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Preconference Workshops

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Preconference Workshops

All Preconference workshops require a separate registration fee and are not included in main conference pricing. Learn more:  https://www.raps.org/europe-2023/register

Preconference Workshops

  • Thursday, May 11th
    09:00 – 10:00 CEST
    IVDR Transition: Quo Vadis? – the current reality
    Location: Carmine & Charcoal
    Moderator & Presenter: Andreas Stange – TUV SUD JAPAN LTD
    Moderator & Presenter: Erica Conway, PhD – MCRA
    Presenter: Tom Patten – NSAI
    Presenter: Niels Bojunga, Dr – Molecular Health GmbH
    Presenter: Kees Maquelin – Abbott Diabetes Care
    Presenter: Leo WJ Klomp – Health and Youth Care Inspectorate (IGJ), Ministry of Health
    IVDDomain: Product Development & RegistrationKnowledge Area: Submission Management
    Supported by 
  • Thursday, May 11th
    11:45 – 12:45 CEST
    Recent developments in UK regulations for IVDs: implications for EU manufacturers.
    Location: Pearl 3
    Moderator: Alex Laan, Dipl.-Ing. – BSI
    Presenter: Philippe M. Auclair, Mr – Abbott
    Presenter: Christèle East, PhD – Namsa
    IVDDomain: Scientific & Health ConceptsKnowledge Area: General
    Supported By
  • Thursday, May 11th
    13:45 – 14:45 CEST
    CDx or Not CDx, That is The Question - The Impact of the Clinical Trial Regulation on Tests Used in Pharma Studies and Whether and How the IVDR Applies
    Location: Pearl 3
    Moderator & Presenter: Sue Spencer – Qserve group
    Presenter: Ed Godber, n/a – Guardant Health
    Presenter: Patrick Fivey – AstraZeneca
    IVDDomain: Regulatory Frameworks & StrategyKnowledge Area: Regulatory Strategy Development
    Supported By
  • Thursday, May 11th
    15:00 – 16:00 CEST
    IVDR – what are the implications for in-house in vitro devices for stakeholders and practical steps for implementation
    Location: Carmine & Charcoal
    Moderator & Presenter: Elisabeth Dequeker, n/a – Prof
    Presenter: Tiina Riihimäki, PhD – Pharmalex Nordics
    IVDDomain: Regulatory Frameworks & StrategyKnowledge Area: General
    Supported By
  • Thursday, May 11th
    16:45 – 17:45 CEST
    Conformity Assessment of Class D Devices: What is the Current Status?
    Location: Pearl 2
    Moderator: Maurizio Suppo, Dr. – Qarad
    Presenter: Marta Carnielli, PharmD – TUV Sud GmbH
    Presenter: Catherine Holzmann – GMED Certification Division
    Presenter: Olga TKACHENKO, PhD – European Commission DG for Health and Food Safety Medical Devices Unit SANTE B.6
    Presenter: Elisabeth PhD Dequeker, PhD – University of Leuven
    Presenter: Richard J. Saunders, FIBMS – QuidelOrtho
    Presenter: Stefan Scheib, PhD – Roche Diagnostics GmbH
    Presenter: Heinrich Scheiblauer, Dr – Paul-Ehrlich-Institut
    IVDDomain: Product Development & RegistrationKnowledge Area: Process & Procedures
    Supported By
  • Friday, May 12th
    10:45 – 11:45 CEST
    Meeting the EU IVDR PMS and PMPF provisions – setting up an effective PMS/PMPF and reporting system
    Location: Carmine & Charcoal
    Moderator: Alex Laan, Dipl.-Ing. – BSI
    Presenter: Kristiane Schmidt, PhD – Qserve Group
    Presenter: Mohamed-Salah GAROUACHI, PhD, PharmD – Constency Healthcare
    Presenter: Marta Carnielli, PharmD – TUV Sud GmbH
    IVDDomain: Post Approval/Post MarketKnowledge Area: General
    Supported By
  • Friday, May 12th
    12:00 – 13:00 CEST
    Research Use Only (RUO): What does this mean for legacy devices and product development of new in vitro diagnostics under the IVDR?
    Location: Pearl 1
    Moderator & Presenter: Ashleigh C. Dawley, RAC – Integrated DNA Technologies, Inc., a Danaher Company
    Presenter: Melissa Finocchio – SOPHiA GENETICS
    Presenter: Alex Laan, Dipl.-Ing. – BSI
    IVDDomain: Regulatory Frameworks & StrategyKnowledge Area: Regulatory Strategy Development
    Supported By
  • Friday, May 12th
    14:00 – 15:00 CEST
    Software and Cybersecurity Specific Requirements - Challenges for Regulatory Compliance and Testing Approaches
    Location: Carmine & Charcoal
    Moderator & Presenter: Alexander Stock, PhD – TÜV SÜD Product Service GmbH
    IVDDomain: Product Development & RegistrationKnowledge Area: Data Management & Analysis
    Supported By
  • Friday, May 12th
    15:30 – 16:30 CEST
    MDCG22-14 Panel: Will IVDR Implementation Benefit From MDCG 2022-14 and if so, How ?
    Location: Pearl 2
    Moderator: Sabina L. Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD Medical Health Service
    Moderator: Anja Wiersma, PhD – mi-CE consultancy
    Presenter: Andreas Stange – TUV SUD JAPAN LTD
    Presenter: Marta Carnielli, PharmD – TUV Sud GmbH
    Presenter: Elizabeth Harrison, PhD – BSI Group
    Presenter: Liz Gommans, PhD – DEKRA Certification B.V.
    Presenter: Tom Patten – NSAI
    IVDDomain: Regulatory Frameworks & StrategyKnowledge Area: Process & Procedures
    Supported By