Full Schedule

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Friday, May 16, 2025
07:30 – 13:30 CEST
Registration
Location: Glass Entrance (-1)
07:30 – 14:00 CEST
Cloakroom
Location: Glass Entrance (-1)
08:30 – 10:00 CEST
Plenary Session - Disruptive Innovation: Redefining Regulatory Roles
Location: Gold Hall (level 0)
Moderator: Stefanie Fasshauer, MBA – Cisema
Moderator: Jennifer Neff, PhD – Entourage GmbH
Panelist: Rebecca Lumsden, PhD (she/her/hers) – Sanofi
Panelist: Muriel Pasté
10:00 – 10:30 CEST
Refreshment Break
Location: Magritte + Silver Foyer (level 0)
10:30 – 11:30 CEST
All in One for Biocompatibility: ISO 10993 Updates, Toxicological Risk Assessment and Post-market Data
Location: Gold Hall (level 0)
Session Leader: Florian Tolkmitt, n/a – PRO-LIANCE GLOBAL SOLUTIONS GmbH
Presenter: Marina Daineko, MSc (she/her/hers) – Intrinsic Medical Group
Presenter: alessia frabetti, PhD (she/her/hers) – Kiwa Cermet Italia SPA
Presenter: Jeremy Tinkler, ERT – ICON plc
Medical Devices
10:30 – 11:30 CEST
China Drug Regulatory Pathways: 2025 Key Updates and Deep-dive
Location: Studio 211 + 212 (level 2)
Session Leader/Speaker: Hamish King, RAC, LLB – Cisema
Speaker: Jacky Li, MSc – Cisema (Hong Kong) Limited
Pharmaceuticals
10:30 – 11:30 CEST
Mastering Post-market Surveillance Under IVDR: From PMPF to PSUR
Location: Silver Hall (level 0)
Session Leader: Anja Wiersma, PhD (she/her/hers) – mi-CE consultancy
Presenter: Liz Gommans, PhD (she/her/hers) – DEKRA B.V.
Presenter: Goran Abdurrahman, PhD (he/him/his) – TÜV Rheinland
Presenter: Leo WJ Klomp – Health and Youth Care Inspectorate (IGJ), Ministry of Health
IVDs
10:30 – 11:30 CEST
On Trend: The Important Considerations for Trend Reporting in Medical Device Safety
Location: Studio 214 + 216 (level 2)
Presenter: Edward Ball, CEng MIPEM (he/him/his) – RQM+
Presenter: Markus Poettker, n/a (he/him/his) – Smith&Nephew
Presenter: Ashley Stratton-Powell
Presenter: Sofia Prata, PhD – DQS
Medical Devices
10:30 – 11:30 CEST
Shaping the Future of Mrna Vaccines: A Regulatory Perspective
Location: The Arc (level 3)
Moderator: Stefanie Fasshauer, MBA – Cisema
Presenter: Mohamad Toutounji (he/him/his) – Molgenium
Presenter: Thomas Larsson, MSc, BSc – European Medicines Agency
Pharmaceuticals
10:30 – 11:30 CEST
Supply Chain Cybersecurity Risk Management
Location: Copper Hall (level 0)
Presenter: Sebastian Fischmeister, MASc, PhD, PEng (he/him/his) – University of Waterloo
Presenter: Stefan Braun, MSc (he/him/his) – FSQ Experts a brand of Wertefest GmbH
Presenter: Ben Kokx – Philips
Software/AI/Cybersecurity
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
Presenter: Stephen Gilbert, PhD (he/him/his) – Else Kröner Fresenius Center for Digital Health, Technische Universität Dresden
Presenter: Eric Henry, BS – King & Spalding LLP
Software/AI/Cybersecurity
11:45 – 12:45 CEST
Device - Drug Borderlines – Challenges in Europe and the USA
Location: The Arc (level 3)
Session Leader/Speaker: Jane L. Arnold-Round, B.Eng Msc. – NAMSA
Presenter: Ortzi OLASOLO – Beyond Conception GmbH
Presenter: Alberto Ganan, PhD – European Medicines Agency
Panelist: Sebastian Fischer – TÜV SÜD Product Service GmbH
Pharmaceuticals
11:45 – 12:45 CEST
Involving European Reference Laboratories in the Conformity Assessment of Class D Ivd's: Operational Update After 6 Months
Location: Copper Hall (level 0)
Moderator: Kirsten Van Garsse, RCC-IVDR (she/her/hers) – Qarad (Part of the QbD Group)
Presenter: Alex Laan, Dipl.-Ing. (he/him/his) – BSI
Presenter: Jennifer Rosendahl, PhD. (she/her/hers) – RISE
Presenter: Angela Filomena, Dr (she/her/hers) – Paul-Ehrlich-Institut
Presenter: Katja Mierish, PhD. – Tuv Rheinland
Panelist: Aisha Sauer – European Commission
IVDs
11:45 – 12:45 CEST
Medical Device - International Focus
Location: Studio 214 + 216 (level 2)
Moderator: Jennifer Neff, PhD – Entourage GmbH
Moderator: Sabina L. Hoekstra-van den Bosch, PharmD, FRAPS – TÜV SÜD Medical Health Services
Presenter: Nada Alkhayat – European Commission
Medical Devices
11:45 – 12:45 CEST
Orphaned Devices - The Needs, Approval Process and Challenges in the EU
Location: Gold Hall (level 0)
Moderator & Presenter: Tom Melvin, n.a. – Trinity College, Dublin
Presenter: Richard G. Holborow, n.a. (he/him/his) – BSI
Presenter: Leo Hovestadt – Elekta
Presenter: Nona Heueis, Phd (she/her/hers) – Heraeus Medical GmbH
Medical Devices
11:45 – 12:45 CEST
Using Artificial Intelligence to Support Regulatory Processes and Decision-Making
Location: Studio 211 + 212 (level 2)
Session Leader/Speaker: Agnes Dangy-Caye, Dr (she/her/hers) – Agnès Dangy-Caye, Regulatory Science and Policy, Sanofi
Speaker: Florian Lasch, PhD (he/him/his) – European Medicines Agency
Speaker: Daria Mari (she/her/hers) – regenold GmbH
Pharmaceuticals
12:45 – 13:30 CEST
Euro Convergence Farewell
Location: Magritte + Silver Foyer (level 0)