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The law and regulation of medicines

Feldschreiber Peter

The law and regulation of medicines - Oxford Oxford University Press 2008 - 473p xxxvi

Contents:
Introduction1:
The Structure and Function of Medicines Regulation in Europe, Dr Peter Feldschreiber and Sir Alasdair Breckenridge
Medicines Legislation, Simon Rogers
The Regulation of Medicines2:
Roles and Responsibilities of the Regulator, Roy Alder CBE
Marketing Authorization, Dr Peter Feldschreiber
Regulation of Clinical Trials, Dr Ian Hudson
The Regulatory Process: Pharmacovigilance in Practice, Dr John Warren
Compliance and Enforcement in the UK, Dr Peter Feldschreiber
The Law of Medicines3:
Civil Law Liability, Leigh-Ann Mulcahy
Public Law Liability, Leigh-Ann Mulcahy
Criminal Liability, Jalil Asif
General Product Safety Law, Jalil Asif
Practical Aspects of Healthcare Product Liability Litigation, Julian Acratopulo and Dr Alexandra McConnell
The Law: Intellectual Property, Alexander Denoon, Daniel Royle, and Anne Christopher

9780199534678


1. Drugs - Law & Legislation - U K

344.041 / FEL