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IVDs and Companion Diagnostics
Session Chair(s)
Stephen Lee
Senior Regulatory Policy Manager
Medicines & Healthcare Products Regulatory Agency (MHRA), United Kingdom
The new conformity assessment route for companion diagnostics could see competent authorities taking more of a premarket role with Notified Bodies reviewing clinical evidence prior to CE marking. In this session you will learn about the roadmap for regulation of companion diagnostics.
Speaker(s)
Big Data and Precision Medicine
Austin Tanney, PHD
Analytics Engines, United Kingdom
Head of Life Sciences
Companion Diagnostics: Notified Body Perspective
Heike Moehlig-Zuttermeister, DRSC
TUV SUD, Germany
Head of Business Line IVD
Companion Diagnostics: Competent Authority Perspective
Stephen Lee
Medicines & Healthcare Products Regulatory Agency (MHRA), United Kingdom
Senior Regulatory Policy Manager