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Session 3: FDA: Ask the Regulators
Session Chair(s)
Ron Fitzmartin, PhD, MBA
Senior Informatics Advisor, Office of Regulatory Operations, CBER
FDA, United States
Dedicated to sharing the latest information on new guidance’s, 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
Mary Ann Slack
FDA, United States
Director, Office of Strategic Programs, CDER
Speaker
Andrew Potter, PhD
FDA, United States
Mathematical Statistician, OB, OTS, CDER
Speaker
Ta-Jen Chen, MS
FDA, United States
Project Management Officer, OSP, CDER
Speaker
Christopher Joneckis, PhD
FDA, United States
Associate Director for Review Management, CBER
Speaker
Ray Wang, MBA, MS
FDA, United States
Director, Data Standards Staff, OSP, CDER