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Full Schedule

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Full Schedule

  • Tuesday, May 5, 2026
  • 07:30 - 19:00 WEST
    Registration Hours
  • 07:30 - 20:00 WEST
    Cloakroom
  • 08:00 - 08:30 WEST
    Preconference Workshops: Welcome Coffee
  • 08:00 - 12:00 WEST
    RAPS General Assembly & RAPS European Council (Invitation Only)
  • 08:30 - 16:00 WEST
    Pre-Conference Workshop: Building Global CDx Studies: Strategic Planning Tools for IVD and Pharma Partners
  • 08:30 - 16:00 WEST
    Pre-Conference Workshop: Driving Change: How to Successfully Implement AI and Digital Transformation in Regulatory Affairs (MD, Pharma, IVDR)
  • 08:30 - 16:00 WEST
    Pre-Conference Workshop: EUDAMED & swissdamed: Practical Steps to Implementation, Strategic and Future Insights
  • 08:30 - 16:00 WEST
    Pre-Conference Workshop: Global Regulatory Pathways - US, China and South Korea
  • 08:30 - 16:00 WEST
    Pre-Conference Workshop: International Regulatory Collaborative Initiatives: Reliance, Work-Sharing - Strategic Regulatory Pathways
  • 08:30 - 16:00 WEST
    Pre-Conference Workshop: Technical Documentation Assessment of MDSW-a Notified Body Perspective
  • 10:30 - 11:00 WEST
    Preconference Workshops: Networking Break
  • 13:00 - 14:00 WEST
    Preconference Workshops: Networking Lunch
  • 13:00 - 16:00 WEST
    Volunteer Leaders Summit (Invitation Only)
  • 15:00 - 16:00 WEST
    RAPS Career Development Session for Students
  • 16:00 - 16:30 WEST
    Preconference Workshops: Afternoon Break
  • 16:30 - 18:30 WEST
    Euro Convergence 2026: Welcome and Opening Plenary: The Evolution of Legislation, the Regulatory Professional and Regulatory Capabilities
  • 18:30 - 19:30 WEST
    Exhibition Hall - Opening Hours
  • 18:30 - 19:30 WEST
    Opening Reception in Exhibition Hall
  • Wednesday, May 6, 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
    MDR 2.0: Kick-off Panel 2026
  • 08:30 - 09:30 WEST
    QMSR: Navigating the New FDA Quality Management System Regulation (QMSR): Regulatory Insights and Compliance Strategies
  • 08:30 - 09:30 WEST
    Regulating for cybersecurity in AI-enabled MDs
  • 08:30 - 09:30 WEST
    Reimagining Europe's Innovation Landscape: Leveraging New Legislation to Accelerate Development and Maintain Competitiveness
  • 08:30 - 09:30 WEST
    Transitional Timelines Unpacked: EU 2024/1860 and Its Impact on Legacy IVDs
  • 08:30 - 09:30 WEST
    Your Documents Are Data You Never Knew You Had: AI Tools Can Unlock Their Knowledge
  • 09:30 - 10:45 WEST
    Chapter and Local Networking Group (LNG) Meet & Greet
  • 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 1: Was SoHO Born From HCT/Ps?
  • 09:40 - 10:10 WEST
    Solutions Circle 2: Early Market Access to Innovative Diagnostics
  • 09:40 - 10:10 WEST
    Solutions Circle 3: Building Foundational Skills for Regulators in the Age of Artificial Intelligence
  • 09:40 - 10:10 WEST
    Solutions Circle 4: Is Consent the Answer? Exploring Regulatory Options for Non-Compliant Devices in Australia
  • 09:40 - 10:20 WEST
    Solutions Cirle 5: Modernizing Regulatory: What's Working, What's Not, What's Next
  • 09:45 - 10:10 WEST
    Sponsored Presentations - Round 1: Breakthrough Medical Devices: Pathway to Market
  • 09:45 - 10:10 WEST
    Sponsored Presentations - Round 1: From Compliance to Control: Building a Quality Operating System for Regulated Growth
  • 09:45 - 10:45 WEST
    Meet the Authors: Software as a Medical Device (Second Edition)
  • 10:15 - 10:40 WEST
    Sponsored Presentations - Round 2: Real Data, Real Results: Unlocking the Power of Post-Market Surveys
  • 10:15 - 10:40 WEST
    Sponsored Presentations - Round 2: The Regulatory Approval Illusion: Why Errors Still Escape in 2026
  • 10:15 - 10:45 WEST
    Solutions Circle CertHub GmbH: From Paperwork to Digital Compliance: Practical Approaches to Managing Regulatory Documentation
  • 10:15 - 10:45 WEST
    Solutions Circle: RCC Informational Roundtable
  • 10:15 - 10:45 WEST
    Solutions Circle: Up, Close and Practical with the European Health Data Space
  • 10:15 - 10:45 WEST
    Solutions Circle: Updates on the Battery Regulation (EU) 2023/1542 and Their Impact on Medical Devices
  • 10:45 - 11:45 WEST
    AI in Regulatory: From Validated Tooling to AI-Ready Submissions
  • 10:45 - 11:45 WEST
    Building IVDR Technical Files Early-Phase Insights and Strategic Approaches
  • 10:45 - 11:45 WEST
    Deregulation/Centralization
  • 10:45 - 11:45 WEST
    New Pharmaceutical Legislation in Europe – From Legislation to Implementation
  • 10:45 - 11:45 WEST
    Singing in Harmony: Leveraging MDSAP to Synergize your QMS
  • 10:45 - 11:45 WEST
    Strategy & Funding: Rise of Regulatory as a Business Driver
  • 12:00 - 13:00 WEST
    Are CE-marked AI ‘Configurable Platforms’ the Future and What Are Their Legal and Regulatory Bounds?
  • 12:00 - 13:00 WEST
    Clinical Evidence beyond Clinical Data, a practical approach considering current legislation and future outlook
  • 12:00 - 13:00 WEST
    Evolving Role of Patients in the Pharmaceutical Landscape: a Two—way Street Enabled by Innovation
  • 12:00 - 13:00 WEST
    Navigating Global CTR–IVDR Trials: Real-World Challenges and Practical Lessons
  • 12:00 - 13:00 WEST
    Opportunities and Challenges with International Collaborative Initiatives
  • 12:00 - 13:00 WEST
    RIM: Building Strong Business Regulatory Processes Around a Regulatory Information Management (RIM) System – a Scenario for Medical Devices
  • 13:00 - 14:30 WEST
    Networking Lunch in the Exhibit Hall
  • 13:15 - 13:45 WEST
    Solutions Circle 5: Regulators Are Using AI — Is Your Submission Ready to Be Reviewed by One?
  • 13:15 - 13:45 WEST
    Solutions Circle: Are You Really Ready for eCTD 4.0?
  • 13:15 - 13:45 WEST
    Solutions Circle: Post-Market Surveillance (PMS) and Post-Market Performance Follow-up (PMPF)
  • 13:15 - 13:45 WEST
    Solutions Circle: The Summary of Safety and Clinical Performance: Enhancing Transparency and Empowering Patients
  • 13:15 - 13:45 WEST
    Solutions Circle: Understanding the Medical Devices Approvals by the Reliance Route in Brazil: Criteria & Benefits
  • 13:15 - 14:15 WEST
    Speed Mentoring
  • 13:30 - 13:55 WEST
    Sponsored Presentations - Round 1: From MDR/IVDR 1.0 to 2.0: Real-World Data Driving Smarter Evidence Strategies
  • 13:30 - 13:55 WEST
    Sponsored Presentations - Round 1: Ensuring Compliance Across the Distribution Chain: A Deep Dive into Economic Operators’ Roles
  • 13:50 - 14:20 WEST
    Solutions Circle: Conformity Assessment of Class D Devices & EURL Implementation: Progress and Challenges Two Years On
  • 13:50 - 14:20 WEST
    Solutions Circle: Reliance That Delivers: From WHO Good Reliance Practices to Project Orbis
  • 13:50 - 14:20 WEST
    Solutions Circle: Toxicological Thresholds in Chemical Characterization of Medical Devices: Practical Use of DBT, AET, and TSL
  • 13:50 - 14:20 WEST
    Solutions Circle: Writing for RAPS
  • 14:00 - 14:25 WEST
    Sponsored Presentations - Round 2: Conquering Regulatory Barriers: Strategies for Effective Representation and Ongoing Compliance Monitoring
  • 14:00 - 14:25 WEST
    Sponsored Presentations - Round 2: How to Rapidly Gain Real-World Value from Regulatory Technology in the Era of AI
  • 14:30 - 15:30 WEST
    Clinical Evidence as the Cornerstone of MDR Compliance: Lessons, Challenges, and the Road Ahead
  • 14:30 - 15:30 WEST
    Combination Products: Navigating Regulatory Landscapes Across EU, US and China
  • 14:30 - 15:30 WEST
    Electronic Product Information (ePI) in Action: From Pilots to successful Implementation in Europe
  • 14:30 - 15:30 WEST
    Implementing the EU AI Act in Practice – A Catchbox Session
  • 14:30 - 15:30 WEST
    Mastering Risk Management for In-vitro Diagnostics Transitioning From Pre to Post Market - How Much Is Enough?
  • 14:30 - 15:30 WEST
    The Mystic Neighbour: Notified Body Oversight with a Watch on SOTA, Risk, PMS, and Claims
  • 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
    Building Quiet Authority: How to Turn Your Expertise into Influence on LinkedIn
  • 15:45 - 16:10 WEST
    Sponsored Presentations - Round 1: From Regulatory Overload to AI-Driven Regulatory Leadership
  • 15:45 - 16:10 WEST
    Sponsored Presentations - Round 1: What High-Growth Companies Do Differently in Regulatory: From Compliance Function to Strategic Growth Engine
  • 16:15 - 16:40 WEST
    Sponsored Presentations - Round 2: EUDAMED Is Mandatory: How to Leverage Your Past Efforts?
  • 16:15 - 16:40 WEST
    Sponsored Presentations - Round 2: Scaling Regulatory Excellence with AI
  • 16:45 - 18:00 WEST
    Conversations That Matter: Interactions with Health Authorities
  • 19:00 - 22:00 WEST
    Networking Dinner (Ticket Required): Páteo Alfacinha
  • 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 Shared Decisions: 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
  • Friday, May 8, 2026
  • 07:30 - 12:00 WEST
    Registration Hours
  • 07:30 - 15:30 WEST
    Cloakroom
  • 08:00 - 08:30 WEST
    Welcome Coffee
  • 08:30 - 10:00 WEST
    Plenary Session: Simplification vs. Innovation in Regulatory Affairs: Which Drives Progress?
  • 10:00 - 11:00 WEST
    Speed Mentoring
  • 10:00 - 11:15 WEST
    Presenters at Posters (Exhibition Hall)
  • 10:00 - 11:15 WEST
    Refreshment Break in the Exhibit Hall
  • 10:00 - 12:30 WEST
    Exhibition Hall - Opening Hours
  • 10:10 - 10:40 WEST
    Solutions Circle: Compliance Amidst Uncertainties for Medical Devices
  • 10:10 - 10:40 WEST
    Solutions Circle: Post-Market Surveillance (PMS) and Post-Market Performance Follow-up (PMPF)
  • 10:10 - 10:40 WEST
    Solutions Circle: The Pitfalls of Only Applying ISO 14971:2019 When Applying for MDR
  • 10:45 - 11:15 WEST
    Solutions Circle: Are You Really Ready for eCTD 4.0?
  • 10:45 - 11:15 WEST
    Solutions Circle: What the proposed IVDR changes mean for IVD manufacturers
  • 10:45 - 11:15 WEST
    Solutions Circle: When Does a Trend Matter? Practical Approaches to MDR Article 88
  • 11:15 - 12:15 WEST
    Biocompatibility in Transition – Integrating Biological Safety, Post-Market Evidence, and Advanced Risk Assessment
  • 11:15 - 12:15 WEST
    International Reliance: Medical Devices in the Tropics: Tips, Tricks and Odds for Your ANVISA Submission
  • 11:15 - 12:15 WEST
    Life After NBOp: Navigating Post-Market Compliance and Mastering Change Management for Combination Products
  • 11:15 - 12:15 WEST
    One year after – Observations, insights, implications on JCA
  • 11:15 - 12:15 WEST
    Performance Evaluation Under EU IVDR for Complex Diagnostics: Multiplex IVDs and Service-Based NGS Panels
  • 11:15 - 12:15 WEST
    Recalibrating Oversight: Post-Market Monitoring and Governance for AI-enabled Clinical Decision Support Software
  • 12:30 - 13:30 WEST
    AI-Powered Conformity Assessment Transforming Notified Body Operations
  • 12:30 - 13:30 WEST
    Aligning Regulatory and HTA Strategies of Digital Health Technologies to Reduce Duplication of Effort and Resources
  • 12:30 - 13:30 WEST
    Environment Regulatory
  • 12:30 - 13:30 WEST
    Falsified Medical Devices & Certificates
  • 12:30 - 13:30 WEST
    M4Q
  • 12:30 - 13:30 WEST
    Mastering EU in-house tests: Real-World Lessons From Laboratories Under the IVDR Article 5(5)
  • 12:30 - 18:00 WEST
    Exhibition Closed - Breakdown starting
  • 13:30 - 14:30 WEST
    Euro Convergence - Farewell Lunch