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Session 4: FDA Electronic Submissions
Session Chair(s)
Jonathan Resnick, PMP
Project Management Officer, OBI, OSP, CDER
FDA, United States
This session will cover the latest information on eCTD related guidance/specification CDER submission mechanisms for certain types of content not required in eCTD, and updates on PQ/CMC and KASA. The presentations topics include eCTD, CDER’s NextGen Portal, CDER’s new Research IND application submission mechanism in the CDER NextGen Portal FDA Forms, and PQ/CMC and KASA. FDA will provide an update on submission metrics, processing challenges, and best practices for successful submission.
Learning Objective : At the conclusion of this session, participants should be able to:
- Understand the latest updates to eCTD guidance and specifications
- Gain general knowledge of CDER’s NextGen Portal and the type of content that can be submitted
- Learn how CDER is leveraging it’s NextGen Portal to collect structured data when a Research IND is submitted in non-eCTD format
- Become familiar with FDA efforts in the areas of PQ/CMC and KASA
Speaker(s)
Electronic Submission Update
Jonathan Resnick, PMP
FDA, United States
Project Management Officer, OBI, OSP, CDER
CDER NextGen Portal and Research IND Application Builder
Seyoum Senay, MS
FDA, United States
Supervisory Operations Research Analyst, CDER/OBI
FDA Forms Update
Daniil Graborov, MS, PMP
FDA, United States
Computer Scientist, CDER/OBI
PQ/CMC and KASA
Norman Schmuff, PhD
FDA, United States
Associate Director for Science, OPMA, OPQ
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