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Session 5: FDA Plenary: Electronic Submissions Update
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, eCTD validations, PQ/CMC standardization, recent updates to CDER’s NextGen portal, and information about how to submit premarket safety reporting to FAERS using ICH E2B R3 standards. FDA will provide details such as metrics, timelines, and where to find more information.
Learning Objective : At the conclusion of this session, participants should be able to:- Prepare for eCTD v4.0
- Develop understanding to publish premarket safety reports using ICH E2B R3 and submitting to FAERS
- Identify content that may be submitted via CDER’s NextGen Portal
- Describe benefits of PQ/CMC submission data standardization
- Identify the most common types of validation failures related to eCTD submissions
Speaker(s)
Heather Crandall, MA
Business Informatics Specialist, OBI, FDA, FDA, United States
eCTD Submissions Update
Jonathan Resnick, PMP
Advisor, Office of Digital Transformation, FDA, United States
eCTD v4.0 Implementation
Seyoum Senay, MS
Supervisory Operations Research Analyst, CDER/OBI, FDA, United States
CDER NextGen Portal: One Stop Shop for the Purpose of Non-eCTD Submission, Collaboration, and Reporting
Zhouxi Wang, PHD
Senior Biologist, OPQ, CDER, FDA, United States
PQ/CMC and KASA
Suranjan De, MBA, MS
Deputy Director, Regulatory Science, OSE, CDER, FDA, United States
PreMarket Safety Reporting to FAERS Using ICH E2B R3 Standards