LEADER 02491nam 2200553 450 001 9910464246403321 005 20200520144314.0 010 $a0-309-28480-5 035 $a(CKB)2670000000517633 035 $a(EBL)3379201 035 $a(SSID)ssj0001215951 035 $a(PQKBManifestationID)11792098 035 $a(PQKBTitleCode)TC0001215951 035 $a(PQKBWorkID)11179331 035 $a(PQKB)10306460 035 $a(MiAaPQ)EBC3379201 035 $a(Au-PeEL)EBL3379201 035 $a(CaPaEBR)ebr10863855 035 $a(OCoLC)862117649 035 $a(EXLCZ)992670000000517633 100 $a20140505h20132013 ua| 0 101 0 $aeng 135 $aurcnu|||||||| 181 $ctxt 182 $cc 183 $acr 200 00$aInternational regulatory harmonization amid globalization of drug development $eworkshop summary /$fVictoria Weisfeld and Tracy A. Lustig, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy 210 1$aWashington, District of Columbia :$cNational Academies Press,$d[2013] 210 4$dİ2013 215 $a1 online resource (128 p.) 300 $aDescription based upon print version of record. 311 $a0-309-28479-1 320 $aIncludes bibliographical references. 327 $a""Front Matter""; ""Reviewers""; ""Contents""; ""Boxes""; ""Acronyms""; ""1 Introduction""; ""2 Principles and Definitional Considerations""; ""3 Overview of the Current Global Regulatory Landscape""; ""4 Areas of Need for Harmonized Standards and Barriers to Progress in Addressing the Gaps""; ""5 Characteristics of Harmonized Regulations and Regulatory Structures""; ""6 Finding Solutions: Options and Systemic Approaches""; ""7 Tactics and Strategies for a Way Forward""; ""References""; ""Appendix A: Workshop Agenda""; ""Appendix B: Participant Biographies"" 606 $aDrug development$vCongresses 608 $aElectronic books. 615 0$aDrug development 676 $a615.19 702 $aWeissfield$b Victoria 702 $aLustig$b Tracy A. 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 $a9910464246403321 996 $aInternational regulatory harmonization amid globalization of drug development$92279542 997 $aUNINA