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Session 4: Real-World Data Standards for Regulatory Submissions: Exploring the Challenges, Solutions, and Potential Alternatives
Session Chair(s)
Diane Gubernot, DrPH, MPH
Epidemiologist
US FDA, United States
Real-world data standards have been of great interest since draft guidance was released by the FDA in 2021. This session will discuss developments in this area, case studies of regulatory use cases, and areas of focus for the future.
Learning Objective : - Share new developments in real-world data (RWD) standards over the past year, including: updates from sponsors, data providers, standards development groups, validation organizations, and themFDA
- Discuss available data standards from FDA’s Catalog and assess other common data models that could be considered as additions
Speaker(s)
Speaker
James Browning, MPH
Amgen, United States
Director of Biostatistical Programming, Center for Observational Research