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.Workshop Summary Forum on Drug Discovery, Development, and Transition, Board on Health Sciences Policy, Institute of Medicine Victoria Weisfeld, Tracy A. Lustig ... Ms. Autora#39;s Directorate, one of four created in July 2011, includes the Office of Regulatory Affairs and the Office of ... Ms. Autor is also a 2011 recipient of the Food and Drug Law Institutea#39;s Distinguished Service and Leadership Award inanbsp;...
|Title||:||International Regulatory Harmonization Amid Globalization of Drug Development:|
|Author||:||Forum on Drug Discovery, Development, and Transition, Board on Health Sciences Policy, Institute of Medicine|
|Publisher||:||National Academies Press - 2013-10-24|