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100   $a20120519d2012      uy         0
101 0 $aeng
135   $aurcn|||||||||
181   $ctxt
182   $cc
183   $acr
200 00$aStrengthening a workforce for innovative regulatory science in therapeutics development $eworkshop summary /$fSteve Olson and Anne B. Claiborne, rapporteurs ; Forum on Drug Discovery, Development, and Translation ; Board on Health Sciences Policy
205   $a1st ed.
210   $aWashington, D.C. $cNational Academies Press$d2012
215   $a1 online resource (119 p.)
300   $a"Forum on Drug Discovery, Development, and Translation ; Board on Health Sciences Policy."
311 08$a0-309-22214-1 
320   $aIncludes bibliographical references.
327   $a""Front Matter""; ""Reviewers""; ""Contents""; ""Figures and Boxes""; ""Acronyms""; ""1 Introduction""; ""2 The Importance of Innovative Regulatory Science""; ""3 Defining a Discipline of Regulatory Science and Core Competencies for 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 Regulatory Science Research and Practice""; ""References""; ""Appendix A: Workshop Agenda""
327   $a""Appendix B: Participant Biographies""
330   $aThe development and application of regulatory science - which FDA has defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products - calls for a well-trained, scientifically engaged, and motivated workforce. FDA faces challenges in retaining regulatory scientists and providing them with opportunities for professional development. In the private sector, advancement of innovative regulatory science in drug development has not always been clearly defined, well coordinated, or connected to the needs of the agency. As a follow-up to a 2010 workshop, the IOM held a workshop on September 20-21, 2011, to provide a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and disciplinary infrastructure as discussed in the 2010 workshop--$cSource other than Library of Congress.
606   $aDrug development$zUnited States$vCongresses
615  0$aDrug development
676   $a615.19
701   $aOlsen$b Steve$01807544
701   $aClaiborne$b Anne B$01805914
712 02$aInstitute of Medicine (U.S.).$bForum on Drug Discovery, Development, and Translation.
712 02$aInstitute of Medicine (U.S.).$bBoard on Health Sciences Policy.
801  0$bMiAaPQ
801  1$bMiAaPQ
801  2$bMiAaPQ
906   $aBOOK
912   $a9910965698403321
996   $aStrengthening a workforce for innovative regulatory science in therapeutics development$94445937
997   $aUNINA