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Session 4: FDA Plenary: Electronic Submissions Update
Session Chair(s)
Jonathan Resnick, PMP
Project Management Officer, OBI, OSP, CDER
FDA, United States
This session will provide information related to electronic submissions. Topics include an update on FDA’s implementation of eCTD v4.0, eCTD validations, PQ/CMC standardization and KASA, recent updates to CDER’s NextGen portal, and latest information on the FDA’s Global Substance Registration System (GSRS). There will also be time for live Q&A with the panel.
Learning Objective : - Discuss updates to FDA’s eCTD program including eCTD v4.0, web page edits, and updates to specification and guidance
- Identify latest updates to CDER’s NextGen Portal
- Follow updates to the FDA eCTD web pages and learn about most common validation issues
- Share benefits of PQ/CMC submission standardization and how it enables FDA’s Knowledge-Aided Assessment and Structured Application (KASA) system
Speaker(s)
Speaker
Representative Invited
FDA, United States
Speaker
Seyoum Senay, MS
FDA, United States
Supervisory Operations Research Analyst, CDER/OBI
Speaker
Representative Invited
FDA, United States
Speaker
Representative Invited
FDA, United States
Speaker
Representative Invited
FDA, United States
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