Pharmacovigilance

1. Pharmaco igilance
Anil Sorout
Associate Professor
AIP, Palwal
Pharmacovigilance Awareness Programme (17 sep - 23 sep)
Boosting Public Confidence In Pharmacovigilance

2. Pharmacovigilance
Assessment
Understanding
Detection
Prevention
The science and activities relating to the Detection,
Assessment, Understanding and Prevention of
adverse effects or anyother medicine-related problem.
WHO

3. Pharmacovigilance
History

4. Terminology

5. Types of ADRs

6. Pharmacovigilance

7. Why do we need Pharmacovigilance

8. Why do we need Pharmacovigilance

9. Why do we need Pharmacovigilance

10. Why do we need Pharmacovigilance

11. Why do we need Pharmacovigilance

12. Why do we need Pharmacovigilance

13. WHO Programme For International
Drug Monitoring

14. WHO Programme For International
Drug Monitoring

15. WHO Programme For International
Drug Monitoring

16. Pharmacovigilance

17. Drug Monitoring Software

18. Serious ADR

19. Pharmacovigilance

20. Valid ADR Report

21. Pharmacovigilance

22. Pharmacovigilance

23. Directorate General of Health
Services

24. PvPI

25. PvPI Centres

26. PvPI Aims and Objectives

27. ADR Reporting Form

28. Good Pharmacovigilance Practice
includes…
 A culture of safety awareness among sales, regulatory and
marketing staff
 A proper data management system for ADR reports
 Procedures to ensure that appropriate and timely action can
be taken including a crisis management plan
 Compliance with local regulations and guidelines
 Compilation/co-ordination of safety reports and analyses
requested by regulatory authority
 A responsible appropriately trained person for pre- and post-
marketing surveillance

29. What happens to reported ADR
 On receipt ---assign number
 Acknowledgement
 Database
 Evaluated individually and also check for similar
reports
 Recommendation made to committee/council
 Act on recommendation.

30. Thank you for your attention!
The future