Title: Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development: Workshop Summary
Publisher: National Academies Press
Publication Date: 2012
Language: English
ISBN 10: 0309222141
ISBN 13: 9780309222143
Binding: Paperback / softback
Condition: New
Weight: 526 grams

About this title

Synopsis

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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