Roundtable Discussion: Navigating the mRNA Regulatory Maze Across EMA FDA & MHRA to Accelerate Approval & Reduce Risk
- 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