Panel: Europe’s ATMP rulebook reset: The 12-month pathway from fragmented rules to trusted EU execution

From legislation to execution: What ATMP developers must change now in regulatory, CMC and evidence planning to stay aligned with EU reform over the next 12 months.

Fixing fragmentation where it hurts: Practical steps regulators and industry can take to reduce national divergence in inspections, QP release and hospital interfaces without waiting for full harmonisation.

AI without regulatory regret: How to deploy AI in development, manufacturing and PV with audit-ready governance that accelerates approval rather than triggering high-risk compliance delays.

Making Europe the smart first move: How tighter EMA-NCA coordination and reliance can shorten timelines and restore Europe as a credible first-launch region for advanced therapies.