Table of contents for An introduction to pharmacovigilance / by Patrick Waller.


Bibliographic record and links to related information available from the Library of Congress catalog


Information from electronic data provided by the publisher. May be incomplete or contain other coding.


Counter
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


Library of Congress subject headings for this publication:
Drugs -- Side effects.
Pharmacoepidemiology.
Pharmacoepidemiology -- methods.
Drug Monitoring -- methods.
Pharmaceutical Preparations -- adverse effects.
Pharmaceutical Preparations -- standards.