Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development
Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2012-04-04

Total Pages: 118

ISBN-13: 0309222176

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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.

Biotechnology Research in an Age of Terrorism
Biotechnology Research in an Age of Terrorism

Author: National Research Council

Publisher: National Academies Press

Published: 2004-03-02

Total Pages: 164

ISBN-13: 0309089778

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In recent years much has happened to justify an examination of biological research in light of national security concerns. The destructive application of biotechnology research includes activities such as spreading common pathogens or transforming them into even more lethal forms. Policymakers and the scientific community at large must put forth a vigorous and immediate response to this challenge. This new book by the National Research Council recommends that the government expand existing regulations and rely on self-governance by scientists rather than adopt intrusive new policies. One key recommendation of the report is that the government should not attempt to regulate scientific publishing but should trust scientists and journals to screen their papers for security risks, a task some journals have already taken up. With biological information and tools widely distributed, regulating only U.S. researchers would have little effect. A new International Forum on Biosecurity should encourage the adoption of similar measures around the world. Seven types of risky studies would require approval by the Institutional Biosafety Committees that already oversee recombinant DNA research at some 400 U.S. institutions. These "experiments of concern" include making an infectious agent more lethal and rendering vaccines powerless.

The Lilliputians of Environmental Regulation
The Lilliputians of Environmental Regulation

Author: Michelle C. Pautz

Publisher: Routledge

Published: 2013

Total Pages: 157

ISBN-13: 0415808154

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The Lilliputians of Environmental Regulation offers a unique perspective about an understudied aspect of environmental policy, by sharing the stories of the front-line regulators that implement policy on a day-to-day basis in the United States.

Environmental Regulation
Environmental Regulation

Author: Robert V. Percival

Publisher: Aspen Publishers

Published: 2000

Total Pages: 1302

ISBN-13:

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In its refined Third Edition, this popular casebook responds to both changes in the field and user feedback. ENVIRONMENTAL REGULATION: Law, Science, and Policy, Third Edition, Is skillfully designed to help students and professors navigate this complex area of law. The authors bring clarity and coherence To The study of environmental regulations And The policy considerations that shape them, with: comprehensive coverage that supplies a complete introduction to environmental law while it allows professors flexibility to choose which topics to emphasize a detailed examination of policy that goes beyond an explanation of the regulatory structure to explore the political, economic, and ethical concerns that influence policy and enforcement effective teaching and study aids including charts and diagrams that map the structure of each major environmental statute, problems and questions based on real-life situations, and 'pathfinders' to explain where to locate crucial source materials a website (http://www.law.umaryland.edu/courses/environment) that continually updates subjects covered in the book with links that enable students to learn more about topics of interest detailed suggestions for teaching from the book provided in an extensive Teacher's Manual engaging and student-friendly text that demystifies the field Updated features of ENVIRONMENTAL REGULATION: Law, Science, and Policy, Third Edition, include: Updated coverage of the Clean Air Act New chapter on Land Use Regulation and Regulatory Policy Broader coverage of issues of federalism and congressional authority New problem exercises, and cases, including the Supreme Court's year 2000 Laidlaw decision on standing in citizen enforcement actions When you select materials for your next course, consider the book that provides you with the most recent information and lets you organize it to suit your individual teaching preferences - ENVIRONMENTAL REGULATION: Law, Science, and Policy, Third Edition. Authors' website: http://www.law.umaryland.edu/courses/environment

Research Regulatory Compliance
Research Regulatory Compliance

Author: Mark A. Suckow

Publisher: Academic Press

Published: 2015-06-14

Total Pages: 345

ISBN-13: 0124200656

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Research Regulatory Compliance offers the latest information on regulations and compliance in the laboratory. With the increasing complexity of regulations and need for institutional infrastructure to deal with compliance of animal use issues, as well as a requirement surrounding human subjects, this publication provides reputable guidance and information. The book is extremely helpful as a resource for researchers, administrators, and technicians in the laboratory, and is also a great asset for faculty or new researchers coming in to the laboratory environment. It will help prepare users for the deluge of regulatory and compliance issues they will face while conducting their scientific programs. The book is edited and authored by known leaders in the field of compliance and regulations, and contains extensive research on the topics. It represents the new standard for information in every laboratory. - Provides a "one-stop" , go-to resource for the many regulatory and compliance issues that affect laboratory study and research models - Extremely helpful as a resource for researchers, administrators, and technicians in the laboratory, and also a great asset for faculty or new researchers coming in to the laboratory environment - Focuses on United States regulations, covering both animal models and human subjects - Written and edited by known leaders in the field of regulatory compliance who bring many years of collective experience to the book

Science at EPA
Science at EPA

Author: Mark R. Powell

Publisher: Routledge

Published: 2014-04-23

Total Pages: 469

ISBN-13: 1134271697

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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.