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@RAPSorg «RAPS European Clinical, Risk, and Postmarket Surveillance Conference» 23-24 Octubre 2024 Barcelona – HABLEMOS EN NUESTRO STAND

por | 19-10-2024 | Boletin, Congresos

Siguiendo el éxito del realizado en Bruselas tenemos una nueva edición de este evento de RAPS en Barcelona

PROGRAMA

23 Octubre 2024

  • 8:30 AM – 10:00 AMOpening 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 Coffee Break & Exhibition
  • 10:30 AM – 11:30 AM 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 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 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 Lunch & Exhibition
  • 1:45 PM – 2:45 PM 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 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 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  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 Coffee Break & exhibition
  • 4:30 PM – 5:30 PM 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 Networking Reception

24 Octubre 2024

  • 9:00 AM – 10:00 AM 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 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 Coffee Break & Exhibition
  • 10:30 AM – 11:30 AM 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 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 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 Lunch & Exhibition
  • 1:45 PM – 2:45 PM 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 Coffee Break & Exhibition
  • 3:15 PM – 4:15 PM 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+

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