Peter Feldschreiber

The Law and Regulation of Medicines and Medical Devices (eBook, PDF)

• Format: PDF

Produktbeschreibung

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.

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Produktdetails

• Verlag: Oxford University Press
• Seitenzahl: 512
• Erscheinungstermin: 16. September 2021
• Englisch
• ISBN-13: 9780192663306
• Artikelnr.: 62642066

Autorenporträt

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.

Inhaltsangabe

* 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