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Conference Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development (2011 : Washington, D.C.)
Title Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development [electronic resource] : workshop summary / Steve Olson and Anne B. Claiborne, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies.
Publication Info. Washington, D.C. : National Academies Press, c2012.
Location Call No. Status Notes
 Libraries Electronic Books  ELECTRONIC BOOK-NCBI Bookshelf    AVAIL. ONLINE
Description xvi, 102 p. : ill. ; 23 cm.
Series NCBI Bookshelf
Bibliography Includes bibliographical references (p. 65).
Contents Introduction -- Defining a discipline of regulatory science and core competencies for its workforce -- Education and training of a regulatory science workforce -- Career paths within academia and industry -- International applications of regulatory science -- Collaborative models and new paradigms for supporting regulatory science research and practice.
Access License restrictions may limit access.
Summary 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-- Source other than Library of Congress.
Subject United States. Food and Drug Administration.
Pharmaceutical policy -- United States -- Regulations -- Congresses.
Drugs -- United States -- Regulations -- Congresses.
Drug development -- United States -- Congresses.
Pharmaceutical industry -- Vocational guidance -- United States -- Congresses.
Pharmaceutical industry -- United States -- Quality control -- Congresses.
Drug Approval -- manpower -- United States -- Congresses.
Added Author Olson, Steve, 1956-
Claiborne, Anne B.
Institute of Medicine (U.S.). Forum on Drug Discovery, Development, and Translation.
NCBI Bookshelf
ISBN 9780309222143
0309222141
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