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

Autor Pierre-Louis Lezotre
en Limba Engleză Hardback – 16 ian 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.

  • 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
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Specificații

ISBN-13: 9780128000533
ISBN-10: 0128000538
Pagini: 376
Ilustrații: 15 illustrations (5 in full color)
Dimensiuni: 152 x 229 x 27 mm
Editura: ELSEVIER SCIENCE

Public țintă

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

Cuprins

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

Recenzii

"…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