Overview

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.

Full Product Details

Author:   Maria Isabel Manley (Partner, Partner, Bristows) ,  Marina Vickers (Associate, Associate, Bristows)
Publisher:   Oxford University Press
Imprint:   Oxford University Press
Dimensions:   Width: 18.60cm , Height: 4.50cm , Length: 24.80cm
Weight:   1.420kg
ISBN:  

9780198717997

ISBN 10:   0198717997
Pages:   736
Publication Date:   24 September 2015
Audience:   College/higher education ,  Professional and scholarly ,  Postgraduate, Research & Scholarly ,  Professional & Vocational
Format:   Hardback
Publisher's Status:   Active
Availability:   To order  
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Table of Contents

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

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Author Information

MARIE 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 sectors; including life cycle management issues, advertising and product liability. MARINA VICKERS is a Senior Associate at Bristows in London, a law firm specialised in advising technology clients. She specialises in EU and UK regulatory law in the biopharma field, both contentious and non-contentious. She has published widely in the field and recently co-authored a chapter on the EU/UK legal framework for an American Bar Association book on Anda litigation strategy. The editors and contributors are delighted to donate all royalties from this edition to the Great Ormond Street Hospital Children's Charity.

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