Navigating European Pharmaceutical Law: An Expert's Guide by Maria Isabel ManleyNavigating European Pharmaceutical Law: An Expert's Guide by Maria Isabel Manley

Navigating European Pharmaceutical Law: An Expert's Guide

EditorMaria Isabel Manley, Marina Vickers

Hardcover | October 24, 2015

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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 expertperspectives 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 andincisive 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 notsay.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.
Maria Manley is a Partner at Bristows in London, a law firm specialised in advising technology clients, and head of the Regulatory Department. She advises on IP matters (both contentious and non-contentious), focusing on European and UK regulatory and competition law in the bio-pharma, chemical, cosmetic, medical devices and food secto...
Title:Navigating European Pharmaceutical Law: An Expert's GuideFormat:HardcoverDimensions:736 pages, 9.69 × 6.73 × 1.77 inPublished:October 24, 2015Publisher:Oxford University PressLanguage:English

The following ISBNs are associated with this title:

ISBN - 10:0198717997

ISBN - 13:9780198717997

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Table of Contents

1. Introduction2. Patent Protection for Pharmaceuticals and Biopharmaceutical Products3. Clinical Trials4. Procedures for Obtaining a Marketing Authorisation and Legal Bases for Application5. Pricing, Reimbursement and Health Technology Appraisals6. Paediatrics7. Orphan Medicinal Products8. Biologicals9. Regulatory Data Protection10. Supplementary Protection Certificates11. The Maximisation of IP Regulatory Rights and Lifecycle Management Strategy12. The interaction between Intellectual Property Law and Competition Law13. Access to Information14. Litigating decisions of the regulatory authorities15. Pharmacovigilance16. Data Protection17. The Promotion of Medicinal Products in the EU18. Borderline Products19. Product Liability20. Licensing Consideration21. Parallel Trade and Stock Management Policies