Exploring Different Approaches & Expectations in Proving Comparability in a Global Setting
Time: 10:00 am
day: Conference Day Two
Details:
- Clarifying the FDA Expectations on Repeat Studies for Non-Clinical Studies Between and Before Phase 3
- Exploring Different Global Approaches to Comparability between the FDA, EMA and other Regulatory Bodies
- Understanding the Depth and Timelines Needed for Comparability Data as Gene Therapy Programs progress to phase 1 and 2 When Resource Burden Increases
