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CDER Electronic Submissions Standards Update
Program Code:
267
Date:
Tuesday, June 26, 2012
Time:
3:30 PM to 4:30 PM
EST
CHAIR
:
Charles Cooper, FDA, United States
PRESENTER
(S):
Behrang Vali, FDA
Mary Ann Slack, FDA, United States
Paul Okwesili is an Operations Research Analyst at FDA, where he leads the development effort for the risk management/decision analysis tools for CDER’s bioresearch monitoring programs. He leverages advanced analytical methods in support of business operations and to help make better decisions.
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Description
This showcase will explore CDER's ongoing efforts to move towards electronic standards and how those standards will help the Center effectively perform its critical public health mission. Topics include CDISC SDTM, ADaM and the OSI site-level dataset. Hosted by the Electronic Regulatory Submissions (ERS) SIAC.
Learning Objectives:
Discuss CDER's ongoing plans for data standardization
Describe CDER's data standardization goals and the rationale behind them.