Navigating IIT & EMA Regulatory Pathways to Accelerate Cell Therapy Global Development
Time: 1:00 pm
day: Pre-Conference Workshop Day Teal Track P2
Details:
With mounting FDA regulatory hurdles and a move towards clinical trials outside the US, this workshop explores IIT and EMA development and clinical trial pathways to evaluate the optimal location for therapeutic development and clinical trial execution.
- Compare regulatory and development challenges for the FDA and EMA, to effectively evaluate the optimal agency to initiate clinical trials
- Explore donor and leukapheresis material regulations across the FDA and EMA to ensure compliant material sourcing
- Decode the EMA and IIT pathways to master cross-border compliance
- Leverage the IIT pathway to accelerate development timelines, maintain capital, and generate reliable clinical data
- Investigate cross-border collaboration strategies to streamline clinical developmentÂ
Speakers:
