Pharmacovigilance Critique and Ways Forward
Written by experienced authors, this book offers expert personal views on what the current problems in pharmacovigilance are and how they should be solved. This book stems from thoughts and ideas discussed in a series of meetings of the International Soci
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Pharmacovigilance Critique and Ways Forward
Pharmacovigilance
I. Ralph Edwards • Marie Lindquist Editors
Pharmacovigilance Critique and Ways Forward
Editors I. Ralph Edwards Uppsala Monitoring Centre Uppsala Sweden
Marie Lindquist Uppsala Monitoring Centre Uppsala Sweden
ISBN 978-3-319-40399-1 ISBN 978-3-319-40400-4 DOI 10.1007/978-3-319-40400-4
(eBook)
Library of Congress Control Number: 2016957290 © Springer International Publishing Switzerland 2017 This work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. The publisher, the authors and the editors are safe to assume that the advice and information in this book are believed to be true and accurate at the date of publication. Neither the publisher nor the authors or the editors give a warranty, express or implied, with respect to the material contained herein or for any errors or omissions that may have been made. Printed on acid-free paper This Adis imprint is published by Springer Nature The registered company is Springer International Publishing AG Switzerland
Foreword
As an answer to the challenges posed by the thalidomide tragedy in the early 1960s, the World Health Assembly endorsed the concept of an international collaborative project aimed at the early detection of possible drug-related problems. This was a seminal moment. Countries found they could join together and discuss safety problems in an open and collaborative manner and create a world data repository for the collected reports of suspected drug harms. Starting in 1968, 10 countries were actively involved in the development of what in 1970 became the WHO Programme for International Drug Monitoring (PIDM), under the leadership of Prof. Jan Venulet. Amongst these early pioneers of drug safety, years later ‘rebranded’ as ‘pharmacovigilance’, were Drs. Hans Halbach and Bruce Royall from WHO Headquarters; Professor David Finney, who first had the basic idea of collating international case reports; and Dr. Ed Napke whose ‘pigeon hole system’ was the forerunner of the disproportionality methods used today to find signals based on pooled medical experiences. By 1978, the operational activities were transferred from Geneva to the WHO Foundation Collaborating Centre for International Drug Monitoring, established for WHO Programme for International Drug Monitoring Founding members: Australia (headed by Dr. Anette Welshe)
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