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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 Services and Solutions, OBI, OSP, CDER
FDA, 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)
Data Quality Challenges in Regulatory Submissions and Their Impact
Sri Mantha, MBA, MS
FDA, United States
Director, Office of Strategic Programs, CDER
Electronic Submission Gateway Next Generation (ESG NextGen)
Jessica Bernhardt, MS
FDA, United States
ESG Program Manager
CBER Updates
Ginny Hussong
FDA, United States
Branch Chief, Data Standards, CBER