Working With Regulators: Designing Trials That Lead to Approval
Time: 9:30 am
day: Day2
Details:
- Share strategies for successful regulatory engagement throughout the full development timeline from pre-IND to BLA/NDA submission
- Tools for managing international trial variability
- Reflections on regulatory engagement strategy across trial phases
- Debate future directions in regulatory science to better accommodate novel endpoints, combination therapies, and precision medicine approaches in dry AMD
