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The law and regulation of medicines / edited by Peter Feldschreiber.

Contributor(s): Material type: TextTextPublisher: Oxford ; New York : Oxford University Press, 2008Description: lii, 473 pages ; 26 cmContent type:
  • text
Media type:
  • unmediated
Carrier type:
  • volume
ISBN:
  • 0199534675
  • 9780199534678
Subject(s): DDC classification:
  • 344.4104233 22
LOC classification:
  • KD3460 .L895 2008
Contents:
I. Introduction -- 1. The Structure and Function of Medicines Regulation in Europe / Peter Feldschreiber and Alasdair Breckenridge -- 2. Medicines Legislation / Simon Rogers -- II. The Regulation of Medicines -- 3. Roles and Responsibilities of the Regulator / Roy Alder -- 4. Marketing Authorization / Peter Feldschreiber -- 5. Regulation of Clinical Trials / Ian Hudson -- 6. The Regulatory Process: Pharmacovigilance in Practice / John Warren -- 7. Compliance and Enforcement in the UK / Peter Feldschreiber -- III. The Law of Medicines -- 8. Civil Law Liability / Leigh-Ann Mulcahy -- 9. Public Law Liability / Leigh-Ann Mulcahy -- 10. Criminal Liability / Jalil Asif -- 11. General Product Safety Law / Jalil Asif -- 12. Practical Aspects of Healthcare Product Liability Litigation / Julian Acratopulo and Alexandra McConnell -- 13. The Law: Intellectual Property / Alexander Denoon, Daniel Royle and Anne Christopher.
Review: "This is a 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." "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."--BOOK JACKET.
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Includes bibliographical references and index.

I. Introduction -- 1. The Structure and Function of Medicines Regulation in Europe / Peter Feldschreiber and Alasdair Breckenridge -- 2. Medicines Legislation / Simon Rogers -- II. The Regulation of Medicines -- 3. Roles and Responsibilities of the Regulator / Roy Alder -- 4. Marketing Authorization / Peter Feldschreiber -- 5. Regulation of Clinical Trials / Ian Hudson -- 6. The Regulatory Process: Pharmacovigilance in Practice / John Warren -- 7. Compliance and Enforcement in the UK / Peter Feldschreiber -- III. The Law of Medicines -- 8. Civil Law Liability / Leigh-Ann Mulcahy -- 9. Public Law Liability / Leigh-Ann Mulcahy -- 10. Criminal Liability / Jalil Asif -- 11. General Product Safety Law / Jalil Asif -- 12. Practical Aspects of Healthcare Product Liability Litigation / Julian Acratopulo and Alexandra McConnell -- 13. The Law: Intellectual Property / Alexander Denoon, Daniel Royle and Anne Christopher.

"This is a 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." "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."--BOOK JACKET.

Machine converted from AACR2 source record.

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