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.
1. Introduction - p. Cover 2. Part I. State of Play and Review of Major Cooperation Initiatives - p. G5 3. Abstract - p. G5 4. I-1) Global Initiatives - p. G9 5. I-2) Regional Initiatives - p. G64 6. I-3) Bilateral Initiatives - p. G152 7. I-4) Other Cooperation Initiatives - p. G163 8. I-5) Conclusion - p. G164 9. Part II. Value and Influencing Factors of the Cooperation, Convergence, and Harmonization in the Pharmaceutical Sector - p. G170 10. Part III. Recommendations to Support the Next Phase of International Cooperation, Convergence, and Harmonization in the Pharmaceutical Domain - p. G219 11. Conclusion - p. G294 12. Acronyms and Abbreviations - p. G297 13. List of Figures, Tables and Plates - p. G297 14. List of References - p. G297 15. Index - p. G297 16. Color Plates - p. G297
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.
1. Introduction - p. Cover 2. Part I. State of Play and Review of Major Cooperation Initiatives - p. G5 3. Abstract - p. G5 4. I-1) Global Initiatives - p. G9 5. I-2) Regional Initiatives - p. G64 6. I-3) Bilateral Initiatives - p. G152 7. I-4) Other Cooperation Initiatives - p. G163 8. I-5) Conclusion - p. G164 9. Part II. Value and Influencing Factors of the Cooperation, Convergence, and Harmonization in the Pharmaceutical Sector - p. G170 10. Part III. Recommendations to Support the Next Phase of International Cooperation, Convergence, and Harmonization in the Pharmaceutical Domain - p. G219 11. Conclusion - p. G294 12. Acronyms and Abbreviations - p. G297 13. List of Figures, Tables and Plates - p. G297 14. List of References - p. G297 15. Index - p. G297 16. Color Plates - p. G297