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International Regulatory Harmonization Amid Globalization of Drug Development

Workshop Summary

Jezik AngleščinaAngleščina
Knjiga Mehka
Knjiga International Regulatory Harmonization Amid Globalization of Drug Development Forum on Drug Discovery
Koda Libristo: 04579517
Založba National Academies Press, november 2013
The past several decades have been a time of rapid globalization in the development, manufacture, ma... Celoten opis
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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 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.

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Polni naslov International Regulatory Harmonization Amid Globalization of Drug Development
Jezik Angleščina
Vezava Knjiga - Mehka
Datum izida 2013
Število strani 128
EAN 9780309284790
ISBN 0309284791
Koda Libristo 04579517
Teža 204
Mere 152 x 229
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