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Learning Level: Foundational
Learning Level: Foundational
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Learning Level: Intermediate
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Learning Level: Advanced
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Learning Level: Expert
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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
    Clean Industrial Deal
  • 08:30 – 09:30 CEST
    Cybersecurity Across the Medical Device Lifecycle: Addressing Modern and Legacy Products
  • 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
    Solutions Circle: ’Growing pains’: an evaluation of evolving pediatric study regulation in the US and EU
  • 09:40 – 10:10 CEST
    Solutions Circle: Decreasing Complexity, defining Regulatory and Evaluation Strategy of LLM based functions.
  • 09:40 – 10:10 CEST
    Solutions Circle: Impact of the Battery Regulation (EU) 2023/1542 on medical devices
  • 09:40 – 10:10 CEST
    Solutions Circle: Key takeaways from 4 years of expert panel views to improve your IVD evaluation
  • 09:45 – 10:10 CEST
    MDSS GmbH: The Importer under MDR. Why the MDR requirements are a Blessing!
  • 09:45 – 10:10 CEST
    Medsec LLC: Cybersecurity Risk Management: Your Next Submission’s Secret Weapon
  • 10:15 – 10:40 CEST
    osapiens / BYRD.Health: Are you up to the 2025 EUDAMED challenge?
  • 10:15 – 10:40 CEST
    Weave Bio: Evaluating Time Savings in Regulatory Writing: A Scientific Comparison of Human and AI Approaches
  • 10:15 – 10:45 CEST
    Solutions Circle: Challenges related to Data in AI Medical Devices in the European Union
  • 10:15 – 10:45 CEST
    Solutions Circle: Cybersecurity in premarket submissions: US vs. EU approach
  • 10:15 – 10:45 CEST
    Solutions Circle: Insight in Motivation: The RA life stories that matter in healthcare
  • 10:15 – 10:45 CEST
    Solutions Circle: Real world evidence through Federated learning (AI) - Monitor drift and local optimization!
  • 10:45 – 11:45 CEST
    Digital transformation in Regulatory Tools and Dossier submission
  • 10:45 – 11:45 CEST
    Navigating IVDR: Performance Evaluation and Usability for Near-Patient and Self-Tests
  • 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
    Revolutionizing product safety and performance: The Role of Computational Modelling, In Silico Trials, and Global Standards
  • 10:45 – 11:45 CEST
    UK Regulatory Landscape: UK MDR Amendments and Impact
  • 12:00 – 13:00 CEST
    CMC strategy / ICH Q9
  • 12:00 – 13:00 CEST
    Current Developments and Regulatory Trends in Clinical Trial Design
  • 12:00 – 13:00 CEST
    Mastering US FDA Cybersecurity Submissions: Requirements, Deficiencies, and Best Practices 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
    MedBoard: Streamlining Regulatory Intelligence and Literature reviews with automation and AI: case studies and proven value
  • 13:10 – 13:35 CEST
    Pearl Pathways: The Global Regulatory Landscape for Companion Diagnostics
  • 13:15 – 13:45 CEST
    Solutions Circle: Intended Use: The foundations of the medical device house
  • 13:15 – 13:45 CEST
    Solutions Circle: Points to consider in deciding on placebo/active comparators in clinical trials.
  • 13:15 – 13:45 CEST
    Solutions Circle: Structured Dialogue - IVDR - Live Example
  • 13:15 – 13:45 CEST
    Solutions Circle: Surviving the EHDS: A Lifeline
  • 13:40 – 14:05 CEST
    LexisNexis Reed Tech: What You Need to Know to Be Compliant
  • 13:40 – 14:05 CEST
    Qserve Group: Navigating the Political Shifts in Global Regulatory Affairs
  • 13:50 – 14:20 CEST
    Solutions Circle: Key Considerations for CDx in Combined Trials under IVDR
  • 13:50 – 14:20 CEST
    Solutions Circle: Mastering PSURs: Streamline Your Process for Faster Approvals
  • 13:50 – 14:20 CEST
    Solutions Circle: The Journey to Becoming RCC Certified!
  • 13:50 – 14:20 CEST
    Solutions Circle: The PFAS Paradox: Regulations, Testing, and Supply Chain Resilience
  • 14:05 – 14:30 CEST
    greenlight.guru: 2025 State of the Medical Device Industry Report
  • 14:05 – 14:30 CEST
    Ketryx Corporation: AI-Driven Document Orchestration and Generation: Managing Systems of Systems, Modular Software Services, and Compliance at Scale
  • 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
    From Confusion to Clarity: Decoding US and European Regulatory Meetings During Development, for Optimal Results
  • 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
    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
    Kiwa Medical: MDR and Clinical Investigation: What’s New?
  • 15:45 – 16:10 CEST
    TÜV SÜD: MDR Structured Dialogue: Clinical Edition
  • 16:15 – 16:40 CEST
    1MED SA: Do I really need a Trial? - Smart Solutions to collect Clinical Data
  • 16:15 – 16:40 CEST
    MAIN5: EMA PMS Data Alignment: Automating Medicinal Product Data Compliance with improved Operational Efficiency
  • 16:45 – 17:45 CEST
    Bringing innovative medical devices to the EU market
  • 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 accelerate Innovation in treating 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
    The value of integrating real-world and trial data to increase patient benefit