Chris Bray

Chris Bray

Company: Merck KGaA

Job title: Head Global Regulatory Affairs, Precision Medicine and Companion Diagnostics

Seminars:

Regulation Panel Discussion: Scaling a Biomarker Test to Global Markets 5:25 pm

• Discussing the nuances in regulatory approvals and launching drug & diagnostic products in different markets (US, EU, APAC) • The importance of China as a market and why industry should come together more to discuss streamlining infrastructure planning and data handling protection to lower costs and planning time when launching biomarker-driven drug programmesRead more

day: Track B - Day 1 pm

IVDR Requirements for Performance Studies: Planning for Clinical Studies with New Regulations on the Horizon 1:30 pm

• Submitting an application for a performance study • Performance studies that require authorisation • Potential impacts on clinical studies (both running and new) • Other strategic considerationsRead more

day: Track A - Day 1 am

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