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03519aam a2200457 a 4500 001 2D2B8F166B5411E69AFE1DDBDAD10320 003 SILO 005 20160826010517 008 120615s2012 dcua b 100 0 eng c 010 $a 2012405371 020 $a 0309222141 020 $a 9780309222143 035 $a (OCoLC)773671733 040 $a BTCTA $b eng $c BTCTA $d DLC $d AAA $d UPM $d YDXCP $d COO $d UKMGB $d CDX $d IWA $d SILO 042 $a pcc 043 $a n-us--- 050 00 $a RM301.25 S768 2011 111 2 $a Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development $d (2011 : $c Washington, D.C.) 245 10 $a Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development : $b workshop summary / $c 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. 246 10 $a Workforce for Innovative Regulatory Science in Therapeutics Development 260 $a Washington, D.C. : $b National Academies Press, $c c2012. 300 $a xvi, 102 p. : $b ill. ; $c 23 cm. 520 $a 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-- $c Source other than Library of Congress. 504 $a Includes bibliographical references (p. 65). 505 0 $a 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. 530 $a Also available in Open Book format via the national Academies Press home page. 610 10 $a United States. $b Food and Drug Administration. 650 0 $a Pharmaceutical policy $z United States $x Regulations $v Congresses. 650 0 $a Drugs $z United States $x Regulations $v Congresses. 650 0 $a Drug development $z United States $v Congresses. 650 0 $a Pharmaceutical industry $x Vocational guidance $z United States $v Congresses. 650 0 $a Pharmaceutical industry $z United States $x Quality control $v Congresses. 700 1 $a Olson, Steve, $d 1956- 700 1 $a Claiborne, Anne B. 710 2 $a Institute of Medicine (U.S.). $b Forum on Drug Discovery, Development, and Translation. 856 41 $3 National Academies Press $u http://www.nap.edu/catalog.php?record_id=13283 941 $a 2 952 $l OVUX522 $d 20171230024448.0 952 $l USUX851 $d 20160826052609.0 956 $a http://locator.silo.lib.ia.us/search.cgi?index_0=id&term_0=2D2B8F166B5411E69AFE1DDBDAD10320 994 $a C0 $b IWAInitiate Another SILO Locator Search