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Session 12: Ask the Regulators
Session Chair(s)
Mark A. Gray
Senior Project Manager, DSB, CBER
FDA, United States
This session provides attendees the opportunity to ask regulators questions. Submit your questions in advance in the Virtual Forum Platform by navigating to the session, clicking on “Polls” then enter your question for the speakers. You can also email AsktheRegRSIDM@DIAglobal.org. Please note: due to the high volume of questions, not all will be answered live at the forum
Speaker(s)
Panelists
Ethan Chen, MBA, MS, PMP
FDA CDER, United States
Director, Division of Data Management
Panelists
Ron Fitzmartin, PhD, MBA
FDA, United States
Senior Advisor, Office of Regulatory Operations, CBER
Panelists
Ginny Hussong
FDA, United States
Branch Chief, Data Standards, CBER
Panelists
Jonathan Resnick, PMP
FDA, United States
Project Management Officer, OBI, OSP, CDER
Panelists
Mary Ann Slack
FDA, United States
Director, Office of Strategic Programs, CDER
Panelists
Norman Schmuff, PhD
FDA, United States
Associate Director for Science, OPMA, OPQ, CDER
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