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

Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development

Workshop Summary

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Washington (DC): National Academies Press (US); .
ISBN-13: 978-0-309-22214-3ISBN-10: 0-309-22214-1

Excerpt

[T]he 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:

  • 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.
  • Consider workforce development needs in areas identified as key components of a robust discipline of innovative regulatory science in therapeutics development.
  • Examine the application and advantages of collaborative (multisector and multidisciplinary) approaches for strengthening the national regulatory science workforce.
  • 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.

Contents

Rapporteurs: Steve Olson, Anne B. Claiborne

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.

Suggested citation:

IOM (Institute of Medicine). 2012. Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development: Workshop Summary. Washington, DC: The National Academies Press.

Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the authors and do not necessarily reflect the view of the organizations or agencies that provided support for this project.

NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine.

Copyright © 2012, National Academy of Sciences.
Bookshelf ID: NBK91502PMID: 22593951
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