EMA Product Lead - Oncology and Radiopharmaceuticals Office
European Medicines Agency (EMA), Netherlands
Elena is a biochemist by training and holds an MSc in Biophysics, Biochemistry, and Biotechnology from KU Leuven.
She is currently a Product Lead in the Oncology and Radiopharmaceuticals Office at the European Medicines Agency (EMA), a role she has held for three years. In this position, she supports the evaluation of centrally authorised medicines by facilitating regulatory interactions between applicants and EMA throughout the entire product lifecycle, with a particular focus on oncology products. Her responsibilities span early development interactions and pre‑submission activities, marketing authorisation applications, and post‑authorisation procedures.
Prior to joining EMA, she gained experience in regulatory affairs in the pharmaceutical industry. Her work focuses on supporting high‑quality regulatory assessments and promoting early and continuous dialogue with medicine developers.
Conditional Approval and Expedited Pathways: EU and US Regulatory Strategies
Thursday, May 7, 2026
12:00 - 13:00 WEST