Feldschreiber's comprehensive text on the science, regulatory policy and law surrounding new medicines and medical devices is a specialist reference for legal, medical, and pharmaceutical professionals: written by both legal and medical experts, it informs the scientifically lay lawyer of the biological science behind recent product innovations, whilst helping the legally lay researcher and developer of these products to understand the legal and regulatory framework encompassing them. Reflecting significant legal and scientific advancements since its first publication in 2008, this second edition, now entitled The Law and Regulation of Medicines and Medical Devices, has been substantially revised and reframed: key areas of review include medical device regulatory legislation (including the new Medical Devices Regulation), international regulatory procedures for life science products, the UK review on blood products, new cancer therapies, the impact of Brexit and the Covid-19 pandemic, and a greatly expanded discussion of criminal legislation on the cultivation of controlled drugs, such as cannabis, and their inclusion in the medical therapeutic armamentarium. The work introduces the structure and function of regulatory authorities and the linkage between the ethical issues underpinning clinical trials regulation, explains the intellectual property, product liability, and litigation issues surrounding life science products, and offers practical guidance on topics such as: 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.
By:
Peter Feldschreiber (Barrister Barrister 4 New Square)
Imprint: Oxford University Press
Country of Publication: United Kingdom
Edition: 2nd Revised edition
Dimensions:
Height: 252mm,
Width: 178mm,
Spine: 32mm
Weight: 998g
ISBN: 9780192847546
ISBN 10: 0192847546
Pages: 512
Publication Date: 27 December 2021
Audience:
College/higher education
,
Primary
Format: Hardback
Publisher's Status: Active
1: Peter Feldschreiber: Introduction 2: John Johnston and Khadija Rantell: Clinical Efficacy and Safety: the Concept of Benefit- Risk 3: Anne Cook, John Johnston, and Louise Bisset: The Regulation of Biological and other Innovative Medicinal Products 4: John Warren: Pharmacovigilance 5: Tony Fox: Biological Products: Molecular Structure and Function 6: Mirella Marlow: Health Technology Assessment: Current Issues Impacting on the Regulatory and Legal Framework 7: Sarah Jane Dobson: Regulation of Medical Devices 8: Emily Jackson and Ian Hudson: Regulation of Clinical Trials 9: John Binns, Eleanor Davison, David Hardstaff, and Aimee Riese: Liability in Criminal Law 10: Leigh- Ann Mulcahy and Alison McAdams: Liability in Civil Law 11: Leigh- Ann Mulcahy and Joseph Farmer: Liability in Public Law 12: Gareth Morgan, Natalie Coan, Tom Errington, and Alasdhair MacDonald: Introduction to Exclusivity Rights 13: Gareth Morgan, Natalie Coan, and Tom Errington: Intellectual Property Rights and Medicines 14: Angela Thomas, John Johnston, and Peter Feldschreiber: Postscript
Dr Peter Feldschreiber is a qualified lawyer and medical doctor. He is a tenant of 4 New Square, specializing in healthcare law and product liability. Prior to this, he enjoyed a successful career in senior international management positions in the pharmaceutical industry.
Reviews for The Law and Regulation of Medicines and Medical Devices
Review from previous edition 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 *
