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.

Autorentext
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.

Klappentext

A practical guide for legal, medical, and pharmaceutical professionals, offering an authoritative and comprehensive source of expertise on the legislation and case law governing regulation of medicines and medical devices, and their liability under consumer protection law in the UK and EU.

Inhalt

• 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