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Full Schedule

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Full Schedule

  • Tuesday, May 13, 2025
  • 07:30 - 19:00 CEST
    Registration
  • 07:30 - 20:00 CEST
    Cloakroom
  • 08:30 - 16:00 CEST
    Pre-Conference Workshop: Clinical Evaluation - Optimizing Clinical Data and State-of-the-Art Searches for MDR Compliance
  • 08:30 - 16:00 CEST
    Preconference Workshop: EU Pharmaceutical Regulatory Reform
  • 08:30 - 16:00 CEST
    Preconference Workshop: From Concept to Compliance: Overcoming the Regulatory Challenges of Clinical Performance Studies
  • 08:30 - 16:00 CEST
    Preconference Workshop
  • 14:00 - 15:00 CEST
    RAPS Career Development Session for Students
  • 16:30 - 18:30 CEST
    Euro Convergence 2025 Welcome and Opening Plenary: The Future of Regulation and European Competitiveness
  • 18:30 - 19:30 CEST
    Opening Reception in Exhibition Hall
  • Wednesday, May 14, 2025
  • 07:30 - 18:00 CEST
    Registration
  • 07:30 - 18:30 CEST
    Cloakroom
  • 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
    Current and Future MedTech AI Regulatory Landscape in the U.S.
  • 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
    Solutions Circle Reg Desk: Global Market Expansion: Navigating Multi-Market Regulatory Complexities
  • 09:40 - 10:10 CEST
    Solutions Circle: FDA unannounced audits
  • 09:40 - 10:10 CEST
    Solutions Circle: Key Considerations for CDx in Combined Trials under IVDR
  • 09:40 - 10:10 CEST
    Solutions Circle: Mastering PSURs: Streamline Your Process for Faster Approvals
  • 09:40 - 10:10 CEST
    Solutions Circle: The Journey to Becoming RCC Certified!
  • 09:45 - 10:10 CEST
    Celegence: AI in Technical and Clinical Writing: Cutting Through the Hype with Real-World Examples
  • 09:45 - 10:10 CEST
    Johner Institut GmbH: Regulatory Intelligence E2E – Is it worth the invest?
  • 09:45 - 10:45 CEST
    Chapters and Local Networking Groups Meet and Greet
  • 10:15 - 10:40 CEST
    NAMSA: Understanding FDA Preclinical Animal Study Requirements for Medical Devices
  • 10:15 - 10:40 CEST
    Purdie Pascoe: Mastering PMCF data collection: how to overcome challenges with PMCF Surveys
  • 10:15 - 10:45 CEST
    Solution Circle: Points to consider in deciding on placebo/active comparators in clinical trials.
  • 10:15 - 10:45 CEST
    Solutions Circle Ketryx Corporation: Put Your Model to the Test—Exploring Off-the-Shelf AI for Medical Devices
  • 10:15 - 10:45 CEST
    Solutions Circle: Intended Use: The foundations of the medical device house
  • 10:15 - 10:45 CEST
    Solutions Circle: Structured Dialogue - IVDR - Live Example
  • 10:15 - 10:45 CEST
    Solutions Circle: Surviving the EHDS: A Lifeline
  • 10:45 - 11:45 CEST
    “Appropriateness” of Clinical Data – Clinical Evaluations based on Non-Clinical Data only
  • 10:45 - 11:45 CEST
    Addressing the Complexities of Using In Vitro Diagnostics (IVDs) in Global Clinical Trials.
  • 10:45 - 11:45 CEST
    Biosimilar Development
  • 10:45 - 11:45 CEST
    EU Variation Regulatory Reform – Creating innovation in the Life-Cycle Management
  • 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
    The EU AI Act
  • 12:00 - 13:00 CEST
    AI Testbeds
  • 12:00 - 13:00 CEST
    Changes in U.S. Politics: Implications for Submissions and Agency Collaboration
  • 12:00 - 13:00 CEST
    HTA Regulation, Joint Clinical Assessments (JCA) & Joint Scientific Consultations (JSC): Adapting to the New EU Framework
  • 12:00 - 13:00 CEST
    Mastering IVD software classification and overcoming PMS regulatory compliance challenges at the interface of the IVDR and the AI Act
  • 12:00 - 13:00 CEST
    Maximizing the value of clinical data for global submissions (EU/China)
  • 12:00 - 13:00 CEST
    New International: Experiences with the latest UK submission routes
  • 13:00 - 14:30 CEST
    Networking Lunch in Exhibition Hall
  • 13:10 - 13:35 CEST
    Flinn AI: The AI Validation Confidence Index - Discover How Much You Can Trust Your AI
  • 13:10 - 13:35 CEST
    MedEnvoy Global: Ensuring Compliance Across the Distribution Chain: A Deep Dive into Economic Operators’ Roles
  • 13:15 - 13:45 CEST
    Solutions Circle Greenlight Guru: Using Clinical Data for More Than Regulatory Approval
  • 13:15 - 13:45 CEST
    Solutions Circle: ’Growing Pains’: An Evaluation of Evolving Pediatric Study Regulation in the US and EU
  • 13:15 - 13:45 CEST
    Solutions Circle: Decreasing Complexity, defining Regulatory and Evaluation Strategy of LLM based functions.
  • 13:15 - 13:45 CEST
    Solutions Circle: Impact of the Battery Regulation (EU) 2023/1542 on medical devices
  • 13:15 - 13:45 CEST
    Solutions Circle: Key takeaways from 4 years of expert panel views to improve your IVD evaluation
  • 13:30 - 14:15 CEST
    RAPS Speed Mentoring
  • 13:40 - 14:05 CEST
    Eclevar Medtech: Smart PMCF for Medical Devices: AI-powered EDC for Cost Savings, MDR Compliance
  • 13:40 - 14:05 CEST
    QbD Group: Can IVDR be your global regulatory compass for market entry?
  • 13:50 - 14:20 CEST
    Solutions Circle LexisNexis Reed Tech: Tips and Tricks for Managing Global UDI Submissions
  • 13:50 - 14:20 CEST
    Solutions Circle: Challenges related to Data in AI Medical Devices in the European Union
  • 13:50 - 14:20 CEST
    Solutions Circle: Cybersecurity in premarket submissions: US vs. EU approach
  • 13:50 - 14:20 CEST
    Solutions Circle: Insight in Motivation: The RA life stories that matter in healthcare
  • 14:05 - 14:30 CEST
    RIMSYS: Getting your ducks in a row for a successful EUDAMED (and global) UDI program
  • 14:05 - 14:30 CEST
    RQM+: Quo Vadis, FDA - and where should we go to...?
  • 14:30 - 15:30 CEST
    EU Green Deal
  • 14:30 - 15:30 CEST
    Accelerating Clinical Trials in EU
  • 14:30 - 15:30 CEST
    AI Sandboxes and Assurances
  • 14:30 - 15:30 CEST
    Career Development: Live LinkedIn Review Session
  • 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
    Medicines Shortages
  • 14:30 - 15:30 CEST
    The Road Ahead: Impact of EU 2024/1860 for MDR and IVDR – Insights from Notified Bodies and Industry
  • 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
    Essenvia RIM Platform: Navigating the Perfect Storm: FDA Capacity Cuts, Tariffs & the New RA Playbook
  • 15:45 - 16:10 CEST
    Pure Global: AI in Action - Transforming Regulatory Workflows for Smarter Technical Documentation and Global Submissions
  • 16:15 - 16:40 CEST
    REG DESK: The Future of Regulatory Affairs: How Technology is Shaping Regulatory Compliance
  • 16:15 - 16:40 CEST
    Veeva Systems Inc: Exploring the AI-powered Future of Promotional Material Review
  • 16:45 - 18:00 CEST
    Conversations That Matter: Interactions with Health Authorities
  • 18:00 - 21:00 CEST
    Networking Dinner (Ticket Required): Plein Publiek
  • Thursday, May 15, 2025
  • 07:30 - 18:00 CEST
    Registration
  • 07:30 - 18:30 CEST
    Cloakroom
  • 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
  • 10:45 - 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: FDA unannounced audits
  • 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!
  • 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
    From Wellness to Clinical Care: Regulating at the Intersection of Medical and Non-Medical Devices in Hybrid Digital Health/AI Suites
  • 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
  • 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: Global Reliance on CE Mark and Industry Strategies
  • 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