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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 , FDA CDER, 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)
Ram Iyer, MS
Chief Data Officer, FDA, United States
Update of the FDA Data Modernization Action Plan
Sri Mantha, MBA, MS
Acting Chief Information Officer, FDA, United States
CDER’s Progress in Cloud Utilization, Data Analytics, and Drug Supply Chain
Christopher Joneckis, PHD
Associate Director for Review Management, CBER, FDA, United States
CBER’s Informatics Modernization Update
Ginny Hussong
Branch Chief, Data Standards, CBER, FDA, United States
Speaker
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