Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development:

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Size: 102 pages, 6 x 9

Publication Year:2012

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PAPERBACK ISBN-10: 0-309-22214-1 ISBN-13: 978-0-309-22214-3	$31.00	Add to Cart

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Authors:
Steve Olson and Anne B. Claiborne, Rapporteurs; Forum on Drug Discovery, Development, and Translation; Institute of Medicine
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Table of Contents
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Front Matter	i-xvi
1 Introduction	1-4	(skim)
2 The Importance of Innovative Regulatory Science	5-18	(skim)
3 Defining a Discipline of Regulatory Science and Core Competencies for Its Workforce	19-30	(skim)
4 Education and Training of a Regulatory Science Workforce	31-42	(skim)
5 Career Paths Within Academia and Industry	43-50	(skim)
6 International Applications of Regulatory Science	51-56	(skim)
7 Collaborative Models and New Paradigms for Supporting Regulatory Science Research and Practice	57-64	(skim)
References	65-66	(skim)
Appendix A: Workshop Agenda	67-80	(skim)
Appendix B: Participant Biographies	81-102	(skim)

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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.

Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development:

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