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Learning Level: Advanced
Learning Level: Expert
Learning Level: Foundational
Learning Level: Intermediate
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Tue, May 5
Wed, May 6
Thu, May 7
Fri, May 8
Full Schedule
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Friday, May 8, 2026
07:30 - 13:00
WEST
Registration Hours
07:30 - 13:00
WEST
Registration Hours
07:30 - 15:30
WEST
Cloakroom
07:30 - 15:30
WEST
Cloakroom
08:30 - 10:00
WEST
Plenary Session: Simplification vs. Innovation in Regulatory Affairs: Which Drives Progress?
08:30 - 10:00
WEST
Plenary Session: Simplification vs. Innovation in Regulatory Affairs: Which Drives Progress?
Location: Auditorium 1
Panelist:
Nataliya Deych (she/her/hers)
– Edwards Lifesciences Sarl
Panelist:
Andreas Emmendoerffer, MD, PhD (he/him/his)
– Roche
10:00 - 11:15
WEST
Refreshment Break in the Exhibit Hall
10:00 - 11:15
WEST
Refreshment Break in the Exhibit Hall
Location: Exhibition - Hall 2
10:00 - 12:30
WEST
Exhibition Hall - Opening Hours
10:00 - 12:30
WEST
Exhibition Hall - Opening Hours
10:10 - 10:40
WEST
Solutions Circle: CertHub GmbH
10:10 - 10:40
WEST
Solutions Circle: CertHub GmbH
Location: Exhibition - Hall 2
Solutions Circle
Supported by
10:10 - 10:40
WEST
Solutions Circle: Compliance Amidst Uncertainties for Medical Devices
10:10 - 10:40
WEST
Solutions Circle: Compliance Amidst Uncertainties for Medical Devices
Location: Exhibition - Hall 2
Facilitator:
Gert BQ Bos, PhD FRAPS
– QServe
Facilitator:
Florian Tolkmitt
– PRO-LIANCE GLOBAL SOLUTIONS GmbH
Solutions Circle
10:10 - 10:40
WEST
Solutions Circle: Post-Market Surveillance (PMS) and Post-Market Performance Follow-up (PMPF)
10:10 - 10:40
WEST
Solutions Circle: Post-Market Surveillance (PMS) and Post-Market Performance Follow-up (PMPF)
Location: Exhibition - Hall 2
Presenter:
Marta Carnielli
– TUV SUD
Solutions Circle
10:10 - 10:40
WEST
Solutions Circle: The Pitfalls of Only Applying ISO 14971:2019 When Applying for MDR
10:10 - 10:40
WEST
Solutions Circle: The Pitfalls of Only Applying ISO 14971:2019 When Applying for MDR
Location: Exhibition - Hall 2
Facilitator:
Beatriz Rodriguez Grande, PhD
– NAMSA
Solutions Circle
10:45 - 11:15
WEST
Solutions Circle: Are You Really Ready for eCTD 4.0?
10:45 - 11:15
WEST
Solutions Circle: Are You Really Ready for eCTD 4.0?
Location: Exhibition - Hall 2
Facilitator:
Diarmuid Waide
– Ennov
Solutions Circle
10:45 - 11:15
WEST
Solutions Circle: What the proposed IVDR changes mean for IVD manufacturers?
10:45 - 11:15
WEST
Solutions Circle: What the proposed IVDR changes mean for IVD manufacturers?
Location: Exhibition - Hall 2
Facilitator:
Marta Carnielli
– TUV SUD
Facilitator:
Tom Patten
– GMED
Solutions Circle
11:15 - 12:15
WEST
Biocompatibility in Transition – Integrating Biological Safety, Post-Market Evidence, and Advanced Risk Assessment
11:15 - 12:15
WEST
Biocompatibility in Transition – Integrating Biological Safety, Post-Market Evidence, and Advanced Risk Assessment
Location: Auditorium 2
Moderator:
Gert BQ Bos, PhD FRAPS
– QServe
Speaker:
Michelle Kelly, ERT (she/her/hers)
– NAMSA
Speaker:
Patrícia da Silva Pérez, PhD
– Qserve Group
Speaker:
Petr Bratka, PhD (he/him/his)
– Centre for Medical Devices Certification, Czech Metrology Institute
Medical Devices
11:15 - 12:15
WEST
International Reliance: Medical Devices in the Tropics: Tips, Tricks and Odds for Your ANVISA Submission
11:15 - 12:15
WEST
International Reliance: Medical Devices in the Tropics: Tips, Tricks and Odds for Your ANVISA Submission
Location: Auditorium 1
Speaker:
Bruno J S Oliveira, Sr., MSc (he/him/his)
– MSC MED Engenharia e Tecnologia Médica Ltda.
Speaker:
Dennis Sarwin, MSc
– Qserve Group
Medical Devices
11:15 - 12:15
WEST
Life After NBOp: Navigating Post-Market Compliance and Mastering Change Management for Combination Products
11:15 - 12:15
WEST
Life After NBOp: Navigating Post-Market Compliance and Mastering Change Management for Combination Products
Location: Room 5A-C
Speaker:
Tiina A. Riihimäki, PhD (she/her/hers)
– Cencora
Speaker:
Theresa Jeary
– BSI
Speaker:
Ana Pilar Olmos
– Beyond Conception
Panelist:
Christelle Bouygues, PharmD
– EMA
Pharmaceuticals
11:15 - 12:15
WEST
One year after – Observations, insights, implications on JCA
11:15 - 12:15
WEST
One year after – Observations, insights, implications on JCA
Location: Auditorium 3
Speaker:
Thomas Ecker, MA, PhD (he/him/his)
– Ecker + Ecker GmbH
Speaker:
Daria Mari (she/her/hers)
– regenold GmbH
Speaker:
Noemie Manent
– European Medicines Agency (EMA)
Speaker:
Matteo Scarabelli
– EFPIA
Pharmaceuticals
11:15 - 12:15
WEST
Performance Evaluation Under EU IVDR for Complex Diagnostics: Multiplex IVDs and Service-Based NGS Panels
11:15 - 12:15
WEST
Performance Evaluation Under EU IVDR for Complex Diagnostics: Multiplex IVDs and Service-Based NGS Panels
Location: Auditorium 4
Speaker:
Carlos Galamba, MSc
– MDx CRO
Speaker:
Javier Varela (he/him/his)
– Pharmalex
IVD's
11:15 - 12:15
WEST
Recalibrating Oversight: Post-Market Monitoring and Governance for AI-enabled Clinical Decision Support Software
11:15 - 12:15
WEST
Recalibrating Oversight: Post-Market Monitoring and Governance for AI-enabled Clinical Decision Support Software
Location: Room 3A-C
Speaker:
Catarina Carrão
– BioSciPons
Speaker:
Zuzanna Kwade, MSc, PhD (she/her/hers)
– Dedalus
Speaker:
Vanda Almeida, PhD
– Philips
Digital Health
12:30 - 13:30
WEST
AI-Powered Conformity Assessment Transforming Notified Body Operations
12:30 - 13:30
WEST
AI-Powered Conformity Assessment: Transforming Notified Body Operations
Location: Room 3A-C
Speaker:
Erik R. Vollebregt
– Axon Lawyers
Speaker:
Tom Patten
– GMED
Speaker:
Sebastian Fischer
– TÜV SÜD Product Service
Medical Devices
12:30 - 13:30
WEST
Aligning Regulatory and HTA Strategies of Digital Health Technologies to Reduce Duplication of Effort and Resources
12:30 - 13:30
WEST
Aligning Regulatory and HTA Strategies of Digital Health Technologies to Reduce Duplication of Effort and Resources
Location: Auditorium 1
Speaker:
Rebecca Mathias, MSc (she/her/hers)
– Else Kröner Fresenius Center for Digital Health, TU Dresden
Speaker:
Stephen Gilbert, PhD (he/him/his)
– Else Kröner Fresenius Center for Digital Health, Technische Universität Dresden
Speaker:
Tom Melvin, M.D.
– Institute for Clinical Trials, University of Galway
Speaker:
David Epstein, Prof. (he/him/his)
– Department of Applied Economics, University of Granada, Spain
Digital Health
12:30 - 13:30
WEST
Environment Regulatory
12:30 - 13:30
WEST
Environment Regulatory
Location: Room 5A-C
Speaker:
Thomas Wejs Møller, Master's degree in Political Science
– EFPIA ERAO and Device Group
Speaker:
Jacob Moberg Sandager, Master’s degree in Materials and Manufacturing (he/him/his)
– Novo Nordisk
Speaker:
Veronika Jekerle, PhD
– European Medicines Agency
Pharmaceuticals
12:30 - 13:30
WEST
Falsified Medical Devices & Certificates
12:30 - 13:30
WEST
Falsified Medical Devices & Certificates
Location: Auditorium 2
Speaker:
Jean McKenzie, MSc
– DEKRA Certification B.V.
Medical Devices
12:30 - 13:30
WEST
M4Q
12:30 - 13:30
WEST
M4Q
Location: Auditorium 3
Moderator:
Michael Craig
– Parexel
Speaker:
David Murray, PhD
– Parexel International
Speaker:
Ivica Malnar, PhD
– Agency for Medicinal Products and Medical Devices (HALMED)
Pharmaceuticals
12:30 - 13:30
WEST
Mastering EU in-house tests: Real-World Lessons From Laboratories Under the IVDR Article 5(5)
12:30 - 13:30
WEST
Mastering EU in-house tests: Real-World Lessons From Laboratories Under the IVDR Article 5(5)
Location: Auditorium 4
Speaker:
Andreas Oberleitner, MSc (he/him/his)
– Platomics
Speaker:
Natalie Batty, MPH
– Immatics
Speaker:
Marina Belonogova, PhD (she/her/hers)
– Johnson & Johnson
IVD's
12:30 - 18:00
WEST
Exhibition Closed - Breakdown starting
12:30 - 18:00
WEST
Exhibition Closed - Breakdown starting
13:30 - 14:30
WEST
Euro Convergence - Farewell Lunch
13:30 - 14:30
WEST
Euro Convergence - Farewell Lunch
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