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Tue, Oct 22
Wed, Oct 23
Thu, Oct 24
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Tuesday, October 22, 2024
8:30 AM – 5:00 PM
CEST
Registration
8:30 AM – 5:00 PM
CEST
Registration
Location/Room: Lobby
9:00 AM – 5:00 PM
CEST
Preconference Workshop: Effective Risk Management at the Core of MDR and IVDR
9:00 AM – 5:00 PM
CEST
Preconference Workshop: Effective Risk Management at the Core of MDR and IVDR
Location/Room: Sants - 3rd fl
Host:
Robert A. van Boxtel, MSc
– Medical Device Project B.V.
Host:
Jennifer Neff, PhD
– Entourage GmbH
Workshop Leader:
Ed Ball, Msc, CEng
– RQM+
Presenter:
Simon Lidgate, PhD
– BSI
Presenter:
Richard Bassett, Msc, LLM
– DLRC
Wednesday, October 23, 2024
8:00 AM – 5:00 PM
CEST
Registration
8:00 AM – 5:00 PM
CEST
Registration
Location/Room: Lobby
8:30 AM – 10:00 AM
CEST
Opening Plenary Session: Evolving regulatory frameworks: Access to Innovation and Patient Safety
8:30 AM – 10:00 AM
CEST
Opening Plenary Session: Evolving Regulatory Frameworks: Access to Innovation and Patient Safety
Location/Room: Sagrada familia - 4th fl
Moderator:
Jennifer Neff, PhD
– Entourage GmbH
Moderator:
Robert A. van Boxtel, MSc
– Medical Device Project B.V.
Panelist:
Donal O'Connor, MD FEBS
– HPRA
Panelist:
Carmen Ruiz-Villar
– Spanish Agency for Medicines and Medical Devices (AEMPS), Spain
Panelist:
Jana Russo, MA
– MedTech Europe
Panelist:
Per Kjaersgaard-Andersen
Panelist:
Alberto Ganan, PhD
– European Medicines Agency
10:00 AM – 10:30 AM
CEST
Coffee Break & Exhibition
10:00 AM – 10:30 AM
CEST
Coffee Break & Exhibition
10:30 AM – 11:30 AM
CEST
Challenges and Opportunities in In-Vitro Diagnostic Risk Management
10:30 AM – 11:30 AM
CEST
Challenges and Opportunities in In-Vitro Diagnostic Risk Management
Location/Room: Sants - 3rd fl
Speaker:
Janet L. Michener Whipple
– ELIQUENT Life Sciences
10:30 AM – 11:30 AM
CEST
How to Tame Your Benefit Risk Evaluation
10:30 AM – 11:30 AM
CEST
How to Tame Your Benefit Risk Evaluation
Location/Room: Sagrada familia - 4th fl
Speaker:
Björn-Carsten Schüre, MA
– Metecon GmbH
Speaker:
Grit Kasper, PhD
– Metecon GmbH
Speaker:
Elke Bess, Dr.
– TÜV Rheinland
11:45 AM – 12:45 PM
CEST
The Interface of the EU AI Act and the MDR/IVDR
11:45 AM – 12:45 PM
CEST
The Interface of the EU AI Act and the MDR/IVDR
Location/Room: Sagrada familia - 4th fl
Speaker:
Leon Doorn, M.Sc.
– MedQAIR
Speaker:
Irina Idler, Dr. rer.nat.
– Entourage
12:45 PM – 1:45 PM
CEST
Lunch & Exhibition
12:45 PM – 1:45 PM
CEST
Lunch & Exhibition
1:45 PM – 2:45 PM
CEST
Clinical Evaluation of High-Risk Implantable; Current state of play, including pediatric
1:45 PM – 2:45 PM
CEST
Clinical Evaluation of High-Risk Implantable; Current State of Play, Including Pediatric
Location/Room: Sagrada familia - 4th fl
Presenter:
Donal O'Connor, MD FEBS
– HPRA
Presenter:
Per Kjaersgaard-Andersen
Presenter:
Alberto Ganan, PhD
– European Medicines Agency
1:45 PM – 2:45 PM
CEST
How to Conduct CDx Clinical Performance Studies in Compliance with IVDR 2017/746
1:45 PM – 2:45 PM
CEST
How to Conduct CDx Clinical Performance Studies in Compliance with IVDR 2017/746
Location/Room: Sants - 3rd fl
Speaker:
Piritta Maunu, MSc
– Pharmalex Finland Oy
3:00 PM – 4:00 PM
CEST
How to Effectively Collect Level 4 Clinical Data With High Quality PMCF Surveys
3:00 PM – 4:00 PM
CEST
How to Effectively Collect Level 4 Clinical Data With High Quality PMCF Surveys
Location/Room: Sagrada familia - 4th fl
Speaker:
Chris Webb
– Purdie Pascoe
Speaker:
Marcus Torr, MSci
– Purdie Pascoe
Speaker:
Gavin Quigley, MBChB FRCS MBA
– BSI
3:00 PM – 4:00 PM
CEST
Strategies for Co-Development of Companion Diagnostics and Medicines in the IVDR Era
3:00 PM – 4:00 PM
CEST
Strategies for Co-Development of Companion Diagnostics and Medicines in the IVDR Era
Location/Room: Sants - 3rd fl
Presenter:
Pieter Bogaert, n/a
– Qarad (part of QbD Group)
Presenter:
Rolf Thermann, PhD
– TUV Rhineland LGA Products GmbH
4:00 PM – 4:30 PM
CEST
Coffee Break & exhibition
4:00 PM – 4:30 PM
CEST
Coffee Break & exhibition
4:30 PM – 5:30 PM
CEST
What are common pitfalls in Clinical Evaluation and Performance Evaluation - An Analysis of the Feedback from Different Notified Bodies
4:30 PM – 5:30 PM
CEST
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
Speaker:
Matthias Fink, MD
– Akra Team Inc.
Speaker:
Marta Carnielli, PharmD
– TUV Sud GmbH
Speaker:
Susan Partridge, PhD
– BSI
Speaker:
Ana Chiva, PhD
– BSI
5:30 PM – 6:30 PM
CEST
Networking Reception
5:30 PM – 6:30 PM
CEST
Networking Reception
Thursday, October 24, 2024
8:00 AM – 4:30 PM
CEST
Registration
8:00 AM – 4:30 PM
CEST
Registration
9:00 AM – 10:00 AM
CEST
A Practical Approach to State of the Art for Legacy IVDs
9:00 AM – 10:00 AM
CEST
A Practical Approach to State of the Art for Legacy IVDs
Location/Room: Sants - 3rd fl
Speaker:
Maurizio Suppo, Dr.
– Qarad
Speaker:
Goran Abdurrahman, PhD
– TÜV Rheinland
9:00 AM – 10:00 AM
CEST
Hands-on Strategies for a Successful Clinical Evaluation under the EU MDR
9:00 AM – 10:00 AM
CEST
Hands-on Strategies for a Successful Clinical Evaluation under the EU MDR
Location/Room: Sagrada familia - 4th fl
Presenter:
Matthias Fink, MD
– Akra Team Inc.
Speaker:
Susan Partridge, PhD
– BSI
Speaker:
Breda Kearney, MSc
– BSI
10:00 AM – 10:30 AM
CEST
Coffee Break & Exhibition
10:00 AM – 10:30 AM
CEST
Coffee Break & Exhibition
10:30 AM – 11:30 AM
CEST
Clinical Evidence IVDR - Flexible Concepts to Satisfy NB Expectations
10:30 AM – 11:30 AM
CEST
Clinical Evidence IVDR - Flexible Concepts to Satisfy NB Expectations
Location/Room: Sants - 3rd fl
Speaker:
Sven Hoffmann, MSc
– Entourage GmbH
Speaker:
Heike Moehlig-Zuttermeister, PhD
– Tüv Süd
10:30 AM – 11:30 AM
CEST
The Chicken or the Egg? Reuniting SOTA and CEP
10:30 AM – 11:30 AM
CEST
The Chicken or the Egg? Reuniting SOTA and CEP
Location/Room: Sagrada familia - 4th fl
Speaker:
Julia Rohrberg, PhD
– PRO-LIANCE GLOBAL SOLUTIONS GmbH
Speaker:
Milica Bajagic, PhD
– PRO-LIANCE GLOBAL SOLUTIONS GmbH
Speaker:
Simon Lidgate, PhD
– BSI
11:45 AM – 12:45 PM
CEST
Post-Market Surveillance under MDR and IVDR: Practical Insights Where Efficiency Meets Compliance
11:45 AM – 12:45 PM
CEST
Post-Market Surveillance under MDR and IVDR: Practical Insights Where Efficiency Meets Compliance
Location/Room: Sagrada familia - 4th fl
Speaker:
Keith Morel, PhD
– Qserve Group
Speaker:
Sven Hoffmann, MSc
– Entourage GmbH
12:45 PM – 1:45 PM
CEST
Lunch & Exhibition
12:45 PM – 1:45 PM
CEST
Lunch & Exhibition
1:45 PM – 2:45 PM
CEST
Post-Market Surveillance, protecting patient safety
1:45 PM – 2:45 PM
CEST
Post-Market Surveillance, Protecting Patient Safety
Location/Room: Sagrada familia - 4th fl
Speaker:
Marta Alonso
Speaker:
Carmen Ruiz-Villar
– Spanish Agency for Medicines and Medical Devices (AEMPS), Spain
2:45 PM – 3:15 PM
CEST
Coffee Break & Exhibition
2:45 PM – 3:15 PM
CEST
Coffee Break & Exhibition
3:15 PM – 4:15 PM
CEST
Closing Plenary: The Holy Trinity of the MDR – Risk management, Clinical evaluation and PMS
3:15 PM – 4:15 PM
CEST
Closing Plenary: The Holy Trinity of the MDR – Risk management, Clinical Evaluation and PMS
Location/Room: Sagrada familia - 4th fl
Moderator:
Robert A. van Boxtel, MSc
– Medical Device Project B.V.
Speaker:
Sarah Panten, Dipl.-Ing.
– avasis solutions GmbH / MDKU e.V.
Speaker:
Milica Bajagic, PhD
– PRO-LIANCE GLOBAL SOLUTIONS GmbH
Speaker:
Ed Ball, Msc, CEng
– RQM+
