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Next-Generation Data Standards for RWD/RWE (FHIR, Dataset-JSON, and the Road Ahead)
Session Chair(s)
James Browning, MPH
Director of Biostatistical Programming, Center for Observational Research
Amgen, United States
This forum will explore current and emerging data standards applicable to RWD when intended for regulatory purposes. Experts from FDA and industry will discuss how today’s standards set the stage for tomorrow’s regulatory landscape.
Learning Objective : Provide context on how today’s CDISC standards set the foundation for RWD/RWE submissions. Discuss evolving data standards, including Dataset-JSON and HL7 FHIR, focusing on how they may complement or extend CDISC. Identify actions sponsors can take now to prepare for evolving regulatory data standards.
Speaker(s)
Panelist
Chris Decker, MS
United States
President and CEO
Panelist
Representative Invited
FDA, United States
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