Organisation:
Pharmacovigilance Inspections/audits readiness and procedures to manage these
PATH & DCVMN consultant
Topics:
1. Specificities of vaccine pharmacovigilance
2. Pharmacovigilance from industry perspective: pre- and post-licensure
3. The PV System Master File (PSMF): Purpose & content
Access the recording for Day 1 here
Access the recording for Day 2 here
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.
