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Electronic Submissions Update
Session Chair(s)
Tessa Brown, BSN, DRSc, MPH, RN
Super Office Deputy Director for Operations, DHHS/FDA/CDER/Office of Strategic Programs, United States
See the latest electronic submission metrics for regulatory submissions and conformance with study data standards. Learn about FDA's current challenges with building upon existing automation in submission processing and how you can help.
Learning Objective : 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)
Heather Crandall, MA
Business Informatics Specialist, OBI, FDA, FDA, United States
FDA Study Data Standards Submission Update
Jonathan Resnick, PMP
Advisor, Office of Digital Transformation, FDA, United States
FDA Electronic Submissions Update
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