An Introduction to Pharmacovigilance

1: What is pharmacovigilance and how has it developed?

Origins and definition of pharmacovigilance

Scope and purposes

Development of pharmacovigilance since the 1960s

Conclusion

2: Basic concepts

Introduction

Adverse Drug Reactions

The concept of safety

Causation - was the drug responsible?

Conclusion

3: Types and sources of data

Introduction

Pre-clinical studies

Human volunteer studies

Clinical trials

Post-marketing surveillance

Conclusion

4: The process of pharmacovigilance

Overview - a risk management process

Signal detection

Evaluation and investigation

Taking Action

Communication

Conclusion

5: Regulatory aspects of pharmacovigilance

Introduction

Legislation and guidelines

Regulatory pharmacovigilance systems

Obligations of pharmaceutical companies

Conclusion

6: International collaboration

Introduction

World Health Organisation

Council for the Organisation of Medical Sciences

International Conference on Harmonisation

Conclusion

7: Ethical and societal considerations

Introduction

Stakeholders and their perspectives

Ethical principles

Ethical safeguards in relation to safety

Transparency

Conflicts of interest

Conclusion

8: Future Directions

Introduction: current limitations

Meeting the challenges

Conclusion

9: Learning more about pharmacovigilance

Books

Journals

Useful websites

Courses

International societies

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.