James Hewitt

Company: TÜV SÜD

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

Seminars:

Panel Discussion: Taking Control of Your IVD Regulatory Submissions to Turbocharge the Future of CDx 11:30 am

What have learned from the recent submission under the new IVDR to turbocharge future submissions? How to avoid IVDR to become a barrier to develop future precision medicine therapies for patient in oncology, NASH and beyond? How to bring harmonisation amongst stakeholders (regulators, notified bodies, drug developers, CDx developers and payers) to ensure successful submissions…Read more

day: Day Two AM

CDx Certifications Under IVDR: State of Play 9:00 am

State of play IVDR with viewpoint on CDx Understanding interactions with EMA Lessons learnt and takeaways from first certification projectsRead more

day: Day Two AM

Panel Discussion: How to Navigate the IVD Regulatory Landscape in Different European Countries to Accelerate Your Companion Diagnostics Approval 9:20 am

What are the key changes introduced by IVDR and how to approach them? What steps can you take to navigate IVDR successfully and what have we learned so far? How IVDR is being approached in different parts of Europe?   How will IVDR impact patients access to trials and treatments across different European countries? Read more

day: Day One