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Bethesda North Marriott Hotel and Conference Center

Feb 12, 2024 8:00 AM - Feb 14, 2024 2:30 PM

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

Regulatory Submissions, Information, and Document Management Forum

Don't miss the latest trends, innovations, and best practices in regulatory submissions, information, and document management (RSIDM)!

Session 2: FDA Plenary: Data and Technology Strategy

Session Chair(s)

Ethan  Chen, MBA, MS, PMP

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


Sri  Mantha, MBA, MS

Data Quality Challenges in Regulatory Submissions and Their Impact

Sri Mantha, MBA, MS

FDA, United States

Director, Office of Strategic Programs, CDER

Jessica  Bernhardt, MS

Electronic Submission Gateway Next Generation (ESG NextGen)

Jessica Bernhardt, MS

FDA, United States

ESG Program Manager

Ginny  Hussong

CBER Updates

Ginny Hussong

FDA, United States

Branch Chief, Data Standards, CBER

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