02491nam 2200553 450 991046424640332120200520144314.00-309-28480-5(CKB)2670000000517633(EBL)3379201(SSID)ssj0001215951(PQKBManifestationID)11792098(PQKBTitleCode)TC0001215951(PQKBWorkID)11179331(PQKB)10306460(MiAaPQ)EBC3379201(Au-PeEL)EBL3379201(CaPaEBR)ebr10863855(OCoLC)862117649(EXLCZ)99267000000051763320140505h20132013 ua| 0engurcnu||||||||txtccrInternational regulatory harmonization amid globalization of drug development workshop summary /Victoria Weisfeld and Tracy A. Lustig, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences PolicyWashington, District of Columbia :National Academies Press,[2013]©20131 online resource (128 p.)Description based upon print version of record.0-309-28479-1 Includes bibliographical references.""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""Drug developmentCongressesElectronic books.Drug development615.19Weissfield VictoriaLustig Tracy A.Institute of Medicine (U.S.).Forum on Drug Discovery, Development, and Translation,Institute of Medicine (U.S.).Board on Health Sciences Policy,MiAaPQMiAaPQMiAaPQBOOK9910464246403321International regulatory harmonization amid globalization of drug development2279542UNINA