinian Territory. descriptive qualitative study. The data are from a broader study, conducted in 2005 at the same hospital as part of a baseline assessment of maternal health services. 31 maternal HCPs; nine midwives and 14 nurses and eight doctors. the quality of care provided for women and infants at this Palestinian public hospital is substandard. The maternal HCPs work within a difficult and resource-constrained environment. ISSUES INCLUDE: high workload, poor compensation, humiliation in the workplace, suboptimal supervision and the absence of professional support and guidance. Midwives are perceived to be at the bottom of the health professional hierarchy. there is a need for managers and policy makers to enable maternal HCPs to provide better quality care for women and infants during childbirth, through facilitating the roles of midwives and nurses and creating a more positive and resourceful environment. Palestinian midwives need to increase their knowledge and use evidence-based practices during childbirth. They need to unite and create their own circle of professional support in the form of a Palestinian midwifery professional body. Copyright © 2009 Elsevier Ltd. All rights reserved.

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

    Science.gov (United States)

    Klitzman, Robert

    2017-02-28

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

  16. Access to energy sources in the face of climate change: Challenges faced by women in rural communities

    Directory of Open Access Journals (Sweden)

    Mphemelang J. Ketlhoilwe

    2018-04-01

    Full Text Available Access to energy is a challenge to rural communities, especially among women who are the prime household energy users. This article is based on research carried out in the Tswapong villages in Botswana where energy sources particularly wood, are slowly getting depleted while electricity connection costs remain unaffordable for the poor. The article provides constructivist analysis of experiences in real-life situations among women. Data were generated through observations, documents analysis, interviews and focus group discussions. It has emerged from the research that majority of the respondents use firewood as energy source. Firewood and gas are mainly used for cooking while electricity is mainly used for lighting. The demand for firewood has led to firewood commercialisation, the depletion of preferred firewood tree species and increase in the impact of climate change. The article recommends economic diversification and subsidies to empower the majority of the rural poor to connect to the national electric grid and reduce on firewood dependence. These could be complemented by harnessing of solar energy and low-cost, energy-saving technologies. Subsidies to enable women access to energy services would contribute immensely to the decade of Sustainable Energy for All and to the attainment of the post 2015 sustainable development goal on energy.

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

    Science.gov (United States)

    Scott, Susan

    2006-01-01

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

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

    Science.gov (United States)

    Eton, Marus; Mwirumubi, Richard; Edaku, Charles

    2017-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Tafadzwa Rugoho

    2017-05-01

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

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

    Science.gov (United States)

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

    2011-01-01

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

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

    Science.gov (United States)

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

    2017-01-01

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

  2. 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

  3. Conference on wind power development in the face of landscape and local project acceptability challenges

    International Nuclear Information System (INIS)

    Victoire Lejzerzon; Sauron, Claire; Villot, Marie; Ratzbor, Guenter; Tausch, Christian; Cagneaux, Bertrand; Jouneau, Agathe; Stemmer, Boris; Huebner, Gundula; Orozco-Souel, Paola; Lhermitte, Charles; Ferus, Elisabeth; Benezech, Philippe; Gunzelmann, Thomas

    2015-01-01

    The French-German office for Renewable energies (OFAEnR) organised a conference on n wind power development in the face of landscape and local project acceptability challenges. In the framework of this French-German exchange of experience, participants addressed the following points: the conciliation between landscape protection and wind power development, the definition of landscape environmental quality criteria, the needs and usages of the departments in charge of the treatment of landscape studies in France, the socio-psychological approach of the local acceptability of wind farm projects, the re-powering tool for the improvement of the wind farm integration in the landscape, and the conciliation between the monuments maintenance and wind power development. This document brings together the available presentations (slides) made during this event: 1 - Conciliating landscape protection and wind power development goals in France (Marie Villot); 2 - Wind turbines: Conflicts between development goals, landscape and acceptance - Perception and criteria (Guenter Ratzbor); 3 - Bayern's wind power atlas: a planning tool which takes into account the landscape aspects (Christian Tausch); 4 - Landscape assessment in wind farms projects: what and how to do in French administrative procedures? (Bertrand Cagneaux); 5 - Methods for evaluation of landscape for wind farms projects - A French project developer's feedback (Agathe Jouneau); 6 - Landscape Assessment: Methods from German Landscape Practice (Boris Stemmer); 7 - Acceptance of Wind Turbines - Social Psychological Research (Gundula Huebner); 8 - Local consultation: who to involve, when and how? (Paola Orozco-Souel); 9 - Local acceptability: what dialogue concepts and strategies, and how to manage wind energy objection (Charles Lhermitte); 10 - Re-powering and landscape: chances and limits (Elisabeth Ferus); 11 - Wind power and cultural heritage: consultation and dialogue to succeed (Philippe Benezech); 12

  4. DATING AND SEXUAL CHALLENGES FACED BY HIV-POSITIVE PEOPLE IN KWAZULU-NATAL, SOUTH AFRICA

    Directory of Open Access Journals (Sweden)

    Mulqueeny, Delarise

    2013-05-01

    Full Text Available According to the 2010 UNAIDS Report, an estimated 320 000 (or 20% fewer people died of AIDS-related causes in 2009 when compared to figures in 2004 in sub-Saharan Africa, when antiretroviral therapy was markedly expanded (UNAIDS, 2010. This decreased mortality rate offers hope for HIV-infected people to plan a future, part of which will include dating and sexual relationships. The Report cites KwaZulu-Natal in South Africa as being at the heart of the HIV/AIDS epidemic; this article is based on research on dating and sexuality among HIV-positive people in KwaZulu-Natal. Dating and sexuality are an integral part of living. Yet HIV-positive persons are denied intimacy at a time when this is most needed (Kasiram in Kasiram, Partab & Dano, 2006. Little is known about the full range of sexual adaptations that HIV-infected individuals choose (Schiltz & Sandfort, 2000. Kasiram, Partab, Dano and Van Greunen (2003:9 cite interaction and intimacy among HIV-positive persons as a neglected research focus, while Painter (2001 adds that insufficient attention is afforded to couple relationships for infected people. An important reason that motivated this study on dating and sexual challenges faced by HIV-positive people was the first author’s (the main researcher’s personal experience of being HIV positive and counselling and life coaching HIV-positive people. She is confronted regularly with variations of the question “Will I be normal?”, which often translates to: “Will I be able to date and have sex.

  5. THE SOCIAL AND OCCUPATIONAL HEALTH PROBLEMS OF CHILD LABOUR: A CHALLENGE THE WORLD IS FACING

    Directory of Open Access Journals (Sweden)

    Kapil Goel

    2012-03-01

    Full Text Available Eliminating child labour is one of the biggest challenges that the world is facing. Child labour not only causes damage to a child’s physical and mental health but also keeps him deprived of his basic rights to education, development, and freedom. Children of lower socio-economic class are known to be inducted as child labour. The main causes of child labour include poverty, unemployment, excess population and urbanization. The construction sector is one of the most hazardous working environments especially for children. Children are exposed to dangerous machinery causing fatal and non-fatal injuries, while operating or working near them. Children are exposed to strenuous labour, which can affect the musculo-skeletal development of the children. In industries, child workers are exposed to various physical, mental, social occupational hazards resulting in lower growth and poor health status. Working long hours, child labourers are often denied a basic school education, normal social interaction, personal development and emotional support from their family. The Child Labour Act was implemented in India in 1986 that outlaws child labour in certain areas and sets the minimum age of employment at fourteen. Eradicating poverty is only the first step on the road for eliminating child labour. There is an urgent need for intensive focus and research along with political and practical decisions to improve the conditions of working children for the betterment of their health and development. Proper education of the children and banning child labor will help in boosting the success of the country.

  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. Challenges Faced by Graduate Business Education in Southern Africa: Perceptions of MBA Participants

    Science.gov (United States)

    Temtime, Zelealem T.; Mmereki, Rebana N.

    2011-01-01

    Purpose: The purpose of this paper is to examine the degree of satisfaction and perceived relevance of the Graduate Business Education (GBE) programme at the University of Botswana. Design/methodology/approach: A self-administered questionnaire and face to face interviews were used to collect data from Master of Business Administration (MBA)…

  12. 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

  13. 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

  14. 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.

  15. An assessment for technical, economic, and environmental challenges facing renewable energy strategy in Egypt

    International Nuclear Information System (INIS)

    Abd El Aziz Mohi El Din, Ehab Mohamed Farouk

    2011-01-01

    Securing energy demand for next generations is one of the most challenges aspects facing any sustained development plans, due to the growing electric energy demand and Egypt as a country of limited fossil fuel resources has to diversify its energy portfolio by utilization of its renewable energy resources, mainly wind due to its economic potential and solar as proved by Egypt's wind and solar atlases. In the year 2009/2010, the total installed capacity in Egypt was 24726 MW with electricity generation 139,000 GWh, of which 89 % was delivered by thermal plants and about 10% from Hydro power with total installed 2800 MW and electricity generated is about 12863 GWh and 1% from Wind energy with total installed 550 MW and electricity generated 1542 GWh. In the solar energy field, the first solar thermal power plant of 140 MW with a solar share of 20 MW using parabolic trough technology was started the initial work since the 1 st of July with estimated total energy generated of 852GWh/year. Recently, Egypt has adopted an ambitious plan to cover 20% of the generated electricity by renewable energy by 2020, including a 12% contribution from wind energy, translating more than 7200 MW grid-connected wind farms. Such plan gives a room enough to the private investment to play the major role in realizing this goal. The plan includes also a 100 MW Solar thermal energy CSP with parabolic trough technology in Kom Ombo city, and also two PV plants in Hurgada and Kom Ombo with a total installed capacity 20 MW each. Due to the high investment cost of solar energy technologies, still limited in spread all over the world on the other hand wind energy has an economic potential and becomes a commercial technology but the future potential for solar energy due to the limited land for wind energy. Current study will evaluate the Egyptian strategy for renewable energy up to 2020 and find how much the planned projects from the Egyptian government will fulfill its target, the economic study

  16. A long hard road? Urban freight transport challenges facing South Africa

    CSIR Research Space (South Africa)

    Ittmann, HW

    2008-05-01

    Full Text Available shown very little interest in the increasingly severe freight transport problems facing urban areas, there is now growing interest in the logistics of collection and delivery services in towns and city centres....

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

    Directory of Open Access Journals (Sweden)

    Tomola M Obamuyi

    2016-04-01

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

  18. 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…

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

    OpenAIRE

    Rozenveld, Marc; Heinonen, Tapio

    2013-01-01

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

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

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1995-12-31

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

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

    International Nuclear Information System (INIS)

    Anon.

    1995-01-01

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

  2. 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...

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

    Science.gov (United States)

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

    2017-01-01

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

  4. Convergence in France facing Big Data era and Exascale challenges for Climate Sciences

    Science.gov (United States)

    Denvil, Sébastien; Dufresne, Jean-Louis; Salas, David; Meurdesoif, Yann; Valcke, Sophie; Caubel, Arnaud; Foujols, Marie-Alice; Servonnat, Jérôme; Sénési, Stéphane; Derouillat, Julien; Voury, Pascal

    2014-05-01

    The presentation will introduce a french national project : CONVERGENCE that has been funded for four years. This project will tackle big data and computational challenges faced by climate modeling community in HPC context. Model simulations are central to the study of complex mechanisms and feedbacks in the climate system and to provide estimates of future and past climate changes. Recent trends in climate modelling are to add more physical components in the modelled system, increasing the resolution of each individual component and the more systematic use of large suites of simulations to address many scientific questions. Climate simulations may therefore differ in their initial state, parameter values, representation of physical processes, spatial resolution, model complexity, and degree of realism or degree of idealisation. In addition, there is a strong need for evaluating, improving and monitoring the performance of climate models using a large ensemble of diagnostics and better integration of model outputs and observational data. High performance computing is currently reaching the exascale and has the potential to produce this exponential increase of size and numbers of simulations. However, post-processing, analysis, and exploration of the generated data have stalled and there is a strong need for new tools to cope with the growing size and complexity of the underlying simulations and datasets. Exascale simulations require new scalable software tools to generate, manage and mine those simulations ,and data to extract the relevant information and to take the correct decision. The primary purpose of this project is to develop a platform capable of running large ensembles of simulations with a suite of models, to handle the complex and voluminous datasets generated, to facilitate the evaluation and validation of the models and the use of higher resolution models. We propose to gather interdisciplinary skills to design, using a component-based approach, a

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

    Directory of Open Access Journals (Sweden)

    Janusz Mindykowski

    2013-12-01

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

  6. 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.

  7. Challenges Facing Chinese Academic Staff in a UK University in Terms of Language, Relationships and Culture

    Science.gov (United States)

    Hsieh, Hui-hua

    2012-01-01

    The recruitment of international academic staff is viewed as one of the strategies to internationalise the universities. International academic staff, however, usually encounter many challenges when in a foreign context. This study aims to investigate the challenges of Chinese academic staff teaching in the UK in terms of language, relationships…

  8. Strategies to Address English Language Writing Challenges Faced by International Graduate Students in the US

    Science.gov (United States)

    Ravichandran, Swathi; Kretovics, Mark; Kirby, Kara; Ghosh, Ankita

    2017-01-01

    Since 2000, there has been a 72% increase in the number of international students attending US institutions of higher education. The increase, specifically of international graduate students, has brought to light the writing challenges experienced by this population of students. This study explored specific writing challenges experienced by…

  9. Challenges Faced by Second Language Doctoral Student Writers in Hong Kong and Their Writing Strategies

    Science.gov (United States)

    Hyland, Fiona

    2016-01-01

    Writing at the doctoral level presents many challenges for second language writers. This paper reports on a longitudinal study investigating English as a second language (ESL) doctoral students' writing problems and the strategies they developed to meet these challenges. Eight students were interviewed four times over a two-year period during…

  10. An Exploratory Study of Distinguishing Challenges Faced by Mid-Life Teacher Candidates

    Science.gov (United States)

    Tanksley, James F.

    2012-01-01

    The United States public education system is facing a possible shortage of several hundred thousand teachers over the next decade. To overcome the projected shortfall in teacher supply, schools of education of state university and college systems may need to look to the fastest growing segment of the college student population, the non-traditional…

  11. Creating Linkages between Private and Public: Challenges Facing Woman Principals in South Africa

    Science.gov (United States)

    Moorosi, Pontso

    2007-01-01

    In trying to understand some of the gendered discourses that shape the management of schools as organisations in South Africa, I analyse woman principals' experiences as they try to navigate a balance between their home and work responsibilities. After their appointment as principals, some South African women face difficulties in striking the…

  12. 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.

  13. 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.

  14. 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.

  15. 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.

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

    Science.gov (United States)

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

    2016-04-01

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

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

    Science.gov (United States)

    Jung, Mary E; Brawley, Lawrence R

    2011-07-01

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

  18. Regulatory, biosafety and safety challenges for novel cells as substrates for human vaccines.

    Science.gov (United States)

    Hess, Ralf D; Weber, Friedemann; Watson, Keith; Schmitt, Siegfried

    2012-04-05

    In the development of novel substrates used for production of human vaccines there has been significant progress made in recent years. Emerging and re-emerging infectious diseases like the recent porcine Influenza A virus (H1N1) pandemic necessitated the availability of unprecedented amounts of vaccines. In addition, the high demand for vaccines in the industrialised countries has also been paralleled by a steep increase in demand in developing countries. The manufacturing capability for viral vaccines produced in embryonated hen eggs and conventional/classical cell substrates, such as chicken embryo fibroblasts, has now reached its capacity limit. This constraint may be overcome by utilising other recognised cell substrates such as Madin Darby Canine Kidney (MDCK) (dog origin), Chinese Hamster Ovary (CHO) (hamster cells) or Vero cells (monkey origin) or as an alternative, introduce new cell substrates of human or avian origin. Using new cell substrates may prove to be a highly replication-proficient way of producing live viral vaccines such as Influenza A viruses. Despite some advantages, cell substrates may pose a small residual risk to humans since some of them are known to be tumourigenic in immunosuppressed animals. However, this residual risk should be considered acceptable by regulators. Safety testing requirements for cell substrates used in the manufacture of vaccines is mandated by published guidance from organisations such as World Health Organization (WHO), United States Food and Drug Administration (FDA), European Medicines Agency (EMA) and International Conferences on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human use (ICH) as well as requirements laid down in compendial monographs (Ph. Eur. and USP). This paper considers the guidance contained in these regulatory documents. In addition, the safety challenges and almost arbitrary risk-based classification of cell substrates used in the production of human

  19. Antituberculosis Drug-Induced Liver Injury with Autoimmune Features: Facing Diagnostic and Treatment Challenges

    Directory of Open Access Journals (Sweden)

    Maria Adriana Rangel

    2017-01-01

    Full Text Available The authors present a case report of antituberculosis drug-induced liver injury that offered diagnostic challenges (namely, the possibility of drug-induced autoimmune hepatitis and treatment difficulties.

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

    Science.gov (United States)

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

    2018-05-02

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

  1. Challenges facing the food industry: Examples from the baked goods sector

    DEFF Research Database (Denmark)

    Hansen, Zaza Nadja Lee; Jacobsen, Peter

    2013-01-01

    This paper investigates the challenges in the food industry, illustrated by a case study from the baked goods sector in Denmark. The paper proposes key elements this sector needs to address in order to limit waste, improve productivity and increase profitability.......This paper investigates the challenges in the food industry, illustrated by a case study from the baked goods sector in Denmark. The paper proposes key elements this sector needs to address in order to limit waste, improve productivity and increase profitability....

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

    Directory of Open Access Journals (Sweden)

    Clever Taderera

    2017-07-01

    Conclusion: The researchers concluded that the participants in this study experience a range of challenges in parenting their children with learning disabilities. The main challenges emanate from financial instability, as well as lack of knowledge regarding services and programmes for children with learning disabilities. This lack of knowledge on the part of participants could indicate poor policy education by policy implementers at grass-roots level.

  3. Systems approach to waste governance: unpacking the challenges facing local government

    CSIR Research Space (South Africa)

    Godfrey, Linda K

    2008-09-01

    Full Text Available and Tourism (DEAT, 2007) highlighted the obstacles that are faced by local government in achieving service delivery for waste. The three identified obstacles included Financial Capacity; Institutional Capacity; Technical Capacity. 2 Opportunity cost... the systems diagrams show (Figure 2), is that without intervention by national government departments, e.g. National Treasury, Department of Provincial and Local Government, or Department of Environmental Affairs and Tourism, municipalities will be unable...

  4. Defense Weather Satellites: DOD Faces Acquisition Challenges for Addressing Capability Needs

    Science.gov (United States)

    2016-07-07

    and compare the operational effectiveness and life cycle costs of potential solutions. This testimony is based on a report GAO issued in March...Technology, House of Representatives For Release on Delivery Expected at 10 a.m. ET Thursday, July 7, 2016 GAO-16-769T United States...Environment, Committee on Science, Space, and Technology, House of Representatives July 2016 DEFENSE WEATHER SATELLITES DOD Faces Acquisition

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

    OpenAIRE

    Tanja Komarac

    2014-01-01

    Museums are part of a wider cultural and entertainment environment, which is ruled by highly demanding visitors who seek immersive experiences (edutainment) and time-saving arrangement. This has encouraged and, in some opinions, forced museums to turn their focus from collections to visitors. In addition, museums have faced competition and new technologies in the form of virtual museums and virtual reality. This has emphasized the need to accept marketing as a survival tool and to make it int...

  6. Facing up to 'challenging behaviour': a model for training in staff-client interaction.

    Science.gov (United States)

    Farrell, Gerald A; Shafiei, Touran; Salmon, Peter

    2010-07-01

    This paper draws on theory and evidence to develop a conceptual staff training model for the management of 'challenging behaviour'. Staff working with clients who are experienced as challenging commonly report negative feelings such as anxiety, anger, guilt, fear, self-blame and powerlessness, as well as dissatisfaction with their jobs. Current training programmes in challenging behaviour offer a 'smorgasbord' of content, without a clearly defined conceptual framework. Medline and PsychInfo were searched for papers in English from 1998 to 2008, linking 'nurs*' to 'challenging behavio*' and its related terms. Additional hand-searching identified informative papers from disciplines outside nursing older than the search period. We developed an applied model for training educators in respect of challenging behaviours. The model directs educators to consider: the influence of the nurse, including their values, emotional processes and behavioural skills; features of the client; and features of the situation in which the behaviour occurs, including its culture and working practices and physical environment. The most striking implication of the model is that it explicitly recognizes the importance of domains of learning other than skill. This enables educators to find educationally appropriate responses to resource limitations that inevitably constrain training. Challenging behaviour should be considered as a product of several intertwined factors: the actors involved - nurses, clients and others - and the situation in which the behaviour occurs, including its culture and working practices and physical environment.

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

    Directory of Open Access Journals (Sweden)

    Tebogo M. Mothiba

    2016-05-01

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

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

    Science.gov (United States)

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

    2013-12-01

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

  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. 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.

  11. HIV / AIDS is a challenge we have to face -- Colin Hollis.

    Science.gov (United States)

    2000-01-01

    On July 21, 2000, the Asian Forum of Parliamentarians on Population and Development (AFPPD) Malaysia, in cooperation with the UN Population Fund and the UN Development Program (Malaysia), organized the National HIV/AIDS Seminar for Parliamentarians in Kuala Lumpur, Malaysia. During the seminar, Mr. Colin Hollis, secretary general of AFPPD, spoke about the challenge posed by HIV/AIDS on the government. He noted that the epidemic is a part of life and these figures should not only challenge the assumptions of legislators but for them to act as well. He further informed that AFPPD would organize the Asia-Africa Meeting of Parliamentarians and Asia European Dialogue.

  12. How to overcome some of the challenges that African scholars are facing in conducting informetrics research

    Directory of Open Access Journals (Sweden)

    Isola Ajiferuke

    2011-01-01

    Full Text Available This article provides evidence to show that the contributions of African researchers to the informetrics literature are minimal. The three main challenges identified as limiting the contributions of African scholars to the informetrics literature are lack of appropriate skills, inadequate data collection sources, and unaffordable analytical tools. To overcome these challenges, it is suggested that regular pre-conference workshops on informetrics should be organized, an African Citation Index should be developed, and the use of free analytical tools should be encouraged.

  13. The challenges and issues facing the radioactive waste management in Croatia

    International Nuclear Information System (INIS)

    Subasic', D.; Saler, A.

    1994-01-01

    There are substantial experiences in Croatia in the field of radioactive waste management concerning both the waste from nuclear applications and waste generated at nuclear power plant. The essential issue now is how set-up infrastructure and to realize institutional and capacity building to get adjusted to needs of the newly independent state. In connection to this, the issues related to national radioactive waste management strategy, past and new organization of the Regulatory Body, and changes in legislation and regulations are discussed. In addition, some on-going projects important for realization of a complete radioactive waste management in the country round up the present situation in the field of radioactive waste management in Croatia

  14. Solution for Data Security Challenges Faced by Smart Grid Evolution - Video

    Science.gov (United States)

    level, and then we can get into the discussion with Dataguise. The security of data is important at generated. So, all of these non-functional attributes of data security are very important, and all of them Text Version | Energy Systems Integration Facility | NREL Solution for Data Security Challenges

  15. Food challenges facing people living with HIV/AIDS in Zimbabwe ...

    African Journals Online (AJOL)

    The findings of the study indicate that the economic situation in the country coupled with the lack of adequate rainfall has posed challenges to the ability of HIV/AIDS patients to maintain a healthy diet. In addition, there were concerns about the departure of non-government organisations which used to provide them with food ...

  16. Vic: The Challenges Facing Schools in a Small, Newly Diverse, Catalan City

    Science.gov (United States)

    Simo, Nuria; Telford, Jon

    2012-01-01

    The arrival over the last 15 years of a substantial number of pupils of immigrant origin has presented Catalan schools with significant challenges. The schools in Vic (70 km north of Barcelona) have been at the forefront of attempts to adjust to this new multicultural reality. This article describes the results of three studies carried out by the…

  17. Metro Profile: A Familiar Name with an Economy Facing Familiar Challenges

    OpenAIRE

    Fernandez Laris, Georgette A; Gascon, Charles S.

    2015-01-01

    Springfield, Mo., a city with a common name, has an economy with familiar successes and challenges. The health care sector is booming, and the cost of living is somewhat low, as are wages. But labor productivity seems to be subpar, and the poverty rate is above average.

  18. Challenges Faced by Cantonese Speakers in a UK University Mandarin Course

    Science.gov (United States)

    Lo, Lan

    2016-01-01

    After Hong Kong returned to China in 1997, those in the Chinese migrant community in the UK who anticipated returning to China saw the significant benefits of learning Mandarin. The challenges are not only related to the social and cultural differences between the Cantonese and Mandarin migrant groups, but also the intrinsic linguistic differences…

  19. Current Challenges Facing Secondary Education and Transition Services: What Research Tells Us.

    Science.gov (United States)

    Johnson, David R.; Stodden, Robert A.; Emanuel, Ellen J.; Luecking, Richard; Mack, Mary

    2002-01-01

    The transition challenges discussed are to ensure that (1) students have access to the full range of curriculum options and learning experiences; (2) high school graduation decisions are based on meaningful indicators of learning; (3) students have access to postsecondary education, employment, and independent living options; (4) student and…

  20. Challenges Faced by Key Stakeholders Using Educational Online Technologies in Blended Tertiary Environments

    Science.gov (United States)

    Tuapawa, Kimberley

    2016-01-01

    Traditional learning spaces have evolved into dynamic blended tertiary environments (BTEs), providing a modern means through which tertiary education institutes (TEIs) can augment delivery to meet stakeholder needs. Despite the significant demand for web-enabled learning, there are obstacles concerning the use of EOTs, which challenge the…

  1. Teaching in the globalised university - how do we face the challenges of the multicultural classroom?

    DEFF Research Database (Denmark)

    Lauridsen, Karen M.

    Changing demographics, internationalisation of higher education, and migration has resulted in much more diverse student cohorts than it has previously been the case in higher education. While this provides new opportunities, many educators also find that there are new challenges to be met...

  2. The Delicate Balancing Act: Challenges and Successes Facing College Student Women in Formal Leadership Roles

    Science.gov (United States)

    Haber-Curran, Paige

    2013-01-01

    This qualitative study focused on the successes and challenges experienced by four undergraduate college women while holding top leadership roles in student organizations. Interpretive and descriptive qualitative research methods were employed with aspects of case study and phenomenological approaches of inquiry. Data were collected through…

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

    Science.gov (United States)

    Rodrigues, Paulo Henrique de Almeida

    2014-01-01

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

  4. Psychosocial challenges facing women living with HIV during the perinatal period in rural Uganda.

    Directory of Open Access Journals (Sweden)

    Scholastic Ashaba

    Full Text Available The complexities of navigating pregnancy while living with HIV predispose women to additional stress. Finding ways to minimize psychosocial challenges during the perinatal period may maximize the well-being of mothers living with HIV and their children. The goal of this study was to explore psychosocial challenges experienced by women living with HIV (WLWH during pregnancy and the postpartum. We conducted individual in-depth interviews with 20 WLWH recruited from an HIV treatment cohort study in Mbarara, Uganda as part of a larger study exploring perinatal depression. We conducted content analyses to identify themes related to challenges of WLWH during pregnancy and the postpartum. Participants had a median age of 33 years [IQR: 28-35], a median of 3 living children [IQR: 2-5], and 95% had achieved HIV-RNA suppression. Challenges were organized around the following themes: HIV -related stigma from health professionals, HIV status disclosure dilemma, unintended pregnancy and intimate partner violence, HIV and environmental structural barriers and distress and fear related to maternal and child health. Stigma centered on discrimination by health care professionals and personal shame associated with being pregnant as a WLWH. This led to difficulty engaging in HIV care, particularly when coupled with structural barriers, such as lack of transportation to clinic. Participants experienced intimate partner violence and lacked support from their partners and family members. Distress and fear about the health and uncertainty about the future of the unborn baby due to maternal deteriorating physical health was common. The perinatal period is a time of stress for WLWH. Challenges experienced by WLWH may compromise successful engagement in HIV care and may reduce quality of life for women and their children. Strategies aimed at alleviating the challenges of WLWH should involve the larger structural environment including partners, family and community member

  5. Psychosocial challenges facing women living with HIV during the perinatal period in rural Uganda.

    Science.gov (United States)

    Ashaba, Scholastic; Kaida, Angela; Coleman, Jessica N; Burns, Bridget F; Dunkley, Emma; O'Neil, Kasey; Kastner, Jasmine; Sanyu, Naomi; Akatukwasa, Cecilia; Bangsberg, David R; Matthews, Lynn T; Psaros, Christina

    2017-01-01

    The complexities of navigating pregnancy while living with HIV predispose women to additional stress. Finding ways to minimize psychosocial challenges during the perinatal period may maximize the well-being of mothers living with HIV and their children. The goal of this study was to explore psychosocial challenges experienced by women living with HIV (WLWH) during pregnancy and the postpartum. We conducted individual in-depth interviews with 20 WLWH recruited from an HIV treatment cohort study in Mbarara, Uganda as part of a larger study exploring perinatal depression. We conducted content analyses to identify themes related to challenges of WLWH during pregnancy and the postpartum. Participants had a median age of 33 years [IQR: 28-35], a median of 3 living children [IQR: 2-5], and 95% had achieved HIV-RNA suppression. Challenges were organized around the following themes: HIV -related stigma from health professionals, HIV status disclosure dilemma, unintended pregnancy and intimate partner violence, HIV and environmental structural barriers and distress and fear related to maternal and child health. Stigma centered on discrimination by health care professionals and personal shame associated with being pregnant as a WLWH. This led to difficulty engaging in HIV care, particularly when coupled with structural barriers, such as lack of transportation to clinic. Participants experienced intimate partner violence and lacked support from their partners and family members. Distress and fear about the health and uncertainty about the future of the unborn baby due to maternal deteriorating physical health was common. The perinatal period is a time of stress for WLWH. Challenges experienced by WLWH may compromise successful engagement in HIV care and may reduce quality of life for women and their children. Strategies aimed at alleviating the challenges of WLWH should involve the larger structural environment including partners, family and community member as well as policy

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

    Directory of Open Access Journals (Sweden)

    Josefina Quintero Corzo

    2011-07-01

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

  7. Overview of the critical disaster management challenges faced during Van 2011 earthquakes.

    Science.gov (United States)

    Tolon, Mert; Yazgan, Ufuk; Ural, Derin N; Goss, Kay C

    2014-01-01

    On October 23, 2011, a M7.2 earthquake caused damage in a widespread area in the Van province located in eastern Turkey. This strong earthquake was followed by a M5.7 earthquake on November 9, 2011. This sequence of damaging earthquakes led to 644 fatalities. The management during and after these earthquake disaster imposed many critical challenges. In this article, an overview of these challenges is presented based on the observations by the authors in the aftermath of this disaster. This article presents the characteristics of 2011 Van earthquakes. Afterward, the key information related to the four main phases (ie, preparedness, mitigation, response, and recovery) of the disaster in Van is presented. The potential strategies that can be taken to improve the disaster management practice are identified, and a set of recommendations are proposed to improve the existing situation.

  8. Positioning Industrial Design Education within Higher Education: How to face increasingly challenging market forces?

    Directory of Open Access Journals (Sweden)

    André Liem

    2014-05-01

    Full Text Available This paper discusses how Industrial Design Education should be adapted to pressing future challenges of higher education with respect to promoting high quality mentorship and scholarship, as well as being more economically self-sufficient through stronger collaborative engagements with industry. The four (4 following trends will be presented on how prospective design programs are to be developed: (1 Mass-education and rationalisation, (2 Links between education and research, (3 Globalisation and internationalisation, and (4 Collaboration with industry and research commercialisation.Given the challenges of market forces within academia, a consensus within the design education community should be established in order to expose students more to “active learning” and to vice-versa commute from generic to specialist and from abstract to concrete modes of working. Comprehensive and collaborative studio projects should be implemented as platforms, where social, interdisciplinary and inquiry-based learning can be developed in line with selected design themes, processes and methods.

  9. Trade Unions facing the dual challenge of globalising work division and globalising environmental degradation

    OpenAIRE

    Räthzel, N; Uzzell, David

    2011-01-01

    This paper presents results of a project aimed at investigating the ways in which trade unions in the “Global North” and the “Global South” respond to the dual challenge of a globalising work division and globalising environmental degradation, and whether and under what conditions trade unions perceive and address these issues as connected. While globalising corporations are forming new international relations of power, trade unions are lagging behind in unifying their efforts to counter glob...

  10. Issues and Challenges Facing Flexible Lithium-Ion Batteries for Practical Application.

    Science.gov (United States)

    Cha, Hyungyeon; Kim, Junhyeok; Lee, Yoonji; Cho, Jaephil; Park, Minjoon

    2017-12-27

    With the advent of flexible electronics, lithium-ion batteries have become a key component of high performance energy storage systems. Thus, considerable effort is made to keep up with the development of flexible lithium-ion batteries. To date, many researchers have studied newly designed batteries with flexibility, however, there are several significant challenges that need to be overcome, such as degradation of electrodes under external load, poor battery performance, and complicated cell preparation procedures. In addition, an in-depth understanding of the current challenges for flexible batteries is rarely addressed in a systematical and practical way. Herein, recent progress and current issues of flexible lithium-ion batteries in terms of battery materials and cell designs are reviewed. A critical overview of important issues and challenges for the practical application of flexible lithium-ion batteries is also provided. Finally, the strategies are discussed to overcome current limitations of the practical use of flexible lithium-based batteries, providing a direction for future research. © 2017 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  11. Challenges faced by gay, lesbian, bisexual and transgender (glbt students at a South African university

    Directory of Open Access Journals (Sweden)

    Sello Sithole

    2015-12-01

    Full Text Available This article explores the academic and social challenges experienced by students from the gay, lesbian, bisexual and transgender (glbt community on campus at a South African university. A qualitative study to investigate some of these academic and social challenges experienced by glbt students at a university campus was conducted. The population of the study was all students from glbt community on campus and a purposive sample of twelve (12 respondents was constituted and a semi-structured interview guide was designed and administered to all twelve (12 participants. Data were audio recorded and transcribed. Content analysis which is a method used to systematically analyse the meaning of communications was used to analyse data. Of central interest were the core themes that speakers referred to, the information or messages that they wanted to pass on to their audience. The findings suggest that glbt students grapple with issues such as labelling, sexual abuse, discrimination/marginalisation and unfairness in the allocation of resources such as accommodation. In response to these cancerous societal ills, the helping professions exhort practitioners to empower vulnerable populations, promote social justice, support client self-determination and keep abreast of current knowledge relevant to professional practice. This article concludes with a set of recommendations on some of the strategies to address the identified socio-academic challenges.

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

    Science.gov (United States)

    Curtis, Katherine

    2013-07-01

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

  13. 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

  14. 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

  15. 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.

  16. Child Health and Nutrition: Getting better and facing new challenges in China

    Directory of Open Access Journals (Sweden)

    Shougang Wei

    2011-03-01

    Full Text Available BackgroundChild healthcare practices in China over the last 60 yearshave extensively improved children’s health and growth, yetnew challenges lie ahead. This review aims to summarisethe successful experiences and the newly identifiedproblems in child healthcare in China.MethodInformation, available to the public, was obtained fromChinese databases and Chinese Government websites,chiefly the Chinese National Knowledge Infrastructuredatabase, the Chinese Biomedical Literature database, theMinistry of Health website and the National WorkingCommittee on Children and Women website.ResultsDuring its poverty-stricken 1950s–1970s, China protectedchildren’s health mainly through prevention and control ofcommon infectious diseases and severe malnutrition withina comprehensive healthcare system. After the subsequent30 years of rapid socio-economic development, China hasachieved great success in reducing childhood mortality ratesand promoting child growth, meeting the MillenniumDevelopment Goal 4 targets and the WHO child growthstandards. Meanwhile, new challenges for children’shealthcare emerged, including: large disparities in thehealth, growth and nutritional status of children, and in theaccessibility and quality of child healthcare, between urbanand rural areas and across different regions of China; thenutritional and healthcare concerns of the fast-expandingpopulation of migrant children and rural left-behindchildren; the burgeoning epidemic of childhood obesity inurban and economically developed areas; micronutrientdeficiencies such as calcium, iron, zinc and vitamin A; andincreasing prevalence of mental and behavioural disorders.ConclusionUnder poor economic conditions, healthcare plays a keyrole in protecting children against diseases. With thedevelopment of social economy, new challenges present tohealthcare services, specifically, to comprehensivelypromote and optimise childrens’ health and nutrition.

  17. E-LEARNING AND THE GLOBAL DIVIDE: The Challenges Facing Distance Education in Africa

    Directory of Open Access Journals (Sweden)

    Bamidele A. OJO

    2009-07-01

    Full Text Available This paper examines the question of distance education and its pivotal role in promoting social change and development in Africa. It also discussed within the context of the global digital divide and the ongoing need for collaborative effort at global education, the limitation imposed by the socio-economic and political environment on the continent. The paper in its findings conclude that the crisis within African societies constitutes a serious challenge to the implementation of and the effectiveness of distance education in Africa and therefore contributes to the widening of the digital divide rather than reducing it.

  18. The 'PEARL' Data Warehouse: Initial Challenges Faced with Semantic and Syntactic Interoperability.

    Science.gov (United States)

    Mahmoud, Samhar; Boyd, Andy; Curcin, Vasa; Bache, Richard; Ali, Asad; Miles, Simon; Taweel, Adel; Delaney, Brendan; Macleod, John

    2017-01-01

    Data about patients are available from diverse sources, including those routinely collected as individuals interact with service providers, and those provided directly by individuals through surveys. Linking these data can lead to a more complete picture about the individual, to inform either care decision making or research investigations. However, post-linkage, differences in data recording systems and formats present barriers to achieving these aims. This paper describes an approach to combine linked GP records with study observations, and reports initial challenges related to semantic and syntactic interoperability issues.

  19. 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

  20. A Cross-Cultural Perspective on Challenges Facing Comparative Cancer Survivorship Research

    International Nuclear Information System (INIS)

    Syse, A.; Syse, A.; Geller, B.

    2011-01-01

    Cancer survivorship research includes the study of physical, psychosocial, and economic consequences of cancer diagnosis and treatment among pediatric and adult cancer survivors. Historically, the majority of cancer survivorship studies were from the United States, but survivorship issues are increasingly being addressed in other developed countries. Cross-cultural studies remain, however, scarce. The degree to which knowledge attained may or may not be transferred across cultures, countries, or regions is not known. Some important challenges for comparative research are therefore discussed in a cross-cultural perspective. Several substantive and methodological challenges that complicate the execution of cross-cultural cancer survivorship research are presented with examples and discussed to facilitate comparative research efforts in the establishment of new survivorship cohorts and in the planning and implementation of survivorship studies. Comparative research is one key to understanding the nature of cancer survivorship, distinguishing modifiable from non modifiable factors at individual, hospital, societal, and system levels and may thus guide appropriate interventions. Lastly, suggested future courses of action within the field of comparative cancer survivorship research are provided.

  1. CHALLENGES AND OPPORTUNITIES TH E INSURANCE INDU STRY FACING WITH IN RELATION TO CLIMATE CHANGE

    Directory of Open Access Journals (Sweden)

    Fekete Mária FARKASNÉ

    2010-07-01

    Full Text Available Apart from the financial risk the insurance industry are facing with in association with climate change, there are also opportun ities to the sector to develop new markets and provide coverage against weather related risks. This study presents a possible method to examine the potential for introducing a new insurance product, namely an agricultural flood insurance scheme in the United Kingdom. The investigation included the calculation of agricultural flood damage costs, the possible changes in flood risk, the description of farmers’ risk attitude and interests in insurance. In a small scale survey, farmers were asked their experiences related to flooding, farm management practices and thei r willingness to pay for flood insurance using a contingent valuation method. Using statistical analysis it was found the insurance demand is positively correlated with the damage cost predicted and association is likely between farm types and WTP for insurance. Linear regression model suggests that the demand for flood insurance is low amongst farmers in the present risk level. The findi ngs of this research highlight that there is little evidence for the viability of a farmer financed agricultural flood insurance scheme at the moment in the United Kingdom.

  2. Establishing a Conceptual Foundation for Addressing Challenges Facing Food-Energy-Water Management

    Science.gov (United States)

    Goldsby, M.; Padowski, J.; Katz, S.; Brady, M.; Hampton, S. E.

    2017-12-01

    Ensuring the security of food, energy and water in the face of a changing environment is a top societal priority. In order to make sound policy decisions aimed at meeting those needs, policy-makers need decision-relevant information. As such, considerable effort and resources have recently been devoted to investigating the Food-Energy-Water (FEW) Nexus in order to better provide that information. However, despite the increased research activity into FEW systems and FEW problems, little attention has been devoted to the fundamental conceptual issues underlying contemporary FEW systems. Consequently, this inattention has led to conceptual confusion about what is and what is not a FEW system. This project aims to fill that lacuna in order to better facilitate the FEW research agenda. Toward that end, we identify three features that distinguish FEW problems from other resource management problems: (1) the production and management of the resources in each sector of a FEW system is specialized to its own sector; (2) interdependencies exist between sectors such that overproduction in one sector, for example, may have impacts on other sectors; and (3) there are real limits to FEW resource availability as well as limits on the ability to transact across sector boundaries. We contend that once armed with this distinction, one can model the stocks and flows of FEW capital in a conceptually rigorous way that may lead to operational innovations of FEW management.

  3. Economic and Market Challenges Facing the U.S. Nuclear Commercial Fleet

    Energy Technology Data Exchange (ETDEWEB)

    Szilard, Ronaldo [Idaho National Lab. (INL), Idaho Falls, ID (United States); Sharpe, Phil [Idaho National Lab. (INL), Idaho Falls, ID (United States); Kee, Edward [Nuclear Economics Consulting Group, Washington, DC (United States); Davis, Edward [Nuclear Economics Consulting Group, Washington, DC (United States); Grecheck, Eugene [Grecheck Consulting LLC, Midlothian, VA (United States)

    2016-09-01

    This report identifies underlying economic and electricity market factors that have led to early retirements of U.S. operating nuclear power plants, assesses the Gap between operating revenues and operating costs for selected nuclear power plants, and discusses a range of actions that might be taken to stop early retirement of operating nuclear power plants. The Kewaunee and Vermont Yankee nuclear power plants were retired early for economic and financial reasons. Early retirement has been announced or proposed for Clinton and Quad Cities in Illinois, Fitzpatrick and Ginna in New York, Fort Calhoun in Nebraska. Other nuclear power plants, including Palisades, Davis-Besse, Prairie Island, and Three Mile Island Unit 1, have been identified as facing financial stress that might lead to early retirement. The early retirement of operating nuclear power plants will mean the loss of a large amount of zero-emission electricity, inconsistent with the goal of reducing carbon emissions in the electricity sector. This report provides a high-level view of the major factors driving early retirement: • The U.S. market and private ownership approach to the electricity sector; • Low electricity market prices resulting from low natural gas prices, low demand growth, increased penetration of renewable generation, and negative electricity market prices; and • No compensation to nuclear power plants for public benefits including zero-emission electricity.

  4. Challenges facing community health workers in Brazil's Family Health Strategy: A qualitative study.

    Science.gov (United States)

    Grossman-Kahn, Rebecca; Schoen, Julia; Mallett, John William; Brentani, Alexandra; Kaselitz, Elizabeth; Heisler, Michele

    2017-09-21

    Community health worker (CHW) programs are implemented in many low- and middle-income countries such as Brazil to increase access to and quality of care for underserved populations; CHW programs have been found to improve certain indicators of health, but few studies have investigated the daily work of CHWs, their perspectives on what both helps and hinders them from fulfilling their roles, and ways that their effectiveness and job satisfaction could be increased. To examine these questions, we observed clinic visits, CHW home visits, and conducted semistructured interviews with CHWs in 7 primary care centers in Brazil-2 in Salvador, Bahia, and 5 in São Paulo, SP-in which CHWs are incorporated into the work of all primary care health teams. In addition to enhancing communication between the medical system and the community, CHWs consider their key roles to be helping persuade community members to seek medical care and increasing health professionals' awareness of the social conditions affecting their patients' health. Key obstacles that CHWs face include failure to be fully integrated into the primary care team, inability to follow-up on identified health needs due to limited resources, as well as community members' lack of understanding of their work and undervaluing of preventative medicine. Increased training, better incorporation of CHWs into clinic flow and decision making, and establishing a clear community awareness of the roles and value of CHWs will help increase the motivation and effectiveness of CHWs in Brazil. Copyright © 2017 John Wiley & Sons, Ltd.

  5. Economic and Market Challenges Facing the U.S. Nuclear Commercial Fleet

    International Nuclear Information System (INIS)

    Szilard, Ronaldo; Sharpe, Phil; Kee, Edward; Davis, Edward; Grecheck, Eugene

    2016-01-01

    This report identifies underlying economic and electricity market factors that have led to early retirements of U.S. operating nuclear power plants, assesses the Gap between operating revenues and operating costs for selected nuclear power plants, and discusses a range of actions that might be taken to stop early retirement of operating nuclear power plants. The Kewaunee and Vermont Yankee nuclear power plants were retired early for economic and financial reasons. Early retirement has been announced or proposed for Clinton and Quad Cities in Illinois, Fitzpatrick and Ginna in New York, Fort Calhoun in Nebraska. Other nuclear power plants, including Palisades, Davis-Besse, Prairie Island, and Three Mile Island Unit 1, have been identified as facing financial stress that might lead to early retirement. The early retirement of operating nuclear power plants will mean the loss of a large amount of zero-emission electricity, inconsistent with the goal of reducing carbon emissions in the electricity sector. This report provides a high-level view of the major factors driving early retirement: • The U.S. market and private ownership approach to the electricity sector; • Low electricity market prices resulting from low natural gas prices, low demand growth, increased penetration of renewable generation, and negative electricity market prices; and • No compensation to nuclear power plants for public benefits including zero-emission electricity.

  6. Cyber crime: can a standard risk analysis help in the challenges facing business continuity managers?

    Science.gov (United States)

    Vande Putte, Danny; Verhelst, Marc

    Risk management has never been easy. Finding efficient mitigating measures is not always straightforward. Finding measures for cyber crime, however, is a really huge challenge because cyber threats are changing all the time. As the sophistication of these threats is growing, their impact increases. Moreover, society and its economy have become increasingly dependent on information and communication technologies. Standard risk analysis methodologies will help to score the cyber risk and to place it in the risk tolerance matrix. This will allow business continuity managers to figure out if there is still a gap with the maximum tolerable outage for time-critical business processes and if extra business continuity measures are necessary to fill the gap.

  7. Facing the challenges of distribution systems operation with high wind power penetration

    DEFF Research Database (Denmark)

    Das, Kaushik; Altin, Müfit; Hansen, Anca Daniela

    2017-01-01

    power flow in 60kV distribution networks through controlling the ability of wind power plants (WPPs) to generate or absorb reactive power. This paper aims to understand the characteristics of a distribution network with high penetration of distributed generation. A detailed analysis of the active...... and reactive power flows in a real distribution network under different wind and load conditions based on actual measurements is performed in order to understand the correlation between the consumption, wind power production, and the network losses. Conclusive remarks are presented, briefly expressing......This paper addresses the challenges associated with the operation of a distribution system with high penetration of wind power. The paper presents some preliminary investigations of an ongoing Danish research work, which has as main objective to reduce the network losses by optimizing the reactive...

  8. Challenges, uncertainties and issues facing gas production from gas hydrate deposits

    Energy Technology Data Exchange (ETDEWEB)

    Moridis, G.J.; Collett, T.S.; Pooladi-Darvish, M.; Hancock, S.; Santamarina, C.; Boswell, R.; Kneafsey, T.; Rutqvist, J.; Kowalsky, M.; Reagan, M.T.; Sloan, E.D.; Sum, A.K.; Koh, C.

    2010-11-01

    The current paper complements the Moridis et al. (2009) review of the status of the effort toward commercial gas production from hydrates. We aim to describe the concept of the gas hydrate petroleum system, to discuss advances, requirement and suggested practices in gas hydrate (GH) prospecting and GH deposit characterization, and to review the associated technical, economic and environmental challenges and uncertainties, including: the accurate assessment of producible fractions of the GH resource, the development of methodologies for identifying suitable production targets, the sampling of hydrate-bearing sediments and sample analysis, the analysis and interpretation of geophysical surveys of GH reservoirs, well testing methods and interpretation of the results, geomechanical and reservoir/well stability concerns, well design, operation and installation, field operations and extending production beyond sand-dominated GH reservoirs, monitoring production and geomechanical stability, laboratory investigations, fundamental knowledge of hydrate behavior, the economics of commercial gas production from hydrates, and the associated environmental concerns.

  9. Social question and social work: contemporary challenges facing the profession in Brazil

    Directory of Open Access Journals (Sweden)

    Rodrigo José Teixeira

    2017-12-01

    Full Text Available This article offers an analysis of the intrinsic relationship between the social question and Social Work. The analysis of the social question starts from the meticulous and rigorous reading of the labor theory of value and the Critique of Political Economy written by Karl Marx. It is from this analysis that we try to justify the genesis of the profession linked to the role of the state and the bourgeoisie in the consolidation of monopoly capitalism. It starts from the analysis of Social Work as a profession inserted in the social and technical division of labor that by its own action, in the contradictory movement of the capitalist reality, defends the interests of capital and labor. In addition, the article presents, in a succinct way, the trajectory of Social Work in Brazil and its ethical and political project in relation to the working class challenges to guarantee this direction in times of dismantling social policies and financial capitalism. 

  10. Perception Challenges Faced by Al-Qaeda on the Battlefield of Influence Warfare

    Directory of Open Access Journals (Sweden)

    James J.F. Forest

    2012-03-01

    Full Text Available Many kinds of entities—including terrorists and insurgents—seek to influence perceptions and behavior among various target audiences, and have become increasingly reliant on the Internet in their efforts, incorporating social media, blogging, public video sharing and other online tools. This article is focused on the ideological messages that terrorist groups use to convey with these tools. Drawing from a study of Al-Qaeda, this discussion illustrates how ideologies of violence have certain vulnerabilities that can be exploited in order to degrade a terrorist group’s ability to achieve its objectives. While crafting and disseminating counter-narratives can be a critical part of a counterterrorism strategy, it is also important to identify ways in which terrorists undermine their own central narratives and exacerbate pre-existing “influence warfare” challenges

  11. The Office of Site Closure: Progress in the Face of Challenges

    International Nuclear Information System (INIS)

    Fiore, J. J.; Murphie, W. E.; Meador, S. W.

    2002-01-01

    The Office of Site Closure (OSC) was formed in November 1999 when the Department of Energy's (DOE's) Office of Environmental Management (EM) reorganized to focus specifically on site cleanup and closure. OSC's objective is to achieve safe and cost-effective cleanups and closures that are protective of our workers, the public, and the environment, now and in the future. Since its inception, OSC has focused on implementing a culture of safe closure, with emphasis in three primary areas: complete our responsibility for the Closure Sites Rocky Flats, Mound, Fernald, Ashtabula, and Weldon Spring; complete our responsibility for cleanup at sites where the DOE mission has been completed (examples include Battelle King Avenue and Battelle West Jefferson in Columbus, and General Atomics) or where other Departmental organizations have an ongoing mission (examples include the Brookhaven, Livermore, or Los Alamos National Laboratories, and the Nevada Test Site); and create a framework a nd develop specific business closure tools that will help sites close, such as guidance for and decisions on post-contract benefit liabilities, records retention, and Federal employee incentives for site closure. This paper discusses OSC's 2001 progress in achieving site cleanups, moving towards site closure, and developing specific business closure tools to support site closure. It describes the tools used to achieve progress towards cleanup and closure, such as the application of new technologies, changes in contracting approaches, and the development of agreements between sites and with host states. The paper also identifies upcoming challenges and explores options for how Headquarters and the sites can work together to address these challenges. Finally, it articulates OSC's new focus on oversight of Field Offices to ensure they have the systems in place to oversee contractor activities resulting in site cleanups and closures

  12. Radiation doses in pediatric computed tomography procedures: challenges facing new technologies

    International Nuclear Information System (INIS)

    Cotelo, E.; Padilla, M.; Dibarboure, L.

    2008-01-01

    Despite the fact that in recent years an increasing number of radiologists and radiological technologists have been applying radiation dose optimization techniques in paediatric Computed Tomography (CT) examinations, dual and multi -slice CT (MSCT) scanners present a new challenge in Radiation Protection (RP). While on one hand these scanners are provided with Automatic Exposure Control (AEC) devices, dose reduction modes and dose estimation software, on the other hand Quality Control (QC) tests and CT Kerma Index (C) measurements and patient dose estimation present specific difficulties and require changes or adaptations of traditional QC protocols. This implies a major challenge in most developing countries where Quality Assurance Programmes (QAP) have not been implemented yet and there is a shortage in the number of medical physicists This paper analyses clinical and technical protocols as well as patient doses in 204 CT body procedures performed in 154 children. The investigation was carried out in a paediatric reference hospital of Uruguay, where are performed an average of 450 paediatric CT examinations per month in a sole CT dual scanner. Besides, C VOL reported from the scanner display was registered in order to be related with the same dosimetric quantity derived from technical parameters and C values published on tables. Results showed that not all the radiologists applied the same protocol in similar clinical situations delivering unnecessary patient dose with no significant differences in image quality. Moreover, it was found that dose reduction modes represent a drawback in order to estimate patient dose when mA changes according to tissue attenuation, in most cases in each rotation. The study concluded on the importance of QAP that must include education on RP of radiologists and technologists, as well as in the need of medical physicists to perform QC tests and patient dose estimations and measurements. (author)

  13. 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

  14. 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.

  15. 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.

  16. Stereotype Threat: A Qualitative Study of the Challenges Facing Female Undergraduate Engineering Students

    Science.gov (United States)

    Entsminger, J. R., II

    From a sociocultural point of view, this qualitative case study explored how upper-level, female undergraduate engineering students perceived the possibility of or experience with stereotype threat as shaping their experiences. The study also investigated how these students explained their reasons for choosing their engineering major, the challenges they encountered in the major, and their reasons for persevering in spite of those challenges. Using Steele and Aronson's (1995) stereotype threat theory as a framework, and considering the documented underrepresentation of females in engineering, the study sought to examine how stereotype threat shaped the experiences of these students and if stereotype threat could be considered a valid reason for the underrepresentation. The study was conducted at a large, four-year public university. First, students in the College of Engineering and Engineering Technology completed the Participant Screening Survey. Based on responses from the survey, six female engineering students from the college were identified and invited to participate in the study. The participants came from the following majors: Electrical Engineering, Industrial and Systems Engineering, and Mechanical Engineering. After receiving the study consent letter and agreeing to participate, the students were involved in a 90-minute focus group meeting, a 45-minute one-on-one interview, and a 30-minute follow-up interview. After conducting the data collection methods, the data were then transcribed, analyzed, and coded for theme development. The themes that emerged coincided with each research question. The themes highlighted the complex interactions and experiences shared by the female engineering majors. The female students were enveloped in an environment where there existed an increased risk for activating stereotype threat. In addition, the female students described feeling pushed to prove to themselves and to others that the negative stereotype that 'females

  17. Facing tomorrow's challenges: U.S. Geological Survey science in the decade 2007-2017

    Science.gov (United States)

    ,

    2007-01-01

    In order for the U.S. Geological Survey (USGS) to respond to evolving national and global priorities, it must periodically reflect on, and optimize, its strategic directions. This report is the first comprehensive science strategy since the early 1990s to examine critically major USGS science goals and priorities. The development of this science strategy comes at a time of global trends and rapidly evolving societal needs that pose important natural-science challenges. The emergence of a global economy affects the demand for all resources. The last decade has witnessed the emergence of a new model for managing Federal lands-ecosystem-based management. The U.S. Climate Change Science Program predicts that the next few decades will see rapid changes in the Nation's and the Earth's environment. Finally, the natural environment continues to pose risks to society in the form of volcanoes, earthquakes, wildland fires, floods, droughts, invasive species, variable and changing climate, and natural and anthropogenic toxins, as well as animal-borne diseases that affect humans. The use of, and competition for, natural resources on the global scale, and natural threats to those resources, has the potential to impact the Nation's ability to sustain its economy, national security, quality of life, and natural environment. Responding to these national priorities and global trends requires a science strategy that not only builds on existing USGS strengths and partnerships but also demands the innovation made possible by integrating the full breadth and depth of USGS capabilities. The USGS chooses to go forward in the science directions proposed here because the societal issues addressed by these science directions represent major challenges for the Nation's future and for the stewards of Federal lands, both onshore and offshore. The six science directions proposed in this science strategy are listed as follows. The ecosystems strategy is listed first because it has a dual nature

  18. Northern Eurasia Future Initiative: Facing the Challenges of Global Change in the 21st century

    Science.gov (United States)

    Groisman, Pavel; Gutman, Garik; Gulev, Sergey; Maksyutov, Shamil; Qi, Jiaguo

    2016-04-01

    foci emerged in discussions within the NEESPI community during the past 20 months. Presentation will provide justification of these foci and approach examples addressing them. The societal challenges, particularly the socio-economic challenges are the top priority in most of them. Throughout the NEESP Initiative duration, support for it studies has been provided by different national and international Agencies of the United States (in particular, the NASA Land Cover and Land Use Change Program), the Russian Federation (in particular, the Ministry of Education and Science, e.g., mega-grant 14.B25.31.0026), European Union, Japan, and China. After the NEFI White Paper release, we anticipate a similar kind of support for this new Initiative.

  19. Challenges Facing the Sacramento–San Joaquin Delta: Complex, Chaotic, or Simply Cantankerous?

    Directory of Open Access Journals (Sweden)

    Samuel N. Luoma

    2015-09-01

    Full Text Available doi: http://dx.doi.org/10.15447/sfews.2015v13iss3art7Freshwater is a scarce and precious resource in California; its overall value is being made clear by the current severe drought. The Sacramento–San Joaquin Delta is a critical node in a complex water supply system that extends throughout much of the western U.S. wherein demand is exceeding supply. The Delta also underpins a major component of the U.S. economy, helps feed a substantial part of the country, is a unique and valuable ecological resource, and is a place with a rich cultural heritage. Sustaining the Delta is a problem that manifests itself in many dimensions including the physical structure of the Delta, the conflicting demands for water, changing water quality, rapidly evolving ecological character, and high institutional complexity. The problems of the California Delta are increasingly complex, sometimes chaotic, and always contentious. There is general agreement that current management will sustain neither the Delta ecosystem nor high-quality water exports, as required under the Delta Reform Act, so there is a renewed urgency to address all dimensions of the problem aggressively. Sustainable management of the Delta ecosystem and California’s highly variable water supply, in the face of global climate change, will require bold political decisions that include adjustments to the infrastructure but give equal emphasis to chronic overuse and misuse of water, promote enhanced efficiency of water use, and facilitate new initiatives for ecosystem recovery. This new approach will need to be underpinned by collaborative science that supports ongoing evaluation and re-adjustment of actions. Problems like the Delta are formally “wicked" problems that cannot be “solved” in the traditional sense, but they can be managed with appropriate knowledge and flexible institutions. Where possible, it is advisable to approach major actions incrementally, with an eye toward avoiding

  20. Challenges faced by health workers in implementing the prevention of mother-to-child HIV transmission (PMTCT) programme in Uganda.

    Science.gov (United States)

    Nuwagaba-Biribonwoha, H; Mayon-White, R T; Okong, P; Carpenter, L M

    2007-09-01

    To report the experience of health workers who had played key roles in the early stages of implementing the prevention of mother-to-child HIV transmission services (PMTCT) in Uganda. Interviews were conducted with 15 key informants including counsellors, obstetricians and PMTCT coordinators at the five PMTCT test sites in Uganda to investigate the benefits, challenges and sustainability of the PMTCT programme. Audio-taped interviews were held with each informant between January and June 2003. These were transcribed verbatim and manually analysed using the framework approach. The perceived benefits reported by informants were improvement of general obstetric care, provision of antiretroviral prophylaxis for HIV-positive mothers, staff training and community awareness. The main challenges lay in the reluctance of women to be tested for HIV, incomplete follow-up of participants, non-disclosure of HIV status and difficulties with infant feeding for HIV-positive mothers. Key informants thought that the programme's sustainability depended on maintaining staff morale and numbers, on improving services and providing more resources, particularly antiretroviral therapy for the HIV-positive women and their families. Uganda's experience in piloting the PMTCT programme reflected the many challenges faced by health workers. Potentially resource-sparing strategies such as the 'opt-out' approach to HIV testing required further evaluation.

  1. An opportunity and an imperative: Chapter 11 in United States-Mexican Borderlands: Facing tomorrow's challenges through USGS science

    Science.gov (United States)

    Updike, Randall G.; Page, William R.

    2013-01-01

    Along the nearly 3,200 kilometers (almost 2,000 miles) of the United States–Mexican border, we are witnessing the expression of the challenges of the 21st century. The Borderlands have become a microcosm for the entire United States and Mexico; the issues faced in that region are felt throughout both nations—water availability and quality, ecosystem health, natural resource needs, safety from natural hazards, and human socioeconomic well-being. If these issues were not challenging enough, we now recognize that the difficulties of addressing them are exacerbated by the onset of climate change, and as we come to better understand the complexities of the components of these challenge themes, we discover that each part is inextricably intertwined with other overarching issues. Further, because we are a creative and progressive society, we all seek to understand and appreciate the natural environments associated with the Borderlands while at the same time benefitting from the region’s many social and economic values. It is little wonder that we as a society find it increasingly difficult to ask the right questions, much less find suitable answers to the questions we do ask. For the many scientists who have worked in the Borderlands and contributed to the preceding chapters, this circular is a way to describe to the two nations of the region the capabilities the U.S. Geological Survey can provide to assist in that quest for knowledge and understanding in preparation for the future.

  2. Challenges faced by China compared with the US in developing wind power

    Science.gov (United States)

    Lu, Xi; McElroy, Michael B.; Peng, Wei; Liu, Shiyang; Nielsen, Chris P.; Wang, Haikun

    2016-06-01

    In the 21st Conference of the Parties held in Paris in December 2015, China pledged to peak its carbon emissions and increase non-fossil energy to 20% by 2030 or earlier. Expanding renewable capacity, especially wind power, is a central strategy to achieve these climate goals. Despite greater capacity for wind installation in China compared to the US (145.1 versus 75.0 GW), less wind electricity is generated in China (186.3 versus 190.9 TWh). Here, we quantify the relative importance of the key factors accounting for the unsatisfactory performance of Chinese wind farms. Different from the results in earlier qualitative studies, we find that the difference in wind resources explains only a small fraction of the present China-US difference in wind power output (-17.9% in 2012); the curtailment of wind power, differences in turbine quality, and delayed connection to the grid are identified as the three primary factors (respectively -49.3%, -50.2%, and -50.3% in 2012). Improvements in both technology choices and the policy environment are critical in addressing these challenges.

  3. Ethics Guidelines in Environmental Epidemiology: Their Development and Challenges We Face.

    Science.gov (United States)

    Kramer, Shira; Soskolne, Colin L

    2017-06-01

    This review integrates historical developments and key events in bringing ethics into epidemiology in general and into environmental epidemiology in particular. The goal is to provide context for and discern among the various approaches and motivations that drive the need for ethical conduct in support of the public interest. The need for ethics guidelines in epidemiology is different from developments in other biomedical-related fields by virtue of its focus on populations rather than on individuals. The need for ethics guidelines in environmental epidemiology as a subspecialty of epidemiology stems from the larger scale of its mission than that of epidemiology per se. Ethics guidelines in the field of environmental epidemiology have been established. They articulate not only the profession's core values and mission, but more specifically, they address the environmental epidemiologist's obligations to the participants in research, to colleagues, and to employers. They are the product of consensus, scholarship, and diligent stewardship over several decades. The next challenge is ensuring their value and impact. The forces that support professional and institutional success, and the power of special interests, are the major threats to achieving the goals of ethical conduct and research for the public good. In environmental epidemiology, these threats have global implications.

  4. Challenges, uncertainties, and issues facing gas production from gas-hydrate deposits

    Science.gov (United States)

    Moridis, G.J.; Collett, T.S.; Pooladi-Darvish, M.; Hancock, S.; Santamarina, C.; Boswel, R.; Kneafsey, T.; Rutqvist, J.; Kowalsky, M.B.; Reagan, M.T.; Sloan, E.D.; Sum, A.K.; Koh, C.A.

    2011-01-01

    The current paper complements the Moridis et al. (2009) review of the status of the effort toward commercial gas production from hydrates. We aim to describe the concept of the gas-hydrate (GH) petroleum system; to discuss advances, requirements, and suggested practices in GH prospecting and GH deposit characterization; and to review the associated technical, economic, and environmental challenges and uncertainties, which include the following: accurate assessment of producible fractions of the GH resource; development of methods for identifying suitable production targets; sampling of hydrate-bearing sediments (HBS) and sample analysis; analysis and interpretation of geophysical surveys of GH reservoirs; well-testing methods; interpretation of well-testing results; geomechanical and reservoir/well stability concerns; well design, operation, and installation; field operations and extending production beyond sand-dominated GH reservoirs; monitoring production and geomechanical stability; laboratory investigations; fundamental knowledge of hydrate behavior; the economics of commercial gas production from hydrates; and associated environmental concerns. ?? 2011 Society of Petroleum Engineers.

  5. The Challenges Facing the Multilateral Trading System in Addressing Global Public Policy Objectives

    Directory of Open Access Journals (Sweden)

    Christophe Bellmann

    2013-02-01

    Full Text Available Despite a record-breaking 14.5 per cent increase in world merchandise exports, the effects of the financial crisis and global recession are still hampering faster economic recovery. Relatively high oil prices combined with persistent unemployment and measures designed to reduce budget deficits have undermined short-term growth prospects. While South–South trade continues to explode, trade imbalances – i.e. the gap between exports and imports – widened in 2010 compared to 2009 (though smaller than pre-crisis levels. Meanwhile, trade negotiations under the Doha Round have reached an impasse, generating uncertainties about the future of the World Trade Organization (WTO as a negotiating forum. Under these circumstances, should the system rethink its decision-making process founded upon the predominance of member states, the principle of consensus and the notion of single undertaking, as some critics have suggested? And, if so, how could such a reform agenda be initiated at the WTO? Moreover, beyond the negotiating function of the WTO, the paralysis of the system also raises urgent questions about the ability of the system to respond to pressing challenges of our times, such as trade and climate change, or food security and price volatility.

  6. Potential challenges facing distributed leadership in health care: evidence from the UK National Health Service.

    Science.gov (United States)

    Martin, Graeme; Beech, Nic; MacIntosh, Robert; Bushfield, Stacey

    2015-01-01

    The discourse of leaderism in health care has been a subject of much academic and practical debate. Recently, distributed leadership (DL) has been adopted as a key strand of policy in the UK National Health Service (NHS). However, there is some confusion over the meaning of DL and uncertainty over its application to clinical and non-clinical staff. This article examines the potential for DL in the NHS by drawing on qualitative data from three co-located health-care organisations that embraced DL as part of their organisational strategy. Recent theorising positions DL as a hybrid model combining focused and dispersed leadership; however, our data raise important challenges for policymakers and senior managers who are implementing such a leadership policy. We show that there are three distinct forms of disconnect and that these pose a significant problem for DL. However, we argue that instead of these disconnects posing a significant problem for the discourse of leaderism, they enable a fantasy of leadership that draws on and supports the discourse. © 2014 The Authors. Sociology of Health & Illness © 2014 Foundation for the Sociology of Health & Illness/John Wiley & Sons Ltd.

  7. Ecosystem-based management of coastal zones in face of climate change impacts: Challenges and inequalities.

    Science.gov (United States)

    Fernandino, Gerson; Elliff, Carla I; Silva, Iracema R

    2018-06-01

    Climate change effects have the potential of affecting both ocean and atmospheric processes. These changes pose serious threats to the millions of people that live by the coast. Thus, the objective of the present review is to discuss how climate change is altering (and will continue to alter) atmospheric and oceanic processes, what are the main implications of these alterations along the coastline, and which are the ecosystem-based management (EBM) strategies that have been proposed and applied to address these issues. While ocean warming, ocean acidification and increasing sea level have been more extensively studied, investigations on the effects of climate change to wind and wave climates are less frequent. Coastal ecosystems and their respective natural resources will respond differently according to location, environmental drivers and coastal processes. EBM strategies have mostly concentrated on improving ecosystem services, which can be used to assist in mitigating climate change effects. The main challenge for developing nations regards gaps in information and scarcity of resources. Thus, for effective management and adaptive EBM strategies to be developed worldwide, information at a local level is greatly needed. Copyright © 2018 Elsevier Ltd. All rights reserved.

  8. Challenge theme 2: assuring water availability and quality in the 21st century: Chapter 4 in United States-Mexican Borderlands: Facing tomorrow's challenges through USGS science

    Science.gov (United States)

    Callegary, James; Langeman, Jeff; Leenhouts, Jim; Martin, Peter

    2013-01-01

    Along the United States–Mexican border, the health of communities, economies, and ecosystems is inextricably intertwined with the availability and quality of water, but effective water management in the Borderlands is complicated. Water users compete for resources, and their needs are increasing. Managers are faced with issues such as finding a balance between agriculture and rapidly growing cities or maintaining public supplies while ensuring sufficient resources for aquatic ecosystems. In addition to human factors, the dry climate of the Borderlands, as compared to more temperate regions, also increases the challenge of balancing water supplies between humans and ecosystems. Warmer, drier, and more variable conditions across the southwestern United States—the projected results of climate change (Seager and others, 2007)—would further stress water supplies.

  9. Investigating Challenges Facing Self-Management Empowerment Education in Adolescents and Youths with Major Thalassemia

    Directory of Open Access Journals (Sweden)

    Razzazan

    2014-10-01

    Full Text Available Background Thalassemia is considered an important public health problem worldwide, especially in developing and poor countries. Although several advanced techniques have been developed for prevention of thalassemia in the recent years, many adolescents and youths are still living with this disease. Independence from parents, decisions about high-risk behaviors, uncovering the identity, and adapting to mental and physical effects of the disease occur together in adolescents. Objectives This study was conducted to explore challenges of self-management empowerment in adolescents and youths with major thalassemia. Materials and Methods This was a descriptive-exploratory study. The study population consisted of adolescents and youths with major thalassemia who had medical records in the Bushehr Thalassemia Center, affiliated with Bushehr University of Medical Sciences. The study samples were purposively selected. Demographic information questionnaire and empowerment questionnaire were used to collect data from the semistructured interview. We analyzed qualitative data by content analysis method and quantitative data by descriptive (mean, standard deviation and analytical (Student's t-test, ANOVA and Pearson’s correlation coefficient statistical methods, using the statistical software SPSS 18. Results In qualitative part of the study, data from semistructured in-depth interviews with 15 participants were coded and summarized in five themes including: 1 awareness of personal changes; 2 need for adaptation; 3 maintaining independence and self-management; 4 uncovering the identity and role playing; and 5 sense of control and satisfaction. Results of the quantitative part showed that the overall score of participants on empowerment was 92.46 of 149 scores, which showed a moderate situation in the empowerment of these individuals. In addition, the empowerment score showed no statistically significant correlation with demographic characteristics

  10. 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.

  11. Challenges for Ecosystem Services Provided by Coral Reefs In the Face of Climate Change

    Science.gov (United States)

    Kikuchi, R. K.; Elliff, C. I.

    2014-12-01

    to increase resilience and guarantee the adaptation of this ecosystem to climate change. Thus, considering that the majority of the marine ecosystem services we benefit from are provided from coastal habitats, of which coral reefs play an important role, the challenge at hand is in fact the interaction between local factors and climate change

  12. Professional development for teachers of students who are deaf or hard of hearing: facing the assessment challenge.

    Science.gov (United States)

    Cawthon, Stephanie

    2009-01-01

    Teachers of students with low-incidence disabilities, such as students who are deaf or hard of hearing, face unique challenges in putting education policy into practice. The present article presents professional development findings from the Third Annual National Survey of Accommodations and Assessment for Students Who Are Deaf or Hard of Hearing (Cawthon, Hersh, Kim, & Online Research Lab, in press). A total of 391 participants described professional development they had experienced related to assessment of students who are deaf or hard of hearing. Teachers reported greater exposure to topics in school/district sessions and discussion with their colleagues than in their preparation programs. Teaching at a school for the deaf or teaching students in high school were significant predictors of an increased prevalence of professional development opportunities on assessment-related topics for students who are deaf or hard of hearing.

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

    Science.gov (United States)

    Alidmat, Ali Odeh Hammoud; Ayassrah, Mohamed Ayed

    2017-01-01

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

  14. Understanding the menstrual hygiene management challenges facing displaced girls and women: findings from qualitative assessments in Myanmar and Lebanon.

    Science.gov (United States)

    Schmitt, Margaret L; Clatworthy, David; Ratnayake, Ruwan; Klaesener-Metzner, Nicole; Roesch, Elizabeth; Wheeler, Erin; Sommer, Marni

    2017-01-01

    There is a significant gap in empirical evidence on the menstrual hygiene management (MHM) challenges faced by adolescent girls and women in emergency contexts, and on appropriate humanitarian response approaches to meet their needs in diverse emergency contexts. To begin filling the gap in the evidence, we conducted a study in two diverse contexts (Myanmar and Lebanon), exploring the MHM barriers facing girls and women, and the various relevant sectoral responses being conducted (e.g. water, sanitation and hygiene (WASH), Protection, Health, Education and Camp Management). Two qualitative assessments were conducted: one in camps for internally displaced populations in Myanmar, and one with refugees living in informal settlements and host communities in Lebanon. Key informant interviews were conducted with emergency response staff in both sites, and focus group discussion and participatory mapping activities conducted with adolescent girls and women. Key findings included that there was insufficient access to safe and private facilities for MHM coupled with displacement induced shifts in menstrual practices by girls and women. Among staff, there was a narrow interpretation of what an MHM response includes, with a focus on supplies; significant interest in understanding what an improved MHM response would include and acknowledgement of limited existing MHM guidance across various sectors; and insufficient consultation with beneficiaries, related to discomfort asking about menstruation, and limited coordination between sectors. There is a significant need for improved guidance across all relevant sectors for improving MHM response in emergency context, along with increased evidence on effective approaches for integrating MHM into existing responses.

  15. "Members of the same club": challenges and decisions faced by US IRBs in identifying and managing conflicts of interest.

    Science.gov (United States)

    Klitzman, Robert

    2011-01-01

    Conflicts of interest (COIs) in research have received increasing attention, but many questions arise about how Institutional Review Boards (IRBs) view and approach these. I conducted in-depth interviews of 2 hours each with 46 US IRB chairs, administrators, and members, exploring COI and other issues related to research integrity. I contacted leaders of 60 IRBs (every fourth one among the top 240 institutions by NIH funding), and interviewed IRB leaders from 34 of these institutions (response rate = 55%). Data were analyzed using standard qualitative methods, informed by Grounded Theory. IRBs confront financial and non-financial COIs of PIs, institutions, and IRBs themselves. IRB members may seek to help, or compete with, principal investigators (PIs). Non-financial COI also often appear to be "indirect financial" conflicts based on gain (or loss) not to oneself, but to one's colleagues or larger institution. IRBs faced challenges identifying and managing these COI, and often felt that they could be more effective. IRBs' management of their own potential COI vary, and conflicted members may observe, participate, and/or vote in discussions. Individual IRB members frequently judge for themselves whether to recuse themselves. Challenges arise in addressing these issues, since institutions and PIs need funding, financial information is considered confidential, and COI can be unconscious. This study, the first to explore qualitatively how IRBs confront COIs and probe how IRBs confront non-financial COIs, suggests that IRBs face several types of financial and non-financial COIs, involving themselves, PIs, and institutions, and respond varyingly. These data have critical implications for practice and policy. Disclosure of indirect and non-financial COIs to subjects may not be feasible, partly since IRBs, not PIs, are conflicted. Needs exist to consider guidelines and clarifications concerning when and how, in protocol reviews, IRB members should recuse themselves

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

    Science.gov (United States)

    Wu, Fenghong; Chi, Yan

    2015-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Amina Abubakar

    2016-02-01

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

  20. Examining the Role of Primary Care Physicians and Challenges Faced When Their Patients Transition to Home Hospice Care.

    Science.gov (United States)

    Shalev, Ariel; Phongtankuel, Veerawat; Lampa, Katherine; Reid, M C; Eiss, Brian M; Bhatia, Sonica; Adelman, Ronald D

    2018-04-01

    The transition into home hospice care is often a critical time in a patient's medical care. Studies have shown patients and caregivers desire continuity with their physicians at the end of life (EoL). However, it is unclear what roles primary care physicians (PCPs) play and what challenges they face caring for patients transitioning into home hospice care. To understand PCPs' experiences, challenges, and preferences when their patients transition to home hospice care. Nineteen semi-structured phone interviews with PCPs were conducted. Study data were analyzed using standard qualitative methods. Participants included PCPs from 3 academic group practices in New York City. Measured: Physician recordings were transcribed and analyzed using content analysis. Most PCPs noted that there was a discrepancy between their actual role and ideal role when their patients transitioned to home hospice care. Primary care physicians expressed a desire to maintain continuity, provide psychosocial support, and collaborate actively with the hospice team. Better establishment of roles, more frequent communication with the hospice team, and use of technology to communicate with patients were mentioned as possible ways to help PCPs achieve their ideal role caring for their patients receiving home hospice care. Primary care physicians expressed varying degrees of involvement during a patient's transition to home hospice care, but many desired to be more involved in their patient's care. As with patients, physicians desire to maintain continuity with their patients at the EoL and solutions to improve communication between PCPs, hospice providers, and patients need to be explored.

  1. Coping in old age with extreme childhood trauma: aging Holocaust survivors and their offspring facing new challenges.

    Science.gov (United States)

    Fridman, Ayala; Bakermans-Kranenburg, Marian J; Sagi-Schwartz, Abraham; Van IJzendoorn, Marinus H

    2011-03-01

    The Holocaust has become an iconic example of immense human-made catastrophes, and survivors are now coping with normal aging processes. Childhood trauma may leave the survivors more vulnerable when they are facing stress related to old age, whereas their offspring might have a challenging role of protecting their own parents from further pain. Here we examine the psychological adaptation of Holocaust survivors and their offspring in light of these new challenges, examining satisfaction with life, mental health, cognitive abilities, dissociative symptoms, and physical health. Careful matching of female Holocaust survivors and comparison subjects living in Israel was employed to form a case-control study design with two generations, including four groups: 32 elderly female Holocaust survivors and 47 daughters, and 33 elderly women in the comparison group, and 32 daughters (total N = 174). Participants completed several measures of mental and physical health, and their cognitive functioning was examined. The current study is a follow-up of a previous study conducted 11 years ago with the same participants. Holocaust survivors showed more dissociative symptomatology (odds = 2.39) and less satisfaction with their life (odds = 2.79) as compared to a matched group. Nonetheless, adult offspring of Holocaust survivors showed no differences in their physical, psychological, and cognitive functioning as compared to matched controls. Holocaust survivors still display posttraumatic stress symptoms almost 70 years after the trauma, whereas no intergenerational transmission of trauma was found among the second generation.

  2. 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.

  3. 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

  4. Challenges Women with Disability Face in Accessing and Using Maternal Healthcare Services in Ghana: A Qualitative Study

    Science.gov (United States)

    Ganle, John Kuumuori; Otupiri, Easmon; Obeng, Bernard; Edusie, Anthony Kwaku; Ankomah, Augustine; Adanu, Richard

    2016-01-01

    Background While a number of studies have examined the factors affecting accessibility to and utilisation of healthcare services by persons with disability in general, there is little evidence about disabled women's access to maternal health services in low-income countries and few studies consult disabled women themselves to understand their experience of care and the challenges they face in accessing skilled maternal health services. The objective of this paper is to explore the challenges women with disabilities encounter in accessing and using institutional maternal healthcare services in Ghana. Methods and Findings A qualitative study was conducted in 27 rural and urban communities in the Bosomtwe and Central Gonja districts of Ghana with a total of 72 purposively sampled women with different physical, visual, and hearing impairments who were either lactating or pregnant at the time of this research. Semi-structured in-depth interviews were used to gather data. Attride-Stirling’s thematic network framework was used to analyse the data. Findings suggest that although women with disability do want to receive institutional maternal healthcare, their disability often made it difficult for such women to travel to access skilled care, as well as gain access to unfriendly physical health infrastructure. Other related access challenges include: healthcare providers’ insensitivity and lack of knowledge about the maternity care needs of women with disability, negative attitudes of service providers, the perception from able-bodied persons that women with disability should be asexual, and health information that lacks specificity in terms of addressing the special maternity care needs of women with disability. Conclusions Maternal healthcare services that are designed to address the needs of able-bodied women might lack the flexibility and responsiveness to meet the special maternity care needs of women with disability. More disability-related cultural competence and

  5. Social, Cultural, and Environmental Challenges Faced by Children on Antiretroviral Therapy in Zimbabwe: a Mixed-Method Study

    Science.gov (United States)

    Macherera, Margaret; Moyo, Lindani; Ncube, Mkhanyiseli; Gumbi, Angella

    2012-01-01

    Objectives Despite the advent of antiretroviral therapy (ART), many children, particularly in the rural communities of Zimbabwe, remain vulnerable. The purpose of this study was to determine the factors and challenges facing children on antiretroviral therapy (ART) in Brunapeg area of Mangwe District, Zimbabwe. Methods A mixed-method approach involving interviewer-guided focus group discussions and piloted semi-structured questionnaires was utilized to collect data from different key population groups. The data obtained were analyzed through content coding procedures based on a set of predetermined themes of interest. Results A number of challenges emerged as barriers to the success of antiretroviral therapy for children. Primary care givers were less informed about HIV and AIDS issues for people having direct impact on the success of antiretroviral therapy in children whilst some were found to be taking the antiretroviral drugs meant for the children. It also emerged that some primary care givers were either too young or too old to care for the children while others had failed to disclose to the children why they frequently visited the Opportunistic Infections (OI) clinic. Most primary care givers were not the biological parents of the affected children. Other challenges included inadequate access to health services, inadequate food and nutrition and lack of access to clean water, good hygiene and sanitation. The lack of community support and stigma and discrimination affected their school attendance and hospital visits. All these factors contributed to non-adherence to antiretroviral drugs. Conclusions and Public Health Implications Children on ART in rural communities in Zimbabwe remain severely compromised and have unique problems that need multi-intervention strategies both at policy and programmatic levels. Effective mitigating measures must be fully established and implemented in rural communities of developing countries in the fight for universal

  6. Social, Cultural, and Environmental Challenges Faced by Children on Antiretroviral Therapy in Zimbabwe: a Mixed Method Study

    Directory of Open Access Journals (Sweden)

    Margaret Macherera, MSc

    2012-11-01

    Full Text Available Objectives:Despite the advent of antiretroviral therapy (ART, many children, particularly in the rural communities of Zimbabwe, remain vulnerable. The purpose of this study was to determine the factors and challenges facing children on antiretroviral therapy (ART in Brunapeg area of Mangwe District, Zimbabwe.Methods:A mixed-method approach involving interviewer-guided focus group discussions and piloted semi-structured questionnaires was utilized to collect data from different key population groups. The data obtained were analyzed through content coding procedures based on a set of predetermined themes of interest.Results:A number of challenges emerged as barriers to the success of antiretroviral therapy for children. Primary care givers were less informed about HIV and AIDS issues for people having direct impact on the success of antiretroviral therapy in children whilst some were found to be taking the antiretroviral drugs meant for the children. It also emerged that some primary care givers were either too young or too old to care for the children while others had failed to disclose to the children why they frequently visited the Opportunistic Infections (OI clinic. Most primary care givers were not the biological parents of the affected children. Other challenges included inadequate access to health services, inadequate food and nutrition and lack of access to clean water, good hygiene and sanitation. The lack of community support and stigma and discrimination affected their school attendance and hospital visits. All these factors contributed to non-adherence to antiretroviral drugs.Conclusions and Public Health Implications:Children on ART in rural communities in Zimbabwe remain severely compromised and have unique problems that need multi-intervention strategies both at policy and programmatic levels. Effective mitigating measures must be fully established and implemented in rural communities of developing countries in the fight for

  7. 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)

  8. Challenges faced by NRCs

    International Nuclear Information System (INIS)

    Longoria, L.C.

    2001-01-01

    The Mexican Nuclear Research Institute (ININ) played an important role in setting up of nuclear power plants (two) and development of fuel technology. However, with no current plans for expansion of this programme, the Institute is looking mainly into multi-cycle fuel management and life extension issues. The Institute focuses on programmes related to radioisotope and radiation applications and on the use of nuclear technologies for non-nuclear applications. The ININ is the major provider of radioisotopes for medical uses. It also promotes and uses nuclear analytical techniques for addressing a variety of problems. In non-nuclear areas some R and D examples include: the use of thermal plasma for hazardous waste incineration, biodegradation of polymers and development of separation techniques for treating industrial effluents. For preservation of knowledge, the Institute has instituted PhD. programmes in materials science, medical physics and nuclear science in collaboration with a university. (author)

  9. 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...

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

    Science.gov (United States)

    Kaur, Rajanbir; Kaur, Kanwaljit; Kaur, Rajinder

    2018-01-01

    Menstruation and menstrual practices still face many social, cultural, and religious restrictions which are a big barrier in the path of menstrual hygiene management. In many parts of the country especially in rural areas girls are not prepared and aware about menstruation so they face many difficulties and challenges at home, schools, and work places. While reviewing literature, we found that little, inaccurate, or incomplete knowledge about menstruation is a great hindrance in the path of personal and menstrual hygiene management. Girls and women have very less or no knowledge about reproductive tract infections caused due to ignorance of personal hygiene during menstruation time. In rural areas, women do not have access to sanitary products or they know very little about the types and method of using them or are unable to afford such products due to high cost. So, they mostly rely on reusable cloth pads which they wash and use again. Needs and requirements of the adolescent girls and women are ignored despite the fact that there are major developments in the area of water and sanitation. Women manage menstruation differently when they are at home or outside; at homes, they dispose of menstrual products in domestic wastes and in public toilets and they flush them in the toilets without knowing the consequences of choking. So, there should be a need to educate and make them aware about the environmental pollution and health hazards associated with them. Implementation of modern techniques like incineration can help to reduce the waste. Also, awareness should be created to emphasize the use of reusable sanitary products or the natural sanitary products made from materials like banana fibre, bamboo fibre, sea sponges, water hyacinth, and so on.

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

    Directory of Open Access Journals (Sweden)

    Rajanbir Kaur

    2018-01-01

    Full Text Available Menstruation and menstrual practices still face many social, cultural, and religious restrictions which are a big barrier in the path of menstrual hygiene management. In many parts of the country especially in rural areas girls are not prepared and aware about menstruation so they face many difficulties and challenges at home, schools, and work places. While reviewing literature, we found that little, inaccurate, or incomplete knowledge about menstruation is a great hindrance in the path of personal and menstrual hygiene management. Girls and women have very less or no knowledge about reproductive tract infections caused due to ignorance of personal hygiene during menstruation time. In rural areas, women do not have access to sanitary products or they know very little about the types and method of using them or are unable to afford such products due to high cost. So, they mostly rely on reusable cloth pads which they wash and use again. Needs and requirements of the adolescent girls and women are ignored despite the fact that there are major developments in the area of water and sanitation. Women manage menstruation differently when they are at home or outside; at homes, they dispose of menstrual products in domestic wastes and in public toilets and they flush them in the toilets without knowing the consequences of choking. So, there should be a need to educate and make them aware about the environmental pollution and health hazards associated with them. Implementation of modern techniques like incineration can help to reduce the waste. Also, awareness should be created to emphasize the use of reusable sanitary products or the natural sanitary products made from materials like banana fibre, bamboo fibre, sea sponges, water hyacinth, and so on.

  12. 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

  13. 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.

  14. 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.

  15. Challenges in war-related thoracic injury faced by French military surgeons in Afghanistan (2009-2013).

    Science.gov (United States)

    de Lesquen, Henri; Beranger, Fabien; Berbis, Julie; Boddaert, Guillaume; Poichotte, Antoine; Pons, Francois; Avaro, Jean-Philippe

    2016-09-01

    This study reports the challenges faced by French military surgeons in the management of thoracic injury during the latest Afghanistan war. From January 2009 to April 2013, all of the civilian, French and Coalition casualties admitted to French NATO Combat Support Hospital situated on Kabul were prospectively recorded in the French Military Health Service Registry (OPEX(®)). Only penetrating and blunt thoracic trauma patients were retrospectively included. Eighty-nine casualties were included who were mainly civilian (61%) and men (94%) with a mean age of 27.9 years old. Surgeons dealt with polytraumas (78%), severe injuries (mean Injury Severity Score=39.2) and penetrating wounds (96%) due to explosion in 37%, gunshot in 53% and stabbing in 9%. Most of casualties were first observed or drained (n=56). In this non-operative group more than 40% of casualties needed further actions. In the operative group, Damage Control Thoracotomy (n=22) was performed to stop ongoing bleeding and air leakage and Emergency Department Thoracotomy (n=11) for agonal patient. Casualties suffered from hemothorax (60%), pneumothorax (39%), diaphragmatic (37%), lung (35%), heart or great vessels (20%) injuries. The main actions were diaphragmatic sutures (n=25), lung resections (wedge n=6, lobectomy n=4) and haemostasis (intercostal artery ligation n=3, heart injury repairs n=5, great vessels injury repairs n=5). Overall mortality was 11%. The rate of subsequent surgery was 34%. The analysis of the OPEX(®) registry reflects the thoracic surgical challenges of general (visceral) surgeons serving in combat environment during the latest Afghanistan War. Copyright © 2016 Elsevier Ltd. All rights reserved.

  16. 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

  17. 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

  18. 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.

  19. 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.

  20. 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.

  1. 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.

  2. 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

  3. Challenges faced by caregivers of children on antiretroviral therapy at Mutale Municipality selected healthcare facilities, Vhembe District, Limpopo Province.

    Science.gov (United States)

    Mafune, Rhudzani V; Lebese, Rachel T; Nemathaga, Livhuwani H

    2017-08-28

    Children depend solely on caregivers who can be either parents or guardians for drug administration to enhance adherence to antiretroviral treatment (ART), which might pose any number of challenges. The purpose of this study was to explore and describe the challenges faced by caregivers of children on ART at Mutale Municipality, Vhembe District, Limpopo Province. The research design was qualitative, explorative, descriptive and contextual in nature. The population consisted of 16 caregivers who were 18 years of age and above, and mentally capable, irrespective of educational qualifications, caring for children aged between 0 and 15 years who were on ART between April 2013 and October 2014. Non-probability, purposive sampling was used to select the 16 caregivers. Required permission, approval and ethical clearance were obtained from the University of Venda Higher Degree Committee, Limpopo Provincial Health Department and relevant institutions. An in-depth, individual, unstructured interview method was used to collect data. One central question was asked: 'What are the challenges you experience when caring for a child on antiretroviral treatment?' Subsequent questions were based on the participants' responses to the central question. Qualitative data were analysed by means of Tesch's open-coding method. The findings of this study revealed that participants, that is, caregivers of children on ART, experienced financial burdens because of transport costs needed to comply with follow-up dates and insufficient of money for food, clothing the child in need of care, pocket money for lunch boxes during school hours and time lost while waiting for consultations. Participants reported some level of stigmatisation against children on ART by family members, especially the husbands or in-laws of the secondary caregivers. Many primary and secondary caregivers seemed to have given up seeking support from government and community structures. The conclusions drawn from this research

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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)

  11. C-A1-04: Challenges Faced as New Members of the HMO Research Network Virtual Data Warehouse

    Science.gov (United States)

    Godwin, Debbie; Mahajan, Bhushan; Silcott, Monica; Kjar, Dean

    2011-01-01

    Background/Aims This presentation will focus on challenges faced by new HMO Research Network (HMORN) sites and their experiences with the Virtual Data Warehouse (VDW) tables for version 3 specifications. The step-by-step procedure developed by Scott and White will be showcased to provide a head start for new incoming sites. Sharing lessons learned during our one year in the HMORN VDW, our objective is to provide best practices regarding resources, time allocation, priorities, schedules, financing, backups, and possible available alternatives. Methods The comprehensive procedure followed by Scott & White to build VDW V3 tables: Setting up your SAS Environment Establishing an architecture and components Analyzing and forecasting server specifications; Identifying and understanding the multiple data sorces embedded in your organization Claims data EMR Lab Pharmacy Other; Detailed variable mapping of sources to VDW specifications; Assessment of source data availability; Getting your site’s first feed from the source and following through with quality checks; Methods for building transformation logic for the table; Choosing the methodology to approach table-building. Results We will showcase Scott & White metrics for building a VDW starting with version 3 and best practices used. We improved the validity and completeness of the data through person-to-person interactions with claims personnel who often were disinterested in the needs of research. Having strong advocates who think of research as a part of the institutional mission was helpful. The VDW data team included a sole programmer for the first 6 months along with the Site Data Manager; adding a second programmer improved the rate of progress. Conclusions A structured, step-by-step, approach is recommended for new incoming sites joining the HMORN. This approach will optimize efficiency and effectiveness. The more information and guidance the existing members can provide, the better the achieved results will be

  12. Benign Tumors of the Pancreas-Radical Surgery Versus Parenchyma-Sparing Local Resection-the Challenge Facing Surgeons.

    Science.gov (United States)

    Beger, Hans G

    2018-03-01

    Pancreaticoduodenectomy and left-sided pancreatectomy are the surgical treatment standards for tumors of the pancreas. Surgeons, who are requested to treat patients with benign tumors, using standard oncological resections, face the challenge of sacrificing pancreatic and extra-pancreatic tissue. Tumor enucleation, pancreatic middle segment resection and local, duodenum-preserving pancreatic head resections are surgical procedures increasingly used as alternative treatment modalities compared to classical pancreatic resections. Use of local resection procedures for cystic neoplasms and neuro-endocrine tumors of the pancreas (panNETs) is associated with an improvement of procedure-related morbidity, when compared to classical Whipple OP (PD) and left-sided pancreatectomy (LP). The procedure-related advantages are a 90-day mortality below 1% and a low level of POPF B+C rates. Most importantly, the long-term benefits of the use of local surgical procedures are the preservation of the endocrine and exocrine pancreatic functions. PD performed for benign tumors on preoperative normo-glycemic patients is followed by the postoperative development of new onset of diabetes mellitus (NODM) in 4 to 24% of patients, measured by fasting blood glucose and/or oral/intravenous glucose tolerance test, according to the criteria of the international consensus guidelines. Persistence of new diabetes mellitus during the long-term follow-up after PD for benign tumors is observed in 14.5% of cases and after surgery for malignant tumors in 15.5%. Pancreatic exocrine insufficiency after PD is found in the long-term follow-up for benign tumors in 25% and for malignant tumors in 49%. Following LP, 14-31% of patients experience postoperatively NODM; many of the patients subsequently change to insulin-dependent diabetes mellitus (IDDM). The decision-making for cystic neoplasms and panNETs of the pancreas should be guided by the low surgical risk and the preservation of pancreatic metabolic

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

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2004-07-01

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

  14. 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.

  15. 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.

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

    OpenAIRE

    Ramos, Alexandra Jacinta

    2011-01-01

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

  17. 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.

  18. 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)

  19. 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.

  20. Northern Eurasia Future Initiative (NEFI): facing the challenges and pathways of global change in the twenty-first century

    Science.gov (United States)

    Groisman, Pavel; Shugart, Herman; Kicklighter, David; Henebry, Geoffrey; Tchebakova, Nadezhda; Maksyutov, Shamil; Monier, Erwan; Gutman, Garik; Gulev, Sergey; Qi, Jiaguo; Prishchepov, Alexander; Kukavskaya, Elena; Porfiriev, Boris; Shiklomanov, Alexander; Loboda, Tatiana; Shiklomanov, Nikolay; Nghiem, Son; Bergen, Kathleen; Albrechtová, Jana; Chen, Jiquan; Shahgedanova, Maria; Shvidenko, Anatoly; Speranskaya, Nina; Soja, Amber; de Beurs, Kirsten; Bulygina, Olga; McCarty, Jessica; Zhuang, Qianlai; Zolina, Olga

    2017-12-01

    During the past several decades, the Earth system has changed significantly, especially across Northern Eurasia. Changes in the socio-economic conditions of the larger countries in the region have also resulted in a variety of regional environmental changes that can have global consequences. The Northern Eurasia Future Initiative (NEFI) has been designed as an essential continuation of the Northern Eurasia Earth Science Partnership Initiative (NEESPI), which was launched in 2004. NEESPI sought to elucidate all aspects of ongoing environmental change, to inform societies and, thus, to better prepare societies for future developments. A key principle of NEFI is that these developments must now be secured through science-based strategies co-designed with regional decision-makers to lead their societies to prosperity in the face of environmental and institutional challenges. NEESPI scientific research, data, and models have created a solid knowledge base to support the NEFI program. This paper presents the NEFI research vision consensus based on that knowledge. It provides the reader with samples of recent accomplishments in regional studies and formulates new NEFI science questions. To address these questions, nine research foci are identified and their selections are briefly justified. These foci include warming of the Arctic; changing frequency, pattern, and intensity of extreme and inclement environmental conditions; retreat of the cryosphere; changes in terrestrial water cycles; changes in the biosphere; pressures on land use; changes in infrastructure; societal actions in response to environmental change; and quantification of Northern Eurasia's role in the global Earth system. Powerful feedbacks between the Earth and human systems in Northern Eurasia (e.g., mega-fires, droughts, depletion of the cryosphere essential for water supply, retreat of sea ice) result from past and current human activities (e.g., large-scale water withdrawals, land use, and governance

  1. 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

  2. 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

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

    Science.gov (United States)

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

    2015-08-27

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

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

    DEFF Research Database (Denmark)

    Louw, Arnt Vestergaard

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

  5. 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.

  6. 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.

  7. 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.

  8. European cinema: face to face with Hollywood

    NARCIS (Netherlands)

    Elsaesser, T.

    2005-01-01

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

  9. 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)

  10. 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

  11. Challenges Faced by Regulators and Technical, Scientific and Support Organizations (TSOs) in Enhancing Nuclear Safety and Security

    International Nuclear Information System (INIS)

    Travers, W.D.

    2011-01-01

    Renewed interest in new reactor build programmes, not only in countries with already established nuclear programmes but also in many other countries with limited or no workforce experienced in the design, licensing, construction and operation of nuclear power plants, has resulted in a need for technical, scientific and support organizations (TSOs) to support regulatory bodies in carrying out their mandated responsibilities. The primary function of a regulatory body, such as the Federal Authority for Nuclear Regulation (FANR) in the United Arab Emirates (UAE), is to regulate the safe use of nuclear facilities and radioactive material for peaceful civilian purposes. In so doing, the regulatory body needs to provide a clear and focused approach to: safety, security and safeguards for licensing; inspection and enforcement of reactor design; construction; commissioning; operation; decommissioning; nuclear waste management activities; and the use, possession or transfer of special nuclear materials and activities within the country. Accomplishing this goal requires a highly educated, multidisciplinary, diverse workforce with significant work experience. Recognizing that it takes several decades and a lot of resources to achieve self-sufficiency, many countries, particularly emergent nuclear countries, would have to rely on TSOs to start their programmes and to carry out their oversight responsibilities. Towards that end, FANR is working closely with international counterparts, the International Atomic Energy Agency and TSOs to exchange information, expertise, industry experience and ongoing research to ensure that high levels of safety, security and safeguards are established and maintained in reactor design and operation throughout the life of the facility, and that special nuclear material within the UAE is properly documented and controlled, is not stolen, lost or diverted to any illicit or non-peaceful activities, and does not pose unreasonable radiological risk due

  12. Challenges that face cultural tourism development in conflict and post-conflict regions: the case of Kurdistan

    OpenAIRE

    Braim, Kadhim Magdid; McCabe, Scott; Rickly, Jillian; Gadi, Mohamed

    2016-01-01

    Tourism has multiple economic benefits for host countries that receive tourists. Policy makers are becoming more and more aware of the importance that appropriate tourism management has to maximise the benefits that tourism flows can bring. However, many developing countries suffer from a lack of an integrated tourism policy. Particular issues are faced in those countries that are dealing with local conflicts (sometimes over many years). These countries often lack investment in tourism resour...

  13. 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.

  14. Face to Face The Challenge Of Thor

    Indian Academy of Sciences (India)

    IAS Admin

    knowledge the potential of thorium as a fuel source for the future. Notable .... especially one oft criticized for its lack of transparency and accountability? Some of the ... secondary school education was all in Hindi and in college it was English.

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

    Directory of Open Access Journals (Sweden)

    Emmanuelle Bermès

    2011-03-01

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

  16. Challenges faced by health-care providers offering infant-feeding counseling to HIV-positive women in sub-Saharan Africa: a review of current research.

    Science.gov (United States)

    Tuthill, Emily L; Chan, Jessica; Butler, Lisa M

    2015-01-01

    Exclusive breastfeeding (EBF) has been identified as the optimal nutrition and critical behavior in attaining human immunodeficiency virus (HIV)-free infant survival in resource-limited settings. Health-care providers (HCPs) in clinic- and community-settings throughout sub-Saharan Africa (sSA) provide infant-feeding counseling. However, rates of EBF at 6 months of age are suboptimal. HCPs are uniquely positioned to educate HIV-positive mothers and provide support by addressing known barriers to EBF. However, limited evidence exists on the experiences faced by HCPs in providing counseling on infant feeding to HIV-positive women. Our objective is to describe experiences faced by HCPs when delivering infant-feeding counseling in the context of HIV in program settings in sSA. We searched a range of electronic databases, including PubMed, CINAHL, and PsycINFO from January 1990 to February 2013, in addition to hand-searching, cross-reference searching, and personal communications. The search was limited to publications in English. Empirical studies of HCP experiences providing infant-feeding counseling in the prevention of mother-to-child transmission (PMTCT) of HIV programs in sSA were selected. We identified 10 peer-reviewed articles reporting HCP challenges in infant-feeding counseling that met inclusion criteria. Articles included qualitative, cross-sectional and mixed-method studies, and cumulatively reported 31 challenges faced by HCPs. Among the challenges identified, the most commonly reported were personal beliefs held by the HCPs toward infant feeding in the context of HIV, contradictory messages, staff workload, directive counseling styles, and a lack of practical strategies to offer mothers, often leading to improvised counseling approaches. Counseling strategies need to be developed that are relevant, meaningful, and responsive to the needs of both HCPs and mothers.

  17. STEM Is Elementary: Challenges Faced by Elementary Teachers in the Era of the Next Generation Science Standards

    Science.gov (United States)

    Isabelle, Aaron D.

    2017-01-01

    For students to achieve the goals of the Next Generation Science Standards (NGSS) by Grade 12, thinking and acting like scientists and engineers must begin in the elementary grades. However, elementary teachers may find this challenging -because language arts and mathematics still dominate many classrooms--often at the expense of science. This…

  18. Facing the Challenge--Developing an Instructional Plan for Portuguese as Foreign Language in Brazil Based on Multiliteracy

    Science.gov (United States)

    Schlindwein, Ana Flora

    2013-01-01

    Adopting the multiliteracy concept and embracing the challenge of developing meaningful and captivating classes for Portuguese as Foreign Language in Brazil, this paper proposes an approach which includes the use of different technologies to learn and teach Portuguese, the reading of graphic novel adaptations of Brazilian literature classics and…

  19. An Insight into the Challenges Faced by Academic Women with Pre-School Age Children in Academic Life

    Science.gov (United States)

    Günçavdi, Gizem; Göktürk, Söheyda; Bozoglu, Oguzhan

    2017-01-01

    This study aimed to explore the challenges academic women, especially those who were mothers of pre-school age children, went through. The main guiding question of this study was "How do academic mothers with pre-school age children survive in the academia from pregnancy through all the various stages of parenting and motherhood?". This…

  20. Proceeding of the Fourth Scientific Presentation on Nuclear Fuel Cycle: Technology of Nuclear Fuel Cycle facing the Challenge of Energy Need on the 21-st Century

    International Nuclear Information System (INIS)

    Suripto, A.; Sajuti, D.; Aiman, S.; Yuwono, I.; Fathurrachman; Suwarno, H.; Suwardi; Amini, S.; Widjaksana

    1999-03-01

    The proceeding contains papers presented in the Fourth Scientific Presentation on Nuclear Fuel Element Cycle with theme of Technology of Nuclear Fuel Cycle facing the Challenge of Energy Need on the 21 s t Century, held on 1-2 December in Jakarta, Indonesia. These papers were divided by three groups that are technology of exploration, processing, purification and analysis of nuclear materials; technology of nuclear fuel elements and structures; and technology of waste management, safety and management of nuclear fuel cycle. There are 36 papers indexed individually. (ID)

  1. An investigation into the challenges facing the future provision of continuing professional development for allied health professionals in a changing healthcare environment

    International Nuclear Information System (INIS)

    Gibbs, Vivien

    2011-01-01

    This paper outlines current challenges facing healthcare providers and education providers in trying to ensure Allied Health Professionals (AHPs) are fit for practice, in a climate driven by financial constraints and service improvement directives from the Department of Health (DH). Research was undertaken in 2009 to investigate the current provision of Continuing Professional Development (CPD) in the southwest region of England. The purpose was to define exactly what problems existed with this provision, and to propose changes which could be implemented in order to ensure that the provision meets the needs of stakeholders in future years.

  2. Proceedings of a USGS Workshop on Facing Tomorrow's Challenges Along the U.S.-Mexico Border - Monitoring, Modeling, and Forecasting Change Within the Arizona-Sonora Transboundary Watersheds

    Science.gov (United States)

    Norman, Laura M.; Hirsch, Derrick D.; Ward, A. Wesley

    2008-01-01

    INTRODUCTION TO THE WORKSHOP PROCEEDINGS Competition for water resources, habitats, and urban areas in the Borderlands has become an international concern. In the United States, Department of Interior Bureaus, Native American Tribes, and other State and Federal partners rely on the U.S. Geological Survey (USGS) to provide unbiased science and leadership in the Borderlands region. Consequently, the USGS hosted a workshop, ?Facing Tomorrow?s Challenges along the U.S.-Mexico Border,? on March 20?22, 2007, in Tucson, Ariz., focused specifically on monitoring, modeling, and forecasting change within the Arizona-Sonora Transboundary Watersheds

  3. Additional Insights Into Problem Definition and Positioning From Social Science Comment on "Four Challenges That Global Health Networks Face".

    Science.gov (United States)

    Quissell, Kathryn

    2017-09-10

    Commenting on a recent editorial in this journal which presented four challenges global health networks will have to tackle to be effective, this essay discusses why this type of analysis is important for global health scholars and practitioners, and why it is worth understanding and critically engaging with the complexities behind these challenges. Focusing on the topics of problem definition and positioning, I outline additional insights from social science theory to demonstrate how networks and network researchers can evaluate these processes, and how these processes contribute to better organizing, advocacy, and public health outcomes. This essay also raises multiple questions regarding these processes for future research. © 2018 The Author(s); Published by Kerman University of Medical Sciences. This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

  4. IAEA news: • Newcomer countries face common challenges in nuclear infrastructure development. • Safety and licensing requirements for small modular reactors: IAEA hosts first workshop for regulators. • IAEA reaches milestone in disposal of radioactive sources

    International Nuclear Information System (INIS)

    Kollar, Lenka; Dyck, Elisabeth; Dixit, Aabha; Gaspar, Miklos; Gil, Laura

    2016-01-01

    • Newcomer countries face common challenges in nuclear infrastructure development: Countries embarking on a nuclear power programme need to make sure that the development of their legal, regulatory and support infrastructure keeps pace with the construction of the power plant itself. This is the only way to ensure that the programme proceeds in a safe, secure and sustainable way, concluded participants of a workshop on nuclear power infrastructure development hosted at the IAEA last February. • Safety and licensing requirements for small modular reactors: IAEA hosts first workshop for regulators: A new generation of advanced, prefab nuclear power reactors called small modular reactors (SMRs) could be licensed and hit the market as early as 2020, and the IAEA is helping regulators prepare for their debut. In a series of workshops that began earlier this year, the IAEA is working closely with regulators on approaches to safety and licensing ahead of potential SMR deployment worldwide. • IAEA reaches milestone in disposal of radioactive sources: Successful tests of a promising technology for moving and storing low level radioactive sealed sources are paving the way for a new disposal method for dealing with small volumes of radioactive waste around the world. The method, which involves placing and covering sealed sources in a narrow hole a few hundred metres deep, would allow countries to safely and securely take charge of their own disused radioactive sources. The proof of concept for the technology was tested in Croatia late last year — without the use of actual radioactive material.

  5. Female entrepreneurship and challenges faced by women entrepreneurs to reconcile conflicts between work and family: multiple case study in travel agencies

    Directory of Open Access Journals (Sweden)

    Rivanda Meira Teixeira

    2016-03-01

    Full Text Available Women have gained more and more space in various professional areas and this development also occurs in the field of entrepreneurship. In Brazil GEM 2013 identified for the first time, that the number of new woman entrepreneurs was higher than male entrepreneurs. However, it is recognized that women entrepreneurs face many difficulties when trying to reconcile their companies with the family. The main objective of this research is to analyse the challenges faced by women entrepreneurs of travel agencies to reconcile the conflict between work and family. This study adopted the multiple cases research strategy and were selected seven women creators and managers of travel agencies in the cities of Aracaju and the Barra dos Coqueiros, in the state of Sergipe (east coast of Brazil. In an attempt to reconcile well the multiple roles these women often face the frustration and guilt. At this moment, it shows the importance of emotional contribution of husband and children. It is noticed that the search for balance between the conflicting demands generate emotional distress and / or physical.

  6. The challenges forensic nurses face when their patient is comatose: addressing the needs of our most vulnerable patient population.

    Science.gov (United States)

    Pierce-Weeks, Jennifer; Campbell, Polly

    2008-01-01

    Since 1996, the American Nurses Association has recognized forensic nursing as a formal specialty. Despite this recognition, Sexual Assault Nurse Examiners and Emergency Department nurses struggle with incorporating evidence collection into the care they give the unconscious or comatose patient they suspect has been sexually assaulted. Through case example, this article provides an abbreviated review of the circumstances under which these patients present for care, current challenges, and barriers in upholding the standard of forensic nursing care, as well as proposed interventions for the practicing forensic nurse.

  7. Challenge theme 6: Natural hazard risks in the Borderlands: Chapter 8 in United States-Mexican Borderlands: Facing tomorrow's challenges through USGS science

    Science.gov (United States)

    Page, William R.; Parcher, Jean W.; Stefanov, Jim

    2013-01-01

    Natural hazards such as earthquakes, landslides and debris flows, wildfires, hurricanes, and intense storm-induced flash floods threaten communities to varying degrees all along the United States–Mexican border. The U.S. Geological Survey (USGS) collaborates with Federal, State, and local agencies to minimize the effects of natural hazards by providing timely, unbiased science information to emergency response officials, resource managers, and the public to help reduce property damage, injury, and loss of life. The USGS often mobilizes response efforts during and after a natural hazard event to provide technical and scientific counsel on recovery and response, and it has a long history of deploying emergency response teams to major disasters in both domestic and international locations. This chapter describes the challenges of natural hazards in the United States–Mexican border region and the capabilities of the USGS in the fields of hazard research, monitoring, and assessment, as well as preventative mitigation and post-disaster response.

  8. Determining the efficacy of national strategies aimed at addressing the challenges facing health personnel working in rural areas in KwaZulu-Natal, South Africa.

    Science.gov (United States)

    Mburu, Grace; George, Gavin

    2017-07-31

    Shortages of Human Resources for Health (HRH) in rural areas are often driven by poor working and living conditions, inadequate salaries and benefits, lack of training and career development opportunities amongst others. The South African government has adopted a human resource strategy for the health sector in 2011 aimed at addressing these challenges. This study reviews the challenges faced by health personnel against government strategies aimed at attracting and retaining health personnel in these underserved areas. The study was conducted in six primary health care service sites in the Hlabisa sub-district of Umkhanyakude, located in northern KwaZulu-Natal, South Africa. The study population comprised 25 health workers including 11 professional nurses, 4 staff nurses and 10 doctors (4 medical doctors, 3 foreign medical doctors and 3 doctors undertaking community service). Qualitative data were collected from semi-structured interviews and analysed using thematic analysis. Government initiatives including the rural allowance, deployment of foreign medical doctors and the presence of health personnel undertaking their community service in rural areas are positively viewed by health personnel working in rural health facilities. However, poor living and working conditions, together with inadequate personal development opportunities, remain unresolved challenges. It is these challenges that will continue to dissuade experienced health personnel from remaining in these underserved areas. South Africa's HRH strategy for the Health Sector 2012/13-2015/16 had highlighted the key challenges raised by respondents and identified strategies aimed at addressing these challenges. Implementation of these strategies is key to improving both living and working conditions, and providing health personnel with opportunities for further development will require inter-ministerial collaboration if the HRH 2030 objectives are to be realised.

  9. Hydrologic analysis of the challenges facing water resources and sustainable development of Wadi Feiran basin, southern Sinai, Egypt

    Science.gov (United States)

    Ahmed, Ayman A.; Diab, Maghawri S.

    2018-04-01

    Wadi Feiran basin is one of the most promising areas in southern Sinai (Egypt) for establishing new communities and for growth in agriculture, tourism, and industry. The present challenges against development include water runoff hazards (flash flooding), the increasing water demand, and water scarcity and contamination. These challenges could be mitigated by efficient use of runoff and rainwater through appropriate management, thereby promoting sustainable development. Strategies include the mitigation of runoff hazards and promoting the natural and artificial recharge of aquifers. This study uses a watershed modeling system, geographic information system, and classification scheme to predict the effects of various mitigation options on the basin's water resources. Rainwater-harvesting techniques could save more than 77% of the basin's runoff (by volume), which could be used for storage and aquifer recharge. A guide map is provided that shows possible locations for the proposed mitigation options in the study basin. Appropriate measures should be undertaken urgently: mitigation of groundwater contamination (including effective sewage effluent management); regular monitoring of the municipal, industrial and agricultural processes that release contaminants; rationalization and regulation of the application of agro-chemicals to farmland; and regular monitoring of contaminants in groundwater. Stringent regulations should be implemented to prevent wastewater disposal to the aquifers in the study area.

  10. Overseas territories facing the challenge of climate change - Report to the Prime Minister and to the Parliament

    International Nuclear Information System (INIS)

    Verges, Paul; Galliot, Michel; Mondon, Sylvain; Reysset, Bertrand; Zilli, Dario; Bourcier, Vincent; Duvernoy, Jerome; Omarjee, Younous; Duvat, Virginie; Mossot, Gabrielle; Magnan, Alexandre; Allenbach, Michel; Bocquet, Aurelie; Bonnardot, Francois; Dandin, Philippe; Palany, Philippe; Pontaud, Marc; Porcher, Michel; Delalande, Daniel

    2012-12-01

    This report identifies the social-environmental challenges associated with climate change for French overseas territories, proposes an analysis of the impact of activities of the different economic sectors on the environment, and proposes some principles for action. After an introduction which outlines the importance of addressing climate change and adaptation, and describes the situation of French overseas territories in front of climate change, a first part identifies and discusses the main social-environmental challenges associated with climate change (climate evolution, role of climate change in a context of economic development, the territory as a resource system, climate change considered as an impact chain, the relative weight of climatic uncertainties). Then, the report analyses the potential impacts of climate change on biodiversity, on tourism, on fishing and aquaculture, on agriculture and breeding, on forestry, on health, and on the energy sector. For each of them, the economic weight is indicated and commented, expected impacts are discussed, and adaptation possibilities and implementation modalities are commented. The issue of coastal planning and risks related to climate change is also addressed

  11. The Borderlands and climate change: Chapter 10 in United States-Mexican Borderlands: Facing tomorrow's challenges through USGS science

    Science.gov (United States)

    Fitzpatrick, Joan; Gray, Floyd; Dubiel, Russell; Langman, Jeff; Moring, J. Bruce; Norman, Laura M.; Page, William R.; Parcher, Jean W.

    2013-01-01

    The prediction of global climate change in response to both natural forces and human activity is one of the defining issues of our times. The unprecedented observational capacity of modern earth-orbiting satellites coupled with the development of robust computational representations (models) of the Earth’s weather and climate systems afford us the opportunity to observe and investigate how these systems work now, how they have worked in the past, and how they will work in the future when forced in specific ways. In the most recent report on global climate change by the Intergovernmental Panel on Climate Change (IPCC; Solomon and others, 2007), analyses using multiple climate models support recent observations that the Earth’s climate is changing in response to a combination of natural and human-induced causes. These changes will be significant in the United States–Mexican border region, where the process of climate change affects all of the Borderlands challenge themes discussed in the preceding chapters. The dual possibilities of both significantly-changed climate and increasing variability in climate make it challenging to take full measure of the potential effects because the Borderlands already experience a high degree of interannual variability and climatological extremes.

  12. 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…

  13. Challenges faced on Cacimbas-Catu gas pipeline (Gascac) construction and the technologies applied to achieve success

    Energy Technology Data Exchange (ETDEWEB)

    Ruschi, Allan; Cardos, Celina; Soares, Felipe; Mariot, Guilherme; Loureiro, Regis R [Petroleo Brasileiro S/A, Petrobras Engineering, Rio de Janeiro/ RJ (Brazil)

    2010-07-01

    The GASENE project is the largest gas pipeline constructed in Brazil in the past 10 years, it interconnects the southeast to the northeast of Brazil. The Cacimbas Catu Gas Pipeline (GASCAC) is a part of the project; it has a 28 inch diameter and is 958 km long. The aim of this paper is to present the construction and assembly process undertaken to meet the deadline and complete the GASCAC to a high quality standard. The main challenges of this project were its length, the short period for completion and the numerous geological and man-made features along the pipeline route. To overcome these difficulties, technologies that had never been used in Brazil before were employed, such as vacuum pipe lifting, bag weights and automatic welding. The GASCAC project was completed in time and with to a high standard of quality, demonstrating that strategic planning and the use of new technologies can increase productivity, quality and safety.

  14. Facing the challenge of Arctic fisheries management within a context of spatially differentiated ecological-economic externalities

    DEFF Research Database (Denmark)

    Kaiser, Brooks; Fernandez, Linda; Sundet, Jan

    inherent in these species’ introductions. The challenges of effectively managing these species are particularly high, mainly due to their twofold role as invasive species and market commodities. Part of the balancing act needed for a solution to the spread of the RKC has been directed at spatial...... less open to the spread of invasive species are now responsible for the expansiveness of the problem. At stake are unique species and co-evolved systems that have taken millennia to develop. Even small-scale disturbances in the pristine Arctic ecosystems are likely to have outsized impacts both...... on an ecological and on an economic level. This work discusses optimal management approaches regarding threats from invasive species on an international scale in order to delineate international policy characteristics that may reduce overall damages and costs. The purposeful introduction of the Red King Crab (RKC...

  15. Challenge theme 7: Information support for management of border security and environmental protection: Chapter 9 in United States-Mexican Borderlands: Facing tomorrow's challenges through USGS science

    Science.gov (United States)

    Parcher, Jean W.; Page, William R.

    2013-01-01

    Historically, international borders were located far from the major political and economic capitals of their countries and rarely received adequate planning or infrastructure development. Today, as a result of global economics and increased movement of goods between nations, border regions play a much greater role in commerce, tourism, and transportation. For example, Mexico is the second largest destination for United States exports (Woodrow Wilson Center Mexico Institute, 2009). The rapid population and economic growth along the United States–Mexican border, undocumented human border crossings, and the unique natural diversity of resources in the Borderlands present challenges for border security and environmental protection. Assessing risks and implementing sustainable growth policies to protect the environment and quality of life greatly increase in complexity when the issues cross an international border, where social services, environmental regulations, lifestyles, and cultural beliefs are unique for each country. Shared airsheds, water and biological resources, national security issues, and disaster management needs require an integrated binational approach to assess risks and develop binational management strategies.

  16. Past, Present, and Future of Informed Consent in Pain and Genomics Research: Challenges Facing Global Medical Community.

    Science.gov (United States)

    Compagnone, Christian; Schatman, Michael E; Rauck, Richard L; Van Zundert, Jan; Kraus, Monika; Primorac, Dragan; Williams, Frances; Allegri, Massimo; Saccani Jordi, Gloria; Fanelli, Guido

    2017-01-01

    In recent decades, there has been a revision of the role of institutional review boards with the intention of protecting human subjects from harm and exploitation in research. Informed consent aims to protect the subject by explaining all of the benefits and risks associated with a specific research project. To date, there has not been a review published analyzing issues of informed consent in research in the field of genetic/Omics in subjects with chronic pain, and the current review aims to fill that gap in the ethical aspects of such investigation. Despite the extensive discussion on ethical challenges unique to the field of genetic/Omics, this is the first attempt at addressing ethical challenges regarding Informed Consent Forms for pain research as the primary focus. We see this contribution as an important one, for while ethical issues are too often ignored in pain research in general, the numerous arising ethical issues that are unique to pain genetic/Omics suggest that researchers in the field need to pay even greater attention to the rights of subjects/patients. This article presents the work of the Ethic Committee of the Pain-Omics Group (www.painomics.eu), a consortium of 11 centers that is running the Pain-Omics project funded by the European Community in the 7th Framework Program theme (HEALTH.2013.2.2.1-5-Understanding and controlling pain). The Ethic Committee is composed of 1 member of each group of the consortium as well as key opinion leaders in the field of ethics and pain more generally. © 2016 The Authors. Pain Practice published by Wiley Periodicals, Inc. on behalf of World Institute of Pain.

  17. 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

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

    NARCIS (Netherlands)

    Ubacht, J.

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

  19. 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)

  20. 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