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.

Pharmacovigilance is the science and activities relating to thedetection, assessment, understanding and prevention of adverseeffects or any other drug-related problems.This introductory guide is designed to aid the rapidunderstanding of the key principles of pharmacovigilance. Packedfull of examples illustrating drug safety issues it not only coversthe processes involved, but the regulatory aspects and ethical andsocietal considerations of pharmacovigilance.Covering the basics step-by-step, this book is perfect forbeginners and is essential reading for those new to drug safetydepartments and pharmaceutical medicine students.

Acknowledgements ixForeword xPreface xiiChapter 1 What is pharmacovigilance and how has it developed? 1Origins and definition of pharmacovigilance 1Scope and purposes of pharmacovigilance 3Development of pharmacovigilance since the 1960s 5Conclusion 14Chapter 2 Basic concepts 15Introduction 15Adverse drug reactions 15The concept of safety 21Causation - was the drug responsible? 25Conclusion 29Chapter 3 Types and sources of data 30Introduction 30Pre-clinical studies 30Human volunteer studies 31Clinical trials 31Post-marketing surveillance 33Systematic reviews and meta-analysis 42Conclusion 43Chapter 4 The process of pharmacovigilance 44Overview - a risk management process 44Signal detection 44Evaluation and investigation 50Taking action 52Communication 56Crisis management 59Conclusion 60Chapter 5 Regulatory aspects of pharmacovigilance 61Introduction 61Legislation and guidelines 62Regulatory pharmacovigilance systems 64Obligations of pharmaceutical companies 65Risk management planning 69Conclusion 73Chapter 6 International collaboration 74Introduction 74World Health Organisation 75Council for the Organisation of Medical Sciences 75International Conference on Harmonisation 78Conclusion 79Chapter 7 Ethical and societal considerations 80Introduction 80Stakeholders and their perspectives 80Ethical principles 83Ethical safeguards in relation to safety 84Transparency 85Conflicts of interest 86Conclusion 87Chapter 8 Future directions 89Introduction--current limitations 89Meeting the challenges 90Conclusion 93Chapter 9 Learning more about pharmacovigilance 94Books 94Journals 95Useful websites 95Courses 96International societies 96Conclusion 96Glossary 98Index 101