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

Forum on Drug Discovery, Development, and Translation,Institute of Medicine

Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development: Workshop Summary
Format
Paperback
Publisher
National Academies Press
Country
United States
Published
15 December 2012
Pages
118
ISBN
9780309222143

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

Forum on Drug Discovery, Development, and Translation,Institute of Medicine

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–

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