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Learning Level: Foundational
Learning Level: Intermediate
Learning Level: Advanced
Learning Level: Expert
Networking Event
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Tue, May 13
Wed, May 14
Thu, May 15
Fri, May 16
Full Schedule
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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 – 19:30
CEST
Cloakroom
07:30 – 19:30
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
Presenter:
Christiane Reinwald, PhD (Dr. rer. nat.)
– be-on-Quality GmbH
Presenter:
Mette Stoedter, PhD (Dr rer medic) (she/her/hers)
– be-on-Quality GmbH
Presenter:
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
Workshop Leader:
Rebecca Lumsden, PhD (she/her/hers)
– Sanofi
Presenter:
Yves Jacob (he/him/his)
– Sanofi
Presenter:
Alberto Ganan, PhD
– European Medicines Agency
Presenter:
Lilia Luchianov
– European Commission
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
Presenter:
Natalie Batty, MPH
– Aignostics
Presenter:
Marina Belonogova, PhD (she/her/hers)
– Johnson and Johnson
Presenter:
Kristiane Schmidt, PhD (she/her/hers)
– Qserve Consultancy BV
Presenter:
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)
Presenter:
Florian Tolkmitt, n/a
– PRO-LIANCE GLOBAL SOLUTIONS GmbH
Presenter:
Stephen Gilbert, PhD (he/him/his)
– Else Kröner Fresenius Center for Digital Health, Technische Universität Dresden
Presenter:
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
Workshop Leader:
Francesca Bevilacqua, PhD (she/her/hers)
– TÜV SÜD Italy
Presenter:
Catherine Holzmann, N/A
– GMED Certification Division
Presenter:
Alex Laan, Dipl.-Ing. (he/him/his)
– BSI
Presenter:
Marco Caproni, n/a (he/him/his)
– TUV SUD
Presenter:
Guillaume Berger
– GMED
IVDs
08:30 – 16:00
CEST
Preconference Workshop: PMS Process- dos and Don'ts
Presenter:
Vaso Basinou, PhD (she/her/hers)
– Freelancer
Presenter:
Ivan Stoyanov, Dr.
– SGS Notified Body, 1639
Presenter:
Andrea Biasiucci, PhD
– confinis
Presenter:
Claudio Alberti, PhD
– 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)
– Novartis Poland
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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