International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations

International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations : A Global Perspective

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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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Product details

  • Hardback | 376 pages
  • 193.04 x 238.76 x 25.4mm | 952.54g
  • Academic Press Inc
  • San Diego, United States
  • English
  • Illustrated; Illustrations, unspecified
  • 0128000538
  • 9780128000533
  • 2,170,684

Table of contents

Preface About the Author Foreword by Stuart Walker Introduction

Part I: State of Play and Review of Major Cooperation Initiatives Part II: Value and Influencing Factors of Cooperation, Convergence and Harmonization in the Pharmaceutical Sector Part III: Recommendations to Support the Next Phase of International Cooperation, Convergence and Harmonization in the Pharmaceutical Domain Conclusion
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Review quote

"...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
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About Pierre-louis Lezotre

Dr. Pierre-Louis Lezotre specializes in global regulatory strategy, and is recognized for his passion and expertiseon international cooperation, convergence, and harmonization of regulations for pharmaceuticaland biotechnology products. He has worked in different cultural environments and lived inboth Europe and the United States.Dr. Lezotre studied biology (University of Sciences, Saint-Etienne, France)and drug development (University of Pharmacy, Montpellier, France) from1992 to 1998. He then received his Master in Regulatory Sciences in 1999 (Universityof Pharmacy, Lille, France). He also recently completed his PhD in Law with honors (DoctoralSchool of "Law, Politics and Management," University of Law, Lille, France).Since 1998, Dr. Lezotre has worked for several international pharmaceutical and biotechnologycompanies, with increasing levels of responsibility. He has served as a regional andthen global regulatory leader for small molecule and biologic/biotech programs in variousstages of research and development (from early discovery to life cycle management). Hesuccessfully led many global regulatory teams in supporting global registrations of majorproducts and numerous development projects in several therapeutic areas, includingdermatology, urology, neurology, and pain. He has been responsible for communicationswith 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 theRegulatory Sciences programs of the University of Southern California (USC).
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