Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development

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Publisher : National Academies Press
ISBN 13 : 0309222176
Total Pages : 118 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development by : Institute of Medicine

Download or read book Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development written by Institute of Medicine and published by National Academies Press. This book was released on 2012-04-04 with total page 118 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

The Regulatory Environment for Science

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Publisher :
ISBN 13 :
Total Pages : 180 pages
Book Rating : 4.0/5 ( download)

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Book Synopsis The Regulatory Environment for Science by :

Download or read book The Regulatory Environment for Science written by and published by . This book was released on 1986 with total page 180 pages. Available in PDF, EPUB and Kindle. Book excerpt:

The Role of Science in Regulatory Reform

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Publisher :
ISBN 13 :
Total Pages : 392 pages
Book Rating : 4.:/5 (319 download)

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Book Synopsis The Role of Science in Regulatory Reform by : United States. Congress. House. Committee on Science and Technology. Subcommittee on Investigations and Oversight

Download or read book The Role of Science in Regulatory Reform written by United States. Congress. House. Committee on Science and Technology. Subcommittee on Investigations and Oversight and published by . This book was released on 2009 with total page 392 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Science at EPA

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Publisher : Routledge
ISBN 13 : 1134271697
Total Pages : 469 pages
Book Rating : 4.1/5 (342 download)

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Book Synopsis Science at EPA by : Mark R. Powell

Download or read book Science at EPA written by Mark R. Powell and published by Routledge. This book was released on 2014-04-23 with total page 469 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Regulation

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Publisher : Mercatus Center at George Mason University
ISBN 13 : 0983607737
Total Pages : 128 pages
Book Rating : 4.9/5 (836 download)

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Book Synopsis Regulation by : Jerry Brito

Download or read book Regulation written by Jerry Brito and published by Mercatus Center at George Mason University. This book was released on 2012-08-13 with total page 128 pages. Available in PDF, EPUB and Kindle. Book excerpt: Federal regulations affect nearly every area of our lives and interest in them is increasing. However, many people have no idea how regulations are developed or how they have an impact on our lives. Regulation: A Primer by Susan Dudley and Jerry Brito provides an accessible overview of regulatory theory, analysis, and practice. The Primer examines the constitutional underpinnings of federal regulation and discusses who writes and enforces regulation and how they do it. Published by the Mercatus Center at George Mason University, it also provides insights into the different varieties of regulation and how to analyze whether a regulatory proposal makes citizens better or worse off. Each chapter discusses key aspects of regulation and provides further readings for those interested in exploring these topics in more detail.

Science in the Regulatory Process

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Publisher :
ISBN 13 :
Total Pages : 286 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Science in the Regulatory Process by : Richard A. Merrill

Download or read book Science in the Regulatory Process written by Richard A. Merrill and published by . This book was released on 2003 with total page 286 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Enhancing Science in the Regulatory Process (ESRP)

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Publisher :
ISBN 13 :
Total Pages : 30 pages
Book Rating : 4.:/5 (448 download)

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Book Synopsis Enhancing Science in the Regulatory Process (ESRP) by : National Environmental Policy Institute (U.S.)

Download or read book Enhancing Science in the Regulatory Process (ESRP) written by National Environmental Policy Institute (U.S.) and published by . This book was released on 1998 with total page 30 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Enhancing the Integrity and Transparency of Science in the Regulatory Process

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Author :
Publisher :
ISBN 13 :
Total Pages : 32 pages
Book Rating : 4.:/5 (38 download)

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Book Synopsis Enhancing the Integrity and Transparency of Science in the Regulatory Process by : National Environmental Policy Institute (U.S.)

Download or read book Enhancing the Integrity and Transparency of Science in the Regulatory Process written by National Environmental Policy Institute (U.S.) and published by . This book was released on 1996 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Models in Environmental Regulatory Decision Making

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Publisher : National Academies Press
ISBN 13 : 0309110009
Total Pages : 286 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Models in Environmental Regulatory Decision Making by : National Research Council

Download or read book Models in Environmental Regulatory Decision Making written by National Research Council and published by National Academies Press. This book was released on 2007-08-25 with total page 286 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Science at EPA

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Publisher : Routledge
ISBN 13 : 9781138465701
Total Pages : pages
Book Rating : 4.4/5 (657 download)

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Book Synopsis Science at EPA by : Mark R. Powell

Download or read book Science at EPA written by Mark R. Powell and published by Routledge. This book was released on 2017-08-30 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Regulatory Policy and the Social Sciences

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Publisher : University of California Press
ISBN 13 : 0520309235
Total Pages : 414 pages
Book Rating : 4.5/5 (23 download)

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Book Synopsis Regulatory Policy and the Social Sciences by : Roger G. Noll

Download or read book Regulatory Policy and the Social Sciences written by Roger G. Noll and published by University of California Press. This book was released on 2021-01-08 with total page 414 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

How Safe is Safe Enough?

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Publisher :
ISBN 13 :
Total Pages : 368 pages
Book Rating : 4.F/5 ( download)

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

Download or read book How Safe is Safe Enough? written by United States. Congress. House. Committee on Science, Space, and Technology. Subcommittee on Investigations and Oversight and published by . This book was released on 1994 with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Application of Best Available Science to the Regulatory Process: The Case of Environmental Regulations. Final Technical Report, February 1990-January 1993

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Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (88 download)

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Book Synopsis Application of Best Available Science to the Regulatory Process: The Case of Environmental Regulations. Final Technical Report, February 1990-January 1993 by :

Download or read book Application of Best Available Science to the Regulatory Process: The Case of Environmental Regulations. Final Technical Report, February 1990-January 1993 written by and published by . This book was released on 1995 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

The Fifth Branch

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Publisher : Harvard University Press
ISBN 13 : 0674264754
Total Pages : 297 pages
Book Rating : 4.6/5 (742 download)

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Book Synopsis The Fifth Branch by : Sheila Jasanoff

Download or read book The Fifth Branch written by Sheila Jasanoff and published by Harvard University Press. This book was released on 1998-08-19 with total page 297 pages. Available in PDF, EPUB and Kindle. Book excerpt: How can decisionmakers charged with protecting the environment and the public’s health and safety steer clear of false and misleading scientific research? Is it possible to give scientists a stronger voice in regulatory processes without yielding too much control over policy, and how can this be harmonized with democratic values? These are just some of the many controversial and timely questions that Sheila Jasanoff asks in this study of the way science advisers shape federal policy. In their expanding role as advisers, scientists have emerged as a formidable fifth branch of government. But even though the growing dependence of regulatory agencies on scientific and technical information has granted scientists a greater influence on public policy, opinions differ as to how those contributions should be balanced against other policy concerns. More important, who should define what counts as good science when all scientific claims incorporate social factors and are subject to negotiation? Jasanoff begins by describing some significant failures—such as nitrites, Love Canal, and alar—in administrative and judicial decisionmaking that fed the demand for more peer review of regulatory science. In analyzing the nature of scientific claims and methods used in policy decisions, she draws comparisons with the promises and limitations of peer review in scientific organizations operating outside the regulatory context. The discussion of advisory mechanisms draws on the author’s close scrutiny of two highly visible federal agencies—the Environmental Protection Agency and the Food and Drug Administration. Here we see the experts in action as they deliberate on critical issues such as clean air, pesticide regulation, and the safety of pharmaceuticals and food additives. Jasanoff deftly merges legal and institutional analysis with social studies of science and presents a strong case for procedural reforms. In so doing, she articulates a social-construction model that is intended to buttress the effectiveness of the fifth branch.

The Manipulation of Science and the Regulatory Process Affecting Oil and Gas Development in Alaska

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Publisher :
ISBN 13 :
Total Pages : 320 pages
Book Rating : 4.0/5 ( download)

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Book Synopsis The Manipulation of Science and the Regulatory Process Affecting Oil and Gas Development in Alaska by : United States. Congress. House. Committee on Interior and Insular Affairs. Subcommittee on Water, Power, and Offshore Energy Resources

Download or read book The Manipulation of Science and the Regulatory Process Affecting Oil and Gas Development in Alaska written by United States. Congress. House. Committee on Interior and Insular Affairs. Subcommittee on Water, Power, and Offshore Energy Resources and published by . This book was released on 1991 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Preparing for Future Products of Biotechnology

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Publisher : National Academies Press
ISBN 13 : 0309452058
Total Pages : 231 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Preparing for Future Products of Biotechnology by : National Academies of Sciences, Engineering, and Medicine

Download or read book Preparing for Future Products of Biotechnology written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-07-28 with total page 231 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Law and Science in Collaboration

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Publisher : Free Press
ISBN 13 :
Total Pages : 328 pages
Book Rating : 4.F/5 ( download)

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Book Synopsis Law and Science in Collaboration by : J. Daniel Nyhart

Download or read book Law and Science in Collaboration written by J. Daniel Nyhart and published by Free Press. This book was released on 1983 with total page 328 pages. Available in PDF, EPUB and Kindle. Book excerpt: