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Tuesday, June 28 • 10:30am - 11:45am
#217: Electronic Submissions Gateway: Next Generation

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Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

Electronic Submissions Gateway (ESG) is an FDA solution for accepting electronic regulatory submissions. It has been in production since 2006. This session will provide an update and Q&A on its status and the technology and process enhancements.

Learning Objectives

Discuss the Electronic Submissions Gateway (ESG) process and solutions for submission of regulatory; Describe the technology and process enhancements planned for ESG._x000D_


Ron D. Fitzmartin, PhD, MBA


FDA eCTD v4.0 Two-Way Communication
Mark A. Gray

Virginia Hussong

La Misha Fields

avatar for Ron Fitzmartin

Ron Fitzmartin

Senior Informatics Advisor, Office of the Director, CBER, FDA, United States
Ron Fitzmartin is Senior Informatics Advisor, Office of the Director, Center for Biologics Evaluation and Research, Food and Drug Administration. In this role Ron provides policy and strategy consultation and support on a wide range of topics focused on electronic regulatory submissions... Read More →

avatar for La Misha Fields

La Misha Fields

IT Program Manager, Electronic Submissions Gateway, OIMT, OC, FDA
La Misha Fields is the Program Manager of the FDA’s Electronic Submissions Gateway (ESG) under the Office of Information Management and Technology located in Rockville, MD. She is an informatics and technology professional with over 6 years of FDA experience, including 5+ years... Read More →
avatar for Mark Gray

Mark Gray

Senior Project Manager, BSS, CBER, FDA
Mark has over 30 years experience in Information Management including; software developer/project manager in CBER; Director of Applications Development & Services in CDER; and PDUFA IT Program Director. Mark currently work’s for CBER’s Bioinformatics Support Staff. His responsibilities... Read More →
avatar for Virginia Hussong

Virginia Hussong

Director, Div. of Data Management Services & Solutions, OBI, OSP, CDER, FDA
Ginny Hussong has over 20 years of experience in the pharmaceutical industry, of which the past 10 have been in CDER. As Acting Director of the Division of Data Management Services and Solutions, she supports the receipt, processing and archive of electronic regulatory submissions... Read More →
avatar for Virginia Hussong

Virginia Hussong

Chief, Data Standards Program, CBER, FDA
Ginny Hussong is Chief of CBER’s Data Standards Program, and has been with FDA for 14 years. She was previously Director of Data Management Services and Solutions within CDER. As Chair of CBER’s Data Standards Committee, Ginny’s recent projects include creating a new joint data... Read More →

Tuesday June 28, 2016 10:30am - 11:45am EDT
201C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA