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Session 2: FDA Plenary – Driving Data and Information Technology
Session Chair(s)
Ron Fitzmartin, PhD, MBA
Senior Informatics Advisor, Office of Regulatory Operations, CBER
FDA, United States
FDA is focused on a strategic approach not only to technology, but to data itself. Data is at the heart of FDA’s work as a science-based Agency, and there is anticipation of ongoing, rapid increases in the amount and complexity of the data that will inform regulatory decision-making and its public health mission. Leaders from the FDA’s Office of Information Management and Technology, CDER’s Office of Strategic Programs, and CBER’s Data Standards Branch, Office of the Director will discuss data topics, for instance, standards, RWD/RWE, quality, stewardship, access / exchange, analytics, cloud, and, artificial intelligence.
Learning Objective : At the conclusion of this session, participants should be able to:
- Discuss the status of FDA’s strategy on data and technology
- Understand current and emerging data standards
- Discuss FDA’s response to the rapidly changing healthcare environment and the central role of data driving much of this change.
Speaker(s)
Speaker
Vid Desai
FDA, United States
Chief Technology Officer; Head, Office of Digital Transformation, OC
Speaker
Mary Ann Slack
FDA, United States
Director, Office of Strategic Programs, CDER
Speaker
Ginny Hussong
FDA, United States
Branch Chief, Data Standards, CBER
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