International regulatory harmonization amid globalization of drug development : workshop summary /

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 regulation...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autores principales: Weisfeld, Victoria D. (Autor), Lustig, Tracy A. (Autor)
Autor Corporativo: International Regulatory Harmonization Amid Globalization of Biomedical Research and Medical Product Development (Workshop)
Formato: Electrónico Congresos, conferencias eBook
Idioma:Inglés
Publicado: Washington, D.C. : National Academies Press, [2013]
Temas:
Drug development.
Drugs > Testing > Standards.
Drug approval > Methods.
Drugs > Design.
Drug Design
Drug Evaluation > standards
Internationality
Legislation, Drug
Pharmaceutical Preparations > supply & distribution
Médicaments > Développement.
Médicaments > Essais cliniques > Normes.
Médicaments > Conception.
MEDICAL > Pharmacology.
Drugs > Design
Drug approval
Drug development
Drugs > Testing > Standards
Congress
proceedings (reports)
Conference papers and proceedings
Methods (Music)
Conference papers and proceedings.
Actes de congrès.
Acceso en línea:Texto completo
Descripción
Sumario: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 regulation of medical product development. Demand has been increasing for globally harmonized, science-based standards for the development and evaluation of the safety, quality, and efficacy of medical products. Consistency of such standards could improve the efficiency and clarity of the drug development and evaluation process and, ultimately, promote and enhance product quality and the public health. To explore the need and prospects for greater international regulatory harmonization for drug development, the IOM Forum on Drug Discovery, Development, and Translation hosted a workshop on February 13-14, 2013. Discussions at the workshop helped identify principles, potential approaches, and strategies to advance the development or evolution of more harmonized regulatory standards. This document summarizes the workshop.
Notas:Title from PDF title page.
Descripción Física:1 online resource
Bibliografía:Includes bibliographical references.
ISBN:9780309284790
0309284791
9780309284806
0309284805

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