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Session 2: Stay Submission-Ready: The Latest on eCTD Standards and FDA Electronic Submission Portals
Session Chair(s)
Jonathan Resnick, PMP
Advisor, Office of Digital Transformation, FDA, United States
This session will provide information related to electronic submissions. Topics include an update on FDA’s implementation of eCTD v4.0 with a focus on Forward Compatibility, general eCTD validations and metrics, recent updates to CDER’s NextGen portal, and ESG NextGen portal.
Learning Objective : At the conclusion of this session, participants should be able to: - Discuss updates to FDA’s eCTD program including eCTD v4.0 and updates to specification and guidance
- Follow updates to the FDA eCTD web pages and learn about most common validation issues
- Identify latest updates to CDER’s NextGen Portal
- Share latest improvements and metrics under the modernized ESG NextGen Portal
Speaker(s)
Speaker
Jonathan Resnick, PMP
Advisor, Office of Digital Transformation, FDA, United States
Speaker
Representative Invited
Advisor, Office of Data Platform Engineering, FDA, United States
Speaker
Seyoum Senay, MS
Advisor, Office of Data Platform Engineering, FDA, United States
Speaker
Jessica Bernhardt, MS
Advisor, Office of Data Platform Engineering, FDA, United States
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