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Bethesda North Marriott Hotel and Conference Center

Feb 11, 2019 7:00 PM - Feb 13, 2019 8:15 PM

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

Regulatory Submissions, Information, and Document Management Forum

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Session 4: FDA – Electronic Submissions

Session Chair(s)

Ethan Chen, MBA, MS, PMP

Ethan Chen, MBA, MS, PMP

Director, Division of Data Management , FDA CDER, United States

During this session, FDA will provide a summary on electronic submissions. As of May 5, 2017 and May 5, 2018, eCTD is required for NDA, BLA, and ANDA and Commercial IND and DMF submissions, respectively. In addition, studies started as of 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 December 17, 2017 or later). 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 and validation at the FDA
Identify key components of lifecycle management for electronic submissions
Apply proposed best practices for handling daily submissions and ensuring validation standards are followed

Speaker(s)

Ethan Chen, MBA, MS, PMP

Ethan Chen, MBA, MS, PMP

Director, Division of Data Management , FDA CDER, United States

Technical Rejection Criteria for Study Data

Jonathan Resnick, PMP

Jonathan Resnick, PMP

Advisor, Office of Digital Transformation, FDA, United States

eCTD Submission Metrics and Guidance Update

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