From Combined Trial Regulatory Requirements to Strategic Efficiency: Driving Innovation & Collaboration for CDx Success

  • Navigating Crossover Regulatory Frameworks, aligning clinical trial design with EU IVDR, EU CTR, UK MDR, and emerging regulations like the EU AI Act
  • Collaboration and Innovation Opportunities, how cross-functional & multidisciplinary partnerships can drive adaptive strategies across evolving regulatory landscapes
  • Current discourse and relevant stakeholders shaping CDx/precision medicine policies in the EU/EEA region