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Session 4: FDA Electronic Submissions
Session Chair(s)
Jonathan Resnick, PMP
Advisor, Office of Digital Transformation, 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)
Jonathan Resnick, PMP
Advisor, Office of Digital Transformation, FDA, United States
Electronic Submission Update
Seyoum Senay, MS
Supervisory Operations Research Analyst, CDER/OBI, FDA, United States
CDER NextGen Portal and Research IND Application Builder
Daniil Graborov, MS, PMP
Computer Scientist, CDER/OBI, FDA, United States
FDA Forms Update
Norman Schmuff, PHD
, Retired, United States
PQ/CMC and KASA
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