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E-raamat: Advanced Introduction to Pharmaceutical Law

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Advanced Introduction to Pharmaceutical LawSuurem pilt
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Elgar Advanced Introductions are stimulating and thoughtful introductions to major fields in the social sciences, business and law, expertly written by the world’s leading scholars. Designed to be accessible yet rigorous, they offer concise and lucid surveys of the substantive and policy issues associated with discrete subject areas.


This Advanced Introduction provides a succinct overview of the vital role of pharmaceuticals in protecting and enhancing life and health. Frederick Abbott examines the global network of researchers and industrial companies involved in the developmental process, from fundamental research to testing, manufacturing and distribution. He evaluates the legal frameworks intended to promote the research and development of these essential medicines, including the use of patents, subsidies and other incentives.


Key Features:

  • Addresses how the interests of diverse stakeholders are reconciled
  • Discusses the use of technology licensing and the impact of AI on pharmaceutical IP
  • Identifies the regulatory frameworks that ensure the safety and efficacy of therapeutic medicines and vaccines
  • Analyses the broad range of pharmaceutical advertising, promotion and prescription, with a particular focus on the growing role of telemedicine
  • Explores burgeoning global topics such as the implications of the USA’s withdrawal from the WHO and the emergence of China as a center for pharmaceutical research, development and patenting


Providing an accessible overview of the complex field of pharmaceutical regulation, this book is a necessary resource for scholars and students of health and biotechnology law. It is also beneficial for practitioners and policymakers in intellectual property law and pharmaceutical law.

Arvustused

This outstanding book provides comprehensive coverage of pharmaceutical law. It is an invaluable read for anyone seeking to understand the pharmaceutical ecosystem. The book also provides a robust foundation for those entering emerging or quickly shifting areas of the law, including artificial intelligence and telemedicine. -- Ana Santos Rutschman, Villanova University, USA Professor Abbotts important book fills a gap in the scholarly literature on pharmaceutical law. It offers an insightful general introduction to a complex and highly technical field of law, covering a broad range of topics with a rigorous analytical approach coupled with an accessible style fit for all audiences. -- Gian Luca Burci, Geneva Graduate Institute, Switzerland In this concise, up-to-date and forward-looking book, Fred Abbott provides a comprehensive yet critical survey of the complex legal issues involved in pharmaceutical development and regulation. The book draws on his decades-long experience as one of the world's foremost experts in international intellectual property law and global health policy. A tour de force and an indispensable guide! -- Peter K. Yu, Texas A&M University, USA

Contents
Preface
1 Introduction to the pharmaceutical sector
2 Pharmaceuticals and the patent system
3 Market entry by originator and generic
pharmaceuticals (small molecule)
4 Approval of biologics and market entry of biosimilars
5 Regulation and liability
6 Pharmaceutical prices
7 Competition law
8 Education, information, advertising, and promotion
9 Artificial intelligence
10 Transfer of technology
11 The Post-WHO era for the United States and the rest of
the world
12 Pharmaceutical law in a changing landscape
Frederick M. Abbott, Edward Ball Eminent Scholar Professor of International Law, Florida State University College of Law, USA
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Püsilink: https://www.kriso.ee/db/97810353927116e.html