Navigating IIT & Subsequent FDA/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, with comparisons to FDA experiences, 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
- 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 development
Speakers:
