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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 Knowledge-Aided Assessment and Structured Application (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 system
Speaker(s)
Speaker
Jonathan Resnick, PMP
FDA, United States
Project Management Officer, OBI, OSP, CDER
Speaker
Heather Crandall, MA
FDA, United States
Business Informatics Specialist, OBI, OSP, CDER
Speaker
Seyoum Senay, MS
FDA, United States
Supervisory Operations Research Analyst, CDER/OBI
Speaker
Representative Invited
FDA, United States
Speaker
Zhouxi Wang, PhD
FDA, United States
Senior Biologist, OPQ, CDER
Speaker
Norman Schmuff, PhD
FDA, United States
Associate Director for Science, OPMA, OPQ, CDER