QbD Group
    Podcast

    IVDs in Clinical Trials: The Sponsor's Survival Guide

    Listen to our podcast episode where our colleagues Kirsten and Annelies sit down together to explore what really happens when the worlds of In Vitro Diagnostics and Pharma collide.

    December 2, 20251 min read

    Speakers

    Host

    Kirsten Van Garsse

    Guest

    Annelies Rotthier

    The Sponsor's Survival Guide

    This podcast episode focuses on the challenges IVD sponsors face, particularly around collaboration in combined studies, and shares practical insights to help navigate these complex projects.

    What you'll learn

    • The key challenges IVD sponsors face in clinical trials
    • How to navigate collaboration in combined studies
    • Practical insights for managing complex IVD projects
    • Understanding IVDR requirements for clinical performance studies

    About the Author

    Kirsten Van Garsse
    Kirsten Van Garsse

    MSc Biomedical Sciences · Director Authorised Representative Services & Manager IVD – Regulatory Affairs

    With over 20 years of experience in the diagnostics industry, Kirsten leads the IVD Regulatory Affairs business unit at QbD Group, guiding regulatory strategy and compliance across all IVDs with a focus on companion diagnostics.

    About the Author

    Annelies Rotthier
    Annelies Rotthier

    Expert in IVD clinical trials and regulatory compliance.

    QbD Group

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