International regulatory harmonization amid globalization of drug development : workshop summary

International regulatory harmonization amid globalization of drug development workshop summary

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"The past several decades have been a time of rapid globalization in the development, manufacture, marketing, and distribution of medical products and technologies. Increasingly, research on the safety and effectiveness of new drugs is being conducted in countries with little experience in regu...

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Detalles Bibliográficos
Autores Corporativos: Institute of Medicine (U.S.). Forum on Drug Discovery, Development, and Translation, issuing body (issuing body), Institute of Medicine (U.S.). Board on Health Sciences Policy, issuing body (sponsoring body), International Regulatory Harmonization Amid Globalization of Biomedical Research and Medical Product Development (Workshop) sponsoring body
Otros Autores: Weisfeld, Victoria D., author (author), Weissfield, Victoria, contributor (contributor), Lustig, Tracy A., contributor
Formato: Libro electrónico
Idioma:Inglés
Publicado: Washington, District of Columbia : National Academies Press [2013]
Edición:1st ed
Materias:
Drug development > Congresses.
Ver en Biblioteca Universitat Ramon Llull:https://discovery.url.edu/permalink/34CSUC_URL/1im36ta/alma991009622115606719
Tabla de Contenidos:
  • ""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""

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