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Virtual

Feb 08, 2021 10:00 AM - Feb 10, 2021 4:30 PM

(Eastern Standard Time)

Regulatory Submissions, Information, and Document Management Forum

Session 2: FDA Plenary – Driving Data and Information Technology

Session Chair(s)

Ron  Fitzmartin, PhD, MBA

Ron Fitzmartin, PhD, MBA

Senior 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)

Vid  Desai

Speaker

Vid Desai

FDA, United States

Chief Technology Officer; Head, Office of Digital Transformation, OC

Mary Ann  Slack

Speaker

Mary Ann Slack

FDA, United States

Director, Office of Strategic Programs, CDER

Ginny  Hussong

Speaker

Ginny Hussong

FDA, United States

Branch Chief, Data Standards, CBER

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