Weitere details

Titel: Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development
Zustand: Neu
Subtitle: Workshop Summary
Contributor: Steve Olson (Edited by), Anne B. Claiborne (Edited by)
Produktart: Taschenbuch
ISBN-10: 0309222141
EAN: 9780309222143
ISBN: 9780309222143
Verlag: National Academies Press
Genre: Medicine
Erscheinungsdatum: 04.05.2012
Description:

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.

Table of Contents
  • Front Matter
  • 1 Introduction
  • 2 The Importance of Innovative Regulatory Science
  • 3 Defining a Discipline of Regulatory Science and Core Competenciesfor Its Workforce
  • 4 Education and Training of a Regulatory Science Workforce
  • 5 Career Paths Within Academia and Industry
  • 6 International Applications of Regulatory Science
  • 7 Collaborative Models and New Paradigms for Supporting RegulatoryScience Research and Practice
  • References
  • Appendix A: Workshop Agenda
  • Appendix B: Participant Biographies

Sprache: Englisch
Herstellungsland und -region: US
Höhe: 229mm
Länge: 152mm
Autor: No Author
Title Format: Taschenbuch

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