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Session 4: FDA Plenary: Electronic Submissions Update
Session Chair(s)
Jonathan Resnick, PMP
Project Management Officer, OBI, OSP, CDER
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)
ECTD v4.0 Implementation Update
Jonathan Resnick, PMP
FDA, United States
Project Management Officer, OBI, OSP, CDER
Study Data Technical Rejection Criteria Update
Lina Cong, MS
FDA, United States
Senior Health Informatics Officer, OBI, CDER
Standardizing Quality Submissions and Assessments: PQ/CMC and KASA
Norman Schmuff, PhD
FDA, United States
Associate Director for Science, OPMA, OPQ
CDER NextGen Portal
Seyoum Senay, MS
FDA, United States
Supervisory Operations Research Analyst, CDER/OBI