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An Introduction to Pharmacovigilance, 2nd Edition

Patrick Waller, Mira Harrison-Woolrych

ISBN: 978-1-119-28974-6 April 2017 Wiley-Blackwell 192 Pages


Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems.

This introductory guide is designed to aid the rapid understanding of the key principles of pharmacovigilance. Packed full of examples illustrating drug safety issues it not only covers the processes involved, but the regulatory aspects and ethical and societal considerations of pharmacovigilance.

Covering the basics step-by-step, this book is perfect for beginners and is essential reading for those new to drug safety departments and pharmaceutical medicine students. The second edition is thoroughly revised and updated throughout and includes a new chapter on clinical aspects of pharmacovigilance.

Foreword ix

Preface to the Second Edition xi

Preface to the First Edition xiii

Acknowledgements xv

List of Abbreviations xvii

1 What is Pharmacovigilance and How Has it Developed? 1

2 Basic Concepts 19

3 Types and Sources of Data 37

4 The Process of Pharmacovigilance 55

5 Regulatory Aspects of Pharmacovigilance 75

6 International Collaboration 95

7 Clinical Aspects of Adverse Drug Reactions 109

8 Ethical and Societal Considerations 123

9 Future Directions 135

10 Learning More About Pharmacovigilance 145

Glossary 151

Index 157