PV WORKSHOP 7: Pharmacovigilance. Preparation of DSUR/PSUR and availability of SOPs to do that
PATH & DCVMN consultant
11:00 – 1:00 pm
1. PSUR production and Co-ordination
• Scheduling and formatting
• Preparation content
Pre-reading for this workshop:
ICH E2C (R2) PERIODIC BENEFIT-RISK EVALUATION REPORT (PBRER).
Available at: https://database.ich.org/sites/default/files/E2C_R2_Guideline.pdf
