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).

• Foreword ixPreface to the Second Edition xiPreface to the First Edition xiiiAcknowledgements xvList of Abbreviations xvii1 What is Pharmacovigilance and How Has it Developed? 12 Basic Concepts 193 Types and Sources of Data 374 The Process of Pharmacovigilance 555 Regulatory Aspects of Pharmacovigilance 756 International Collaboration 957 Clinical Aspects of Adverse Drug Reactions 1098 Ethical and Societal Considerations 1239 Future Directions 13510 Learning More About Pharmacovigilance 145Glossary 151Index 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).

• Foreword ixPreface to the Second Edition xiPreface to the First Edition xiiiAcknowledgements xvList of Abbreviations xvii1 What is Pharmacovigilance and How Has it Developed? 12 Basic Concepts 193 Types and Sources of Data 374 The Process of Pharmacovigilance 555 Regulatory Aspects of Pharmacovigilance 756 International Collaboration 957 Clinical Aspects of Adverse Drug Reactions 1098 Ethical and Societal Considerations 1239 Future Directions 13510 Learning More About Pharmacovigilance 145Glossary 151Index 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).

• Foreword ixPreface to the Second Edition xiPreface to the First Edition xiiiAcknowledgements xvList of Abbreviations xvii1 What is Pharmacovigilance and How Has it Developed? 12 Basic Concepts 193 Types and Sources of Data 374 The Process of Pharmacovigilance 555 Regulatory Aspects of Pharmacovigilance 756 International Collaboration 957 Clinical Aspects of Adverse Drug Reactions 1098 Ethical and Societal Considerations 1239 Future Directions 13510 Learning More About Pharmacovigilance 145Glossary 151Index 157