Legend:
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
