James Hewitt

Company: TÜV SÜD

Job title: IVD Business Line Manager & Senior Specialist (CDx)

Seminars:

Panel Discussion: Strengthening the Interface between Competent & Notified Bodies to Define a Unified Path Towards IVDR Compliance for Streamlined Approvals 8:30 am

What are the current and future expectations for CDx conformity? How closely are the new UK regulations expected to mirror or diverge from IVDR?  How are stakeholders harmonizing the interpretation of performance studies, from a technical and regulatory perspective?  How is the changing global landscape of laboratory developed tests expected to impact biomarker driven trials?Read more

day: Day 2 AM