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International regulatory harmonization amid globalization of drug development : workshop summary

Author: Victoria D Weisfeld; Tracy A Lustig; Institute of Medicine (U.S.). Forum on Drug Discovery, Development, and Translation,
Publisher: Washington, D.C. : National Academies Press, [2013]
Edition/Format:   eBook : Document : Conference publication : EnglishView all editions and formats
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 of medical product development. Demand has been increasing for globally harmonized, science-based standards for the  Read more...
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Genre/Form: Congresses
Electronic books
Methods (Music)
Additional Physical Format: Print version:
International regulatory harmonization amid globalization of drug development.
Washington, D.C. : National Academies Press, 2013
Material Type: Conference publication, Document, Internet resource
Document Type: Internet Resource, Computer File
All Authors / Contributors: Victoria D Weisfeld; Tracy A Lustig; Institute of Medicine (U.S.). Forum on Drug Discovery, Development, and Translation,
ISBN: 9780309284790 0309284791 9780309284806 0309284805
OCLC Number: 862117649
Notes: Title from PDF title page.
Description: 1 online resource
Contents: Introduction --
Principles and definitional considerations --
Overview of the current global regulatory landscape --
Areas of need for harmonized standards and barriers to progress in addressing the gaps --
Characteristics of harmonized regulations and regulatory structures --
Finding solutions: options and systemic approaches --
Tactics and strategies for a way forward.
Responsibility: Victoria Weisfeld and Tracy A. Lustig, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies.

Abstract:

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  Read more...

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