Panel Discussion: Highlighting Strategies to Streamline Regulatory Approval Across Regulatory Agencies
- Detailing the transition process between FDA, EMA and IIT clinical programs to streamline clinical development across borders
- Discussing strategies for incorporating early clinical readouts from international studies to enable faster decision making before US trial initiation
- Evaluating evolving US regulatory comfort with globally generated data to showcase how aligned global development strategies can accelerate innovation while maintaining regulatory rigor