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NEW IVD REGULATIONS IN THE EU
Session Chair(s)
Jesus Rueda
Director for Regulatory Affairs
European Diagnostic Manufacturers Association, (EDMA), Belgium
Anticipation of the Coming Changes in the EU Regulatory Framework for Companion Diagnostics
Learning Objective : The audience will gain from this presentation an overview of the expected changes of the current European IVD regulation, in particular the major new requirements that should apply to Companion Diagnostics in the next future. This presentation will provide the audience with key considerations for co-development of CDx and medicinal products in Europe.
Speaker(s)
MSdialog: A Novel System for Engaging Patients with Multiple Sclerosis in Routine Health Outcomes Reporting and Monitoring
Mark Thristan
EMD Serono, United States
Associate Director, IS - R&D - Embedded IT
View from a Notified Body
Catherine Holzmann, PharmD
LNE/GMED Certification Division, France
IVD Department Manager
Anticipation of the Coming Changes in the EU Regulatory Framework for Companion Diagnostics
Sylvie Le Gledic, DrSc
Voisin Consulting Life Sciences, France
Director, IVD/CDx
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