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Tuesday, May 13th
08:30 - 16:00 CEST
Preconference Workshop: AI - Your Best Buddy on the Path to Regulatory Compliance
Location: Studio 201 AB (level 2)
Speaker: Florian Tolkmitt, n/a – PRO-LIANCE GLOBAL SOLUTIONS GmbH
Speaker: Stephen Gilbert, PhD (he/him/his) – Else Kröner Fresenius Center for Digital Health, Technische Universität Dresden
Speaker: Sarai Pahla, Bachelors Degree in Medicine and Surgery, Masters Degree in Regulatory Affairs – CriterionEdge, self-employed
Software/AI/Cybersecurity
Wednesday, May 14th
08:30 - 09:30 CEST
Current and Future MedTech AI Regulatory Landscape in the U.S.
Location: Studio 214 + 216 (level 2)
Presenter: Eric Henry, BS – King & Spalding LLP
Software/AI/Cybersecurity
Wednesday, May 14th
10:45 - 11:45 CEST
The EU AI Act
Location: Gold Hall (level 0)
Speaker: Udo Heintz, PhD (he/him/his) – Ada Health GmbH
Speaker: Sarah Mathew – BSI
Speaker: Marco Caproni (he/him/his) – TUV SUD
Speaker: Nada Alkhayat – European Commission
Moderator: Koen Cobbaert (he/him/his) – Philips
Software/AI/Cybersecurity
Wednesday, May 14th
12:00 - 13:00 CEST
AI Testbeds
Location: Gold Hall (level 0)
Moderator: Koen Cobbaert (he/him/his) – Philips
Speaker: Alexander von Janowski, MSc – TÜV AI.Lab
Speaker: Natascha J. Cuper, PhD – Kiwa Dare
Speaker: Sabyne van Mourik, MBA RSE (she/her/hers) – Kiwa Nederland BV
Speaker: Jérôme-Alexis Chevalier, PhD – National Laboratory of Metrology and Testing (LNE)
Software/AI/Cybersecurity
Wednesday, May 14th
14:30 - 15:30 CEST
AI Sandboxes and Assurances
Location: Copper Hall (level 0)
Moderator: Celia Cruz, PhD (she/her/hers) – Complear
Speaker: Hannah Bowden, PhD (she/her/hers) – Medicines and Healthcare products Regulatory Agency
Speaker: Natasha Motsi, PhD (she/her/hers) – Medicines and Healthcare products Regulatory Agency
Speaker: Antonino Rotolo
Speaker: Liron Bar Yaakov
Panelist: Alberto Ganan, PhD – European Medicines Agency
Software/AI/Cybersecurity
Thursday, May 15th
08:30 - 09:30 CEST
Cybersecurity Across the Medical Device Lifecycle: Addressing Modern and Legacy Products
Location: Gold Hall (level 0)
Session Leader/Speaker: Julian Alpers, PhD (he/him/his) – seleon GmbH
Speaker: Kevin Veldman – Kiwa
Speaker: Pieter Smits – QbDGroup
Software/AI/Cybersecurity
Thursday, May 15th
10:45 - 11:45 CEST
Patient-centricity, Value, and Cost-effectiveness of Ai-enabled Medical Devices (AIeMDs)
Location: Copper Hall (level 0)
Session Leader/Speaker: Catarina Carrão – BioSciPons
Speaker: Zuzanna Kwade, MSc, PhD. (she/her/hers) – Dedalus Healthcare
Speaker: Anastasia Chalkidou, MD, MA, MSc, PhD – National Institute for Health and Care Excellence
Software/AI/Cybersecurity
Thursday, May 15th
12:00 - 13:00 CEST
Mastering US FDA Cybersecurity Submissions: Requirements, Deficiencies, and Best Practices
Location: Copper Hall (level 0)
Session Leader/Speaker: Matthew Hazelett (he/him/his) – MedSec
Speaker: Rene' Hardee, MS (she/her/hers) – MedSec
Software/AI/Cybersecurity
Thursday, May 15th
14:30 - 15:30 CEST
From Wellness to Clinical Care: Regulating at the Intersection of Medical and Non-Medical Devices in Hybrid Digital Health/AI Suites
Location: Studio 214 + 216 (level 2)
Session Leader: Stephen Gilbert, PhD (he/him/his) – Else Kröner Fresenius Center for Digital Health, Technische Universität Dresden
Speaker: Rebecca Mathias, MSc (she/her/hers) – Else Kröner Fresenius Center for Digital Health,TUD Dresden University of Technology
Speaker: Vincent Vercamer, PhD – DNS - French Ministry of Health
Software/AI/Cybersecurity
Thursday, May 15th
16:45 - 17:45 CEST
Evolving with Technology: Navigating Current Regulatory Challenges and Future Directions in IoMT Cybersecurity
Location: Gold Hall (level 0)
Moderator & Presenter: Oscar Freyer (he/him/his) – Else Kröner Fresenius Center for Digital Health,TUD Dresden University of Technology
Speaker: Julian Alpers, PhD (he/him/his) – seleon GmbH
Speaker: Pascal Werner, M.Sc. – Ostrich Consulting LLC
Speaker: Alexander Stock, PhD (he/him/his) – TÜV SÜD
Software/AI/Cybersecurity
Friday, May 16th
10:30 - 11:30 CEST
Supply Chain Cybersecurity Risk Management
Location: Copper Hall (level 0)
Session Leader/Speaker: Stefan Braun, MSc (he/him/his) – FSQ Experts a brand of Wertefest GmbH
Speaker: Sebastian Fischmeister, MASc, PhD, PEng (he/him/his) – University of Waterloo
Speaker: Ben Kokx – Philips
Software/AI/Cybersecurity
Friday, May 16th
11:45 - 12:45 CEST
Adaptive and Evolving Ai-enabled Medical Devices
Location: Silver Hall (level 0)
Moderator & Presenter: Koen Cobbaert (he/him/his) – Philips
Speaker: Stephen Gilbert, PhD (he/him/his) – Else Kröner Fresenius Center for Digital Health, Technische Universität Dresden
Speaker: Eric Henry, BS – King & Spalding LLP
Software/AI/Cybersecurity