1. Edition - October 2009
26.90 Euro
2009. 120 Pages, Softcover
- Practical Approach Book -
ISBN-10: 1-4051-9471-5
ISBN-13: 978-1-4051-9471-6 - John Wiley & Sons






Sample Chapter

Short description
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).

From the contents
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