The Law and Regulation of Medicines

Hardcover | July 31, 2008

EditorPeter Feldschreiber

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This is a comprehensive textbook on the science, regulatory policy and law surrounding the discovery, development and marketing of new medicines. It is a reference work and source of expertise for legal, medical, and pharmaceutical professionals working in the fields of medicine regulation,medical law and product liability. Written by an author team comprising specialists in pharmaceutical medicine, pharmacology and therapeutics, and lawyers specialising in product liability law and intellectual property, this book reviews all the areas of science, regulatory policy and legislation, together with the consumerprotection and intellectual property law as applicable to the development and commercialisation of medicinal products. Serving as a practical introduction for practitioners wishing to undertake work in this highly complex area of law, this book is specifically designed to facilitate deeper mutual understanding of the scientific and technical issues for the lawyer, and the legal issues for those involved withregulatory policy and decision making and senior executives in the pharmaceutical industry. The work covers the European and UK legislation on medicines and healthcare products, including the principal directives and regulations, together with UK implementing legislation and instruments, and the key case law. It covers the structure and function of the regulatory authorities, applicationsto carry out clinical trials, intellectual property issues, product liability issues and litigation.This book provides practical guidance on drafting regulatory submissions, preparing litigation against decisions of the regulatory authorities; determining appropriate regulatory submission strategies throughout the European Community, and preparing litigation relating to medicinal productsliability under the Product Liability Directive and the Consumer Protection Act 1985.

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This is a comprehensive textbook on the science, regulatory policy and law surrounding the discovery, development and marketing of new medicines. It is a reference work and source of expertise for legal, medical, and pharmaceutical professionals working in the fields of medicine regulation,medical law and product liability. Written by ...

Dr Peter Feldschreiber is a qualified lawyer and medical doctor. He is a tenant of 4 New Square, specialising in healthcare law and product liability. Prior to this, he enjoyed a successful career in senior international management positions in the pharmaceutical industry. He is the Medical Assessor to the Commission on Human Medicine...
Format:HardcoverDimensions:440 pages, 9.69 × 6.73 × 1.29 inPublished:July 31, 2008Publisher:Oxford University PressLanguage:English

The following ISBNs are associated with this title:

ISBN - 10:0199534675

ISBN - 13:9780199534678

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Table of Contents

1. Dr Peter Feldschreiber and Sir Alasdair Breckenridge: The Structure and Function of Medicines Regulation in Europe2. Simon Rogers: The Legislation3. Roy Alder CBE: The Roles and Responsibilities of the UK Regulator4. Dr Peter Feldschreiber: Regulatory Organisational Structure5. Dr Ian Hudson: The Regulatory Process: The Regulation of Clinical Trials6. Dr John Warren: The Regulatory Process: Pharmacovigilance and Post-Marketing Safety Monitoring7. Dr Peter Feldschreiber: The Regulatory Process: Control of Advertising and Marketing8. Leigh-Ann Mulcahy and Jalil Asif: The Law: Product Liability for Medicines and Medical Devices9. Alexander Denoon: The Law: Intellectual Property of Medicines10. Dr Alexadra McConnell and Julian Acratopulo: The Law: Practical Aspects of Healthcare Product Liability of Medicines