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Navigating European Pharmaceutical Law: An Expert's Guide

Navigating European Pharmaceutical Law: An Expert's Guide

Author: Marie Manley; Marina Vickers
Publisher: Oxford University Press
ISBN: 9780198717997
Published In: September 2015
Format: Hardback , 736 pages
Jurisdiction: U.K. ? Disclaimer:
Countri(es) stated herein are used as reference only

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Description
Contents

Details

European pharmaceutical law can be a minefield, due to the peculiarities of the European single market, the complexity of contemporary issues, and the rapid pace of scientific advancement. This book offers a comprehensive and in-depth analysis of EU pharmaceutical law, including expert perspectives on the most cutting-edge and contentious legal issues faced by the industry today. It provides analytical and informed discussion of legislation and jurisprudence relevant to the entire lifecycle of pharmaceutical and biopharmaceutical products.

This is supported by case studies and incisive commentary to give a full understanding of the controversial policy considerations which shape interpretation of the law in practice. The legislation does not always provide answers, and the book adopts a creative approach which addresses both what the law says and what the law does not say. Written by a team of experts in the field, Navigating European Pharmaceutical Law is an accessible guide for those new to the field, and an invaluable resource for experienced practitioners advising on critical and topical issues.

1. Introduction
2. Patent Protection for Pharmaceuticals and Biopharmaceutical Products
3. Clinical Trials
4. Procedures for Obtaining a Marketing Authorisation and Legal Bases for Application
5. Pricing, Reimbursement and Health Technology Appraisals
6. Paediatrics
7. Orphan Medicinal Products
8. Biologicals
9. Regulatory Data Protection
10. Supplementary Protection Certificates
11. The Maximisation of IP Regulatory Rights and Lifecycle Management Strategy
12. The interaction between Intellectual Property Law and Competition Law
13. Access to Information
14. Litigating decisions of the regulatory authorities
15. Pharmacovigilance
16. Data Protection
17. The Promotion of Medicinal Products in the EU
18. Borderline Products
19. Product Liability
20. Licensing Consideration
21. Parallel Trade and Stock Management Policies