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Session 2: FDA Plenary: Data and Technology Strategy
Session Chair(s)
Ethan Chen, MBA, MS, PMP
Director, Division of Data Management , FDA CDER, United States
During this session presenters will cover a variety of topics about the FDA Data and Technology Strategy. Topics will include Next Generation of the Electronic Submissions Gateway, data quality challenges in regulatory submissions, and CBER updates.
Learning Objective : At the conclusion of this session, participants should be able to:
- Discuss current FDA data quality challenges in regulatory submissions and identify areas of improvement to submit better quality data for FDA review
- Describe the details that encompass the next generation of the electronic submissions gateway in the cloud
- List and explain selected key data standards initiatives in CDER and CBER
Speaker(s)
Sri Mantha, MBA, MS
Acting Chief Information Officer, FDA, United States
Data Quality Challenges in Regulatory Submissions and Their Impact
Jessica Bernhardt, MS
IT Project Manager ODT, FDA, United States
Electronic Submission Gateway Next Generation (ESG NextGen)
Ginny Hussong
Branch Chief, Data Standards, CBER, FDA, United States
CBER Updates