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Learning Level: Foundational
Learning Level: Intermediate
Learning Level: Advanced
Learning Level: Expert
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Tue, May 13
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Fri, May 16
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Friday, May 16, 2025
07:30 - 13:30
CEST
Registration
07:30 - 13:30
CEST
Registration
Location: Glass Entrance (-1)
07:30 - 14:00
CEST
Cloakroom
07:30 - 14:00
CEST
Cloakroom
Location: Glass Entrance (-1)
08:30 - 10:00
CEST
Plenary Session - Disruptive Innovation: Redefining Regulatory Roles
08:30 - 10:00
CEST
Plenary Session - Disruptive Innovation: Redefining Regulatory Roles
Location: Gold Hall (level 0)
Moderator:
Gert W. Bos, PhD FRAPS
– QServe Group
Moderator:
Jennifer Neff, PhD
– Entourage GmbH
Keynote Panelist:
Rebecca Lumsden, PhD (she/her/hers)
– Sanofi
Panelist:
Stefanie Fasshauer, MBA
– Cisema
Panelist:
Udo Heintz, PhD (he/him/his)
– Ada Health GmbH
Panelist:
Muriel Pasté, PhD (she/her/hers)
– UCB
Panelist:
Michal Wosiak, MPharm (he/him/his)
– Pharmaceutical Company
10:00 - 10:30
CEST
Refreshment Break
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
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
Speaker:
Marina Daineko, MSc (she/her/hers)
– Intrinsic Medical Group
Speaker:
alessia frabetti, PhD (she/her/hers)
– Kiwa Cermet Italia SPA
Speaker:
Jeremy Tinkler, ERT
– ICON plc
Medical Devices
10:30 - 11:30
CEST
China drug regulatory pathways: 2025 Key Updates and Deep-Dive
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
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
Speaker:
Liz Gommans, PhD (she/her/hers)
– DEKRA B.V.
Speaker:
Goran Abdurrahman, PhD (he/him/his)
– TÜV Rheinland
Speaker:
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
10:30 - 11:30
CEST
On Trend: The Important Considerations for Trend Reporting in Medical Device Safety
Location: Studio 214 + 216 (level 2)
Speaker:
Edward Ball, CEng MIPEM (he/him/his)
– RQM+
Speaker:
Markus Poettker, n/a (he/him/his)
– Smith&Nephew
Speaker:
Ashley Stratton-Powell
Speaker:
Sofia Prata, PhD
– DQS
Medical Devices
10:30 - 11:30
CEST
Shaping the Future of mRNA Vaccines: A Regulatory Perspective
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
Speaker:
Thomas Larsson, MSc, BSc
– European Medicines Agency
Pharmaceuticals
10:30 - 11:30
CEST
Supply chain cybersecurity risk management
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
11:45 - 12:45
CEST
Adaptive and Evolving AI-enabled Medical Devices
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
11:45 - 12:45
CEST
Drug-device combination - borderline case studies
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
Speaker:
Ortzi OLASOLO
– Beyond Conception GmbH
Speaker:
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.
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)
Speaker:
Alex Laan, Dipl.-Ing. (he/him/his)
– BSI
Speaker:
Jennifer Rosendahl, PhD. (she/her/hers)
– RISE
Speaker:
Angela Filomena, Dr (she/her/hers)
– Paul-Ehrlich-Institut
Speaker:
Katja Mierish
– Tuv Rheinland
Panelist:
Aisha Sauer
– European Commission
IVDs
11:45 - 12:45
CEST
Medical Device – International Focus: Global Reliance on CE Mark and Industry Strategies
11:45 - 12:45
CEST
Medical Device – International Focus: Global Reliance on CE Mark and Industry Strategies
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
Speaker:
Nada Alkhayat
– European Commission
Speaker:
Dennis Sarwin, MSc
– Qserve Consultancy BV
Medical Devices
11:45 - 12:45
CEST
Orphaned devices - the needs, approval process and challenges in the EU.
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
Speaker:
Richard G. Holborow, n.a. (he/him/his)
– BSI
Speaker:
Leo Hovestadt
– Elekta
Speaker:
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
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
12:45 - 13:30
CEST
Euro Convergence Farewell
Location: Magritte + Silver Foyer (level 0)
