Siguiendo el éxito del realizado en Bruselas tenemos una nueva edición de este evento de RAPS en Barcelona
PROGRAMA
23 Octubre 2024
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8:30 AM – 10:00 AMOpening Plenary Session: Evolving Regulatory Frameworks: Access to Innovation and Patient SafetyLocation/Room: Sagrada familia – 4th flModerator: Jennifer Neff, PhD – Entourage GmbHModerator: Robert A. van Boxtel, MSc – Medical Device Project B.V.Panelist: Donal O’Connor, MD FEBS – HPRAPanelist: Carmen Ruiz-Villar – Spanish Agency for Medicines and Medical Devices (AEMPS), SpainPanelist: Jana Russo, MA – MedTech EuropePanelist: Per Kjaersgaard-AndersenPanelist: Alberto Ganan, PhD – European Medicines Agency
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10:00 AM – 10:30 AM Coffee Break & Exhibition
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10:30 AM – 11:30 AM Challenges and Opportunities in In-Vitro Diagnostic Risk ManagementLocation/Room: Sants – 3rd flSpeaker: Janet L. Michener Whipple – ELIQUENT Life Sciences
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10:30 AM – 11:30 AM How to Tame Your Benefit Risk EvaluationLocation/Room: Sagrada familia – 4th flSpeaker: Björn-Carsten Schüre, MA – Metecon GmbHSpeaker: Grit Kasper, PhD – Metecon GmbHSpeaker: Elke Bess, Dr. – TÜV Rheinland
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11:45 AM – 12:45 PM The Interface of the EU AI Act and the MDR/IVDRLocation/Room: Sagrada familia – 4th flSpeaker: Leon Doorn, M.Sc. – MedQAIRSpeaker: Irina Idler, Dr. rer.nat. – Entourage
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12:45 PM – 1:45 PM Lunch & Exhibition
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1:45 PM – 2:45 PM Clinical Evaluation of High-Risk Implantable; Current State of Play, Including PediatricLocation/Room: Sagrada familia – 4th flPresenter: Donal O’Connor, MD FEBS – HPRAPresenter: Per Kjaersgaard-AndersenPresenter: Alberto Ganan, PhD – European Medicines Agency
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1:45 PM – 2:45 PM How to Conduct CDx Clinical Performance Studies in Compliance with IVDR 2017/746Location/Room: Sants – 3rd flSpeaker: Piritta Maunu, MSc – Pharmalex Finland Oy
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3:00 PM – 4:00 PM How to Effectively Collect Level 4 Clinical Data With High Quality PMCF SurveysLocation/Room: Sagrada familia – 4th flSpeaker: Chris Webb – Purdie PascoeSpeaker: Marcus Torr, MSci – Purdie PascoeSpeaker: Gavin Quigley, MBChB FRCS MBA – BSI
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3:00 PM – 4:00 Strategies for Co-Development of Companion Diagnostics and Medicines in the IVDR EraLocation/Room: Sants – 3rd flPresenter: Pieter Bogaert, n/a – Qarad (part of QbD Group)Presenter: Rolf Thermann, PhD – TUV Rhineland LGA Products GmbH
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4:00 PM – 4:30 PM Coffee Break & exhibition
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4:30 PM – 5:30 PM What are Common Pitfalls in Clinical Evaluation and Performance Evaluation – An Analysis of the Feedback from Different Notified BodiesLocation/Room: Sagrada familia – 4th flSpeaker: Matthias Fink, MD – Akra Team Inc.Speaker: Marta Carnielli, PharmD – TUV Sud GmbHSpeaker: Susan Partridge, PhD – BSISpeaker: Ana Chiva, PhD – BSI
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5:30 PM – 6:30 PM Networking Reception
24 Octubre 2024
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9:00 AM – 10:00 AM A Practical Approach to State of the Art for Legacy IVDsLocation/Room: Sants – 3rd flSpeaker: Maurizio Suppo, Dr. – QaradSpeaker: Goran Abdurrahman, PhD – TÜV Rheinland
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9:00 AM – 10:00 AM Hands-on Strategies for a Successful Clinical Evaluation under the EU MDRLocation/Room: Sagrada familia – 4th flPresenter: Matthias Fink, MD – Akra Team Inc.Speaker: Susan Partridge, PhD – BSISpeaker: Breda Kearney, MSc – BSI
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10:00 AM – 10:30 AM Coffee Break & Exhibition
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10:30 AM – 11:30 AM Clinical Evidence IVDR – Flexible Concepts to Satisfy NB ExpectationsLocation/Room: Sants – 3rd flSpeaker: Sven Hoffmann, MSc – Entourage GmbHSpeaker: Heike Moehlig-Zuttermeister, PhD – Tüv Süd
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10:30 AM – 11:30 AM The Chicken or the Egg? Reuniting SOTA and CEPLocation/Room: Sagrada familia – 4th flSpeaker: Julia Rohrberg, PhD – PRO-LIANCE GLOBAL SOLUTIONS GmbHSpeaker: Milica Bajagic, PhD – PRO-LIANCE GLOBAL SOLUTIONS GmbHSpeaker: Simon Lidgate, PhD – BSI
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11:45 AM – 12:45 PM Post-Market Surveillance under MDR and IVDR: Practical Insights Where Efficiency Meets ComplianceLocation/Room: Sagrada familia – 4th flSpeaker: Keith Morel, PhD – Qserve GroupSpeaker: Sven Hoffmann, MSc – Entourage GmbH
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12:45 PM – 1:45 PM Lunch & Exhibition
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1:45 PM – 2:45 PM Post-Market Surveillance, Protecting Patient SafetyLocation/Room: Sagrada familia – 4th flSpeaker: Marta AlonsoSpeaker: Carmen Ruiz-Villar – Spanish Agency for Medicines and Medical Devices (AEMPS), Spain
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2:45 PM – 3:15 PM Coffee Break & Exhibition
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3:15 PM – 4:15 PM Closing Plenary: The Holy Trinity of the MDR – Risk management, Clinical Evaluation and PMSLocation/Room: Sagrada familia – 4th flModerator: 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 GmbHSpeaker: Ed Ball, Msc, CEng – RQM+
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nos vemos allí ….