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International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations
A Global Perspective
Features the current status, driving influences and future potential of global harmonization efforts with recommendations to support next steps
Pierre-Louis Lezotre (Author)
9780128000533, Elsevier Science
Hardback, published 17 January 2014
376 pages, 15 illustrations (5 in full color)
22.9 x 15.1 x 2.6 cm, 0.95 kg
"…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
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.
PrefaceAbout the AuthorForeword by Stuart WalkerIntroduction 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 SectorPart III: Recommendations to Support the Next Phase of International Cooperation, Convergence and Harmonization in the Pharmaceutical DomainConclusion
Subject Areas: Pharmacy / dispensing [MQP], Pharmacology [MMG]
