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Learning Level: Foundational
Learning Level: Foundational
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Learning Level: Expert
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Full Schedule

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Full Schedule

  • Wednesday, May 14, 2025
  • 07:30 – 18:00 CEST
    Cloakroom
  • 07:30 – 18:00 CEST
    Registration
  • 08:30 – 09:30 CEST
    AI/SaMD - China
  • 08:30 – 09:30 CEST
    America first – Europe second? Defining global market access strategies for start-ups and new devices
  • 08:30 – 09:30 CEST
    EU Pharmaceutical Regulatory Reforms – time to consider implementation challenges and opportunities?
  • 08:30 – 09:30 CEST
    Innovating regulation: The use of AI by Notified Bodies for conformity assessment
  • 08:30 – 09:30 CEST
    MDR Kick-off Panel
  • 08:30 – 09:30 CEST
    Regulatory Considerations for Gene Therapy in pediatric patients
  • 09:30 – 10:45 CEST
    Presenters at Posters (Exhibition Hall)
  • 09:30 – 10:45 CEST
    Refreshment Break in the Exhibition Hall
  • 09:40 – 10:10 CEST
    Solution Circle: Key Considerations for CDx in Combined Trials under IVDR
  • 09:40 – 10:10 CEST
    Solution Circle: Mastering PSURs: Streamline Your Process for Faster Approvals
  • 09:40 – 10:10 CEST
    Solution Circle: The PFAS Paradox: Regulations, Testing, and Supply Chain Resilience
  • 10:15 – 10:45 CEST
    Solution Circle: Intended Use: The foundations of the medical device house
  • 10:15 – 10:45 CEST
    Solution Circle: Points to consider in deciding on placebo/active comparators in clinical trials.
  • 10:15 – 10:45 CEST
    Solution Circle: Structured Dialogue - IVDR - Live Example
  • 10:15 – 10:45 CEST
    Solution Circle: Surviving the EHDS: A Lifeline
  • 10:45 – 11:45 CEST
    Clinical Evaluation 1
  • 10:45 – 11:45 CEST
    Companion Diagnostics
  • 10:45 – 11:45 CEST
    EU Variation Reform + Worksharing
  • 10:45 – 11:45 CEST
    Global Perspectives on Usability and Human Factors Studies in Regulatory Submissions: Navigating the US, EU, and China Landscape
  • 10:45 – 11:45 CEST
    Streamlining Biosimilar Development Based on 20 Years’ Experience
  • 10:45 – 11:45 CEST
    The EU AI Act
  • 12:00 – 13:00 CEST
    Artificial Intelligence - Testbeds
  • 12:00 – 13:00 CEST
    Clinical Evaluation 2
  • 12:00 – 13:00 CEST
    HTA Regulation, Joint Clinical Assessments (JCA) & Joint Scientific Consultations (JSC)
  • 12:00 – 13:00 CEST
    New International: Experiences with the latest UK submission routes
  • 12:00 – 13:00 CEST
    Software
  • 12:00 – 13:00 CEST
    USA - Walhalla
  • 13:00 – 14:30 CEST
    Networking Lunch in Exhibition Hall
  • 13:10 – 13:35 CEST
    Sponsored presentations - Round 1
  • 13:15 – 13:45 CEST
    Solution Circle: ’Growing pains’: an evaluation of evolving pediatric study regulation in the US and EU
  • 13:15 – 13:45 CEST
    Solution Circle: Decreasing Complexity, defining Regulatory and Evaluation Strategy of LLM based functions.
  • 13:15 – 13:45 CEST
    Solution Circle: Impact of the Battery Regulation (EU) 2023/1542 on medical devices
  • 13:15 – 13:45 CEST
    Solution Circle: Key takeaways from 4 years of expert panel views to improve your IVD evaluation
  • 13:40 – 14:05 CEST
    Sponsored presentations - Round 2
  • 13:50 – 14:20 CEST
    Solution Circle: Challenges related to Data in AI Medical Devices in the European Union
  • 13:50 – 14:20 CEST
    Solution Circle: Cybersecurity in premarket submissions: US vs. EU approach
  • 13:50 – 14:20 CEST
    Solution Circle: Insight in Motivation: The RA life stories that matter in healthcare
  • 13:50 – 14:20 CEST
    Solution Circle: Real world evidence through Federated learning (AI) - Monitor drift and local optimization!
  • 14:05 – 14:30 CEST
    Sponsored presentations - Round 3
  • 14:30 – 15:30 CEST
    EU Green Deal
  • 14:30 – 15:30 CEST
    Accelerating Clinical Trials in EU
  • 14:30 – 15:30 CEST
    Clinical data challenges for novel and legacy medical devices - panel discussion with clinical experts from multiple notified bodies
  • 14:30 – 15:30 CEST
    Establishing AI Assurance: Establishing Laboratory and Testing Facilities in the EU and US
  • 14:30 – 15:30 CEST
    Medicines Shortages
  • 14:30 – 15:30 CEST
    Regulation Changes: EU IVDR
  • 15:30 – 16:45 CEST
    Presenters at Posters (Exhibition Hall)
  • 15:30 – 16:45 CEST
    Refreshment Break in the Exhibition Hall
  • 15:45 – 16:10 CEST
    Sponsored presentations - Round 1
  • 16:15 – 16:40 CEST
    Sponsored presentations - Round 2
  • 16:45 – 18:00 CEST
    Conversations That Matter: Interactions with Health Authorities
  • 19:00 – 22:00 CEST
    Networking Dinner (ticket required): Plein Publiek