Skip to main content
RAPS Euro Convergence 2023 Main banner
Icon Legend
This session is not in your schedule.
This session is in your schedule. Click again to remove it.

Full Schedule

  1. Home
  2. 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