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Session 2: FDA Strategy on Data and Technology Modernization
Session Chair(s)
Ethan Chen, MBA, MS, PMP
Director, Division of Data Management Services and Solutions, OBI, OSP, CDER
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 Office of Business Informatics, and CBER Office of Director will discuss data topics, for instance, standards, analytics, cloud utilization, 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 modernizations
- Discuss FDA’s response to the rapidly changing healthcare environment and the central role of data driving much of this change
- Gain general knowledge of CBER informatics modernization effort and data standards update
Speaker(s)
Update of the FDA Data Modernization Action Plan
Ram Iyer, MS
FDA, United States
Chief Data Officer
CDER’s Progress in Cloud Utilization, Data Analytics, and Drug Supply Chain
Sri Mantha, MBA, MS
FDA, United States
Director, Office of Strategic Programs, CDER
CBER’s Informatics Modernization Update
Christopher Joneckis, PhD
FDA, United States
Associate Director for Review Management, CBER
Speaker
Ginny Hussong
FDA, United States
Branch Chief, Data Standards, CBER