JSM 2011 Online Program

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19 *	Sun, 7/31/2011, 2:00 PM - 3:50 PM	CC-B215
Good Statistical Practice — Topic Contributed Papers
Biopharmaceutical Section
Organizer(s): Jianxiong Chu, U.S. Food and Drug Administration, Xiaolu Su, Abbott Vascular
Chair(s): Roseann White, Abbott Vascular
2:05 PM	Assuring Device Trial Data Quality for Regulatory Decisionmaking: Can Data Standards Help? — Jianxiong Chu, U.S. Food and Drug Administration
2:25 PM	Good Statistical Practice for Medical Device Trial Submission — Huyuan Yang, Boston Scientific Corporation ; Matthew Rousseau, Boston Scientific Corporation ; Peter Lam, Boston Scientific Corporation
2:45 PM	Two Case Studies of Using Quantitative Decision Analysis in the Regulation of Medical Devices — Xuefeng Li, U.S. Food and Drug Administration
3:05 PM	Reducing Cost in Clinical Trial Data Monitoring Using Simulation — Lan Pan, Boston Scientific Corporation ; Peter Lam, Boston Scientific Corporation ; Joseph Bero, Boston Scientific Corporation
3:25 PM	Floor Discussion

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