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Full Schedule

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Full Schedule

  • Wednesday, May 10, 2023
  • 08:00 – 16:00 CEST
    Be ready for EU CTR: Strategy, Systems and Lessons Learned
  • 08:00 – 18:00 CEST
    Cloak Room
  • 08:00 – 18:00 CEST
    Registration Open
  • 08:30 – 16:00 CEST
    IVDR Rollout 2023: Innovation vs Legacy: How to define a Clinical Evidence Strategy for an established analyte/marker or technology versus a novel product.
  • 08:30 – 16:00 CEST
    PMCF Workshop: how to collect valuable data and use it to your benefit?
  • 08:30 – 16:00 CEST
    Risk Management Workshop
  • 08:30 – 16:00 CEST
    UDI / EUDAMED Workshop
  • 08:30 – 16:00 CEST
    Workshop: Global Regulatory CMC Strategies and Challenges for Biologicals
  • 12:00 – 17:00 CEST
    Speaker Ready Room Open
  • 14:30 – 16:00 CEST
    Career Development for Students
  • 16:30 – 18:30 CEST
    Opening Plenary Session: Leveraging our joint clinical data: the new frontier - a debate on our dreams!
  • 18:30 – 20:00 CEST
    Opening Reception
  • 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
  • Friday, May 12, 2023
  • 08:00 – 16:30 CEST
    Cloak Room
  • 08:00 – 16:30 CEST
    Registration Open
  • 08:30 – 16:00 CEST
    Poster Viewing
  • 08:45 – 10:00 CEST
    Conversations That Matter: Interactions with Health Authorities
  • 10:00 – 10:30 CEST
    Chapter/Local Networking Group Meet and Greets
  • 10:00 – 10:45 CEST
    Refreshment Break in Exhibit Area
  • 10:15 – 10:45 CEST
    Presenters at Posters
  • 10:45 – 11:45 CEST
    Device Lifetime and Lifecycle Management
  • 10:45 – 11:45 CEST
    EMA's PRIME Scheme in Review: Findings, Lessons Learnt and Future Directions
  • 10:45 – 11:45 CEST
    Medical Device Software: Top Recurrent Regulatory Deficiencies from Both FDA and Notified Bodies
  • 10:45 – 11:45 CEST
    Meeting the EU IVDR PMS and PMPF provisions – setting up an effective PMS/PMPF and reporting system
  • 12:00 – 13:00 CEST
    Real World Evidence...What Could Possibly go Wrong? A Clinician's Perspective
  • 12:00 – 13:00 CEST
    Research Use Only (RUO): What does this mean for legacy devices and product development of new in vitro diagnostics under the IVDR?
  • 12:00 – 13:00 CEST
    UKCA: challenges and opportunities
  • 12:00 – 13:00 CEST
    Will Data-Driven Regulatory Science Stimulate Innovation and Initiate a New Regulatory Paradigm?
  • 12:45 – 13:45 CEST
    Chapter/Local Networking Group Meet and Greets
  • 13:00 – 14:00 CEST
    Lunch, Exhibits, Posters
  • 13:15 – 13:45 CEST
    Sponsored Presentations: Digitized Regulatory Intelligence: Empowering Compliance & Professionals
  • 13:15 – 13:45 CEST
    Sponsored Presentations: FDA first, CE later. Clinical and regulatory strategy trends
  • 13:15 – 13:45 CEST
    Sponsored Presentations: Global regulatory platform vs integrations: Challenges for data consistency
  • 13:15 – 13:45 CEST
    Sponsored Presentations: Streamlining Regulatory Affairs: Industry trends & Innovations
  • 13:15 – 13:45 CEST
    Sponsored Presentations: The Impact of AI on MedTech: Current and Future Applications
  • 14:00 – 15:00 CEST
    Due Diligence: Critical Importance of Regulatory & Quality to Support Company or Product Acquisitions
  • 14:00 – 15:00 CEST
    Software and Cybersecurity Specific Requirements - Challenges for Regulatory Compliance and Testing Approaches
  • 14:00 – 15:00 CEST
    Standards & Compliance: Updates on ‘Sustainable’ Medical Devices
  • 14:00 – 15:00 CEST
    Strategic approaches in pregnancy and paediatrics: Is it time for a paradigm shift?
  • 15:00 – 15:30 CEST
    Chapter/Local Networking Group Meet and Greets
  • 15:00 – 15:30 CEST
    Presenters at Posters
  • 15:00 – 15:30 CEST
    Refreshment Break in Exhibit Area
  • 15:30 – 16:30 CEST
    Closing Panel: Impact of MDCG 2022-14 Position Paper on NB Capacity Since Publication
  • 15:30 – 16:30 CEST
    Cybersecurity: Compliantly Securing our Healthcare Future
  • 15:30 – 16:30 CEST
    European Expedited Approval Pathways in a Global Context
  • 15:30 – 16:30 CEST
    MDCG22-14 Panel: Will IVDR Implementation Benefit From MDCG 2022-14 and if so, How ?
  • 16:30 – 17:00 CEST
    Closing Remarks & Farewell Toast