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A
Abdurrahman, Goran
TÜV Rheinland
A Practical Approach to State of the Art for Legacy IVDs
Location/Room:Sants - 3rd fl
Goran Abdurrahman
Favorite
Alonso, Marta
Medtronic Iberica
Post-Market Surveillance, Protecting Patient Safety
Location/Room:Sagrada familia - 4th fl
Marta Alonso
Favorite
B
Bajagic, Milica
PRO-LIANCE GLOBAL SOLUTIONS GmbH
Closing Plenary: The Holy Trinity of the MDR – Risk management, Clinical Evaluation and PMS
Location/Room:Sagrada familia - 4th fl
Milica Bajagic
Favorite
The Chicken or the Egg? Reuniting SOTA and CEP
Location/Room:Sagrada familia - 4th fl
Milica Bajagic
Favorite
Ball, Ed
RQM+
Closing Plenary: The Holy Trinity of the MDR – Risk management, Clinical Evaluation and PMS
Location/Room:Sagrada familia - 4th fl
Ed Ball
Favorite
Preconference Workshop: Effective Risk Management at the Core of MDR and IVDR
Location/Room:Sants - 3rd fl
Ed Ball
Favorite
Bassett, Richard
DLRC
Preconference Workshop: Effective Risk Management at the Core of MDR and IVDR
Location/Room:Sants - 3rd fl
Richard Bassett
Favorite
Bess, Elke
TÜV Rheinland
How to Tame Your Benefit Risk Evaluation
Location/Room:Sagrada familia - 4th fl
Elke Bess
Favorite
Bogaert, Pieter
Qarad (part of QbD Group)
Strategies for Co-Development of Companion Diagnostics and Medicines in the IVDR Era
Location/Room:Sants - 3rd fl
Pieter Bogaert
Favorite
C
Carnielli, Marta
TUV Sud GmbH
Clinical Evidence IVDR - Flexible Concepts to Satisfy NB Expectations
Location/Room:Sants - 3rd fl
Marta Carnielli
Favorite
What are Common Pitfalls in Clinical Evaluation and Performance Evaluation - An Analysis of the Feedback from Different Notified Bodies
Location/Room:Sagrada familia - 4th fl
Marta Carnielli
Favorite
Chiva, Ana
BSI
What are Common Pitfalls in Clinical Evaluation and Performance Evaluation - An Analysis of the Feedback from Different Notified Bodies
Location/Room:Sagrada familia - 4th fl
Ana Chiva
Favorite
D
Doorn, Leon
MedQAIR
The Interface of the EU AI Act and the MDR/IVDR
Location/Room:Sagrada familia - 4th fl
Leon Doorn
Favorite
F
Fink, Matthias
Akra Team Inc.
Hands-on Strategies for a Successful Clinical Evaluation under the EU MDR
Location/Room:Sagrada familia - 4th fl
Matthias Fink
Favorite
What are Common Pitfalls in Clinical Evaluation and Performance Evaluation - An Analysis of the Feedback from Different Notified Bodies
Location/Room:Sagrada familia - 4th fl
Matthias Fink
Favorite
G
Ganan, Alberto
European Medicines Agency
Clinical Evaluation of High-Risk Implantable; Current State of Play, Including Pediatric
Location/Room:Sagrada familia - 4th fl
Alberto Ganan
Favorite
Opening Plenary Session: Evolving Regulatory Frameworks: Access to Innovation and Patient Safety
Location/Room:Sagrada familia - 4th fl
Alberto Ganan
Favorite
H
Hoffmann, Sven
Entourage GmbH
Clinical Evidence IVDR - Flexible Concepts to Satisfy NB Expectations
Location/Room:Sants - 3rd fl
Sven Hoffmann
Favorite
Post-Market Surveillance under MDR and IVDR: Practical Insights Where Efficiency Meets Compliance
Location/Room:Sagrada familia - 4th fl
Sven Hoffmann
Favorite
I
Idler, Irina
Entourage
The Interface of the EU AI Act and the MDR/IVDR
Location/Room:Sagrada familia - 4th fl
Irina Idler
Favorite
K
Kasper, Grit
Metecon GmbH
How to Tame Your Benefit Risk Evaluation
Location/Room:Sagrada familia - 4th fl
Grit Kasper
Favorite
Kearney, Breda
BSI
Hands-on Strategies for a Successful Clinical Evaluation under the EU MDR
Location/Room:Sagrada familia - 4th fl
Breda Kearney
Favorite
Kjaersgaard-Andersen, Per
Clinical Evaluation of High-Risk Implantable; Current State of Play, Including Pediatric
Location/Room:Sagrada familia - 4th fl
Per Kjaersgaard-Andersen
Favorite
Opening Plenary Session: Evolving Regulatory Frameworks: Access to Innovation and Patient Safety
Location/Room:Sagrada familia - 4th fl
Per Kjaersgaard-Andersen
Favorite
L
Lidgate, Simon
BSI
Preconference Workshop: Effective Risk Management at the Core of MDR and IVDR
Location/Room:Sants - 3rd fl
Simon Lidgate
Favorite
The Chicken or the Egg? Reuniting SOTA and CEP
Location/Room:Sagrada familia - 4th fl
Simon Lidgate
Favorite
M
Maunu, Piritta
Pharmalex Finland Oy
How to Conduct CDx Clinical Performance Studies in Compliance with IVDR 2017/746
Location/Room:Sants - 3rd fl
Piritta Maunu
Favorite
Michener Whipple, Janet
ELIQUENT Life Sciences
Challenges and Opportunities in In-Vitro Diagnostic Risk Management
Location/Room:Sants - 3rd fl
Janet Michener Whipple
Favorite
Morel, Keith
Qserve Group
Post-Market Surveillance under MDR and IVDR: Practical Insights Where Efficiency Meets Compliance
Location/Room:Sagrada familia - 4th fl
Keith Morel
Favorite
N
Neff, Jennifer
Entourage GmbH
Opening Plenary Session: Evolving Regulatory Frameworks: Access to Innovation and Patient Safety
Location/Room:Sagrada familia - 4th fl
Jennifer Neff
Favorite
Preconference Workshop: Effective Risk Management at the Core of MDR and IVDR
Location/Room:Sants - 3rd fl
Jennifer Neff
Favorite
O
O'Connor, Donal
HPRA
Clinical Evaluation of High-Risk Implantable; Current State of Play, Including Pediatric
Location/Room:Sagrada familia - 4th fl
Donal O'Connor
Favorite
Opening Plenary Session: Evolving Regulatory Frameworks: Access to Innovation and Patient Safety
Location/Room:Sagrada familia - 4th fl
Donal O'Connor
Favorite
P
Panten, Sarah
avasis solutions GmbH / MDKU e.V.
Closing Plenary: The Holy Trinity of the MDR – Risk management, Clinical Evaluation and PMS
Location/Room:Sagrada familia - 4th fl
Sarah Panten
Favorite
Partridge, Susan
BSI
Hands-on Strategies for a Successful Clinical Evaluation under the EU MDR
Location/Room:Sagrada familia - 4th fl
Susan Partridge
Favorite
What are Common Pitfalls in Clinical Evaluation and Performance Evaluation - An Analysis of the Feedback from Different Notified Bodies
Location/Room:Sagrada familia - 4th fl
Susan Partridge
Favorite
Q
Quigley, Gavin
BSI
How to Effectively Collect Level 4 Clinical Data With High Quality PMCF Surveys
Location/Room:Sagrada familia - 4th fl
Gavin Quigley
Favorite
R
Rohrberg, Julia
PRO-LIANCE GLOBAL SOLUTIONS GmbH
The Chicken or the Egg? Reuniting SOTA and CEP
Location/Room:Sagrada familia - 4th fl
Julia Rohrberg
Favorite
Ruiz-Villar, Carmen
Spanish Agency for Medicines and Medical Devices (AEMPS), Spain
Opening Plenary Session: Evolving Regulatory Frameworks: Access to Innovation and Patient Safety
Location/Room:Sagrada familia - 4th fl
Carmen Ruiz-Villar
Favorite
Post-Market Surveillance, Protecting Patient Safety
Location/Room:Sagrada familia - 4th fl
Carmen Ruiz-Villar
Favorite
Russo, Jana
MedTech Europe
Opening Plenary Session: Evolving Regulatory Frameworks: Access to Innovation and Patient Safety
Location/Room:Sagrada familia - 4th fl
Jana Russo
Favorite
S
Schüre, Björn-Carsten
Metecon GmbH
How to Tame Your Benefit Risk Evaluation
Location/Room:Sagrada familia - 4th fl
Björn-Carsten Schüre
Favorite
Suppo, Maurizio
Qarad
A Practical Approach to State of the Art for Legacy IVDs
Location/Room:Sants - 3rd fl
Maurizio Suppo
Favorite
T
Thermann, Rolf
TUV Rhineland LGA Products GmbH
Strategies for Co-Development of Companion Diagnostics and Medicines in the IVDR Era
Location/Room:Sants - 3rd fl
Rolf Thermann
Favorite
Torr, Marcus
Purdie Pascoe
How to Effectively Collect Level 4 Clinical Data With High Quality PMCF Surveys
Location/Room:Sagrada familia - 4th fl
Marcus Torr
Favorite
V
van Boxtel, Robert
Medical Device Project B.V.
Closing Plenary: The Holy Trinity of the MDR – Risk management, Clinical Evaluation and PMS
Location/Room:Sagrada familia - 4th fl
Robert van Boxtel
Favorite
Opening Plenary Session: Evolving Regulatory Frameworks: Access to Innovation and Patient Safety
Location/Room:Sagrada familia - 4th fl
Robert van Boxtel
Favorite
Preconference Workshop: Effective Risk Management at the Core of MDR and IVDR
Location/Room:Sants - 3rd fl
Robert van Boxtel
Favorite
W
Webb, Chris
Purdie Pascoe
How to Effectively Collect Level 4 Clinical Data With High Quality PMCF Surveys
Location/Room:Sagrada familia - 4th fl
Chris Webb
Favorite
