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Session 4: FDA Plenary: Electronic Submissions Update
Session Chair(s)
Jonathan Resnick, PMP
Advisor, Office of Digital Transformation, FDA, United States
Session 4: FDA Plenary
Learning Objective : At the conclusion of this session, participants should be able to:
- Prepare for eCTD v4.0
- Identify content that may be submitted via CDER’s NextGen Portal
- Describe benefits of PQ/CMC submission data standardization
- Identify tops reasons a submission containing study data fails an eCTD validation
Speaker(s)
Jonathan Resnick, PMP
Advisor, Office of Digital Transformation, FDA, United States
ECTD v4.0 Implementation Update
Lina Cong, MS
Senior Health Informatics Officer, OBI, CDER, FDA, United States
Study Data Technical Rejection Criteria Update
Norman Schmuff, PhD
, Retired, United States
Standardizing Quality Submissions and Assessments: PQ/CMC and KASA
Seyoum Senay, MS
Supervisory Operations Research Analyst, CDER/OBI, FDA, United States
CDER NextGen Portal