Pharmacovigilance | Faculty of Pharmacy

Overview

• Introduction of basic definitions and the key concepts of Pharmacovigilance.

Specific aims

• To provide a specific knowledge on the system requirements and the steps of effective pharmacovigilance for pharmacists, and discussing the scientific and legal aspects and organization

Specific Topics

1. Key Elements and Activities of the PhV
2. Concept of reporting, coding, signal detection
3. Risk management approach: RMP, risk minimization
4. Continuous pharmacovigilance, PASS, PAES;  DSUR/PSUR
5. GVP Modules and  public health
6. Pharmacovigilance during drug development process.
7. Documentation of clinical trial, reference safety information
8. Basics of the scientific and statistical approaches