An Introduction to Pharmacovigilance

Pharmacovigilance is the science relating to the detection, assessment, understanding and prevention of the adverse effects of medicines. An Introduction to Pharmacovigilance is an accessible textbook which is perfect for beginners as it starts with the basics. This book is internationally applicable and is suitable for members of the pharmaceutical industry in all regulatory environments (EU, US, Asia and ANZ).

Dr Patrick Waller has been an independent consultant in pharmacovigilance and pharmacoepidemiology based in Southampton since 2002. He also holds honorary academic appointments at the London School of Hygiene and Tropical Medicine and the University of Dundee. From 1998-2004 he was Visiting Professor in the Department of Pharmacological Sciences at the University of Newcastle-upon-Tyne. From 1990-2002 he worked in the field of pharmacovigilance for the Medicines Control Agency in London. From 1998-2000 he was one of the UK delegates to the Committee for Proprietary Medicinal Products and Chairman of its Pharmacovigilance Working Party.

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

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