Brian Baker

Brian Baker

Company: Regeneron Pharmaceuticals Inc

Job title: Senior Director, Companion Diagnostics Regulatory Affairs


Exploring the Implications of Companion Diagnostics on Gene Therapy Clinical Trials 9:30 am

Understand the key differences to FDA regulations to avoid pitfalls later on in your study pipeline Demystify the In Vitro Diagnostics Regulations (IVDR) to ensure compliance and regulatory requirements are met to obtain necessary approvals and gain access to the EU market Clarifying the differences in emphasis on clinical evidence and risk classification between the…Read more

day: Conference Day One

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