Regulatory and PV Working Groups Workshop

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.

Dr. Malika Al Mansouri is a regulatory affairs expert with over 20 years of experience in the pharmaceutical sector, including more than 15 years in the vaccine industry. She has extensive expertise in global vaccine regulatory strategy, CMC and clinical submissions, and regulatory systems strengthening.

At Coalition for Epidemic Preparedness Innovations (CEPI), she contributed to regulatory strategy for vaccine development programs, including Middle East Respiratory Syndrome (MERS) vaccines, and led regulatory strengthening initiatives across Africa and the Middle East. She currently works as an independent consultant supporting organizations such as Developing Countries Vaccine Manufacturers Network (DCVMN) and PATH to advance regulatory strategies and strengthen vaccine manufacturing capacity in developing countries.