QPPV or Qualified Person for Pharmacovigilance is a Requirement for Marketed Medicinal Products, and QPPV is Responsible for the Fulfillment of Key Functions, and in This Course, We Will Learn:
- PV Definitions
- What is Adverse Reaction (ADRs)
- Processing of Individual Case Safety Report (ICSRs)
- PV Guidelines in GCC & Saudi Arabia
- Role of Qualified Person for Pharmacovigilance (QPPV)
- Pharmacovigilance System Master File (PSMF)
- Periodic Safety Update Report (PSURs)
- Risk Management Plan (RMPs), & MedDRA Coding
