Qualified Person form Pharmacovigilance (QPPV)

Course Agenda :

1. Definitions & Introduction
2. Adverse Reaction (ADRs)
3. Individual Case Safety Report (ICSRs)
4. PV Guidelines in GCC & Saudi Arabia
5. Qualified Person for Pharmacovigilance (QPPV)
6. Pharmacovigilance System Master File (PSMF)
7. Periodic Safety Update Report (PSURs)
8. Risk Management Plan (RMPs)
9. MedDRA Coding
10. Evaluation Exam