Overview
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 consumer protection 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 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.
Full Product Details
Author: Peter Feldschreiber (Barrister, Four New Square, Lincoln's Inn and Senior Medical Assessor, Medicines and Healthcare Products Regulatory Agency)
Publisher: Oxford University Press
Imprint: Oxford University Press
Dimensions:
Width: 17.70cm
, Height: 3.30cm
, Length: 25.30cm
Weight: 1.048kg
ISBN: 9780199534678
ISBN 10: 0199534675
Pages: 528
Publication Date: 31 July 2008
Audience:
Professional and scholarly
,
Professional & Vocational
Format: Hardback
Publisher's Status: Out of Print
Availability: Out of stock
Reviews
This is a superb textbook. It should be required reading and used as a reference source for all those involved in the development, regulation and legal practices of Medicines. District Judge Stephen Gold
Author Information
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.
