Research Catalog
Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development : workshop summary / Steve Olson and Anne B. Claiborne, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies.
- Title
- Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development : workshop summary / Steve Olson and Anne B. Claiborne, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies.
- Author
- Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development (2011 : Washington, D.C.)
- Publication
- Washington, D.C. : National Academies Press, c2012.
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| Status | Format | Access | Call Number | Item Location |
|---|---|---|---|---|
| Text | Request in advance | RM301.25 .S768 2011g | Off-site | |
Not available - Please for assistance. | Text | Use in library | Off-site |
Details
- Additional Authors
- Description
- xvi, 102 p. : ill.; 23 cm.
- Summary
- 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.
- Subjects
- Congress
- Drug Approval > manpower
- Pharmaceutical policy > United States > Regulations > Congresses
- Pharmaceutical industry > Vocational guidance > United States > Congresses
- Drugs > United States > Regulations > Congresses
- Pharmaceutical industry > United States > Quality control > Congresses
- Drug development > United States > Congresses
- United States > Food and Drug Administration
- Genre/Form
- Congress.
- Bibliography (note)
- Includes bibliographical references (p. 65).
- Additional Formats (note)
- Also available in Open Book format via the national Academies Press home page.
- Contents
- Introduction -- Defining a discipline of regulatory science and core competencies for its workforce -- Education and training of a regulatory science workforce -- Career paths within academia and industry -- International applications of regulatory science -- Collaborative models and new paradigms for supporting regulatory science research and practice.
- ISBN
- 9780309222143
- 0309222141
- Owning Institutions
- Columbia University Libraries