Navigating Global Regulatory Pathways for mRNA-Based Gene Editing to Accelerate Clinical Translation & Reduce Approval Risk
- Compare how EMA, FDA, and MHRA approach transient mRNA-based editing tools versus permanent genome modifications
- Understand classification and risk-based assessment challenges for mRNA-delivered editors (e.g., ATMP designation)
- Learn how early regulator engagement can de-risk trial design, accelerate timelines, and improve approval outcomes