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The law and regulation of medicines

By: Contributor(s):
Publication details: Oxford Oxford University Press 2008Description: 473p xxxviISBN:
  • 9780199534678
Subject(s): DDC classification:
  • 344.041 FEL
Contents:
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
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BOOKs . 344.041 FEL (Browse shelf(Opens below)) Available 26615

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