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CC = Vancouver Convention Centre   F = Fairmont Waterfront Vancouver
* = applied session       ! = JSM meeting theme

Activity Details

575 * Wed, 8/1/2018, 2:00 PM - 3:50 PM CC-West 214
Translating Real World Data into Robust Evidence to Inform Decisions on Medical Product Development and Life Cycle Management — Topic Contributed Papers
Section on Medical Devices and Diagnostics, Biopharmaceutical Section
Organizer(s): Weili He, AbbVie
Chair(s): Weili He, AbbVie
2:05 PM Evaluating Different Analytic Strategies to Translate Real World Data to Robust Evidence for Decision Making

Hongwei Wang, AbbVie Inc; Weili He, AbbVie; Yabing Mai, AbbVie, Inc; Meijing Wu, AbbVie; Dajun Tian, Chiltern
2:25 PM Opportunities of Using Real World Data to Inform Regulatory Considerations for Medical Devices

Martin Ho, FDA
2:45 PM Real World Data Analysis to Inform Clinical Trial Modeling and Simulation

Zhaoling Meng, sanofi; Dimple Patel, sanofi; Qi Tang, Sanofi; Nadia Gaudel-Dedieu, sanofi; James Rogers, Metrum Research Group
3:05 PM The Use of Real World Data as a Bayesian Prior in a Device Clinical Trial

Roseann White, Duke Clinical Research Institute
3:25 PM Discussant: Mark Levenson, FDA CDER
3:45 PM Floor Discussion