Legend:
CC = Baltimore Convention Center,
H = Hilton Baltimore
* = applied session ! = JSM meeting theme
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382
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Tue, 8/1/2017,
2:00 PM -
3:50 PM
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CC-308
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Improving the Efficiency of Medical Device Clinical Trials by Combining Simulations and Experiments — Invited Papers
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Section on Medical Devices and Diagnostics , Biopharmaceutical Section , Society for Medical Decision Making
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Organizer(s): Rajesh Nair, FDA/CDRH/OSB/DBS
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Chair(s): Tarek Haddad, Medtronic Cardiac Rhythm and Heart Failure
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2:05 PM
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The Past Is Prologue: The Use of Prior Information and Bayesian Methodologies in Designing Medical Device Regulatory Approval Trial
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Roseann White, Pragmatic clinical trial Statistics, Duke Clinical Research Institute
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2:20 PM
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Incorporation of Stochastic Engineering Models as Prior Information in Bayesian Medical Device Trials
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Valentin Parvu, BDX Corporate/Shared services, BD
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2:35 PM
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Discussant: Telba Irony, Office of Biostatistics and Epidemiology, CBER, FDA
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2:50 PM
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Discussant: Kyle Myers, Office of Science and Engineering Laboratories, CDRH
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3:05 PM
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Discussant: Scott Evans, Harvard University
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3:20 PM
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Discussant: Greg Campbell, GC stat consulting and former Director DBS/CDRH
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3:35 PM
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Floor Discussion
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