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DEVELOPING A CULTURE OF …
DEVELOPING A CULTURE OF pharmacovigilance Towards International Best PracticesBy Professor Meir Pugatch, Dr David Torstensson and Ma ayan LauferSECTIOND eveloping a CULTURE of Pharmacovigilance2 This report was commissioned by Novartis Pharmaceuticals Corporation. The views represented here are those of the authors Pugatch Consilium 2014 The moral right of the authors has been rights reserved. Without limiting the rights under copyright reserved above, no part of this publication may be reproduced, stored or introduced into a retrieval system, or transmitted, in any form or by any means (electronic, mechanical, photocopying, recording or otherwise), without the prior written permission of both the copyright owner and the a CULTURE of Pharmacovigilance3 LIST OF ABBREVIATIONS 4 EXECUTIVE SUMMARY 7 INTRODUCTION 111 THE IMPORTANCE OF MONITORING THE SAFETY OF MEDICINES 14 The biopharmaceutical R&D process Essential pillars safety, quality and efficacy International standardization 172 CAPTURING THE ESSENCE OF pharmacovigilance 20 Background The clinical phase The post-marketi
Developing a Culture of Pharmacovigilance 4 ANDA Abbreviated New Drug Application ANVISA Brazilian National Health Surveillance Agency API …
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