Download or read book WHO Coordinated Scientific Advice procedure for health product research and development written by and published by World Health Organization. This book was released on 2021-07-09 with total page 21 pages. Available in PDF, EPUB and Kindle. Book excerpt: The WHO Coordinated Scientific Advice Procedure for health product R&D (CSA) represents a WHO corporate platform for interaction between health product developers and the relevant technical department(s) and the Prequalification team within WHO. The goal of the CSA procedure is to provide advice to product developers on the generation of robust data for future evaluation towards a WHO policy recommendation and product prequalification in areas of unmet public health needs
Download or read book Evidence generation for development of health products written by World Health Organization and published by World Health Organization. This book was released on 2023-12-15 with total page 40 pages. Available in PDF, EPUB and Kindle. Book excerpt: This document describes the main elements that World Health Organization (WHO) technical departments should elaborate on when providing guidance on evidence generation to research and development (R&D) specialists who are developing health products to address critical unmet needs in public health. While WHO’s TPPs, preferred product characteristics (PPCs) and target regimen profiles (TRPs) provide high-level information on the desired characteristics of the product, the target population, and the key endpoints for safety and efficacy evaluation, more detailed guidance is needed to enable the development of suitable trial/study designs aimed at producing relevant evidence for WHO’s normative products such as guidelines. The objective of the Guidance for evidence generation (GEG) process is to produce a guidance document on how best to perform studies for the development of novel products (diagnostics, drugs, vaccines, vector control) and thus how to enable the generation of robust data and evidence to inform a WHO evidence review process.
Download or read book WHO meeting on preferred product characteristics for monoclonal antibodies for malaria prevention written by World Health Organization and published by World Health Organization. This book was released on 2022-10-21 with total page 16 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Beyond the HIPAA Privacy Rule written by Institute of Medicine and published by National Academies Press. This book was released on 2009-03-24 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.
Download or read book WHO Handbook for Guideline Development written by World Health Organization and published by . This book was released on 2015-04-20 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook provides detailed instructions for guideline developers on the following topics: application of high quality methodology for guideline development using systematic search strategies, synthesis and quality assessment of the best available evidence to support the recommendations; appropriate collection and management of experts' declared conflict of interest; expert group composition including content experts, methodologists, target users, policy makers, with gender and geographical balance; instructions for the management of group process to achieve consensus among experts; standards for a transparent decision-making process, taking into consideration potential harms and benefits, end users values and preferences; developing plans for implementing and adapting guidelines; and minimum standards for reporting.--Publisher description.
Download or read book Dietary Supplements written by United States. Federal Trade Commission. Bureau of Consumer Protection and published by . This book was released on 1998 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Science the Endless Frontier written by Vannevar Bush and published by Princeton University Press. This book was released on 2021-02-02 with total page 186 pages. Available in PDF, EPUB and Kindle. Book excerpt: The classic case for why government must support science—with a new essay by physicist and former congressman Rush Holt on what democracy needs from science today Science, the Endless Frontier is recognized as the landmark argument for the essential role of science in society and government’s responsibility to support scientific endeavors. First issued when Vannevar Bush was the director of the US Office of Scientific Research and Development during the Second World War, this classic remains vital in making the case that scientific progress is necessary to a nation’s health, security, and prosperity. Bush’s vision set the course for US science policy for more than half a century, building the world’s most productive scientific enterprise. Today, amid a changing funding landscape and challenges to science’s very credibility, Science, the Endless Frontier resonates as a powerful reminder that scientific progress and public well-being alike depend on the successful symbiosis between science and government. This timely new edition presents this iconic text alongside a new companion essay from scientist and former congressman Rush Holt, who offers a brief introduction and consideration of what society needs most from science now. Reflecting on the report’s legacy and relevance along with its limitations, Holt contends that the public’s ability to cope with today’s issues—such as public health, the changing climate and environment, and challenging technologies in modern society—requires a more capacious understanding of what science can contribute. Holt considers how scientists should think of their obligation to society and what the public should demand from science, and he calls for a renewed understanding of science’s value for democracy and society at large. A touchstone for concerned citizens, scientists, and policymakers, Science, the Endless Frontier endures as a passionate articulation of the power and potential of science.
Download or read book Malaria vaccines preferred product characteristics and clinical development considerations written by World Health Organization and published by World Health Organization. This book was released on 2022-09-30 with total page 77 pages. Available in PDF, EPUB and Kindle. Book excerpt: Preferred product characteristics” (PPCs) are key tools to incentivize and guide the development of urgently needed health products. The PPCs published here aim to articulate the public health need, preferred characteristics, and clinical development considerations for new malaria vaccines. WHO PPCs were initially conceived in 2012-2013 as a class of research-oriented normative guidance documents. The first edition of the WHO PPCs for malaria vaccines (WHO/IVB/14.09), published in 2014, was the first-in-class of these documents. The document published here is an update to the 2014 edition. Since the first malaria vaccine PPCs were published in 2014, major milestones in malaria vaccine R&D have been achieved. In 2021, RTS,S/AS01 became the first malaria vaccine to be recommended by WHO for use in moderate- to high-transmission settings in sub-Saharan Africa. However, a healthy market of vaccines will be needed to meet the global demand. A continued focus on developing new and improved vaccines will be vital in our efforts to reduce global malaria burden and to achieve elimination and eradication. This includes malaria vaccines to prevent blood-stage infection, reduce morbidity and mortality, and/or reduce community-level transmission.
Download or read book Health Care Comes Home written by National Research Council and published by National Academies Press. This book was released on 2011-06-22 with total page 202 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the United States, health care devices, technologies, and practices are rapidly moving into the home. The factors driving this migration include the costs of health care, the growing numbers of older adults, the increasing prevalence of chronic conditions and diseases and improved survival rates for people with those conditions and diseases, and a wide range of technological innovations. The health care that results varies considerably in its safety, effectiveness, and efficiency, as well as in its quality and cost. Health Care Comes Home reviews the state of current knowledge and practice about many aspects of health care in residential settings and explores the short- and long-term effects of emerging trends and technologies. By evaluating existing systems, the book identifies design problems and imbalances between technological system demands and the capabilities of users. Health Care Comes Home recommends critical steps to improve health care in the home. The book's recommendations cover the regulation of health care technologies, proper training and preparation for people who provide in-home care, and how existing housing can be modified and new accessible housing can be better designed for residential health care. The book also identifies knowledge gaps in the field and how these can be addressed through research and development initiatives. Health Care Comes Home lays the foundation for the integration of human health factors with the design and implementation of home health care devices, technologies, and practices. The book describes ways in which the Agency for Healthcare Research and Quality (AHRQ), the U.S. Food and Drug Administration (FDA), and federal housing agencies can collaborate to improve the quality of health care at home. It is also a valuable resource for residential health care providers and caregivers.
Download or read book Monoclonal antibodies for malaria prevention preferred product characteristics and clinical development considerations written by World Health Organization and published by World Health Organization. This book was released on 2023-04-20 with total page 36 pages. Available in PDF, EPUB and Kindle. Book excerpt: Preferred product characteristics (PPCs) are key tools to incentivize and guide the development of urgently needed health products. The PPCs published here aim to articulate the public health need, preferred characteristics, and clinical development considerations for monoclonal antibodies (mAbs) for malaria prevention. Alongside the development of new malaria vaccines and chemoprevention drugs, there have been recent R&D advances in the development of mAbs for malaria prevention. Passive immunization with mAbs through direct administration of functional antibodies could potentially overcome some of the limitations of vaccines by providing immediate protection. Furthermore, mAbs with simplified dose regimens could potentially circumvent some of the coverage and adherence issues faced by malaria chemoprevention. To support this quickly developing R&D area, WHO convened a scientific development group to consider the PPCs for mAbs to be used for malaria prevention, with a focus on the reduction of morbidity and mortality in infants and children due to Plasmodium falciparum.
Download or read book Malaria chemoprevention preferred product characteristics written by World Health Organization and published by World Health Organization. This book was released on 2023-04-20 with total page 38 pages. Available in PDF, EPUB and Kindle. Book excerpt: Preferred product characteristics” (PPCs) are key tools to incentivize and guide the development of urgently needed health products. The PPCs published here aim to articulate the public health need, preferred characteristics, and clinical development considerations for drugs for malaria chemoprevention. WHO recommends several chemoprevention strategies for malaria control, including seasonal malaria chemoprevention, perennial malaria chemoprevention, intermittent preventive treatment of malaria in pregnancy, and mass drug administration. These strategies face a number of challenges such as suboptimal adherence and coverage and the emergence and spread of drug resistance. This document presents PPCs for the development of drugs for malaria chemoprevention in children, in pregnancy and in non-immune travellers, and outlines potential clinical development approaches, including the repurposing of approved malaria treatments for use as chemoprevention, recombining approved individual drugs into new combinations for malaria prevention, and the development of new drug combinations specifically for chemoprevention.
Download or read book Public Health Innovation and Intellectual Property Rights written by and published by WHO. This book was released on 2006-01-01 with total page 204 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Commission was established by the World Health Assembly in 2003 to: "...collect data and proposals from the different actors involved and produce an analysis of intellectual property rights, innovation, and public health, including the question of appropriate funding and incentive mechanisms for the creation of new medicines and other products against diseases that disproportionately affect developing countries..." This report looks at the process of innovation, the path to application and the ways of getting products to patients, ways of fostering innovation in developing countries, and ways to promote both innovation and access
Download or read book Federal Register written by and published by . This book was released on 2013-11 with total page 228 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Implementation Research in Health written by David H. Peters and published by World Health Organization. This book was released on 2013 with total page 69 pages. Available in PDF, EPUB and Kindle. Book excerpt: Interest in implementation research is growing, largely in recognition of the contribution it can make to maximizing the beneficial impact of health interventions. As a relatively new and, until recently, rather neglected field within the health sector, implementation research is something of an unknown quantity for many. There is therefore a need for greater clarity about what exactly implementation research is, and what it can offer. This Guide is designed to provide that clarity. Intended to support those conducting implementation research, those with responsibility for implementing programs, and those who have an interest in both, the Guide provides an introduction to basic implementation research concepts and language, briefly outlines what it involves, and describes the many opportunities that it presents. The main aim of the Guide is to boost implementation research capacity as well as demand for implementation research that is aligned with need, and that is of particular relevance to health systems in low- and middle-income countries (LMICs). Research on implementation requires the engagement of diverse stakeholders and multiple disciplines in order to address the complex implementation challenges they face. For this reason, the Guide is intended for a variety of actors who contribute to and/or are impacted by implementation research. This includes the decision-makers responsible for designing policies and managing programs whose decisions shape implementation and scale-up processes, as well as the practitioners and front-line workers who ultimately implement these decisions along with researchers from different disciplines who bring expertise in systematically collecting and analyzing information to inform implementation questions. The opening chapters (1-4) make the case for why implementation research is important to decision-making. They offer a workable definition of implementation research and illustrate the relevance of research to problems that are often considered to be simply administrative and provide examples of how such problems can be framed as implementation research questions. The early chapters also deal with the conduct of implementation research, emphasizing the importance of collaboration and discussing the role of implementers in the planning and designing of studies, the collection and analysis of data, as well as in the dissemination and use of results. The second half of the Guide (5-7) detail the various methods and study designs that can be used to carry out implementation research, and, using examples, illustrates the application of quantitative, qualitative, and mixed-method designs to answer complex questions related to implementation and scale-up. It offers guidance on conceptualizing an implementation research study from the identification of the problem, development of research questions, identification of implementation outcomes and variables, as well as the selection of the study design and methods while also addressing important questions of rigor.
Download or read book Report of the sixth meeting of the WHO Strategic and Technical Advisory Group of Experts for Maternal Newborn Child and Adolescent Health and Nutrition 15 17 November 2022 written by World Health Organization and published by World Health Organization. This book was released on 2023-03-28 with total page 60 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Minutes of Meeting written by National Institutes of Health (U.S.). Recombinant DNA Advisory Committee and published by . This book was released on 1985 with total page 64 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Minutes of Meeting September 23 1985 written by National Institutes of Health (U.S.). Recombinant DNA Advisory Committee. Meeting and published by . This book was released on 1985 with total page 68 pages. Available in PDF, EPUB and Kindle. Book excerpt:
