News & Events
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June 15, 2021 - June 16, 2021
VIEW NOW | Design of Clinical Trials in New-Onset Type 1 Diabetes: Regulatory Considerations for Drug Development
Critical Path Institute held a free virtual workshop, Design of Clinical Trials in New-Onset Type 1 Diabetes: Regulatory Considerations for Drug Development, June 15-16, 2021. Workshop Summary The purpose of this scientific workshop was to discuss the existing evidence regarding the role of C-peptide in clinical trials intended to support regulatory decision making, unique regulatory considerations...... -
September 9, 2019 - September 10, 2019
Solutions to Drug Development Challenges Workshop: Utilizing Quantitative Approaches, Data Sharing, and Novel Biomarkers
Title Presenter Presentation Link Introduction Dr. John-Michael Sauer (C-Path) Keynote Address Dr. Joseph Scheeren (C-Path) Welcoming Remarks Dr. Janet Woodcock (US FDA) Session 2: Benefits of DDT progression to regulatory acceptance Moderators: Dr. Inish O’Doherty (C-Path) and Dr. Ameeta Parekh (US FDA) 2.1 A perspective on the history and evolution of drug development......