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Learning Level: Foundational
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Full Schedule

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Full Schedule

  • Friday, May 16, 2025
  • 07:30 – 13:30 CEST
    Registration
  • 07:30 – 14:00 CEST
    Cloakroom
  • 08:30 – 10:00 CEST
    Plenary Session - Disruptive Innovation: Redefining Regulatory Roles
  • 10:00 – 10:30 CEST
    Refreshment Break
  • 10:30 – 11:30 CEST
    All in one for Biocompatibility: ISO 10993 Updates, Toxicological Risk Assessment and Post-Market Data
  • 10:30 – 11:30 CEST
    China drug regulatory pathways: 2025 Key Updates and Deep-Dive
  • 10:30 – 11:30 CEST
    Mastering Post-Market Surveillance under IVDR: From PMPF to PSUR
  • 10:30 – 11:30 CEST
    On trend: The Important Considerations for Trend Reporting in Medical Device Safety
  • 10:30 – 11:30 CEST
    Shaping the Future of mRNA Vaccines: A Regulatory Perspective
  • 10:30 – 11:30 CEST
    Supply chain cybersecurity risk management
  • 11:45 – 12:45 CEST
    Adaptive and Evolving AI-enabled Medical Devices
  • 11:45 – 12:45 CEST
    Drug-device combination - borderline case studies
  • 11:45 – 12:45 CEST
    Involving European Reference Laboratories in the conformity assessment of Class D IVD's: Operational update after 6 months.
  • 11:45 – 12:45 CEST
    Medical device - International focus
  • 11:45 – 12:45 CEST
    Orphaned devices - the needs, approval process and challenges in the EU.
  • 11:45 – 12:45 CEST
    Using Artificial Intelligence to Support Regulatory Processes and Decision-Making
  • 12:45 – 13:30 CEST
    Euro Convergence Farewell