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Tuesday, June 20 • 2:00pm - 3:15pm
#241: FDA Session: Electronic Submissions and Data

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

Study Data Standards are required in clinical and nonclinical studies that start after December 17, 2016. Technical rejection criteria will be added to the existing eCTD validation criteria to enforce the deadlines. This session will provide an update on these topics and others focused on eCTD and standardized study data.

Learning Objectives

Discuss the status of electronic submissions, standardized data requirements, and data validation at FDA.

Chair

Ron D. Fitzmartin, PhD, MBA

Speaker

Moving Forward: Statistical Review of CDISC ADaM Standardized Data at CDER
Weiya Zhang, PhD

Results from the CDISC-SEND Fit for Use Pilot: A Structured Assessment of Nonclinical Pilot Submissions to FDA
Elaine Thompson, PhD

CDER Perspective
Colleen Ratliffe, MS, PMP

CBER Perspective
Virginia Hussong


Speakers
avatar for Ron Fitzmartin

Ron Fitzmartin

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... Read More →
avatar for Virginia Hussong

Virginia Hussong

Branch Chief, Data Standards, CBER, FDA, United States
Ginny serves as Chief of CBER's Data Standards Branch, where she leads a multidisciplinary team that advances standards such as eCTD, CDISC, IDMP, ICSR, SPL and related terminologies. In addition, conducts technical validation of clinical study data, leads related reviewer training... Read More →
avatar for Colleen Ratliffe

Colleen Ratliffe

Project Management Officer, Office of Strategic Programs, CDER, FDA
Colleen Ratliffe is a project management officer on the Data Standards team within the Office of Strategic Programs, CDER. The data standards team’s core functions include coordinating and leading projects that support and promote the development of data standards and policy and... Read More →
avatar for Elaine Thompson

Elaine Thompson

Senior Staff Fellow, OTS, OCS, CDER, FDA
Dr. Thompson is focused on enhancing FDA review of nonclinical CDISC-SEND submissions by expanding and improving the SEND standard with CDISC and PhUSE, leading the KickStart reviewer service, and developing software to visualize SEND data. Before joining CDER, she completed a FDA... Read More →
WZ

Weiya Zhang

Mathematical Statistician, OB, Office of Translational Science, CDER, FDA
Weiya Zhang received her Ph.D. in Statistics from the University of Illinois at Chicago in 2007. She joint US Food and Drug Administration (FDA) in 2014 working as a Statistical Reviewer in the Office of Biostatistics, Center for Drug Evaluation and Research (CDER). Before that, she... Read More →

Tuesday June 20, 2017 2:00pm - 3:15pm CDT
N228 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  01: Data-BigData-eHealth, Forum