Join the TransCelerate Embedded Pragmatic Trials initiative team for a panel discussion focused on sponsor oversight and safety reporting, including speakers from FDA’s CDER Center for Clinical Trial Innovation (C3TI).
During this webinar, our panelists will:
- Explore ways to accelerate Selective Safety Data Collection (SSDC) implementation, including insights from recent FDA-TransCelerate discussions and the ICH E19 guidelines
- Provide updates on FDA’s STEP program and SSDC demonstration project
- Engage in a live Q&A
Panelists:
- Cheryl Grandinetti, Associate Director for Clinical Policy, CDER/FDA
- Mary Thanh Hai, Director, Office of New Drugs, CDER/FDA
- Zhanna Jumadilova, Pragmatic Clinical Trials Lead, Pfizer R&D, Pfizer
- Karen Outten, Executive Director, Clinical Trial Safety Reporting, Merck
- Stacy Tegan, Program Director, TransCelerate