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Ian Dodds-Smith - Medicine Medical Devices and the Law

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In recent years the need for specialist knowledge of the laws governing the regulation of medicines has become apparent. This is the case among not only lawyers but also hospitals, researchers, prescribers and many others involved in the provision of healthcare. Such a need has been precipitated by a number of factors including the changing structure of healthcare in the UK and Europe, the increasing specialisation in litigation relating to medicines control and provision and the various changes in regulation that have arisen both from challenges in the courts and from the intervention of public bodies. Until now the information resources available to those involved in the complex interrelations between medicines, medical devices and the law have remained scarce. This book is designed to address this situation by bringing together the knowledge of the laws governing the regulation of medicines of the most experienced and qualified experts in one volume ranging across all aspects of the field. All areas of the law relating to the research, development, manufacture, distribution and dispensation of medicines and medical devices in the UK are covered as well as various topics within the law governing responsibilities, procedures and compensation in cases of malpractice and injury.

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title Medicines Medical Devices and the Law author OGrady John - photo 1

title:Medicines, Medical Devices and the Law
author:O'Grady, John
publisher:Greenwich Medical Media Limited
isbn10 | asin:1900151073
print isbn13:9781900151078
ebook isbn13:9780511043376
language:English
subjectDrugs--Law and legislation--Great Britain, Medical instruments and apparatus industry--Law and legislation--Great Britain, Products liability--Drugs--Great Britain, Drugs--Law and legislation--European Union countries, Medical instruments and apparatus in
publication date:1999
lcc:
ddc:
subject:Drugs--Law and legislation--Great Britain, Medical instruments and apparatus industry--Law and legislation--Great Britain, Products liability--Drugs--Great Britain, Drugs--Law and legislation--European Union countries, Medical instruments and apparatus in
Page iii
Medicines, Medical Devices and The Law
Edited by
Professor John O'Grady MD FRCP FFPM
Medical Director for Europe
Daiichi Pharmaceuticals UK Ltd
London
Mr Ian Dobbs-Smith
Solicitor and Partner
Cameron McKenna
London
Mr Nigel Walsh
The Medical Expert Partnership
Steppes Mill, Bodenham
Hereford
Michael Spencer QC
1 Paper Buildings
Temple
London
Page iv
Medicine Medical Devices and the Law - image 2
1999
Greenwich Medical Media Ltd 4th. Floor 137 Euston Road London NW1 2AA
ISBN: 1 900151 073
First Published 1999
Apart from any fair dealing for the purposes of research or private study, or criticism or review, as permitted under the UK Copyright Designs and Patents Act, 1988, this publication may not be reproduced, stored, or transmitted, in any form or by any means, without the prior permission in writing of the publishers, or in the case of reprographic reproduction only in accordance with the terms of the licences issued by the Copyright Licensing Agency in the UK, or in accordance with the terms of the licences issued by the appropriate Reproduction Rights Organization outside the UK. Enquiries concerning reproduction outside the terms stated here should be sent to the publishers at the London address printed above.
The right of John O'Grady, Ian Dodds-Smith, Michael Spencer and Nigel Walsh to be identified as editors of this work has been asserted by them in accordance with the Copyright, Designs and Patents Act 1998.
The publishers make no representation, express or implied, with regard to the accuracy of the information contained in this book and cannot accept any legal responsibility or liability for any errors or omissions that may be made.
A catalogue record for this book is available from the British library.
Distributed worldwide by Oxford University Press
Designed and Produced by Diane Parker, Saldatore Limited
Printed in Great Britain by the Alden Group, Oxford
Page v
About the Editors
John O'Grady is Medical Director for Europe, Daiichi Pharmaceuticals UK Ltd, a director of Imperial Cancer Research Technology Ltd, Visiting Professor of Clinical Pharmacology and Therapeutics, University of Vienna, Austria and Visiting Professor of Clinical Pharmacology, University of London. He is examiner to the Royal College of Physicians and external examiner, University of Guildford, Surrey. He has published widely in the field of medicine and in clinical pharmacology and therapeutics and is editor of several books dealing with drug effects in man including the Textbook of Pharmaceutical Medicine and Medicines Regulation. In the medicolegal field, Professor O'Grady was formerly HM Coroner and specialises in drug-induced injury and malpractice in relation to drugs as well as patent and intellectual property issues in relation to medical products.
Ian Dodds-Smith graduated in law from Downing College, Cambridge, qualified as a solicitor at McKenna & Co. and later became a partner in 1984. He is now head of the Life Sciences Group in the merged firm, Cameron McKenna and head of the healthcare group - a sub-group specialising in regulatory, research and product liability issues concerning the pharmaceutical and chemical sectors. The Group has conducted several cases concerning national licensing issues for pharmaceutical companies with a number resulting in references to the European Court, including two relating to the scope of abridged applications. It co-ordinates such litigation for clients across the EU. His appointments include Consultant Editor of the Personal and Medical Injuries Law Letter, Member of the Editorial Board of the Regulatory Affairs Journal and various Royal College and Medical Research Council Working Parties on research issues. He is a Fellow of the Royal Society of Medicine and Member of the Drug Information Association and Federation of Insurance & Corporate Counsel. He has written widely on regulatory and product liability issues.
Nigel Walsh is a Consultant Pharmaceutical Physician. After serving in the RAMC, he worked as a principal in general practice in England and Australia for 15 years before becoming Medical Director, Parke Davis and Co. UK and then Medical Director, International Medical Affairs, Warner Lambert Company in the USA. For the last 12 years he has worked independently as a pharmaceutical physician and is a founder of the Medical Expert Partnership specialising in drug-induced injury and medical negligence.
Michael Spencer was called to the bar in 1970, having read law at Oxford University. Most of his practice has been in the medical field, specialising in group litigation, particularly that relating to pharmaceutical products, and in medical negligence. He became a Crown Court Recorder in 1987, Queen's Counsel in 1989 and a Master of the Bench of the Inner Temple in 1996.
Page vii
Contributors
Dr Anthony Barton
42 Gibson Square
London
Dr Margaret Bloom
7 New Square
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