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Full Schedule

Full Schedule

  • Thursday, May 11, 2023
  • 08:00 – 09:00 CEST
    Live LinkedIn Profile Feedback Session
  • 08:00 – 18:00 CEST
    Registration Open
  • 08:30 – 17:45 CEST
    Poster Viewing & Voting
  • 09:00 – 10:00 CEST
    Data Security & Digital Health: Medical Devices, IVDs and the Increasing EU Regulation of Health Data
  • 09:00 – 10:00 CEST
    IVDR Transition: Quo Vadis? – the current reality
  • 09:00 – 10:00 CEST
    MDCG 2022-14: Game-Changer or 'Shopping List' for MDR Implementation?
  • 09:00 – 10:00 CEST
    Will the Revision of the EU general pharmaceuticals legislation deliver a world-class, future-proof medicines regulatory system for Europe? (Part 1)
  • 10:00 – 10:30 CEST
    Chapter/Local Networking Group Meet and Greets
  • 10:00 – 10:30 CEST
    Coffee Break - Exhibits, Presenters at Posters
  • 10:00 – 10:30 CEST
    Presenters at Posters
  • 10:00 – 10:30 CEST
    Refreshment Break in Exhibit Area
  • 10:30 – 11:30 CEST
    Clinical Evaluation: Measurable Outcome Parameters: Much More Than a Requirement for an MDR-Complaint CER
  • 10:30 – 11:30 CEST
    IMDRF- latest developments and future perspectives
  • 10:30 – 11:30 CEST
    Traceability of devices; the administrative burden or a smart set-up for legal manufacturers?
  • 10:30 – 11:30 CEST
    Will the Revision of the EU general pharmaceuticals legislation deliver a world-class, future-proof medicines regulatory system for Europe? (Part 2)
  • 11:45 – 12:45 CEST
    Clinical assessment: how to minimize the questions from your Notified Body
  • 11:45 – 12:45 CEST
    Making full use of early access and regultatory tools available to ATMPs
  • 11:45 – 12:45 CEST
    Recent developments in UK regulations for IVDs: implications for EU manufacturers.
  • 11:45 – 12:45 CEST
    Using TPLC and GMLP as Your Lighthouse, When Sailing Blind Among AI Icebergs
  • 12:45 – 13:45 CEST
    Chapter/Local Networking Group Meet and Greets
  • 12:45 – 13:45 CEST
    Lunch, Exhibits, Posters
  • 13:00 – 13:30 CEST
    Impact of CER on PMCF and Clinical Investigation
  • 13:00 – 13:30 CEST
    Sponsored Presentation: Cybersecurity - New FDA Requirements for Market Applications Effective Now!
  • 13:00 – 13:30 CEST
    Sponsored Presentation: EU MDR: how attractive is Europe for innovation?
  • 13:00 – 13:30 CEST
    Sponsored Presentation: Getting Started With FDA eSTAR Submissions: Common Pitfalls and Suggestions
  • 13:00 – 13:30 CEST
    Sponsored Presentation: Regulatory Strategies for EU Orphan Drug Development
  • 13:45 – 14:45 CEST
    AI/machine learning based-medical software: case studies on model development and regulatory compliance
  • 13:45 – 14:45 CEST
    CDx or Not CDx, That is The Question - The Impact of the Clinical Trial Regulation on Tests Used in Pharma Studies and Whether and How the IVDR Applies
  • 13:45 – 14:45 CEST
    Designing Training for an Evolving Regulatory Environment
  • 13:45 – 14:45 CEST
    MDR Art. 117 for Combination Products After 2 years. Still the same? State of Play from EMA, NB and Industry
  • 15:00 – 16:00 CEST
    IVDR – what are the implications for in-house in vitro devices for stakeholders and practical steps for implementation
  • 15:00 – 16:00 CEST
    Medical device regulation in international perspective: EU IMDRF Chair in 2023
  • 15:00 – 16:00 CEST
    Regulatory Policies and Guidelines – Are These Enabling Timely Development of Orphan Medicines Globally?
  • 15:00 – 16:00 CEST
    Responsibilities and Liabilities in an Interconnected World
  • 16:00 – 16:45 CEST
    Chapter/Local Networking Group Meet and Greets
  • 16:00 – 16:45 CEST
    Presenters at Posters
  • 16:00 – 16:45 CEST
    Refreshment Break in Exhibit Area
  • 16:05 – 16:35 CEST
    Sponsored Presentation: Economic Operators: Role of the Importer
  • 16:05 – 16:35 CEST
    Sponsored Presentation: Is the EU MDR extension a blessing or a curse?
  • 16:05 – 16:35 CEST
    Sponsored Presentation: MDR & IVDR lessons for regulatory strategy
  • 16:45 – 17:45 CEST
    Conformity Assessment of Class D Devices: What is the Current Status?
  • 16:45 – 17:45 CEST
    EU Regulatory CMC Strategies and Challenges
  • 16:45 – 17:45 CEST
    Expert Advisory Panel - What Have we Learned?
  • 16:45 – 17:45 CEST
    Regulation Changes: Incentives for Pediatric Medical Devices in the US and Japan. Implications for the EU.
  • 18:30 – 21:00 CEST
    Networking Dinner – Kanarie Club