Evolving EU Regulatory Processes: How CGT Companies Can Accelerate First-in-Human Trials
Katrina Cordovado1,2 Geraldine Guenot1,2 Omnium Global Consulting Inc. ENABLE Biotech AG Introduction: Why This Matters for CGT Companies The European regulatory landscape for Cell & Gene Therapies is evolving. With the EU Clinical Trials Regulation (CTR) (Regulation (EU) No 536/2014) now fully implemented, CGT companies looking to conduct their clinical trial in EU member states now […]