Download or read book Current Challenges in Pharmacovigilance written by World Health Organization and published by . This book was released on 2001-01-01 with total page 381 pages. Available in PDF, EPUB and Kindle. Book excerpt: In spite of recent progress in the harmonization of terminology and processes affecting work on the clinical safety of medicines consensus is needed on standards for many difficult aspects of day-to-day pharmacovigilance that continue to pose problems for both the pharmaceutical industry and drug regulators. The CIOMS V Working Group has generated proposals for pragmatic approaches to dealing with such issues as: classification and handling of individual safety case reports from a variety of sources (spontaneous consumer reports solicited reports literature the Internet observational studies and secondary data bases disease and other registries regulatory ADR databases and licensor-licensee interactions); new approaches to case management and regulatory reporting practices (proper clinical evaluation of cases incidental vs other events patient and reporter identifiability seriousness criteria expectedness criteria case follow-up criteria and the role and structure of case narratives); improvements and efficiencies in the format content and reporting of periodic safety update reports (PSURs) (including results of an industry survey on PSUR workloads and practices; proposals for high case volume and long time-period reports simplification of certain PSURs summary bridging reports addendum reports license renewal reports for EU and Japan dealing with old products and other technical details); determination and use of population exposure (denominator) data (sources of data and a guide to analytical approaches for a variety of circumstances).The Group has also taken stock of the current state of expedited and periodic clinical safety reporting requirements around the world with summary data on regulations from more than 60 countries. Recommendations are made for enhancing the harmonization steps already taken as a result of previous CIOMS publications and the ICH process. In addition to dealing with unfinished and unresolved issues from previous CIOMS initiatives the report covers many emerging topics such as those involving new technologies. Its 20 Appendices provide a wealth of detailed explanations and reference information. It is the most comprehensive and recent treatment of difficult pharmacovigilance issues affecting the working practices and systems of drug safety and other pharmaceutical professionals.
Download or read book Energy Balance and Obesity written by Isabelle Romieu and published by IARC Working Group Report. This book was released on 2018-01-12 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Understanding the relationship between energy balance and obesity is essential to develop effective prevention programs and policies. The International Agency for Research on Cancer convened a Working Group of world-leading experts in December 2015 to review the evidence regarding energy balance and obesity, with a focus on low- and middle-income countries, and to consider the following scientific questions: (i) Are the drivers of the obesity epidemic related only to energy excess and/or do specific foods or nutrients play a major role in this epidemic? (ii) What are the factors that modulate these associations? (iii) Which types of data and/or studies will further improve our understanding? This book provides summaries of the evidence from the literature as well as the Working Group's conclusions and recommendations to tackle the global epidemic of obesity.
Download or read book Mycotoxin Control in Low and Middle Income Countries written by Christopher P. Wild and published by IARC Working Group Report. This book was released on 2016-02-15 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides an evaluation of measures to reduce exposure to highly toxic and carcinogenic contaminants in staple diets in Africa as well as parts of Asia and Latin America. Many of the poorest people in these regions are exposed to the pervasive natural toxins, aflatoxins and fumonisins, on a daily basis by eating their staple diet of groundnuts, maize, and other cereals. Exposure to mycotoxins at these high levels substantially increases mortality and morbidity. Aflatoxins are a cause of human liver cancer, and fatalities from acute aflatoxin poisoning outbreaks occur in Africa and Asia. The International Agency for Research on Cancer convened a Working Group of world-leading experts to review the health effects of aflatoxins and fumonisins and to evaluate intervention measures. The panel concluded that these mycotoxins not only are a cause of acute poisoning and cancer but also are a likely contributor to the high levels of stunting in children in affected populations. The Working Group also identified effective measures to reduce exposure in developing countries. The panel evaluated 15 interventions, considering the strength of the evidence as well as its completeness and its transferability at an individual, community, or national level. Four of the interventions were judged to be ready for implementation: improvement of dietary diversity; crop sorting; post-harvest measures, including improved storage; and, in Latin America for maize, optimized nixtamalization. These recommendations would be relevant for investment of public, nongovernmental organization, and private funds at the scale of the subsistence farmer, the smallholder, and through to a more advanced value chain.
Download or read book Managing the Risks of Extreme Events and Disasters to Advance Climate Change Adaptation written by Intergovernmental Panel on Climate Change and published by Cambridge University Press. This book was released on 2012-05-28 with total page 593 pages. Available in PDF, EPUB and Kindle. Book excerpt: Extreme weather and climate events, interacting with exposed and vulnerable human and natural systems, can lead to disasters. This Special Report explores the social as well as physical dimensions of weather- and climate-related disasters, considering opportunities for managing risks at local to international scales. SREX was approved and accepted by the Intergovernmental Panel on Climate Change (IPCC) on 18 November 2011 in Kampala, Uganda.
Download or read book Exposure to Artificial UV Radiation and Skin Cancer written by IARC Working Group on Risk of Skin Cancer and Exposure to Artificial Ultraviolet Light and published by World Health Organization. This book was released on 2006 with total page 84 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report represents the views and expert opinions of an IARC Working Group that met in Lyon, France, 27-29 June 2005
Download or read book Report of a Working Group on Beta and World Beta Network written by and published by Bioversity International. This book was released on with total page 133 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The UN Working Group on Arbitrary Detention written by Jared Genser and published by Cambridge University Press. This book was released on 2019-09-26 with total page 655 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is a practical guide to freeing political prisoners and provides a comprehensive review of this UN body's 1,200 jurisprudence cases.
Download or read book Evidence Synthesis and Meta analysis for Drug Safety written by Council for International Organizations of Medical Sciences (CIOMS) and published by World Health Organization. This book was released on 2016 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: At any point in the drug development process, systematic reviews and meta-analysis can provide important information to guide the future path of the development program and any actions that might be needed in the post-marketing setting. This report gives the rationale for why and when a meta-analysis should be considered, all in the context of regulatory decision-making, and the tasks, data collection, and analyses that need to be carried out to inform those decisions. There is increasing demand by decision-makers in health care, the bio-pharmaceutical industry, and society at large to have access to the best available evidence on benefits and risks of medicinal products. The best strategy will take an overview of all the evidence and where it is possible and sensible, combine the evidence and summarize the results. For efficacy, the outcomes generally use the same or very similar predefined events for each of the trials to be included. Most regulatory guidance and many Cochrane Collaboration reviews have usually given more attention to assessment of benefits, while issues around combining evidence on harms have not been as well-covered. However, the (inevitably) unplanned nature of the data on safety makes the process more difficult. Combining evidence on adverse events (AEs), where these were not the focus of the original studies, is more challenging than combining evidence on pre-specified benefits. This focus on AEs represents the main contribution of the current CIOMS X report. The goal of the CIOMS X report is to provide principles on appropriate application of meta-analysis in assessing safety of pharmaceutical products to inform regulatory decision-making. This report is about meta-analysis in this narrow area, but the present report should also provide conceptually helpful points to consider for a wider range of applications, such as vaccines, medical devices, veterinary medicines or even products that are combinations of medicinal products and medical devices. Although some of the content of this report describes highly technical statistical concepts and methods (in particular Chapter 4), the ambition of the working group has been to make it comprehensible to non-statisticians for its use in clinical epidemiology and regulatory science. To that end, Chapters 3 and 4, which contain the main technical statistical aspects of the appropriate design, analysis and reporting of a meta-analysis of safety data are followed by Chapter 5 with a thought process for evaluating the findings of a meta-analysis and how to communicate these.
Download or read book The PGA Handbook written by Nicole Ruder and published by . This book was released on 2011-06-30 with total page 124 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Practical Aspects of Signal Detection in Pharmacovigilance written by Council for International Organizations of Medical Sciences (CIOMS) and published by Cioms. This book was released on 2010 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years public expectations for rapid identification and prompt management of emerging drug safety issues have grown swiftly. Over a similar timeframe, the move from paper-based adverse event reporting systems to electronic capture and rapid transmission of data has resulted in the accrual of substantial datasets capable of complex analysis and querying by industry, regulators and other public health organizations. These two drivers have created a fertile environment for pharmacovigilance scientists, information technologists and statistical experts, working together, to deliver novel approaches to detect signals from these extensive and quickly growing datasets, and to manage them appropriately. In following this exciting story, this report looks at the practical consequences of these developments for pharmacovigilance practitioners. The report provides a comprehensive resource for those considering how to strengthen their pharmacovigilance systems and practices, and to give practical advice. But the report does not specify instant solutions. These will inevitably be situation specific and require careful consideration taking into account local needs. However, the CIOMS Working Group VIII is convinced that the combination of methods and a clear policy on the management of signals will strengthen current systems. Finally, in looking ahead, the report anticipates a number of ongoing developments, including techniques with wider applicability to other data forms than individual case reports. The ultimate test for pharmacovigilance systems is the demonstration of public health benefit and it is this test which signal detection methodologies need to meet if the expectations of all stakeholders are to be fulfilled.
Download or read book Conflict of Interest in Medical Research Education and Practice written by Institute of Medicine and published by National Academies Press. This book was released on 2009-09-16 with total page 436 pages. Available in PDF, EPUB and Kindle. Book excerpt: Collaborations of physicians and researchers with industry can provide valuable benefits to society, particularly in the translation of basic scientific discoveries to new therapies and products. Recent reports and news stories have, however, documented disturbing examples of relationships and practices that put at risk the integrity of medical research, the objectivity of professional education, the quality of patient care, the soundness of clinical practice guidelines, and the public's trust in medicine. Conflict of Interest in Medical Research, Education, and Practice provides a comprehensive look at conflict of interest in medicine. It offers principles to inform the design of policies to identify, limit, and manage conflicts of interest without damaging constructive collaboration with industry. It calls for both short-term actions and long-term commitments by institutions and individuals, including leaders of academic medical centers, professional societies, patient advocacy groups, government agencies, and drug, device, and pharmaceutical companies. Failure of the medical community to take convincing action on conflicts of interest invites additional legislative or regulatory measures that may be overly broad or unduly burdensome. Conflict of Interest in Medical Research, Education, and Practice makes several recommendations for strengthening conflict of interest policies and curbing relationships that create risks with little benefit. The book will serve as an invaluable resource for individuals and organizations committed to high ethical standards in all realms of medicine.
Download or read book Report of the Third Session of the COFI Advisory Working Group on Aquatic Genetic Resources and Technologies Rome 20 21 August 2019 written by Food and Agriculture Organization of the United Nations and published by Food & Agriculture Org.. This book was released on 2020-02-14 with total page 38 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report contains the main discussion points and general conclusions and recommendations from the third session of the Working Group convened from 20-21 August 2019 in FAO headquarters, Rome, Italy. The working group considered a range of issues including: a brief review of the process of preparation of the first report on The State of the World’s Aquatic Genetic Resources for Food and Agriculture; (SoWAqGR); the preparation of a GPA on AqGR (GPA); the development of a global information system on aquatic genetic resources including a registry of farmed types; the development of a strategic approach to work on AqGR at FAO; and reviewed its terms of reference (ToR) and update its workplan. A series of recommendations were made to FAO and to the Committee on Fisheries’ sub-committee on aquaculture.
Download or read book The Work of the Future written by David H. Autor and published by MIT Press. This book was released on 2022-06-21 with total page 189 pages. Available in PDF, EPUB and Kindle. Book excerpt: Why the United States lags behind other industrialized countries in sharing the benefits of innovation with workers and how we can remedy the problem. The United States has too many low-quality, low-wage jobs. Every country has its share, but those in the United States are especially poorly paid and often without benefits. Meanwhile, overall productivity increases steadily and new technology has transformed large parts of the economy, enhancing the skills and paychecks of higher paid knowledge workers. What’s wrong with this picture? Why have so many workers benefited so little from decades of growth? The Work of the Future shows that technology is neither the problem nor the solution. We can build better jobs if we create institutions that leverage technological innovation and also support workers though long cycles of technological transformation. Building on findings from the multiyear MIT Task Force on the Work of the Future, the book argues that we must foster institutional innovations that complement technological change. Skills programs that emphasize work-based and hybrid learning (in person and online), for example, empower workers to become and remain productive in a continuously evolving workplace. Industries fueled by new technology that augments workers can supply good jobs, and federal investment in R&D can help make these industries worker-friendly. We must act to ensure that the labor market of the future offers benefits, opportunity, and a measure of economic security to all.
Download or read book Reports and Documents written by United States. Congress and published by . This book was released on with total page 1516 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Belmont Report written by United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and published by . This book was released on 1978 with total page 614 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book State of The Global Workplace written by Gallup and published by Gallup Press. This book was released on 2017-12-19 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Only 15% of employees worldwide are engaged at work. This represents a major barrier to productivity for organizations everywhere – and suggests a staggering waste of human potential. Why is this engagement number so low? There are many reasons — but resistance to rapid change is a big one, Gallup’s research and experience have discovered. In particular, organizations have been slow to adapt to breakneck changes produced by information technology, globalization of markets for products and labor, the rise of the gig economy, and younger workers’ unique demands. Gallup’s 2017 State of the Global Workplace offers analytics and advice for organizational leaders in countries and regions around the globe who are trying to manage amid this rapid change. Grounded in decades of Gallup research and consulting worldwide -- and millions of interviews -- the report advises that leaders improve productivity by becoming far more employee-centered; build strengths-based organizations to unleash workers’ potential; and hire great managers to implement the positive change their organizations need not only to survive – but to thrive.
Download or read book Hearings Reports and Prints of the Senate Committee on Appropriations written by United States. Congress. Senate. Committee on Appropriations and published by . This book was released on 1966 with total page 1848 pages. Available in PDF, EPUB and Kindle. Book excerpt:
