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Session 11: FDA - Ask the Regulators Part 2– Standards for Product Quality, IDMP, and ICSRs
Session Chair(s)
Norman Schmuff, PhD
Associate Director for Science, OPMA, OPQ
FDA, United States
Speaker(s)
Speaker
Ta-Jen Chen, MS
FDA, United States
Project Management Officer, OSP, CDER
Speaker
Suranjan De, MBA, MS
FDA, United States
Deputy Director, Regulatory Science, OSE, CDER
Speaker
Ron Fitzmartin, PhD, MBA
FDA, United States
Senior Informatics Advisor, Office of Regulatory Operations, CBER
Speaker
Ginny Hussong
FDA, United States
Branch Chief, Data Standards, CBER
Speaker
Mark A. Gray
FDA, United States
Senior Project Manager, DSB, CBER