The Law and Regulation of Medicines

Summary

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 specializing in product liability law and intellectual property, this book reviews all the areas of science, regulatory policy and legislation, together with the consumer protection and intellectual property law as applicable to the development and commercialization 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 with regulatory 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, applications to 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 products liability under the Product Liability Directive and the Consumer Protection Act 1987.

Author Biography

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 Medicines and a fellow of the Faculty of Pharmaceutical Medicine of the Royal College of Physicians.

Dr Peter Feldschreiber and Sir Alasdair Breckenridge: The Structure and Function of Medicines Regulation in Europe
Simon Rogers: The Legislation
Roy Alder CBE: The Roles and Responsibilities of the UK Regulator
Dr Peter Feldschreiber: Regulatory Organisational Structure
Dr Ian Hudson: The Regulatory Process: The Regulation of Clinical Trials
Dr John Warren: The Regulatory Process: Pharmacovigilance and Post-Marketing Safety Monitoring
Dr Peter Feldschreiber: The Regulatory Process: Control of Advertising and Marketing
Leigh-Ann Mulcahy and Jalil Asif: The Law: Product Liability for Medicines and Medical Devices
Alexander Denoon: The Law: Intellectual Property of Medicines
Dr Alexadra McConnell and Julian Acratopulo: The Law: Practical Aspects of Healthcare Product Liability of Medicines
Table of Contents provided by Publisher. All Rights Reserved.

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