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Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development: Workshop Summary.

Editors

Institute of Medicine (US).

Source

Washington (DC): National Academies Press (US); 2012.
The National Academies Collection: Reports funded by National Institutes of Health.

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.

Copyright © 2012, National Academy of Sciences.

PMID:
22593951
[PubMed]
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