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Learning Level: Foundational
Learning Level: Intermediate
Learning Level: Advanced
Learning Level: Expert
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Tue, May 13
Wed, May 14
Thu, May 15
Fri, May 16
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Tuesday, May 13, 2025
07:30 - 19:00
CEST
Registration
07:30 - 19:00
CEST
Registration
Location: Glass Entrance (-1)
07:30 - 20:00
CEST
Cloakroom
07:30 - 20:00
CEST
Cloakroom
Location: Glass Entrance (-1)
08:30 - 16:00
CEST
Pre-Conference Workshop: Clinical Evaluation - Optimizing Clinical Data and State-of-the-Art Searches for MDR Compliance
08:30 - 16:00
CEST
Preconference Workshop: Clinical Evaluation - Optimizing Clinical Data and State-of-the-art Searches for MDR Compliance
Location: Studio 211 (level 2)
Speaker:
Christiane Reinwald, PhD (Dr. rer. nat.)
– be-on-Quality GmbH
Speaker:
Mette Stoedter, PhD (Dr rer medic) (she/her/hers)
– be-on-Quality GmbH
Speaker:
David John Mandley, PhD (he/him/his)
– NAMSA
Medical Devices
08:30 - 16:00
CEST
Preconference Workshop: EU Pharmaceutical Regulatory Reform
08:30 - 16:00
CEST
Preconference Workshop: EU Pharmaceutical Regulatory Reform
Location: Studio 202 (level 2)
Workshop Leader:
Rebecca Lumsden, PhD (she/her/hers)
– Sanofi
Speaker:
Yves Jacob (he/him/his)
– Sanofi
Speaker:
Alberto Ganan, PhD
– European Medicines Agency
Speaker:
Lilia Luchianov
– European Commission
Speaker:
Nikos Dedes
Pharmaceuticals
08:30 - 16:00
CEST
Preconference Workshop: From Concept to Compliance: Overcoming the Regulatory Challenges of Clinical Performance Studies
08:30 - 16:00
CEST
Preconference Workshop: From Concept to Compliance: Overcoming the Regulatory Challenges of Clinical Performance Studies
Location: Studio 204 (level 2)
Speaker:
Natalie Batty, MPH
– Aignostics
Speaker:
Marina Belonogova, PhD (she/her/hers)
– Johnson and Johnson
Speaker:
Kristiane Schmidt, PhD (she/her/hers)
– Qserve Consultancy BV
Speaker:
Carlos Galamba
– MDx CRO
IVDs
08:30 - 16:00
CEST
Preconference Workshop
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
08:30 - 16:00
CEST
Preconference Workshop: IVDR Technical Documentation
Location: Studio 206 (level 2)
Workshop Leader:
Francesca Bevilacqua, PhD (she/her/hers)
– TÜV SÜD Italy
Speaker:
Catherine Holzmann, PhD
– GMED Certification Division
Speaker:
Alex Laan, Dipl.-Ing. (he/him/his)
– BSI
Speaker:
Marco Caproni (he/him/his)
– TUV SUD
Speaker:
Guillaume Berger
– GMED
IVDs
08:30 - 16:00
CEST
Preconference Workshop: PMS Process- dos and Don'ts
Location: Studio 212 (level 2)
Speaker:
Vaso Basinou, PhD (she/her/hers)
– Freelancer
Speaker:
Ivan Stoyanov, Dr.
– SGS Notified Body, 1639
Speaker:
Andrea Biasiucci, PhD
– confinis
Speaker:
Claudio Alberti, PhD (he/him/his)
– confinis
Medical Devices
14:00 - 15:00
CEST
RAPS Career Development Session for Students
14:00 - 15:00
CEST
RAPS Career Development Session for Students
Location: Studio 312
Moderator:
Kim Young, MSc (she/her/hers)
– RAPS
Panelist:
Maham Ansari, MS, RAC
– Precision for Medicine
Panelist:
Kate Stockman
Panelist:
Corinne Delorme, RAC
– nexialist
Panelist:
Michal Wosiak, MPharm (he/him/his)
– Pharmaceutical Company
16:30 - 18:30
CEST
Euro Convergence 2025 Welcome and Opening Plenary: The Future of Regulation and European Competitiveness
16:30 - 18:30
CEST
Euro Convergence 2025 Welcome and Opening Plenary: The Future of Regulation and European Competitiveness
Location: Gold Hall (level 0)
Keynote Panelist:
Peter Bischoff-Everding, PhD (he/him/his)
– European Commission, Directorate-General Health and Food safety
Moderator:
Koen Cobbaert (he/him/his)
– Philips
Panelist:
Stephen Gilbert, PhD (he/him/his)
– Else Kröner Fresenius Center for Digital Health, Technische Universität Dresden
Panelist:
Jana Russo, MA
– MedTech Europe
Panelist:
Steffen Thirstrup, MD, PhD (he/him/his)
– European Medicines Agency (EMA)
Panelist:
Erik R. Vollebregt
– Axon Lawyers
18:30 - 19:30
CEST
Opening Reception in Exhibition Hall
18:30 - 19:30
CEST
Opening Reception in Exhibition Hall
Location: Grand Hall 1/2 (Level -2)
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