International Regulatory Harmonization Amid Globalization of Drug Development: Workshop Summary

Author:   Institute of Medicine ,  Board on Health Sciences Policy ,  Forum on Drug Discovery, Development, and Translation ,  Tracy A. Lustig
Publisher:   National Academies Press
ISBN:  

9780309284790


Pages:   128
Publication Date:   24 November 2013
Format:   Paperback
Availability:   In Print   Availability explained
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International Regulatory Harmonization Amid Globalization of Drug Development: Workshop Summary


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Overview

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. This document summarizes the workshop.

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Author:   Institute of Medicine ,  Board on Health Sciences Policy ,  Forum on Drug Discovery, Development, and Translation ,  Tracy A. Lustig
Publisher:   National Academies Press
Imprint:   National Academies Press
ISBN:  

9780309284790


ISBN 10:   0309284791
Pages:   128
Publication Date:   24 November 2013
Audience:   College/higher education ,  Professional and scholarly ,  Postgraduate, Research & Scholarly ,  Professional & Vocational
Format:   Paperback
Publisher's Status:   Active
Availability:   In Print   Availability explained
This item will be ordered in for you from one of our suppliers. Upon receipt, we will promptly dispatch it out to you. For in store availability, please contact us.

Table of Contents

1 Front Matter; 2 1 Introduction; 3 2 Principles and Definitional Considerations; 4 3 Overview of the Current Global Regulatory Landscape; 5 4 Areas of Need for Harmonized Standards and Barriers to Progress in Addressing the Gaps; 6 5 Characteristics of Harmonized Regulations and Regulatory Structures; 7 6 Finding Solutions: Options and Systemic Approaches; 8 7 Tactics and Strategies for a Way Forward; 9 References; 10 Appendix A: Workshop Agenda; 11 Appendix B: Participant Biographies

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