LEADER 03779nam 2200505 450 001 9910798442303321 005 20180821235201.0 010 $a0-309-43887-X 010 $a0-309-43885-3 035 $a(CKB)3710000000748911 035 $a(MiAaPQ)EBC4591892 035 $a(EXLCZ)993710000000748911 100 $a20160803h20162016 uy 0 101 0 $aeng 135 $aurcnu|||||||| 181 $2rdacontent 182 $2rdamedia 183 $2rdacarrier 200 00$aAdvancing the discipline of regulatory science for medical product development $ean update on progress and a forward-looking agenda : workshop summary : proceedings of a workshop /$fMorgan L. Boname, Amanda Wagner Gee, and Anne B. Claiborne, rapporteurs ; Forum on Drug Discovery, Development, and Translation [and three others] 210 1$aWashington, District of Columbia :$cThe National Academies Press,$d2016. 210 4$dİ2016 215 $a1 online resource (105 pages) $cillustrations 311 $a0-309-43884-5 320 $aIncludes bibliographical references at the end of each chapters. 327 $aIntroduction -- Characterizing the Implementation science landscape -- Regulatory science applications: using case studies to focus on approaches to advance the discipline -- Regulatory science infrastructure and workforce -- Challenges and opportunities in regulatory science -- Appendix A: Bibliography -- Appendix B: Workshop agenda -- Appendix C: Participant biographies. 330 1 $a"The field of endeavors known as 'regulatory science' has grown out of the need to link and integrate knowledge within and among basic science research, clinical research, clinical medicine, and other specific scientific disciplines whose focus, aggregation, and ultimate implementation could inform biomedical product development and regulatory decision making. Substantial efforts have been devoted to defining regulatory science and communicating its value and role across the scientific and regulatory ecosystems. Investments are also being made in technology infrastructure, regulatory systems, and workforce development to support and advance this burgeoning discipline. In October 2015, the National Academies of Sciences, Engineering, and Medicine held a public workshop to facilitate dialogue among stakeholders about the current state and scope of regulatory science, opportunities to address barriers to the discipline's success, and avenues for fostering collaboration across sectors. Participants explored key needs for strengthening the discipline of regulatory science, including considering what are the core components of regulatory science infrastructure to foster innovation in medical product development. This report summarizes the presentations and discussions from the workshop"--Publisher's description. 606 $aPharmaceutical policy$zUnited States 606 $aDrug development$xTechnological innovations$zUnited States 607 $aUnited States 615 0$aPharmaceutical policy 615 0$aDrug development$xTechnological innovations 676 $a362.17820973 700 $aBoname$b Morgan L.$01512499 702 $aBoname$b Morgan L. 702 $aWagner Gee$b Amanda 702 $aClaiborn$b Anne B. 712 02$aInstitute of Medicine (U.S.).$bForum on Drug Discovery, Development, and Translation. 712 12$aAdvancing the Discipline of Regulatory Science for Medical Product Development: an Update on Progress and a Forward-Looking Agenda (Workshop)$f(2015 :$eWashington, D.C.) 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910798442303321 996 $aAdvancing the discipline of regulatory science for medical product development$93746394 997 $aUNINA