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Bethesda North Marriott Hotel and Conference Center

Feb 12, 2024 8:00 AM - Feb 14, 2024 2:30 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Don't miss the latest trends, innovations, and best practices in regulatory submissions, information, and document management (RSIDM)!

Session 5: FDA Plenary: Electronic Submissions Update

Session Chair(s)

Jonathan  Resnick, PMP

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


Heather  Crandall, MA

eCTD Submissions Update

Heather Crandall, MA

FDA, United States

Business Informatics Specialist, OBI, OSP, CDER

Jonathan  Resnick, PMP

eCTD v4.0 Implementation

Jonathan Resnick, PMP

FDA, United States

Project Management Officer, OBI, OSP, CDER

Seyoum  Senay, MS

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

Zhouxi  Wang, PhD


Zhouxi Wang, PhD

FDA, United States

Senior Biologist, OPQ, CDER

Suranjan  De, MBA, MS

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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