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Full Schedule

Full Schedule

  • Wednesday, October 23, 2024
  • 8:00 AM – 5:00 PM CEST
    Registration
  • 8:30 AM – 10:00 AM CEST
    Opening Plenary Session: Evolving regulatory frameworks: Access to Innovation and Patient Safety
  • 10:00 AM – 10:30 AM CEST
    Coffee Break & Exhibition
  • 10:30 AM – 11:30 AM CEST
    Challenges and Opportunities in In-Vitro Diagnostic Risk Management
  • 10:30 AM – 11:30 AM CEST
    How to Tame Your Benefit Risk Evaluation
  • 11:45 AM – 12:45 PM CEST
    The Interface of the EU AI Act and the MDR/IVDR
  • 12:45 PM – 1:45 PM CEST
    Lunch & Exhibition
  • 1:45 PM – 2:45 PM CEST
    Clinical Evaluation of High-Risk Implantable; Current state of play, including pediatric
  • 1:45 PM – 2:45 PM CEST
    How to Conduct CDx Clinical Performance Studies in Compliance with IVDR 2017/746
  • 3:00 PM – 4:00 PM CEST
    How to Effectively Collect Level 4 Clinical Data With High Quality PMCF Surveys
  • 3:00 PM – 4:00 PM CEST
    Strategies for Co-Development of Companion Diagnostics and Medicines in the IVDR Era
  • 4:00 PM – 4:30 PM CEST
    Coffee Break & exhibition
  • 4:30 PM – 5:30 PM CEST
    What are common pitfalls in Clinical Evaluation and Performance Evaluation - An Analysis of the Feedback from Different Notified Bodies
  • 5:30 PM – 6:30 PM CEST
    Networking Reception