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
PV WORKSHOP 5: Pharmacovigilance. Collation of AEFIs in validated PV databases, AND Knowledge of safety database systems
July 14, 2021
- July 15, 2021
11:00-12:30 CET
WebEx
Organisation:
DCVMN International
Dr Katharina Hartmann
Independent consultant in pharmacovigilance and pharmacoepidemiology
Katharina is a seasoned pharmacovigilance expert with over 35 years of experience in vaccine safety. She led national and global PV systems at the Swiss Drug Monitoring Center, Crucell, J&J, and Takeda, establishing and integrating major vaccine PV frameworks. Since 2019, she has consulted for DCVMN and CEPI. A long‑time ETH Zurich lecturer and former president of the Swiss pharmaceutical examination board, she has also contributed to CIOMS, Brighton Definitions, and international training and publications.
Varun Sharma
Director - Pharmacovigilance, Center for Vaccine Innovation and Access at PATH
