International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations

A Global Perspective

By

  • Pierre-Louis Lezotre, PhD, MS, Director, Global Regulatory Affairs, Allergan, Inc., Irvine, CA, USA

International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations: A Global Perspective provides the current status of the complex and broad phenomenon of cooperation, convergence and harmonization in the pharmaceutical sector (Part I), thoroughly evaluates its added value and its critical parameters and influencing factors (Part II) in order to recommend actions and measures to support the next steps for cooperation, convergence and harmonization (Part III). All of these recommendations in the book support the establishment of a better coordinated global pharmaceutical system which represents the best realistic alternative to fulfill the objective to establish a global coalition of regulators and to respond to an increased demand to further cooperation in the pharmaceutical sector. This proposed framework, which leverages all of the ongoing positive cooperation initiatives and uses as foundations all of the numerous harmonization projects developed over the years, presents advantages for all stakeholders and would definitively have significant added value to the promotion and protection of global public health.
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Audience

Regulatory professionals from pharmaceutical companies, academia and regulatory agencies worldwide, as well as students in regulatory affairs programs

 

Book information

  • Published: December 2013
  • Imprint: ACADEMIC PRESS
  • ISBN: 978-0-12-800053-3

Reviews

“…thoroughly covers the current state of international cooperative initiatives, underlying principles, why cooperation is important, and productive objectives for the future… This book has been selected for The First Clinical Research Bookshelf Essential reading for clinical research professionals.”--Journal of Clinical Research Best Practices, July 2014




Table of Contents

Preface
About the Author
Foreword by Professor Stuart Walker
Introduction

Part I: State of Play and Review of Major Cooperation Initiatives
 I-1. Global Initiatives
 I-2. Regional Intiatives
 I-3. Bilateral Initiatives
 I-4. Other Cooperation Initiatives
 I-5. Conclusion

Part II: Value and Influencing Factors of Cooperation, Convergence and Harmonization in the Pharmaceutical Sector
 II-1. Value of Cooperation, Convergence and Harmonization in the Pharmaceutical Domain
 II- 2. Critical Parameters and Influencing Factors for Cooperation, Convergence and Harmonization

Part III: Recommendations to Support the Next Phase of International Cooperation, Convergence and Harmonization in the Pharmaceutical Domain
 III-1. Overview and Key Principles of the Proposal Global Pharmaceutical System
 III-2.  Recommendations

Conclusion
Acronyms and Abbreviations
List of Figures and Tables
List of References
Index
Color Plates