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Learning Level: Advanced
Learning Level: Advanced
Learning Level: Expert
Learning Level: Expert
Learning Level: Foundational
Learning Level: Foundational
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Learning Level: Intermediate
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Full Schedule

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Full Schedule

  • 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
    Documents Are Data You Never Knew You Had: AI Tools Can Unlock Their Knowledge
  • 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
  • 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
    New Pharmaceutical Legislation in Europe – From Legislation to Implementation
  • 10:45 - 11:45 WEST
    Simplification and Centralization
  • 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