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Activity Number: 113
Type: Topic Contributed
Date/Time: Monday, August 1, 2016 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #319084
Title: Design and Analysis of Multiregional Clinical Trials in Evaluation of Medical Devices: Some Points to Consider from a Regional Regulatory Perspective
Author(s): Yunling Xu* and Nelson LU
Companies: FDA/CDRH and FDA/CDRH
Keywords: MRCT ; Medical devices ; Reginal regulatory decision
Abstract:

Within the context of statistical design and analysis of multiregional clinical trials for medical devices, some issues encountered in regional regulatory review will be illustrated with examples. Accordingly, statistical approaches to inform regional regulatory decision will be discussed.


Authors who are presenting talks have a * after their name.

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