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Preconference Workshops

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Preconference Workshops

  • Wednesday, May 10th
    08:00 – 16:00 CEST
    Be ready for EU CTR: Strategy, Systems and Lessons Learned
    Location: Saffron (1st fl)
    Workshop Leader: Carla Gomes – Thermo Fisher Clinical Research Group
    Presenter: Maria Alexandra Ribeiro – Portuguese National Ethics Committee for Clinical Research (CEIC)
    Presenter: Paolo Croce, PhD – PPD, part of Thermo Fisher Scientific
    Presenter: Eileen Smith, RA – PPD, part of Thermo Fisher Scientific
    Presenter: Rina Kacha – PPD, part of Thermo Fisher Scientific
    Preconference WorkshopPharmaceuticals
  • Wednesday, May 10th
    08:30 – 16:00 CEST
    IVDR Rollout 2023: Innovation vs Legacy: How to define a Clinical Evidence Strategy for an established analyte/marker or technology versus a novel product.
    Location: Cyan (1st fl)
    Workshop Leader: Warren Jameson, PhD – NAMSA
    Presenter: Ciara Airey – Inivata (a subsidiary of NeoGenomics)
    Presenter: Heike Moehlig-Zuttermeister – Tüv Süd
    Preconference WorkshopIVDR
  • Wednesday, May 10th
    08:30 – 16:00 CEST
    PMCF Workshop: how to collect valuable data and use it to your benefit?
    Location: Charcoal (1st floor)
    Workshop Leader: Bianca Lutters – QServe Group
    Presenter: Marius Woitok, n/a – Med-Clinical
    Presenter: Chris Webb – Purdie Pascoe
    Presenter: Martha Vakalopoulou – Purdie Pascoe
    Preconference WorkshopDevices
  • Wednesday, May 10th
    08:30 – 16:00 CEST
    Risk Management Workshop
    Location: Carmine (1st fl)
    Workshop Leader: Janet L. Michener Whipple – Validant
    Presenter: Keith Morel, Ph.D. – Qserve Group
    Presenter: Leo Hovestadt – Elekta
    Presenter: Andreas Purde, Dr – TÜV SÜD Product Service GmbH
    Presenter: Meredith Smith, MPA, PhD, FISPE – EVIDERA
    Preconference WorkshopDevices
  • Wednesday, May 10th
    08:30 – 16:00 CEST
    UDI / EUDAMED Workshop
    Location: Coral (1st fl)
    Workshop Leader: Vincent van der Meer – Medical Device Project B.V.
    Presenter: Manon Gielkens – Medtronic
    Presenter: Pilar Mestrom – Medtronic
    Preconference WorkshopDevices
  • Wednesday, May 10th
    08:30 – 16:00 CEST
    Workshop: Global Regulatory CMC Strategies and Challenges for Biologicals
    Location: Lavender (1st floor)
    Workshop Leader: Neha Parashar, PMP – argenx
    Presenter: Ankit Geete – BioNTech, Germany
    Preconference WorkshopPharmaceuticals