Coverart for item
The Resource 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, (electronic resource)

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, (electronic resource)

Label
Strengthening a workforce for innovative regulatory science in therapeutics development : workshop summary
Title
Strengthening a workforce for innovative regulatory science in therapeutics development
Title remainder
workshop summary
Statement of responsibility
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
Contributor
Subject
Language
eng
Summary
  • The Forum (Forum on Drug Discovery, Development, and Translation) convened a workshop on September 20-21, 2011, entitled "Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development." This workshop provided a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and infrastructure as articulated in the 2010 workshop on regulatory science. The broad objectives of the workshop were (1) to consider opportunities and needs for advancing innovation in the discipline of regulatory science for therapeutics development through an interdisciplinary regulatory science workforce and (2) to examine specific strategies for developing a discipline of innovative regulatory science through development of a robust workforce within academia and industry and at FDA (Food and Drug Administration). Specific objectives included the following:1. Define and discuss the current regulatory science workforce, with particular attention to the disciplines involved, professional training opportunities, and gaps in the essential components of this workforce.2. Consider workforce development needs in areas identified as key components of a robust discipline of innovative regulatory science in therapeutics development.3. Examine the application and advantages of collaborative (multisector and multidisciplinary) approaches for strengthening the national regulatory science workforce.4. Explore the resources and stakeholder engagement needed, not only within FDA and other federal agencies but throughout the extramural sector, to build the discipline and establish career paths in regulatory science for therapeutics development
  • The Forum (Forum on Drug Discovery, Development, and Translation) convened a workshop on September 20-21, 2011, entitled "Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development." This workshop provided a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and infrastructure as articulated in the 2010 workshop on regulatory science. The broad objectives of the workshop were (1) to consider opportunities and needs for advancing innovation in the discipline of regulatory science for therapeutics development through an interdisciplinary regulatory science workforce and (2) to examine specific strategies for developing a discipline of innovative regulatory science through development of a robust workforce within academia and industry and at FDA (Food and Drug Administration). Specific objectives included the following:1. Define and discuss the current regulatory science workforce, with particular attention to the disciplines involved, professional training opportunities, and gaps in the essential components of this workforce.2. Consider workforce development needs in areas identified as key components of a robust discipline of innovative regulatory science in therapeutics development.3. Examine the application and advantages of collaborative (multisector and multidisciplinary) approaches for strengthening the national regulatory science workforce.4. Explore the resources and stakeholder engagement needed, not only within FDA and other federal agencies but throughout the extramural sector, to build the discipline and establish career paths in regulatory science for therapeutics development
  • The Forum (Forum on Drug Discovery, Development, and Translation) convened a workshop on September 20-21, 2011, entitled "Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development." This workshop provided a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and infrastructure as articulated in the 2010 workshop on regulatory science. The broad objectives of the workshop were (1) to consider opportunities and needs for advancing innovation in the discipline of regulatory science for therapeutics development through an interdisciplinary regulatory science workforce and (2) to examine specific strategies for developing a discipline of innovative regulatory science through development of a robust workforce within academia and industry and at FDA (Food and Drug Administration). Specific objectives included the following:1. Define and discuss the current regulatory science workforce, with particular attention to the disciplines involved, professional training opportunities, and gaps in the essential components of this workforce.2. Consider workforce development needs in areas identified as key components of a robust discipline of innovative regulatory science in therapeutics development.3. Examine the application and advantages of collaborative (multisector and multidisciplinary) approaches for strengthening the national regulatory science workforce.4. Explore the resources and stakeholder engagement needed, not only within FDA and other federal agencies but throughout the extramural sector, to build the discipline and establish career paths in regulatory science for therapeutics development
  • 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--
Assigning source
Source other than Library of Congress
Cataloging source
DNLM
Funding information
This study was supported by contracts between the National Academy of Sciences and Department of Health and Human Services (Contract Nos. N01-OD-4-2139 TO #158 and HHSF223001003T), American Society for Microbiology, Amgen Inc., Association of American Medical Colleges, Bristol-Myers Squibb, Burroughs Wellcome Fund, Celtic Therapeutics, LLLP, Critical Path Institute, Doris Duke Charitable Foundation, Eli Lilly & Co., FasterCures, Foundation for the NIH, Friends of Cancer Research, GlaxoSmithKline, Johnson & Johnson, Merck & Co., Inc., Novartis Pharmaceuticals Corporation, and Pfizer Inc.
NLM call number
  • 2012 E-651
  • QV 736
http://library.link/vocab/relatedWorkOrContributorDate
1956-
http://library.link/vocab/relatedWorkOrContributorName
  • Olson, Steve
  • Claiborne, Anne B
  • Institute of Medicine (U.S.)
http://library.link/vocab/subjectName
  • United States
  • Government Regulation
  • Biomedical Research
  • Health Workforce
  • Interdisciplinary Communication
  • United States
Label
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, (electronic resource)
Instantiates
Publication
Bibliography note
Includes bibliographical references
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
Control code
OCM1bookssj0000649765
Dimensions
unknown
Isbn
9780309222143
Specific material designation
remote
System control number
(WaSeSS)bookssj0000649765
Label
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, (electronic resource)
Publication
Bibliography note
Includes bibliographical references
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
Control code
OCM1bookssj0000649765
Dimensions
unknown
Isbn
9780309222143
Specific material designation
remote
System control number
(WaSeSS)bookssj0000649765

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