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Session Chair(s)
Ron Fitzmartin, PHD, MBA
Principal Consultant
Decision Analytics, United States
Learning Objective : List FDASIA/PDUFA V commitments related to electronic study data standards; Discuss the eSource guidance and its impact on EDC and EHRs; Summarize the status of various FDA initiatives focused on EHRs and study data and therapeutic area standards.
Speaker(s)
Panelist
Leonard Sacks, MD
FDA, United States
Director, Clinical Methodologies,Office of Medical Policy, CDER
Panelist
Mitra Rocca, MSC
FDA, United States
Associate Director, Medical Informatics, Office of Translational Science, CDER
Panelist
Jonathan Solomon Helfgott, MS
Johns Hopkins University, United States
Senior Lecturer, Faculty, & Program Coordinator,
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