Skip to main content
Toggle navigation
Login
Search
Home
Tweets by RAPS European Clinical and Risk Management Conference
Icon Legend
This session is not in your schedule.
This session is in your schedule. Click again to remove it.
Full Schedule
Home
Full Schedule
All Days
Tue, Oct 24
Wed, Oct 25
Thu, Oct 26
Full Schedule
Type here to filter the list
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
