Pharamcovigilance Courses

Pharmacovigilance Course - Syllabus

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.  Safety data exchange agreements

11.  Literature surveillance - global and local

12.  Reference safety information and Xevmpd updates

13.  Safety data exchange agreements

14.  Pharmacovigilance regulations

15.  Reporting obligation for MAH and timelines for reporting

16.  Documentation in Pharmacovigilance (Aggregate reports.: Pader, psur, rmp, pbrer )

17.  Case Studies in Pharmacovigilance

18.  Setting Pharmacovigilance Centre

19.  Pharmacovigilance Programmes across globe

20.  Risk benefit assessment

21.  Resume writing

22.  Interview skills

PG Diploma in Pharmacovigilance - 6 months online distance learning program