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
