ENGLISH

Navigating European Pharmaceutical Law

By Maria Isabel Manley (editor) , Marina Vickers (editor)

Book information

Publisher
Oxford University Press
Year
2015
ISBN
0198717997, 9780198717997
Language
english
Format
PDF
Filesize
7 MB (7329076 bytes)
Pages
736\723
Time added
2025-04-19 08:05:14

Description

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. Preface Summary Contents Detailed Contents List of Contributors Table of Cases Table of Legislation List of Abbreviations 1. Patents • Dominic Adair, Greg Bacon, and Vanessa Rieu 2. Clinical Trials • Helen Middleton 3. Procedures for Obtaining a Marketing Authorisation and Legal Bases for Application • Maria Isabel Manley and Libby Amos 4. Pricing, Reimbursement, and Health Technology Appraisals (Market Access) • Maria Isabel Manley and Maria Georgiou 5. Paediatrics • Georgia Gavriilidou 6. Orphan Drugs • Maria Isabel Manley and Chris Boyle 7. Biological Medicinal Products and Biosimilars • Dev Kumar and Lauren Wilks 8. Regulatory Data Protection • Maria Isabel Manley and Grant Strachan 9. Supplementary Protection Certificates • Maria Isabel Manley and Marina Vickers 10. Maximisation of Regulatory IP Rights • Maria Isabel Manley and Marina Vickers 11. The Interaction between Intellectual Property Law and Competition Law • Pat Treacy 12. Access to Information • Vincenzo Salvatore 13. Litigating Decisions of Regulatory Authorities • Kelyn Bacon QC and Hugo Leith 14. Pharmacovigilance • Maria Isabel Manley and Edward Bray 15. Data Protection • Hazel Grant 16. The Promotion of Medicinal Products in the EU • Maria Isabel Manley and Libby Amos 17. Borderline Products • Maria Isabel Manley and Joanna Hook 18. Product Liability: The UK perspective • Mark Brown 19. Pharmaceutical Licensing and Collaboration Agreements: Key Consideration from the Licensee’s Perspective • Jerry Temko 20. Trade Mark Protection and Enforcement in the Pharmaceutical Field • Sally Dunstan Index

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