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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.