Diagnostic Track

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

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 Zollner

Petra Zoellner

Senior Manager Regulations and Industrial Policy, MedTech Europe

Panel

Robert Johnstone

Robert Johnstone

Board Member, European Patient Forum

Armin Ritzhaupt

Armin Ritzhaupt

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

 Dr.-Dieter-Schonwald

Dr. Dieter Schönwald

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