QbD Group
    On Demand Webinar

    Navigating Grey Zones & Growing Pains

    Developments in the Regulatory CDx Space

    Join Kirsten van Garsse (QbD Group) and Jules Petit (GenDx) as they discuss key regulatory developments and trends in the Companion Diagnostics space, exploring the grey zones and growing pains of CDx co-development between Pharma and IVD manufacturers.

    On Demand
    55 min
    Regulatory Affairs
    English

    Contents

    Chapters

    1. 00:00Introduction
    2. 07:50The CDx ecosystem & regulatory framework
    3. 12:09IVD options in clinical trials
    4. 16:04Performance study requirements
    5. 20:01Combined studies: roles & responsibilities
    6. 23:37Practical implications from an IVD manufacturer
    7. 25:03What is a companion diagnostic?
    8. 27:21Study design & planning
    9. 34:54Governance & timeline considerations
    10. 38:18Study startup & conduct
    11. 44:55Article 55 route
    12. 47:34Key takeaways
    13. 49:35Q&A
    PrecisionDx (CDx)

    Advance Your Companion Diagnostic to Market

    End-to-end companion diagnostics and precision medicine expertise, synchronizing Pharma and IVD workstreams.


    About this webinar

    The tremendous advances in the Precision Medicine field are shifting the focus of treatment towards more precise and targeted treatments that leverage intrinsic features of the immune system. As the genetic background of the patient and/or disease determines the efficacy of such therapies, there is a growing need for companion diagnostics (CDx).

    The co-development of a CDx between Pharma and IVD manufacturers comes with its own Grey Zones and Growing Pains, with differing regulations, submission processes, and different understanding of the roles and responsibilities. These challenges also offer opportunities to improve the ways of working and increase partnership effectiveness.

    What you will learn

    During this webinar, Kirsten van Garsse (QbD Group) and Jules Petit (GenDx) will discuss key elements of their joint panel discussion at the 16th World Clinical Biomarkers & Companion Diagnostics Summit Europe and dive deeper into the regulatory impact of current developments and trends in the Companion Diagnostics space.

    • Key regulatory developments shaping the CDx landscape
    • Grey zones in the co-development of CDx between Pharma and IVD manufacturers
    • How differing regulations and submission processes impact partnerships
    • Opportunities to improve collaboration and partnership effectiveness

    Interactive Q&A

    During the live webinar, we would like to answer your questions regarding the regulatory CDx space. You are invited to submit questions during registration or live during the session.

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