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 ...
Read More
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.
Read Less
Add this copy of The Law and Regulation of Medicines to cart. $26.20, good condition, Sold by Anybook rated 5.0 out of 5 stars, ships from Lincoln, UNITED KINGDOM, published 2008 by Oxford University Press.
Choose your shipping method in Checkout. Costs may vary based on destination.
Seller's Description:
This is an ex-library book and may have the usual library/used-book markings inside. This book has hardback covers. Clean from markings. In good all round condition. No dust jacket. Please note the Image in this listing is a stock photo and may not match the covers of the actual item, 1100grams, ISBN: 9780199534678.
Add this copy of The Law and Regulation of Medicines to cart. $22.62, good condition, Sold by Phatpocket Limited rated 4.0 out of 5 stars, ships from Waltham Abbey, ESSEX, UNITED KINGDOM, published 2008 by Oxford University Press, USA.
Choose your shipping method in Checkout. Costs may vary based on destination.
Seller's Description:
Good. Ships from UK in 48 hours or less (usually same day). Your purchase helps support Sri Lankan Children's Charity 'The Rainbow Centre'. Ex-library, so some stamps and wear, but in good overall condition. 100% money back guarantee. We are a world class secondhand bookstore based in Hertfordshire, United Kingdom and specialize in high quality textbooks across an enormous variety of subjects. We aim to provide a vast range of textbooks, rare and collectible books at a great price. Our donations to The Rainbow Centre have helped provide an education and a safe haven to hundreds of children who live in appalling conditions. We provide a 100% money back guarantee and are dedicated to providing our customers with the highest standards of service in the bookselling industry.
Add this copy of The Law and Regulation of Medicines to cart. $121.87, good condition, Sold by Bonita rated 4.0 out of 5 stars, ships from Newport Coast, CA, UNITED STATES, published 2008 by Oxford University Press.
