Applied Pharmacovigilance System

Description:
This course will discuss the Importance of pharmacovigilance & how to apply it for Pharmaceutical Companies manufacturing & marketing Generic Pharmaceutical Products.

Learning outcomes:
- Introduction To pharmacovigilance
- QPPV/LSR job description
- ICSR Processing
- Signal Detection
- RMP Importance & preparation
- RMM Measures & Judgment
- Continuous Monitoring of Pharmaceutical product Safety
- PBRER/ACO Importance & preparation
- Internal & external communication needed in Pharmacovigilance
- Data Management
- SDEA main items
- PSMF preparation & Documentation
- Quality system & KPIs used in PV