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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
    Will the Revision of the EU general pharmaceuticals legislation deliver a world-class, future-proof medicines regulatory system for Europe? (Part 1)
    Location: Pearl 1
    Moderator & Presenter: Rebecca Lumsden, PhD – Sanofi
    Presenter: Francesca A. Day, PhD – European Medicines Agency
    Presenter: Julie Spony, MA – European Patients' Forum
    Presenter: Laetitia Szaller, MA – AM-Pharma
    Presenter: Fabio Datri, PhD – European Commission
    PharmaceuticalsDomain: Regulatory Frameworks & StrategyKnowledge Area: Regulatory Strategy Development
    Supported by 
  • Thursday, May 11th
    10:30 – 11:30 CEST
    Will the Revision of the EU general pharmaceuticals legislation deliver a world-class, future-proof medicines regulatory system for Europe?(Part 2 )
    Location: Pearl 1
    Moderator & Presenter: Rebecca Lumsden, PhD – Sanofi
    Presenter: Francesca A. Day, PhD – European Medicines Agency
    Presenter: Julie Spony, MA – European Patients' Forum
    Presenter: Fabio Datri, PhD – European Commission
    PharmaceuticalsDomain: Regulatory Frameworks & StrategyKnowledge Area: Regulatory Strategy Development
    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
  • 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