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Learning Level: Foundational
Learning Level: Foundational
Learning Level: Intermediate
Learning Level: Intermediate
Learning Level: Advanced
Learning Level: Advanced
Learning Level: Expert
Learning Level: Expert
Networking Event
Networking Event
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Sponsor Presentation
Ticketed Event
Ticketed Event

Full Schedule

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Full Schedule

  • Thursday, May 15, 2025
  • 07:30 – 18:00 CEST
    Cloakroom
  • 07:30 – 18:00 CEST
    Registration
  • 08:30 – 09:30 CEST
    Cybersecurity Across the Medical Device Lifecycle: Addressing Modern and Legacy Products
  • 08:30 – 09:30 CEST
    EU Green Deal inc OSOA, UWWTD
  • 08:30 – 09:30 CEST
    EUDAMED unlocked: Navigating the current Landscape and Implementation Strategies
  • 08:30 – 09:30 CEST
    Large panel genomic profiling and IVDR: strategies for manufacturers
  • 08:30 – 09:30 CEST
    Reliance pathways such as WHO Collaborative Registration Procedure (CRP) to accelerate the assessment and registration of medicinal products
  • 08:30 – 09:30 CEST
    The Power of Teamwork: Risk management, Clinical evaluation and PMS aka “the Holy Trinity of the MDR” – but what about claims?!
  • 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: ’Growing pains’: an evaluation of evolving pediatric study regulation in the US and EU
  • 09:40 – 10:10 CEST
    Solution Circle: Decreasing Complexity, defining Regulatory and Evaluation Strategy of LLM based functions.
  • 09:40 – 10:10 CEST
    Solution Circle: Impact of the Battery Regulation (EU) 2023/1542 on medical devices
  • 09:40 – 10:10 CEST
    Solution Circle: Key takeaways from 4 years of expert panel views to improve your IVD evaluation
  • 10:15 – 10:45 CEST
    Solution Circle: Challenges related to Data in AI Medical Devices in the European Union
  • 10:15 – 10:45 CEST
    Solution Circle: Cybersecurity in premarket submissions: US vs. EU approach
  • 10:15 – 10:45 CEST
    Solution Circle: Insight in Motivation: The RA life stories that matter in healthcare
  • 10:15 – 10:45 CEST
    Solution Circle: Real world evidence through Federated learning (AI) - Monitor drift and local optimization!
  • 10:45 – 11:45 CEST
    Digital Transformation
  • 10:45 – 11:45 CEST
    EU IVD Performance Evaluation Studies
  • 10:45 – 11:45 CEST
    Insilico
  • 10:45 – 11:45 CEST
    Patient-centricity, value, and cost-effectiveness of AI-enabled Medical Devices (AIeMDs)
  • 10:45 – 11:45 CEST
    Patient-focused Drug Development in EU: From EPAR to SmPC?
  • 10:45 – 11:45 CEST
    UK Regulatory Landscape: UK MDR Amendments and Impact
  • 12:00 – 13:00 CEST
    Clinical Trial Design
  • 12:00 – 13:00 CEST
    CMC strategy / ICH Q9
  • 12:00 – 13:00 CEST
    FDA Cybersecurity Submission
  • 12:00 – 13:00 CEST
    Navigating Pitfalls in Clinical Performance Studies: CRO Insights on Sample Management and Ethical Considerations
  • 12:00 – 13:00 CEST
    Navigating the intersection of MDR and HTA: Strategic implications for medical device manufacturers
  • 12:00 – 13:00 CEST
    PSUR: Requirements, experiences and lessons learned to date from three stakeholder perspectives
  • 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: Intended Use: The foundations of the medical device house
  • 13:15 – 13:45 CEST
    Solution Circle: Points to consider in deciding on placebo/active comparators in clinical trials.
  • 13:15 – 13:45 CEST
    Solution Circle: Structured Dialogue - IVDR - Live Example
  • 13:15 – 13:45 CEST
    Solution Circle: Surviving the EHDS: A Lifeline
  • 13:40 – 14:05 CEST
    Sponsored presentations - Round 2
  • 13:50 – 14:20 CEST
    Solution Circle: Key Considerations for CDx in Combined Trials under IVDR
  • 13:50 – 14:20 CEST
    Solution Circle: Mastering PSURs: Streamline Your Process for Faster Approvals
  • 13:50 – 14:20 CEST
    Solution Circle: The PFAS Paradox: Regulations, Testing, and Supply Chain Resilience
  • 14:05 – 14:30 CEST
    Sponsored presentations - Round 3
  • 14:30 – 15:30 CEST
    Benefits of standardized data models for digitalization in the Medtech industry
  • 14:30 – 15:30 CEST
    Combined studies. Interface between the Regulations on clinical trials of medicinal products, medical devices and in vitro diagnostics (current situation and future regulatory framework)
  • 14:30 – 15:30 CEST
    ML-based Medical Devices on General Purpose Wearable Hardware
  • 14:30 – 15:30 CEST
    Navigating Mergers and Acquisitions: Transitioning Products from IVDD/MD to IVDR/MDR Compliance"
  • 14:30 – 15:30 CEST
    Scientific Advice EU & US
  • 14:30 – 15:30 CEST
    Using IMDRF codes to analyse complaints and connections with Risk Management
  • 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 – 17:45 CEST
    Bilateral benefit of structured dialogues between Manufacturers and Notified Bodies
  • 16:45 – 17:45 CEST
    China: Key Regulatory & Clinical Updates and their Implementation
  • 16:45 – 17:45 CEST
    Critical IVDR milestones & EU Reference Laboratories… a testing time
  • 16:45 – 17:45 CEST
    EMA and FDA programs to support innovation and unmet medical needs.
  • 16:45 – 17:45 CEST
    Evolving with Technology: Navigating Current Regulatory Challenges and Future Directions in IoMT Cybersecurity
  • 16:45 – 17:45 CEST
    RWE