戻る Agenda
Session 5: FDA Electronic Submissions
Session Chair(s)
Jonathan Resnick, PMP
Project Management Officer, OBI, OSP, CDER
FDA, United States
During this session, FDA will provide a summary on electronic submissions. Studies started after December 17, 2016 are required to be submitted in standardized format when submitted to NDA, BLA, and ANDA (required for Commercial INDs if study start date is after December 17, 2017). FDA will discuss how eCTD validation is used to check a submission containing study data for conformance to the requirement. In addition, 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:
- Discuss the status of electronic submissions at the FDA
- Identify key components of study data submission subject to eCTD validation
- Apply proposed best practices for handling daily submissions and ensuring validation standards are followed
- Understand when CDER NextGen Portal may be used for a submission
Speaker(s)
Electronic Submissions Update
Jonathan Resnick, PMP
FDA, United States
Project Management Officer, OBI, OSP, CDER
Study Data Conformance: Technical Rejection Criteria for Study Data and Self Check Worksheet
Ethan Chen, MBA, MS, PMP
FDA CDER, United States
Director, Division of Data Management