Science In The Regulatory Process

Author : Anonim
Publisher : Unknown
Page : 184 pages
File Size : 43,7 Mb
Release : 1986
Category : Research
ISBN : UCAL:B4244205

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The Regulatory Environment for Science by Anonim Pdf

Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Publisher : National Academies Press
Page : 118 pages
File Size : 46,8 Mb
Release : 2012-04-04
Category : Medical
ISBN : 9780309222174

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Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development by Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation Pdf

The development and application of regulatory science - which FDA has defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products - calls for a well-trained, scientifically engaged, and motivated workforce. FDA faces challenges in retaining regulatory scientists and providing them with opportunities for professional development. In the private sector, advancement of innovative regulatory science in drug development has not always been clearly defined, well coordinated, or connected to the needs of the agency. As a follow-up to a 2010 workshop, the IOM held a workshop on September 20-21, 2011, to provide a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and disciplinary infrastructure as discussed in the 2010 workshop.

Author : Roger G. Noll
Publisher : University of California Press
Page : 414 pages
File Size : 43,6 Mb
Release : 2021-01-08
Category : Social Science
ISBN : 9780520309234

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Regulatory Policy and the Social Sciences by Roger G. Noll Pdf

This title is part of UC Press's Voices Revived program, which commemorates University of California Press’s mission to seek out and cultivate the brightest minds and give them voice, reach, and impact. Drawing on a backlist dating to 1893, Voices Revived makes high-quality, peer-reviewed scholarship accessible once again using print-on-demand technology. This title was originally published in 1985.

Author : Sidney Green
Publisher : CRC Press
Page : 312 pages
File Size : 43,6 Mb
Release : 2019-08-30
Category : Electronic
ISBN : 0367391082

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Toxicology and Regulatory Process by Sidney Green Pdf

Providing detailed examples and valuable discussions of the development of specific methods, approaches, and legislation, this reference presents the latest information on the impact of toxicology on the regulatory process and illustrates the interrelationship between toxicology and the regulation of chemicals, pharmaceutical compounds, and food substances.

Author : Mark R. Powell
Publisher : Routledge
Page : 128 pages
File Size : 45,5 Mb
Release : 2017-08-30
Category : Electronic
ISBN : 1138465704

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Science at EPA by Mark R. Powell Pdf

The U.S. Environmental Protection Agency was created to protect public health and the environment, and it has traditionally emphasized its regulatory mission over its scientific mission. Yet for environmental policy to be credible with the public and policymakers, EPA's actions must have a sound basis in science. In Science at EPA, Mark Powell offers detailed case studies that map the origins, flow, and impact of scientific information in eight EPA decisions involving the agency's major statutory programs. Drawing on extensive research and interviews, he provides the most comprehensive examination available on the acquisition and use of science in environmental regulation. Powell describes the key obstacles to the practical, efficient, and effective acquisition and use of knowledge in what is a crucial, but complex endeavor. His book is an essential contribution for practitioners, scholars and students, and citizens who are determined to protect our environment rationally and effectively.

Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Publisher : National Academies Press
Page : 94 pages
File Size : 53,5 Mb
Release : 2011-03-15
Category : Medical
ISBN : 9780309158893

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Building a National Framework for the Establishment of Regulatory Science for Drug Development by Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation Pdf

The Food and Drug Administration (FDA) is tasked with ensuring the safety and effectiveness of medicine. FDA's science base must be strong enough to make certain that regulatory decisions are based on the best scientific evidence. The IOM held a public workshop on February 26, 2010, to examine the state of regulatory science and to consider approaches for enhancing it.

Author : International Atomic Energy Agency
Publisher : Unknown
Page : 0 pages
File Size : 51,8 Mb
Release : 2018
Category : Technology & Engineering
ISBN : 9201007183

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Functions and Processes of the Regulatory Body for Safety by International Atomic Energy Agency Pdf

This Safety Guide provides recommendations on meeting the requirements of IAEA Safety Standards Series No. GSR Part 1 (Rev. 1), Governmental, Legal and Regulatory Framework for Safety, on the regulatory body's core functions and associated regulatory processes. This guidance is particularly important for regulatory bodies having responsibilities covering a range of facilities and activities that give rise to radiation risks and the important organizational interfaces between various regulatory authorities, which require effective coordination and cooperation. It promotes a consistent approach to regulation and specifically addresses the release of facilities and activities from regulatory control including sites, buildings, equipment and material. The publication is intended to be used mainly by regulatory bodies but will also be useful for governments that are developing a regulatory framework for safety. It will also assist authorized parties and others dealing with radiation sources in understanding regulatory procedures, processes and expectations.

Author : Wendy E. Wagner,Rena I. Steinzor
Publisher : Unknown
Page : 0 pages
File Size : 45,9 Mb
Release : 2014
Category : Electronic
ISBN : OCLC:1375311922

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Rescuing Science from Politics by Wendy E. Wagner,Rena I. Steinzor Pdf

Rescuing Science from Politics debuts fourteen chapters by the nation's leading academics in law, science, and philosophy who explore the ways that special interests can abuse the law to intrude on the way that scientists conduct research. The high stakes and adversarial features of regulation create the worst possible climate for the production and use of honest science, especially by those who will ultimately bear the cost of the resulting regulatory standards. Yet the academic or popular literature has paid scant attention to efforts by dominant interest groups to distort the available science in support of their positions. The book begins by establishing what should be noncontroversial principles of good scientific practice. These principles serve as the benchmark against which each chapter's author explains how science is misused in specific regulatory settings and isolates problems in the integration of science by the regulatory process. Dr. Donald Kenney, editor of Science, writes the prologue for the book.

Author : United States. Congress. House. Committee on Science, Space, and Technology. Subcommittee on Investigations and Oversight
Publisher : Unknown
Page : 368 pages
File Size : 47,9 Mb
Release : 1994
Category : Medical
ISBN : STANFORD:36105022044007

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How Safe is Safe Enough? by United States. Congress. House. Committee on Science, Space, and Technology. Subcommittee on Investigations and Oversight Pdf

Author : National Academies of Sciences, Engineering, and Medicine,Division on Earth and Life Studies,Board on Chemical Sciences and Technology,Board on Agriculture and Natural Resources,Board on Life Sciences,Committee on Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System
Publisher : National Academies Press
Page : 231 pages
File Size : 42,8 Mb
Release : 2017-07-28
Category : Science
ISBN : 9780309452052

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Preparing for Future Products of Biotechnology by National Academies of Sciences, Engineering, and Medicine,Division on Earth and Life Studies,Board on Chemical Sciences and Technology,Board on Agriculture and Natural Resources,Board on Life Sciences,Committee on Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System Pdf

Between 1973 and 2016, the ways to manipulate DNA to endow new characteristics in an organism (that is, biotechnology) have advanced, enabling the development of products that were not previously possible. What will the likely future products of biotechnology be over the next 5â€"10 years? What scientific capabilities, tools, and/or expertise may be needed by the regulatory agencies to ensure they make efficient and sound evaluations of the likely future products of biotechnology? Preparing for Future Products of Biotechnology analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making. This report identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of biotechnology are well understood.

Author : J. Daniel Nyhart,Milton Michael Carrow
Publisher : Free Press
Page : 328 pages
File Size : 47,5 Mb
Release : 1983
Category : Law
ISBN : STANFORD:36105037464000

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Law and Science in Collaboration by J. Daniel Nyhart,Milton Michael Carrow Pdf

Author : Shein-Chung Chow
Publisher : CRC Press
Page : 298 pages
File Size : 52,6 Mb
Release : 2019-11-14
Category : Mathematics
ISBN : 9781000710816

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Innovative Statistics in Regulatory Science by Shein-Chung Chow Pdf

Statistical methods that are commonly used in the review and approval process of regulatory submissions are usually referred to as statistics in regulatory science or regulatory statistics. In a broader sense, statistics in regulatory science can be defined as valid statistics that are employed in the review and approval process of regulatory submissions of pharmaceutical products. In addition, statistics in regulatory science are involved with the development of regulatory policy, guidance, and regulatory critical clinical initiatives related research. This book is devoted to the discussion of statistics in regulatory science for pharmaceutical development. It covers practical issues that are commonly encountered in regulatory science of pharmaceutical research and development including topics related to research activities, review of regulatory submissions, recent critical clinical initiatives, and policy/guidance development in regulatory science. Devoted entirely to discussing statistics in regulatory science for pharmaceutical development. Reviews critical issues (e.g., endpoint/margin selection and complex innovative design such as adaptive trial design) in the pharmaceutical development and regulatory approval process. Clarifies controversial statistical issues (e.g., hypothesis testing versus confidence interval approach, missing data/estimands, multiplicity, and Bayesian design and approach) in review/approval of regulatory submissions. Proposes innovative thinking regarding study designs and statistical methods (e.g., n-of-1 trial design, adaptive trial design, and probability monitoring procedure for sample size) for rare disease drug development. Provides insight regarding current regulatory clinical initiatives (e.g., precision/personalized medicine, biomarker-driven target clinical trials, model informed drug development, big data analytics, and real world data/evidence). This book provides key statistical concepts, innovative designs, and analysis methods that are useful in regulatory science. Also included are some practical, challenging, and controversial issues that are commonly seen in the review and approval process of regulatory submissions. About the author Shein-Chung Chow, Ph.D. is currently a Professor at Duke University School of Medicine, Durham, NC. He was previously the Associate Director at the Office of Biostatistics, Center for Drug Evaluation and Research, United States Food and Drug Administration (FDA). Dr. Chow has also held various positions in the pharmaceutical industry such as Vice President at Millennium, Cambridge, MA, Executive Director at Covance, Princeton, NJ, and Director and Department Head at Bristol-Myers Squibb, Plainsboro, NJ. He was elected Fellow of the American Statistical Association and an elected member of the ISI (International Statistical Institute). Dr. Chow is Editor-in-Chief of the Journal of Biopharmaceutical Statistics and Biostatistics Book Series, Chapman and Hall/CRC Press, Taylor & Francis, New York. Dr. Chow is the author or co-author of over 300 methodology papers and 30 books.

Author : Ira R. Berry
Publisher : Drugs and the Pharmaceutical Sciences
Page : 650 pages
File Size : 52,9 Mb
Release : 2019-06-07
Category : Drugs
ISBN : 1138381284

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The Pharmaceutical Regulatory Process by Ira R. Berry Pdf

This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by top industry professionals, practicing attorneys, and FDA regulators, it includes policies and procedures that pharmaceutical companies need to implement regulatory compliance post-approval. New chapters cover: the marketing of unapproved new drugs and FDA efforts to keep them in regulatory compliance pharmacovigilance programs designed to prevent widespread safety issues legal issues surrounding the sourcing of foreign APIs the issues of counterfeit drugs updates on quality standards

Author : Science Council of Canada,G. Bruce Doern
Publisher : Unknown
Page : 201 pages
File Size : 46,7 Mb
Release : 1977
Category : Electronic
ISBN : OCLC:1016312105

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Regulatory Processes and Jurisdictional Issues in the Regulation of Hazardous Products in Canada by Science Council of Canada,G. Bruce Doern Pdf

Author : National Research Council,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Committee on Models in the Regulatory Decision Process
Publisher : National Academies Press
Page : 286 pages
File Size : 52,7 Mb
Release : 2007-08-25
Category : Political Science
ISBN : 9780309110006

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Models in Environmental Regulatory Decision Making by National Research Council,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Committee on Models in the Regulatory Decision Process Pdf

Many regulations issued by the U.S. Environmental Protection Agency (EPA) are based on the results of computer models. Models help EPA explain environmental phenomena in settings where direct observations are limited or unavailable, and anticipate the effects of agency policies on the environment, human health and the economy. Given the critical role played by models, the EPA asked the National Research Council to assess scientific issues related to the agency's selection and use of models in its decisions. The book recommends a series of guidelines and principles for improving agency models and decision-making processes. The centerpiece of the book's recommended vision is a life-cycle approach to model evaluation which includes peer review, corroboration of results, and other activities. This will enhance the agency's ability to respond to requirements from a 2001 law on information quality and improve policy development and implementation.