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Wednesday, October 25, 2023
08:00 - 17:00
CET
Registration
08:00 - 17:00
CET
Registration
09:00 - 10:00
CET
Opening Remarks & Plenary Session: Navigating Evolving Regulatory Landscape in Europe
09:00 - 10:00
CET
Opening Remarks & Plenary Session: Navigating Evolving Regulatory Landscape in Europe
Location: Catherine Ballroom
Moderator:
Robert A. van Boxtel
– Medical Device Project B.V.
Moderator:
Jennifer Neff, PhD
– Entourage GmbH
Panelist:
Danielle Giroud, MSci
– MD-CLINICALS SA
Panelist:
Paul Piscoi
– European Commission - Directorate-General for Health and Food Safety
Panelist:
Silvy Da Rocha Dias
– European Medicines Agency
Panelist:
Petra Zoellner
– MedTech Europe
10:00 - 10:30
CET
Coffee Break
10:00 - 10:30
CET
Coffee Break
Location: Elizabeth Ballroom
10:30 - 11:30
CET
Developing Your Clinical Strategy
10:30 - 11:30
CET
Developing Your Clinical Strategy
Location: Maya Meeting Room
Presenter:
Nataliya Deych
Presenter:
Peter Schrutka-Rechtenstamm
– Entourage GmbH
Clinical Evaluation
10:30 - 11:30
CET
Risk Management Throughout the Product Lifestyle
10:30 - 11:30
CET
Risk Management Throughout the Product Lifestyle
Location: Catherine Ballroom
Presenter:
Robert A. van Boxtel
– Medical Device Project B.V.
Presenter:
Rachel Mead, BEng MIET
– BSI Group
Risk Management
11:45 - 12:45
CET
FMEA is Not the Only Way
11:45 - 12:45
CET
FMEA is Not the Only Way
Location: Catherine Ballroom
Presenter:
Richard Bassett, Bsc, Msc, LLM
– DLRC
Risk Management
11:45 - 12:45
CET
Sufficient Clinical Evidence for Medical Device Under MDR
11:45 - 12:45
CET
Sufficient Clinical Evidence for Medical Device Under MDR
Location: Maya Meeting Room
Presenter:
Yu Jin, MD, PhD
– Notified Body 1639, SGS Belgium
Clinical Evaluation
12:45 - 13:45
CET
Lunch
12:45 - 13:45
CET
Lunch
Location: Elizabeth Ballroom
13:45 - 14:45
CET
Medical Device and Pharmaceutical Risk Management Approaches - What can we Learn Together?
13:45 - 14:45
CET
Medical Device and Pharmaceutical Risk Management Approaches - What can we Learn Together?
Location: Catherine Ballroom
Presenter:
Bruno Čok
– anteris helvetia AG
Risk Management
13:45 - 14:45
CET
The Value of Real World Evidence
13:45 - 14:45
CET
The Value of Real World Evidence
Location: Maya Meeting Room
Presenter:
Richard G. Holborow, BSc (Hons) MSCST RCCP
– BSI Notified Body (NL)
Clinical Evaluation
14:45 - 15:15
CET
Coffee Break
14:45 - 15:15
CET
Coffee Break
Location: Elizabeth Ballroom
15:15 - 16:15
CET
Usability in Risk Management (MD & IVD)
15:15 - 16:15
CET
Usability in Risk Management (MD & IVD)
Location: Catherine Ballroom
Presenter:
Leon Assink, bSC
– Medical Device Project
Presenter:
Isabel Koch, PhD
– TÜV SÜD Product Service GmbH
Presenter:
Torsten Gruchmann, Dipl.-Ing.
– Use-Lab GmbH
Risk Management
15:15 - 16:15
CET
WET: What we Know and What we Don't
15:15 - 16:15
CET
WET: What we Know and What we Don't
Location: Maya Meeting Room
Presenter:
David Mandley, BSc, PhD
– NAMSA
Clinical Evaluation
16:30 - 17:30
CET
Clinical Evaluation in the MDR Era: Mastering the Equivalence Route
16:30 - 17:30
CET
Clinical Evaluation in the MDR Era: Mastering the Equivalence Route
Location: Maya Meeting Room
Presenter:
Olga Gusyatiner, MSc, PhD, DAS
– Ypsomed
Clinical Evaluation
16:30 - 17:30
CET
Streamlining Clinical Evaluation, Risk Management and PMS- the Medical Device Knowledge Unit approach
16:30 - 17:30
CET
Streamlining Clinical Evaluation, Risk Management and PMS- the Medical Device Knowledge Unit approach
Location: Catherine Ballroom
Presenter:
Florian Tolkmitt
Presenter:
Sarah Panten
Risk Management
17:30 - 18:30
CET
Networking Reception
17:30 - 18:30
CET
Networking Reception
Location: Elizabeth Ballroom
