Veterinary Pharmacovigilance: Adverse Reactions to Veterinary Medicinal Products PDF
Preview Veterinary Pharmacovigilance: Adverse Reactions to Veterinary Medicinal Products
Veterinary Pharmacovigilance Adverse Reactions to Veterinary Medicinal Products Edited by K.N. Woodward A John Wiley & Sons, Ltd., Publication Veterinary Pharmacovigilance Veterinary Pharmacovigilance Adverse Reactions to Veterinary Medicinal Products Edited by K.N. Woodward A John Wiley & Sons, Ltd., Publication This edition fi rst published 2009 © 2009 Blackwell Publishing Ltd. Wiley-Blackwell is an imprint of John Wiley & Sons, formed by the merger of Wiley’s global Scientifi c, Technical and Medical business with Blackwell Publishing. Registered offi ce John Wiley & Sons Ltd, The Atrium, Southern Gate, Chichester, West Sussex, PO19 8SQ, United Kingdom Editorial offi ce John Wiley & Sons Ltd, The Atrium, Southern Gate, Chichester, West Sussex, PO19 8SQ, United Kingdom For details of our global editorial offi ces, for customer services and for information about how to apply for permission to reuse the copyright material in this book please see our website at www.wiley.com/wiley-blackwell. The right of the author to be identifi ed as the author of this work has been asserted in accordance with the Copyright, Designs and Patents Act 1988. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, except as permitted by the UK Copyright, Designs and Patents Act 1988, without the prior permission of the publisher. Wiley also publishes its books in a variety of electronic formats. Some content that appears in print may not be available in electronic books. Designations used by companies to distinguish their products are often claimed as trademarks. All brand names and product names used in this book are trade names, service marks, trademarks or registered trademarks of their respective owners. The publisher is not associated with any product or vendor mentioned in this book. This publication is designed to provide accurate and authoritative information in regard to the subject matter covered. It is sold on the understanding that the publisher is not engaged in rendering professional services. If professional advice or other expert assistance is required, the services of a competent professional should be sought. Library of Congress Cataloging-in-Publication Data Veterinary pharmacovigilance : adverse reactions to veterinary medicinal products / Kevin N. Woodward, editor. p. cm. Includes bibliographical references and index. ISBN 978-1-4051-6968-4 (alk. paper) 1. Veterinary drugs--Side effects. I. Woodward, Kevin N. SF917.V495 2009 636.089’57042–dc22 2008044761 A catalogue record for this book is available from the British Library. Set in 10.5 on 14 pt Palatino by SNP Best-set Typesetter Ltd., Hong Kong Printed and bound in Singapore by Markono Print Media Pte Ltd 1 2009 To Diana, Alastair, Frances and Felicity And to Jenny, Sally and Patsy, to Alfi e and Molly, and to Jack Russell Terriers everywhere. Contents List of contributors ix 7 Veterinary adverse drug event Preface xi reporting in the United States, Acknowledgements xiii Australia and Canada 119 K.N. Woodward Introduction 1 8 Veterinary pharmacovigilance: D. Skilton a South African perspective 151 1 Elements of veterinary V. Naidoo pharmacovigilance 9 9 Pharmacovigilance inspections in the K.N. Woodward European Union 163 2 Veterinary pharmacovigilance in the K.N. Woodward and C.W. Evans European Union 19 10 Essential elements of veterinary K.N. Woodward pharmacovigilance and the role and 3 Pharmacovigilance and the European duties of the Qualifi ed Person 177 Medicines Agency: conduct of B. Cornez pharmacovigilance activities 47 11 Veterinary pharmacovigilance in an K. Grein industry setting – the European 4 Veterinary pharmacovigilance in Union 209 France 55 M. O’Gorman G. Keck and X. Pineau 12 Pharmacovigilance in the US – an 5 Pharmacovigilance in Germany 65 industry perspective 231 C. Ibrahim and A. Wilke T.M. Hodge 6 Veterinary pharmacovigilance – 13 Practical veterinary the UK experience 91 pharmacovigilance 287 K.N. Woodward D. O’Rourke
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