An MHRA Perspective on the Evolving Regulatory Landscape for Advanced Gene & Genetic Therapies

2:45 pm - Thursday 7th May 2026

  • Understanding emerging regulatory frameworks for genome editing products and their unique analytical burdens
  • Reviewing regulatory priorities and recent developments across ATMPs
  • Exploring the latest advances in regulatory thinking for rare and ultra-rare disease therapies, including how risk-benefit, evidentiary expectations and analytical robustness are assessed when patient populations are small 

Speakers:

Expert Quality Assessor
Medicines & Healthcare Products Regulatory Agency (MHRA)