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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.
Washington, D.C. : National Academies Press, c2012.
1 online resource (PDF file (xv, 102 p.)) : ill.
0309222141, 030922215X (electronic bk.), 1280380195, 9780309222143, 9780309222150 (electronic bk.), 9781280380198
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Washington, D.C. : National Academies Press, c2012.
030922215X (electronic bk.)
9780309222150 (electronic bk.)
Licensed for access by TSH users only.
contents note
Introduction -- The importance of innovative regulatory sciences -- Defining a discipline of regulatory science and core competencies for its workforce -- Education and training of a regulatory science workforce -- Career paths withine academia and industry -- International applications of regulatory sciences -- Collaborative models and new paradigms for supporting regulatory science research and practice.
The Forum (Forum on Drug Discovery, Development, and Translation) convened a workshop on September 20-21, 2011, entitled "Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development." This workshop provided a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and infrastructure as articulated in the 2010 workshop on regulatory science. The broad objectives of the workshop were (1) to consider opportunities and needs for advancing innovation in the discipline of regulatory science for therapeutics development through an interdisciplinary regulatory science workforce and (2) to examine specific strategies for developing a discipline of innovative regulatory science through development of a robust workforce within academia and industry and at FDA (Food and Drug Administration). Specific objectives included the following:1. Define and discuss the current regulatory science workforce, with particular attention to the disciplines involved, professional training opportunities, and gaps in the essential components of this workforce.2. Consider workforce development needs in areas identified as key components of a robust discipline of innovative regulatory science in therapeutics development.3. Examine the application and advantages of collaborative (multisector and multidisciplinary) approaches for strengthening the national regulatory science workforce.4. Explore the resources and stakeholder engagement needed, not only within FDA and other federal agencies but throughout the extramural sector, to build the discipline and establish career paths in regulatory science for therapeutics development.
catalogue key
Includes bibliographical references.
This study was supported by contracts between the National Academy of Sciences and Department of Health and Human Services (Contract Nos. N01-OD-4-2139 TO #158 and HHSF223001003T), American Society for Microbiology, Amgen Inc., Association of American Medical Colleges, Bristol-Myers Squibb, Burroughs Wellcome Fund, Celtic Therapeutics, LLLP, Critical Path Institute, Doris Duke Charitable Foundation, Eli Lilly & Co., FasterCures, Foundation for the NIH, Friends of Cancer Research, GlaxoSmithKline, Johnson & Johnson, Merck & Co., Inc., Novartis Pharmaceuticals Corporation, and Pfizer Inc.

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