International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations book cover

International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations

A Global Perspective

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.

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

Hardbound, 376 Pages

Published: December 2013

Imprint: Academic Press

ISBN: 978-0-12-800053-3

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

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