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Bethesda North Marriott Hotel and Conference Center

Feb 14, 2022 8:30 AM - Feb 16, 2022 2:15 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Session 2: FDA Strategy on Data and Technology Modernization

Session Chair(s)

Ethan  Chen, MBA, MS, PMP

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

Update of the FDA Data Modernization Action Plan

Ram Iyer, MS

FDA, United States

Chief Data Officer

Sri  Mantha, MBA, MS

CDER’s Progress in Cloud Utilization, Data Analytics, and Drug Supply Chain

Sri Mantha, MBA, MS

FDA, United States

FDA CDER Super Office Director, CDER

Christopher  Joneckis, PhD

CBER’s Informatics Modernization Update

Christopher Joneckis, PhD

FDA, United States

Associate Director for Review Management, CBER

Ginny  Hussong

Speaker

Ginny Hussong

FDA, United States

Branch Chief, Data Standards, CBER

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