#217: Electronic Submissions Gateway: Next Generation
Chair
Senior Informatics Advisor, Office of Regulatory Operations, CBER, FDA, United States
Ron Fitzmartin is Senior Informatics Advisor, Office of Regulatory Operations, 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...
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Speakers
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...
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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...
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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...
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Branch Chief, Data Standards, CBER, FDA, United States
Ginny serves as Chief of CBER's Data Standards Program, where she leads a multidisciplinary team that advances standards such as eCTD, SDTM, ADaM, SEND, ICSR, IDMP, SPL and related terminologies. In addition, the team leads reviewer training and support related to the review of study...
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Tuesday June 28, 2016 10:30am - 11:45am EDT
201C
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA