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In Conversation with FDA: Advancing Selective Safety Data Collection in Pragmatic Trials  

 

Date: Monday, May 4, 2026

Time: 10:00 to 11:00 a.m. ET

 

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

 This event does not constitute nor should be considered as any type of endorsement by TransCelerate or its members of any vendor, product, or technology. TransCelerate webinars may be recorded in whole or in part.