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Full Schedule

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Full Schedule

  • Wednesday, May 6, 2026
  • 07:30 - 18:00 WEST
    Registration Hours
  • 08:30 - 09:30 WEST
    AI Tools
  • 08:30 - 09:30 WEST
    Cybersecurity
  • 08:30 - 09:30 WEST
    MDR 2.0: Kick-off Panel 2026
  • 08:30 - 09:30 WEST
    New Pharma Legislation: Part 1
  • 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
    Transitional Timelines Unpacked: EU 2024/1860 and Its Impact on Legacy IVDs
  • 09:30 - 10:45 WEST
    Presenters at Posters (Exhibition Hall)
  • 09:30 - 10:45 WEST
    Refreshment Break in the Exhibit Hall
  • 09:40 - 10:10 WEST
    Solutions Circle: Building Foundational Skills for Regulators in the Age of Artificial Intelligence
  • 09:40 - 10:10 WEST
    Solutions Circle: Early Market Access to Innovative Diagnostics
  • 09:40 - 10:10 WEST
    Solutions Circle: Is Consent the Answer? Exploring Regulatory Options for Non-Compliant Devices in Australia
  • 09:40 - 10:10 WEST
    Solutions Circle: Was SoHO Born From HCT/Ps?
  • 09:45 - 10:10 WEST
    Sponsored Presentations: Round 1
  • 10:15 - 10:40 WEST
    Sponsored Presentations: Round 2
  • 10:15 - 10:45 WEST
    Solutions Circle: RCC Informational Roundtable
  • 10:15 - 10:45 WEST
    Solutions Circle: Regulators Are Using AI — Is Your Submission Ready to Be Reviewed by One?
  • 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 Tooling for regulated processes
  • 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
    MDSAP
  • 10:45 - 11:45 WEST
    New Pharma Legislation: Part 2
  • 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 Evaluation
  • 12:00 - 13:00 WEST
    Combined CTR+IVDR Trials
  • 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
    International Reliance
  • 12:00 - 13:00 WEST
    RIM: Building Strong Business Regulatory Processes Around a Regulatory Information Management (RIM) System – a Scenario for Medical Devices
  • 12:00 - 13:00 WEST
    Role of Patients
  • 13:00 - 14:30 WEST
    Networking Lunch in the Exhibit Hall
  • 13:10 - 13:35 WEST
    Sponsored Presentations: Round 1
  • 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
  • 13:40 - 14:05 WEST
    Sponsored Presentations: Round 2
  • 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: 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
  • 14:05 - 14:30 WEST
    Sponsored Presentations: Round 3
  • 14:30 - 15:30 WEST
    Clinical Evidence as the Cornerstone of MDR Compliance: Lessons, Challenges, and the Road Ahead
  • 14:30 - 15:30 WEST
    E-labelling: German DiGItal Project: A Blueprint for European-Wide Electronic Product Information Implementation in Healthcare Ecosystem
  • 14:30 - 15:30 WEST
    EU AI Act: What Manufacturers Should Do Now
  • 14:30 - 15:30 WEST
    Global Development Drug/Combination: Registration Across Major Markets EU, China, US
  • 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
  • 15:45 - 16:10 WEST
    Sponsored Presentations: Round 1
  • 16:15 - 16:40 WEST
    Sponsored Presentations: Round 2
  • 16:45 - 18:00 WEST
    Conversations That Matter: Interactions with Health Authorities
  • 18:30 - 21:30 WEST
    Networking Dinner (Ticket Required): Páteo Alfacinha