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JSM 2012 Online Program

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Activity Details

270 * ! Tue, 7/31/2012, 8:30 AM - 10:20 AM HQ-Sapphire C
CDISC - Marching Ahead by Facing Challenges: A Pharmaceutical Industry Experience — Invited Papers
Section for Statistical Programmers and Analysts , Biopharmaceutical Section , International Indian Statistical Association
Organizer(s): Vipin Arora, Abbott Laboratories
Chair(s): Stephen Wilson, FDA/CDER/OB/DBIII
8:35 AM Some Limitations of CDISC: SDTM and ADaM as Sponsor Operational Models Mario Widel, Roche Molecular Systems, Inc. ; Henry B. Winsor, Winsorworks Ltd.
8:55 AM The Interaction Between CDISC and a Metadata-Driven Process Dan Crawford, Octagon Research Solutions
9:15 AM A Strategy for Creating Integrated Analysis Data Sets Based on ADaM Using SDTM Compliant and Noncompliant Data Sets Melvin Munsaka, Takeda Global Research and Development, Inc.
9:35 AM Control Terminology vs. Warnings from Open CDISC Validation: A Submission (SBLA) Preparation Experience Jian Wang, Regeneron Pharmaceuticals, Inc.
9:55 AM Discussant: Marian Fisher, University of Wisconsin-Madison
10:05 AM Floor Discussion

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