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Certificate Course in Pharmacovigilance (CCPV)



Certificate Course in Pharmacovigilance (CCPV)

Duration: 3 months

Fees: Online: 30,000 INR

Course Contents:

1. Introduction and objectives of Pharmacovigilance
2. Adverse drug reactions and their types: The difference between adverse drug reactions and adverse events
3. ADR and Drug Dictionaries
4. Signal detection, strengthening and analysis
5. Safety databases – argus and arisg
6. Good Pharmacovigilance Practices
7. Pharmacovigilance methods and Electronic reporting E2b
8. Safety data exchange agreements
9. Sources of safety data- handling of reports from psp, clinical trials
10. Literature surveillance – global and local
11. Reference safety information and Xevmpd updates
12. Pharmacovigilance regulations
13. Reporting obligation for MAH and timelines for reporting
14. Documentation in Pharmacovigilance (Aggregate reports.: Pader, psur, rmp, pbrer )
15. Case Studies in Pharmacovigilance
16. Setting Pharmacovigilance Centre
17. Pharmacovigilance Programmes across globe
18. Risk benefit assessment
19. Resume writing
20. Interview skills

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