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
Patrick Waller MD, MPH, FRCPEd, FFPM, Formerly Honorary Professor, London School of Hygiene and Tropical Medicine, London, United Kingdom.
Mira Harrison-Woolrych BM, DM, DFFP, FRCOG, Honorary Research Associate Professor, Dunedin School of Medicine, University of Otago, New Zealand; Senior Medical Assessor, Vigilance and Risk Management, Medicines and Healthcare products Regulatory Agency (MHRA), London, UK and Secretary General of the International Society of Pharmacovigilance (ISoP).
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