Talk Pharmacovigilance & Safety track
S0704 - Innovation in Pharmacovigilance: CAR-T, Gene Therapies and New Modalities
Wed, Mar 19, 2025 · 3:00–4:10 PM CET Delhi Room, Congress Center Basel
About this session
How has pharmacovigilance evolved to address the complexities of modern therapies? Initially focused on simpler medicines, pharmacovigilance now tackles sophisticated modalities like CAR T-cell and gene therapies. This session will explore the benefits of early risk profiling for CAR T-cell therapies and the harmonization of pharmacovigilance guidance for next-generation biologic therapies. The session will feature a panel discussion with industry and regulatory experts, who will discuss the challenges of maintaining an effective pharmacovigilance system capable of handling the complexities of new therapeutic advancements.
Programme:
- 2. Benefits of Early Risk Profiling for CAR T-Cell Therapies — Purav Thakkar
- 1. Safety Considerations and Risk Management of CAR-T Cell Therapy in Clinical Development — Sara Rito
- 3. Harmonization of pharmacovigilance guidance for next biologic generation therapies: focus on gene therapy — Irene Navarro de la Fuente
- Panel Discussion — Caroline Pothet
Speakers
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Head of advanced therapies and haemato-oncology · European Medicines Agency
Panelist
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Senior Medical Director - Principal Patient Safety Physician · AstraZeneca
Chair
