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Session 5: 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, 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)
eCTD Submissions Update
Heather Crandall, MA
FDA, United States
Business Informatics Specialist, OBI, OSP, CDER
eCTD v4.0 Implementation
Jonathan Resnick, PMP
FDA, United States
Project Management Officer, OBI, OSP, CDER
CDER NextGen Portal: One Stop Shop for the Purpose of Non-eCTD Submission, Collaboration, and Reporting
Seyoum Senay, MS
FDA, United States
Supervisory Operations Research Analyst, CDER/OBI
PQ/CMC and KASA
Zhouxi Wang, PhD
FDA, United States
Senior Biologist, OPQ, CDER
PreMarket Safety Reporting to FAERS Using ICH E2B R3 Standards
Suranjan De, MBA, MS
FDA, United States
Deputy Director, Regulatory Science, OSE, CDER
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