Design of Clinical Trials in New-Onset Type 1 Diabetes: Regulatory Considerations for Drug Development
Critical Path Institute, invites you to the upcoming free virtual workshop, Design of Clinical Trials in New-Onset Type 1 Diabetes: Regulatory Considerations for Drug Development, June 15-16, 2021.
The purpose of this scientific workshop is to discuss the existing evidence regarding the role of c-peptide in clinical trials intended to support regulatory decision making, unique regulatory considerations from FDA and EMA, and next steps for the T1D drug development community.
The preliminary agenda includes:
- Welcome and Introductory Remarks
- Session I: Regulatory Framework: How does c-peptide fit into the US and EU regulatory frameworks?
- Session II: Scientific Framework: The rationale for c-peptide preservation and use as a clinical trial endpoint
- Session III: Establishing/confirming clinical benefit
- Session IV: Overall Issues of Study Design: Considerations and panel discussion/open comment