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Full Schedule

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  2. Full Schedule

Full Schedule

  • Wednesday, May 8, 2024
  • 07:30 – 15:30 CEST
    Speaker Ready Room Open (B04)
  • 07:30 – 16:00 CEST
    Registration Hours
  • 07:30 – 17:00 CEST
    Cloakroom
  • 08:30 – 09:45 CEST
    Conversations That Matter: Interactions with Health Authorities
  • 09:45 – 10:25 CEST
    Coffee Break in the Exhibit Hall on all Levels
  • 09:45 – 10:25 CEST
    Presenters at Posters (C Level)
  • 09:45 – 15:45 CEST
    Exhibition Open
  • 10:25 – 11:25 CEST
    Application of article 61(10), non-clinical data, for SaMD and AI
  • 10:25 – 11:25 CEST
    Career Development: LIVE LinkedIn review Session
  • 10:25 – 11:25 CEST
    CTA with Devices
  • 10:25 – 11:25 CEST
    Global IVDs
  • 10:25 – 11:25 CEST
    Risk Management
  • 10:25 – 11:25 CEST
    The paradigm shift in the EU market approval of devices and IVDs - a hot potato?!
  • 11:45 – 12:45 CEST
    Clinical Evaluation
  • 11:45 – 12:45 CEST
    Data Security & Digital Health
  • 11:45 – 12:45 CEST
    Environmental Regulation
  • 11:45 – 12:45 CEST
    Maintaining Compliance: IVDR Post-Certification Activities
  • 11:45 – 12:45 CEST
    Patient-Centric Endpoints and Use of Digital Health Technologies
  • 11:45 – 12:45 CEST
    Supply Chain/Shortage
  • 12:45 – 13:15 CEST
    SESSION IS FULL Circle: Essentials of EU Regulatory Intelligence; Overview of Key Aspects of Regulatory Intelligence
  • 12:45 – 13:15 CEST
    Solution Circle: Cyber Security – Pitfalls for IVDR Technical File Submission
  • 12:45 – 13:15 CEST
    Solution Circle: How does the SSCP improve patient safety in less than 100 pages?
  • 12:45 – 14:00 CEST
    Chapter/Local Networking Group Meet and Greets (C Level)
  • 12:45 – 14:00 CEST
    Networking Lunch in Exhibit Hall on all Levels
  • 13:15 – 13:45 CEST
    Sponsored Presentation: Consolidating Economic Operators for Market Access Globally
  • 13:15 – 13:45 CEST
    Sponsored Presentation: Navigating The Future - Insights From The 2024 State Of Medtech Report
  • 13:15 – 13:45 CEST
    Sponsored Presentation: Raising the Bar on Cybersecurity: Understanding New Regulations and How IEC 81001-5-1 can Help Navigate
  • 13:15 – 13:45 CEST
    Sponsored Presentation: State of the art and the medical device lifecycle
  • 13:15 – 13:45 CEST
    Sponsored Presentation: The challenge of the transition: a practical guide on how to use data historicity to produce correct rationales and deal effectively with the transition from MDD to MDR
  • 13:15 – 13:45 CEST
    Sponsored Presentation: The top gotchas when expanding your clinical development into the US
  • 13:30 – 14:00 CEST
    Solution Circle: Effective Strategies When Approaching Regulatory Due Diligence under the MDR
  • 13:30 – 14:00 CEST
    Solution Circle: Intended purpose, device classification, NB codes and corresponding types of devices /sampling TD under the IVDR
  • 13:30 – 14:00 CEST
    Solution Circle:Effective Strategies for High-Quality Clinical Data Collection through Post-market Clinical Follow-Up (PMCF) Surveys and Medical Device Registries
  • 14:00 – 15:00 CEST
    International Regulatory Frameworks to Accelerate Orphan Drug Registrations
  • 14:00 – 15:00 CEST
    Core Data Sheets
  • 14:00 – 15:00 CEST
    Cybersecurity
  • 14:00 – 15:00 CEST
    Experience gain from implementing Article 5(5) of the IVDR in a network of European Laboratories
  • 14:00 – 15:00 CEST
    IMDRF Coding
  • 14:00 – 15:00 CEST
    Post Market Clinical Studies
  • 15:00 – 15:40 CEST
    Coffee Break in the Exhibit Hall
  • 15:00 – 15:40 CEST
    Presenters at Posters (C Level)
  • 15:40 – 16:40 CEST
    An overview of AI, Software and Cybersecurity regulations in Asia
  • 15:40 – 16:40 CEST
    Blood, Sweat and Tears - Biologics and their Challenges
  • 15:40 – 16:40 CEST
    IVDR Track Closing Panel: What Are The Remaining Challenges for IVDR?
  • 15:40 – 16:40 CEST
    Orphan Devices
  • 15:40 – 16:40 CEST
    Regulatory Intelligence and Policy Strategy; Dynamic Regulatory Assessment as a case study
  • 15:40 – 16:40 CEST
    Structured Dialogue
  • 16:40 – 17:15 CEST
    Closing Remarks & Farewell Toast