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