Ruben Rizzi
SVP Global Regulatory Affairs BioNTech
Seminars
Thursday 29th January 2026
Roundtable Discussion: Navigating the mRNA Regulatory Maze Across EMA FDA & MHRA to Accelerate Approval & Reduce Risk
10:00 am
- Comparing how EMA, FDA, and MHRA currently define and assess mRNA-based therapeutics
- Understanding where regulatory definitions diverge (e.g., biologic vs. ATMP) and how to plan accordingly
- Learning how companies are building global regulatory strategies that reduce friction and misalignment
Thursday 29th January 2026
Creating Regulatory Pathways for Personalized & Oncology-Focused mRNA Therapies in a Framework Built for Vaccines
9:00 am
- Understanding how personalized and patient-specific mRNA products are being approached by EMA and MHRA
- Learning from ongoing oncology-focused mRNA trials navigating the current patchwork of global expectations
- Discussing gaps in guidance for non-infectious mRNA indications and how companies are addressing them
