An Introduction to Pharmacovigilance
November 2009, Wiley-Blackwell
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.
Origins and definition of pharmacovigilance.
Scope and purposes.
Development of pharmacovigilance since the 1960s.
2: Basic concepts.
Adverse Drug Reactions.
The concept of safety.
Causation – was the drug responsible?.
3: Types and sources of data.
Human volunteer studies.
4: The process of pharmacovigilance.
Overview – a risk management process.
Evaluation and investigation.
5: Regulatory aspects of pharmacovigilance.
Legislation and guidelines.
Regulatory pharmacovigilance systems.
Obligations of pharmaceutical companies.
6: International collaboration.
World Health Organisation.
Council for the Organisation of Medical Sciences.
International Conference on Harmonisation.
7: Ethical and societal considerations.
Stakeholders and their perspectives.
Ethical safeguards in relation to safety.
Conflicts of interest.
8: Future Directions.
Introduction: current limitations.
Meeting the challenges.
9: Learning more about pharmacovigilance.
- Pharmacovigilance is the science relating to the detection, assessment, understanding and prevention of the adverse effects of medicines
- Covering the basics step-by-step this an accessible introductory textbook which is perfect for beginners
- Internationally applicable - suitable for members of the pharmaceutical industry in all regulatory environments (EU, US, Asia and ANZ)