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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
    10:30 – 11:30 CEST
    IMDRF- latest developments and future perspectives
    Location: Carmine & Charcoal
    Moderator & Presenter: Philippe M. Auclair, Mr – Abbott
    IVDRDomain: Regulatory Frameworks & StrategyKnowledge Area: General
    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
    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
    Expert Advisory Panel - What Have we Learned?
    Location: Pearl 1
    Presenter: Richard Holborow – BSI
    Presenter: Silvy Da Rocha Dias – European Medicines Agency
    Presenter: Rohan Shah, BS – BD
    Medical DevicesDomain: Product Development & RegistrationKnowledge Area: General
    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
    14:00 – 15:00 CEST
    Due Diligence: Critical Importance of Regulatory & Quality to Support Company or Product Acquisitions
    Location: Pearl 3
    Moderator & Presenter: Susana de Azevedo Wäsch – Ypsomed
    Presenter: Patrik J. Spirig, MA – Konapharma
    Regulatory BusinessDomain: Business AcumenKnowledge Area: General
    Supported By