Diagnostic Track
26th November – 09:00 – 10:15 – Session I

Regulatory Framework for Companion Diagnostics
Thoughtful regulation is vital to ensuring that personalised medicine lives up to its promise. Regulation is also one of the primary political mechanisms for shaping and fostering advances in personalised medicine.
The goal should be to approach the regulatory framework holistically, exploring how the development and delivery of precision-medicine diagnostics differ from those of “traditional” diagnostic tools and what rethought policies are necessary to balance patient safety with launch and uptake of innovative tests.
Chair

Petra Zoellner
Senior Manager Regulations and Industrial Policy, MedTech Europe
Panel

Robert Johnstone
Board Member, European Patient Forum

Armin Ritzhaupt
Regulatory Affairs Office, Scientific and Regulatory Management Department, European Medicines Agency (EMA)

Dr. Dieter Schönwald
Senior Manager International Affairs (IVD), Global Technical Officer IVD, TÜV SÜD PRODUCT SERVICE GMBH