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Session 5: FDA - Ask the Regulators
Session Chair(s)
Ethan Chen, MBA, MS, PMP
Director, Division of Data Management Services and Solutions, OBI, OSP, CDER
FDA, United States
Dedicated to sharing the latest information on new guidances, this session will allow open discussion between the audience and an esteemed panel of regulatory experts. This session provides attendees the opportunity to ask regulators questions directly. Please note: due to the high volume of questions, not all will be answered live at the forum
Speaker(s)
Speaker
Ginny Hussong
FDA, United States
Branch Chief, Data Standards, CBER
Speaker
Ram Iyer, MS
FDA, United States
Chief Data Officer
Speaker
Sri Mantha, MBA, MS
FDA, United States
Director, Office of Strategic Programs, CDER
Speaker
Christopher Joneckis, PhD
FDA, United States
Associate Director for Review Management, CBER