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Bethesda North Marriott Hotel and Conference Center

Feb 14, 2022 8:30 AM - Feb 16, 2022 2:15 PM

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

Regulatory Submissions, Information, and Document Management Forum

Session 4: FDA Electronic Submissions

Session Chair(s)

Jonathan  Resnick, PMP

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)

Jonathan  Resnick, PMP

Electronic Submission Update

Jonathan Resnick, PMP

FDA, United States

Project Management Officer, OBI, OSP, CDER

Seyoum  Senay, MS

CDER NextGen Portal and Research IND Application Builder

Seyoum Senay, MS

FDA, United States

Supervisory Operations Research Analyst, CDER/OBI

Daniil  Graborov, MS, PMP

FDA Forms Update

Daniil Graborov, MS, PMP

FDA, United States

Computer Scientist, CDER/OBI

Norman  Schmuff, PhD

PQ/CMC and KASA

Norman Schmuff, PhD

FDA, United States

Associate Director for Science, OPMA, OPQ, CDER

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