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PHARMACOVIGILANCE FOR PRACTICAL BEGINNERS

A PRACTICAL Guide on PHARMACOVIGILANCE for BEGINNERS First Edition A PHARMACOVIGILANCE FOR. PRACTICAL . GUIDE ON BEGINNERS . , MBBS, MD. KUMAR, A PRACTICAL Guide on PHARMACOVIGILANCE for BEGINNERS A PRACTICAL Guide on PHARMACOVIGILANCE for BEGINNERS First Edition, 2010. Copyright Gunasakaran & Satheesh kumar, 2010. All rights reserved. No part of this publication may be reproduced or distributed in any form or by any means (electronic, mechanical, photocopying, recording or otherwise), or stored in a database or retrieval system, without the written permission from the authors.

relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e., the relationship cannot be ruled out. Regarding marketed medicinal products, a well-accepted definition of an adverse drug reaction in the post-marketing setting is found in WHO Technical Report 498 [1972] and reads as follows:

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