Advancing Regulatory Science For Public Health
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Advancing Regulatory Science For Public Health
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Author : Barry Leonard
language : en
Publisher: DIANE Publishing
Release Date : 2011
Advancing Regulatory Science For Public Health written by Barry Leonard and has been published by DIANE Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011 with Health & Fitness categories.
This is a print on demand edition of a hard to find publication. Recent breakthroughs in science and tech. -- ranging from sequencing of the human genome to advances in the application of nanotech. to new medical products -- may transform our ability to prevent, diagnose and treat disease. Similarly, advances in research and IT enable us to more efficiently identify microbial pathogens, track food contamination outbreaks and determine where foods and other FDA-regulated products are produced or manufactured, how they are transported, where they go and who uses them. This report outlines a broad vision for advancing regulatory science and unleashing its potential to improve public health. It discusses the role of the FDA to strengthen the field, both within the agency and throughout the Nation. Illustrations.
Advancing Regulatory Science For Medical Countermeasure Development
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2011-08-27
Advancing Regulatory Science For Medical Countermeasure Development written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-08-27 with Medical categories.
Whether or not the United States has safe and effective medical countermeasures-such as vaccines, drugs, and diagnostic tools-available for use during a disaster can mean the difference between life and death for many Americans. The Food and Drug Administration (FDA) and the scientific community at large could benefit from improved scientific tools and analytic techniques to undertake the complex scientific evaluation and decision making needed to make essential medical countermeasures available. At the request of FDA, the Institute of Medicine (IOM) held a workshop to examine methods to improve the development, evaluation, approval, and regulation of medical countermeasures. During public health emergencies such as influenza or chemical, biological, radiological/nuclear (CBRN) attacks, safe and effective vaccines, treatments, and other medical countermeasures are essential to protecting national security and the well being of the public. Advancing Regulatory Science for Medical Countermeasure Development examines current medical countermeasures, and investigates the future of research and development in this area. Convened on March 29-30, 2011, this workshop identified regulatory science tools and methods that are available or under development, as well as major gaps in currently available regulatory science tools. Advancing Regulatory Science for Medical Countermeasure Development is a valuable resource for federal agencies including the Food and Drug Administration (FDA), the Department of Health and Human Services (HHS), the Department of Defense (DoD), as well as health professionals, and public and private health organizations.
Governing Science And Technology Under The International Economic Order
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Author : Shin-yi Peng
language : en
Publisher: Edward Elgar Publishing
Release Date :
Governing Science And Technology Under The International Economic Order written by Shin-yi Peng and has been published by Edward Elgar Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on with Electronic books categories.
Against the backdrop of the recent trend towards megaregional trade initiatives, this book addresses the most topical issues that lie at the intersection of law and technology. By assessing international law and the political economy, the contributing authors offer an enhanced understanding of the challenges of diverging regulatory approaches to innovation.
Advancing Regulatory Science For Public Health
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Author : United States. Food and Drug Administration
language : en
Publisher:
Release Date : 2010
Advancing Regulatory Science For Public Health written by United States. Food and Drug Administration and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010 with Administrative regulation drafting categories.
Science And Decisions
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Author : National Research Council
language : en
Publisher: National Academies Press
Release Date : 2009-03-24
Science And Decisions written by National Research Council and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-03-24 with Political Science categories.
Risk assessment has become a dominant public policy tool for making choices, based on limited resources, to protect public health and the environment. It has been instrumental to the mission of the U.S. Environmental Protection Agency (EPA) as well as other federal agencies in evaluating public health concerns, informing regulatory and technological decisions, prioritizing research needs and funding, and in developing approaches for cost-benefit analysis. However, risk assessment is at a crossroads. Despite advances in the field, risk assessment faces a number of significant challenges including lengthy delays in making complex decisions; lack of data leading to significant uncertainty in risk assessments; and many chemicals in the marketplace that have not been evaluated and emerging agents requiring assessment. Science and Decisions makes practical scientific and technical recommendations to address these challenges. This book is a complement to the widely used 1983 National Academies book, Risk Assessment in the Federal Government (also known as the Red Book). The earlier book established a framework for the concepts and conduct of risk assessment that has been adopted by numerous expert committees, regulatory agencies, and public health institutions. The new book embeds these concepts within a broader framework for risk-based decision-making. Together, these are essential references for those working in the regulatory and public health fields.
Advancing The Discipline Of Regulatory Science For Medical Product Development
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Author : National Academies of Sciences, Engineering, and Medicine
language : en
Publisher: National Academies Press
Release Date : 2016-07-11
Advancing The Discipline Of Regulatory Science For Medical Product Development written by National Academies of Sciences, Engineering, and Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-07-11 with Medical categories.
The field of endeavors known as "regulatory science" has grown out of the need to link and integrate knowledge within and among basic science research, clinical research, clinical medicine, and other specific scientific disciplines whose focus, aggregation, and ultimate implementation could inform biomedical product development and regulatory decision making. Substantial efforts have been devoted to defining regulatory science and communicating its value and role across the scientific and regulatory ecosystems. Investments are also being made in technology infrastructure, regulatory systems, and workforce development to support and advance this burgeoning discipline. In October 2015, the National Academies of Sciences, Engineering, and Medicine held a public workshop to facilitate dialogue among stakeholders about the current state and scope of regulatory science, opportunities to address barriers to the discipline's success, and avenues for fostering collaboration across sectors. Participants explored key needs for strengthening the discipline of regulatory science, including considering what are the core components of regulatory science infrastructure to foster innovation in medical product development. This report summarizes the presentations and discussions from the workshop.
Regulatory Affairs In The Pharmaceutical Industry
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Author : Javed Ali
language : en
Publisher: Academic Press
Release Date : 2021-11-14
Regulatory Affairs In The Pharmaceutical Industry written by Javed Ali and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-11-14 with Medical categories.
Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more. Updated reference on drug approval processes in key global markets Provides comprehensive coverage of concepts and regulatory affairs Presents a concise compilation of the regulatory requirements of different countries Introduces the fundamentals of manufacturing controls and their regulatory importance
Sharing Clinical Trial Data
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2015-04-20
Sharing Clinical Trial Data written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-04-20 with Medical categories.
Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Rare Diseases And Orphan Products
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2011-04-03
Rare Diseases And Orphan Products written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-04-03 with Medical categories.
Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Ai And Data Science In Drug Development And Public Health Highlights From The Mcbios 2022 Conference
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Author : Ramin Homayouni
language : en
Publisher: Frontiers Media SA
Release Date : 2023-03-27
Ai And Data Science In Drug Development And Public Health Highlights From The Mcbios 2022 Conference written by Ramin Homayouni and has been published by Frontiers Media SA this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-03-27 with Science categories.