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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 7, 2026
  • 07:30 - 18:00 WEST
    Registration Hours
  • 07:30 - 18:30 WEST
    Cloakroom
  • 08:00 - 08:30 WEST
    Welcome Coffee
  • 08:30 - 09:30 WEST
    From Parallel Pathways to Collaborative workstreams: The Evolving EMA–FDA Regulatory Partnership
  • 08:30 - 09:30 WEST
    Interoperability of Medical Devices in a Connected World - From Regulatory to Reality
  • 08:30 - 09:30 WEST
    PSUR: The Power of One: Aligning PSURs Across EU, GB and Canada
  • 08:30 - 09:30 WEST
    SSCP – The Challenge of Determining Frequencies of Side Effects and Residual Risks in Medical Devices
  • 08:30 - 09:30 WEST
    The Unique Challenges of Managing Risks for IVDs Under ISO 14971:2019
  • 08:30 - 09:30 WEST
    Variations 1 Year In
  • 09:30 - 10:45 WEST
    Presenters at Posters (Exhibition Hall)
  • 09:30 - 10:45 WEST
    Refreshment Break in the Exhibit Hall
  • 09:30 - 18:00 WEST
    Exhibition Hall - Opening Hours
  • 09:40 - 10:10 WEST
    Solutions Circle: Compliance Amidst Uncertainties for Medical Devices
  • 09:40 - 10:10 WEST
    Solutions Circle: Reliance That Delivers: From WHO Good Reliance Practices to Project Orbis
  • 09:40 - 10:10 WEST
    Solutions Circle: Understanding the Medical Devices Approvals by the Reliance Route in Brazil: Criteria & Benefits
  • 09:40 - 10:10 WEST
    Solutions Circle: What the proposed IVDR changes mean for IVD manufacturers
  • 09:45 - 10:10 WEST
    Sponsored Presentations - Round 1: From Zero to Digital: Efficient Approaches for Technical Documentation Fueled by AI
  • 09:45 - 10:10 WEST
    Sponsored Presentations - Round 1:Navigating MDR / IVDR Notified Body Audits: Expectations, Pitfalls, and Practical Insights
  • 09:45 - 10:45 WEST
    Speed Mentoring
  • 10:15 - 10:40 WEST
    Sponsored Presentations - Round 2: Benchmarking the Regulatory Information Management Maturity Curve
  • 10:15 - 10:40 WEST
    Sponsored Presentations - Round 2: Evaluation & Qualification of Novel Technologies in Medicinal Products' Clinical Trials: Another Field of Interaction Between Medtech and Pharma Sectors
  • 10:15 - 10:45 WEST
    Solutions Circle Scilife: Is Your Quality System Built for Growth or Just for Compliance?
  • 10:15 - 10:45 WEST
    Solutions Circle: Conformity Assessment of Class D Devices & EURL Implementation: Progress and Challenges Two Years On
  • 10:15 - 10:45 WEST
    Solutions Circle: RCC Informational Roundtable
  • 10:15 - 10:45 WEST
    Solutions Circle: The Summary of Safety and Clinical Performance: Enhancing Transparency and Empowering Patients
  • 10:15 - 10:45 WEST
    Solutions Circle: Toxicological Thresholds in Chemical Characterization of Medical Devices: Practical Use of DBT, AET, and TSL
  • 10:45 - 11:45 WEST
    Change Notification Process of IVD Devices Under the IVDR: Are You Ready?!
  • 10:45 - 11:45 WEST
    COMBINE: Navigating the Latest Trends in Combined Trials
  • 10:45 - 11:45 WEST
    Health Technology Assessment (HTA)
  • 10:45 - 11:45 WEST
    MHRA AI Airlock, CERSI AI and RADIANT CERSI: Regulatory Innovation for AI Medical Devices
  • 10:45 - 11:45 WEST
    Real-World Evidence
  • 10:45 - 11:45 WEST
    SOTA: Breaking the Chicken-Egg Loop
  • 12:00 - 13:00 WEST
    Conditional Approval and Expedited Pathways: EU and US Regulatory Strategies
  • 12:00 - 13:00 WEST
    First Time Right – Best Practices for Generation of High-quality Data in IVDR Performance Studies
  • 12:00 - 13:00 WEST
    In Silico: Virtual Patients, Real Evidence: The Current Use of In Silico Regulatory Evidence
  • 12:00 - 13:00 WEST
    Orphan Devices - Finding Rarity: A Case Study in Achieving Orphan Device Designation in the EU
  • 12:00 - 13:00 WEST
    Regulatory Affairs as a Cornerstone for NAMs Implementation Building Collaborative Pathways with EU Health Authorities
  • 12:00 - 13:00 WEST
    Regulatory Sandboxes in Practice Turning AI Airlock Learnings Into Policy, Regulatory and Industry Strategy
  • 13:00 - 13:55 WEST
    Sponsored Presentation - Round 1: How to Ensure Data Quality and Reliability in Clinical Trials and PMCF under MDR
  • 13:00 - 13:55 WEST
    Sponsored Presentations - Round 1: CMC Strategy for First-in-Human: A Practical Roadmap for Development
  • 13:00 - 14:30 WEST
    Chapter and Local Networking Group (LNG) Meet & Greet
  • 13:00 - 14:30 WEST
    Networking Lunch in the Exhibit Hall
  • 13:15 - 13:45 WEST
    Solution Circle: Is Consent the Answer? Exploring Regulatory Options for Non-Compliant Devices in Australia
  • 13:15 - 13:45 WEST
    Solutions Circle: Building Foundational Skills for Regulators in the Age of Artificial Intelligence
  • 13:15 - 13:45 WEST
    Solutions Circle: Early Market Access to Innovative Diagnostics
  • 13:15 - 13:45 WEST
    Solutions Circle: Was SoHO Born From HCT/Ps?
  • 13:15 - 13:45 WEST
    Solutions Circle: When Does a Trend Matter? Practical Approaches to MDR Article 88
  • 13:15 - 14:25 WEST
    Beyond the Acronyms: Choosing the Right RAPS Credential for You or Your Team
  • 13:50 - 14:20 WEST
    Solution Circle: Up, Close and Practical with the European Health Data Space
  • 13:50 - 14:20 WEST
    Solutions Circle: Regulators Are Using AI — Is Your Submission Ready to Be Reviewed by One?
  • 13:50 - 14:20 WEST
    Solutions Circle: The Pitfalls of Only Applying ISO 14971:2019 When Applying for MDR
  • 13:50 - 14:20 WEST
    Solutions Circle: Updates on the Battery Regulation (EU) 2023/1542 and Their Impact on Medical Devices
  • 14:00 - 14:25 WEST
    Sponsored Presentations - Round 2: Change Management: NBCG-MED Document on Procedures and Criteria for Notification of Changes under MDR/IVDR
  • 14:00 - 14:25 WEST
    Sponsored Presentations - Round 2: Navigating EU MDR Article 117: Regulatory Alignment for Drug–Device Combination Products
  • 14:30 - 15:30 WEST
    Advanced therapy medicinal products (ATMPs), challenges of their regulatory pathways and their global potential in rare diseases
  • 14:30 - 15:30 WEST
    Environmental Convergence: Horizontal EU Requirements Reshaping Medical Device and IVD Regulation
  • 14:30 - 15:30 WEST
    EU CTR, UK CTA Reform, and ICH E6(R3): Strategies for Clinical Trial Success in the EU and UK
  • 14:30 - 15:30 WEST
    Multi-Omics & AI
  • 14:30 - 15:30 WEST
    Novel Approaches for PMPF Surveys Under IVDR – Industry and Notified Body Perspectives
  • 14:30 - 15:30 WEST
    UK Regulations
  • 15:30 - 16:45 WEST
    Presenters at Posters (Exhibition Hall)
  • 15:30 - 16:45 WEST
    Refreshment Break in the Exhibit Hall
  • 15:40 - 16:40 WEST
    Your RAPS Engagement Passport: From First Steps to Fellow
  • 15:45 - 16:10 WEST
    Sponsored Presentations - Round 1: AI-Driven Product Compliance: Accelerating MedTech Innovation
  • 15:45 - 16:10 WEST
    Sponsored Presentations - Round 1: Cybersecurity Without Surprises: Strategies to Avoid Deficiencies and Delays in US and EU Submissions
  • 16:45 - 17:45 WEST
    Custom-made and other Personalized Medical Devices: International Regulatory Requirements
  • 16:45 - 17:45 WEST
    Effective Innovation on Digital Mental Health Technologies
  • 16:45 - 17:45 WEST
    European Regulatory System for Medicines - Any Question Goes
  • 16:45 - 17:45 WEST
    Navigating the Challenges of Medical AI Usability
  • 16:45 - 17:45 WEST
    PMS and PMPF Under IVDR: From Compliance Obligation to Continuous Performance Strategy
  • 16:45 - 17:45 WEST
    Supply Chain/Manufacturing