Maren Von Fritschen
Head of Regulatory Policy Europe Moderna
Seminars
Tuesday 27th January 2026
Navigating Global Regulatory Pathways for mRNA-Based Gene Editing to Accelerate Clinical Translation & Reduce Approval Risk
10:00 am
- 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
Thursday 29th January 2026
Leveraging Regulatory Sandboxes & Platform Approaches to Accelerate Innovative mRNA Therapies from Concept to Clinic
9:30 am
- Explore how regulatory sandbox models can provide early, flexible engagement with agencies to de-risk novel mRNA therapeutic development
- Understand how platform-based regulatory strategies can streamline approvals by leveraging prior data across multiple products
- Learn from emerging case studies on how these frameworks have reduced timelines, improved regulatory predictability, and enabled faster patient access
