Pharmaceuticals, Biotechnology and the Law, 2nd Edition

Author: Trevor Cook
Publisher: LexisNexis U.K.
ISBN: 9780406914415
Published In: January 2009
Format: Hardback
Jurisdiction: U.K. ? Disclaimer:
Countri(es) stated herein are used as reference only

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Description
Contents

Details

Pharmaceuticals Biotechnology and the Law is the definitive guide to the law in Europe relating to pharmaceuticals, biotechnology and their related areas such as medical devices.

Written by one of the country's leading patent and regulatory lawyers, this is the only text which comprehensively covers the wide variety of legal and regulatory issues which surround these industry sectors.

The book examines the background to, and the impact of, the law affecting this area. The text is primarily written from the perspective of European Community law, although in those relatively few areas where this is not harmonised it is written from the perspective of English law.

Contents:: Introduction and Overview; Drug discovery and industry overview; Intellectual property overview; Regulatory overview; Competition law overview; Early stage R&D; Regulatory issues associated with early stage pharmaceuticals R&D, including ethical issues associated with stem cells, and animal experimentation; Special regulatory issues associated with biotechnology, including contained use and deliberate release; Patents issues associated with early stage pharmaceuticals R&D; Patents issues associated with biotechnology; Agreements in early stage R&D; Late stage R&D; Regulatory issues associated with pharmaceuticals, including clinical trials; Regulatory issues associated with late stage R&D in other applications of biotechnology than pharmaceuticals; Regulatory issues associated with late stage R&D in other life sciences sectors; Patents issues associated with late stage pharmaceuticals R&D Agreements in late stage R&D; Trade mark issues associated with pharmaceuticals; Post Authorisation; Agreements for exploiting proven products, including co-marketing and co-promotion; Regulatory issues post authorisation for pharmaceuticals, including pricing; Regulatory issues post associated in other applications of biotechnology than pharmaceuticals; Product liability; Parallel Imports and Generic Competition; Parallel imports; Patents and generic competition; Regulatory data protection and generic competition;