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Session 5: FDA Ask the Regulators: Part I
Session Chair(s)
Ginny Hussong
Branch Chief, Data Standards, CBER
FDA, United States
Session 5: FDA Ask the Regulators: Part I
Speaker(s)
Speaker
Ron Fitzmartin, PhD, MBA
FDA, United States
Senior Informatics Advisor, Office of Regulatory Operations, CBER
Speaker
Mark A. Gray
FDA, United States
Senior Project Manager, DSB, CBER
Speaker
Ethan Chen, MBA, MS, PMP
FDA, United States
Director, Division of Data Management Services and Solutions, OBI, OSP, CDER
Speaker
Leonard Sacks, MD
FDA, United States
Director, Clinical Methodologies,Office of Medical Policy, CDER
Speaker
Cheryl Grandinetti, PharmD
FDA, United States
Clinical Pharmacologist, OSI, OC, CDER
Speaker
La Misha Fields, MBA
FDA, United States
IT Program Manager, Electronic Submissions Gateway, OIMT, OC
Speaker
Jean M. Mulinde, MD
FDA, United States
Associate Director, Division of Clinical Compliance Evaluation, OSI