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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)
FDA Study Data Standards Submission Update
Heather Crandall, MA
FDA, United States
Business Informatics Specialist, OBI, FDA
FDA Electronic Submissions Update
Jonathan Resnick, PMP
FDA, United States
Project Management Officer, OBI, OSP, CDER