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Learning Level: Foundational
Learning Level: Foundational
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Learning Level: Intermediate
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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
    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