Designing for Success: Accelerating Patient Inclusion in Early-Phase Translational Medicine

• Practical strategies for successful IVD and CDx regulatory submissions and clinical studies 
• How the EU IVDR Article 5(5) Health Institution Exemption can provide speed and flexibility for pharma-led precision medicine programmes
• Lessons learned and case studies from ARC’s collaborations in translational and precision medicine trials

Speakers:

Seamus Kearney

Founder & Chief Executive Officer

ARC Regulatory