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PV WORKSHOP 5: Parmacovigilance. Collation of AEFIs in validated PV databases, AND Knowledge of safety database systems

July 14 - 15, 2021

Workshop 5: Pharmacovigilance. Collation of AEFIs in validated PV databases, AND Knowledge of safety database systems
PATH & DCVMN Consultant
1. ICSR receipt and handling including follow up and reconciliation
2. Safety database operation, validation, back-up, disaster recovery
3. Expedited reporting to Regulatory Authorities

Documents
Draft Agenda
One pager report
ICSR case receipt handling follow up recconciliation- Katharina Hartmann
Safety database operation and expedited reporting- Varun Sharma