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  • Monday, May 6th
    08:30 – 16:00 CEST
    Pre-Conference Workshop: Artificial Intelligence Knocking on Your Door? The Upcoming Artificial Intelligence Regulation’s Technical Documentation Requirements and How to Integrate Them Into an MDR Submission
    Location: B 05 + B 06
    Session Leader/Speaker: Sarah Mathew – BSI
    Presenter: Marco Caproni – TÜV SÜD
    Presenter: Daniela Seneca – BSI
    AI/Software
  • Tuesday, May 7th
    08:30 – 09:30 CEST
    The EU’s AI Act: Understanding the challenges to AI-enabled Medical Devices conformity assessments
    Location: B 09
    Presenter: Abhineet Johri – Siemens Healthineers
    Presenter: Inma Pérez Ruiz – Bsi Group The Netherlands
    AI/Software
  • Tuesday, May 7th
    09:50 – 10:50 CEST
    Artificial Intelligence in the Context of the IVDR – How to Keep the Revolution Under Control
    Location: C 01
    Session Leader/Speaker: Alexander Stock – TÜV SÜD
    Presenter: Sebastian Grömminger – Entourage GmbH
    AI/Software
  • Tuesday, May 7th
    11:30 – 12:30 CEST
    The MDR and The AI Act: A Match Made in Heaven or The Odd Couple?
    Location: C 01
    Moderator: James Gallagher – Mason Hayes & Curran LLP
    Presenter: Koen Cobbaert – Philips
    Presenter: Erik R. Vollebregt, LLM – Axon Lawyers
    Presenter: Stephen Gilbert, MRes, PhD – Else Kröner Fresenius Center for Digital Health
    Presenter: Ariana Sliwa – TÜV Verband
    AI/Software
  • Tuesday, May 7th
    13:45 – 14:45 CEST
    Randomized Clinical Trials vs. Validation Cohort Studies of AI/ML-Based SaMDs: What Are the Differences and Guidelines for Appraisal of the Clinical Evidence?
    Location: B 05 + B 06
    Presenter: Catarina Carrão – BioSciPons
    Presenter: Zuzanna Kwade, PhD – Dedalus
    AI/Software
  • Tuesday, May 7th
    15:05 – 16:05 CEST
    Securing AI Solutions in Medtech Products
    Location: A 05 + A 06
    Presenter: Xander C.W Heemskerk, ing CISSP CCSK – Royal Philips
    AI/Software
  • Tuesday, May 7th
    16:45 – 17:45 CEST
    Navigating the future: Embracing AI and ChatGPT in Regulatory Affairs and Quality Management for Pharma and MedTech Professionals Alike
    Location: B 09
    Session Leader/Speaker: Paul Kuiken, BSc (HONS), MBA, FTOPRA, MIOD – G&L Healthcare Advisors
    Presenter: Grace Fu, MBA – China Med Device, LLC
    Presenter: Andreas Kalchschmid-Lehmann, MSc – Johner Institut GmbH
    AI/Software
  • Tuesday, May 7th
    16:45 – 17:45 CEST
    Regulators and Industry Perspective on Use of Artificial Intelligence in the Drug Development Lifecycle
    Location: B 07 + B 08
    Session Leader: Stefanie Faßhauer, MBA – Vita Green Group
    Session Leader/Speaker: Khushboo Sharma, MBA – Accumulus Synergy
    Presenter: Claire Harrison
    Presenter: Florian Lasch, PhD – European Medicines Agency
    Presenter: Helena Corte-Real Correia, PhD – F.Hoffmann-La Roche, Ltd.
    AI/Software
  • Wednesday, May 8th
    10:25 – 11:25 CEST
    Application of Article 61(10), Non-Clinical Data, for SaMD and AI
    Location: B 09
    Session Leader/Speaker: Natascha J. Cuper, PhD – Kiwa Dare
    Presenter: Vincent van der Meer – Medical Device Project B.V.
    AI/Software
  • Wednesday, May 8th
    11:45 – 12:45 CEST
    Data Security and Digital Health: Medical Devices, IVDs and the Increasing EU Regulation of Health Data
    Location: B 05 + B 06
    Presenter: Cecile E. Van der Heijden – Axon Lawyers
    Presenter: Leo Hovestadt – Elekta
    AI/Software
  • Wednesday, May 8th
    14:00 – 15:00 CEST
    Cybersecurity: Integrating Medical Device Cybersecurity in the Quality Management System
    Location: B 07 + B 08
    Session Leader/Speaker: Gregg W. Van Citters, PhD – MEDIcept, Inc.
    Presenter: Kimberly A. Trautman, MS – RAPS BoD
    AI/Software
  • Wednesday, May 8th
    15:40 – 16:40 CEST
    An overview of AI, Software and Cybersecurity regulations in Asia
    Location: B 09
    Presenter: Zhencan Xu, M.Sc. – FSQ Experts
    Presenter: Harshita Menon, MS – Merative
    Presenter: Pei Yu (Amy) Chen – Compliance and risks
    AI/Software