Description

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.

Key Features

  • The status of all major worldwide harmonization and cooperation initiatives (at bilateral, regional, and global levels)
  • The value of cooperation in the pharmaceutical sector and the driving factors behind harmonization
  • The proposition of a structure for the global pharmaceutical system and timely recommendations for enhancing international cooperation, as well as further discussion and policy changes in this area

Readership

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

Table of Contents

Dedication

Preface

About the Author

Foreword by Professor Stuart Walker

Introduction

Part I. State of Play and Review of Major Cooperation Initiatives

Abstract

I-1) Global Initiatives

I-2) Regional Initiatives

I-3) Bilateral Initiatives

I-4) Other Cooperation Initiatives

I-5) Conclusion

Part II. Value and Influencing Factors of the Cooperation, Convergence, and Harmonization in the Pharmaceutical Sector

Abstract

II-1) Value of the 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

Abstract

III-1) Overview and Key Principles of the Proposed Global Pharmaceutical System

III-2) Recommendations

Conclusion

Acronyms and Abbreviations

List of Figures, Tables and Plates

Figures

Tables

Color Plates

List of References

Index

Color Plates

Details

No. of pages:
376
Language:
English
Copyright:
© 2014
Published:
Imprint:
Academic Press
Print ISBN:
9780128000533
Electronic ISBN:
9780128005699

About the author

Pierre-Louis Lezotre

Dr. Pierre-Louis Lezotre specializes in global regulatory strategy, and is recognized for his passion and expertise on international cooperation, convergence, and harmonization of regulations for pharmaceutical and biotechnology products. He has worked in different cultural environments and lived in both Europe and the United States. Dr. Lezotre studied biology (University of Sciences, Saint-Etienne, France) and drug development (University of Pharmacy, Montpellier, France) from 1992 to 1998. He then received his Master in Regulatory Sciences in 1999 (University of Pharmacy, Lille, France). He also recently completed his PhD in Law with honors (Doctoral School of “Law, Politics and Management,” University of Law, Lille, France). Since 1998, Dr. Lezotre has worked for several international pharmaceutical and biotechnology companies, with increasing levels of responsibility. He has served as a regional and then global regulatory leader for small molecule and biologic/biotech programs in various stages of research and development (from early discovery to life cycle management). He successfully led many global regulatory teams in supporting global registrations of major products and numerous development projects in several therapeutic areas, including dermatology, urology, neurology, and pain. He has been responsible for communications with worldwide Drug Regulatory Authorities and has also worked with external partners/ companies through co-development agreements and business development programs. Dr. Lezotre has recently been invited to teach courses on international regulation in the Regulatory Sciences programs of the University of Southern California (USC).

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