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Thursday, June 27 • 9:00am - 10:15am
#406: Electronic Submissions Update

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Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-719-L04-P; CME 1.25; IACET 1.25; RN 1.25

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 Objectives

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.

Chair

Tessa Brown, BSN, DrSc, MPH, RN

Speaker

FDA Study Data Standards Submission Update
Heather Crandall, MA

FDA Electronic Submissions Update
Jonathan Resnick, PMP



Speakers
avatar for Tessa Brown

Tessa Brown

Deputy Director, Office of Business Informatics /OSP / CDER, FDA
CAPT Tessa Brown DHSc, MPH, BSN, RN began her career as a Commission Corp Officer of the U.S. Public Health Service (USPHS) in 2001. She has held positions in various organizations to include the Bureau of Prisons, Health Resources and Services Administration, and the Food and Drug... Read More →
avatar for Heather Crandall

Heather Crandall

Operations Research Analyst, OBI, OSP, CDER, FDA
Heather Crandall has been with the FDA for over 6 years, working in CDER’s Office of Business Informatics. She currently focuses on standards and processes around electronic submissions.
avatar for Jonathan Resnick

Jonathan Resnick

Project Management Officer, OBI, OSP, CDER, FDA
Jonathan Resnick is a member of CDER’s Electronic Submissions Team, with a focus on eCTD and has been with FDA for eight years. Prior to joining FDA, Jonathan spent 18 years working in IT project management supporting federal and private sector clients.


Thursday June 27, 2019 9:00am - 10:15am
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA