IVDR & WHO Requirements for Clinical Performance: With a focus on HPV studies

    🕐 9 AM CEST

    Date subject to final confirmation

    For IVD manufacturers developing HPV and STI assays, or broader infectious disease portfolios (HIV, HCV, HBV, syphilis), navigating IVDR and WHO Prequalification (PQ) requirements at the same time is a growing challenge. High assay complexity, limited in-region networks for multi-site studies, and gaps in IVDR knowledge make it hard to translate ambition into a lean, regulator-ready clinical strategy.

    This webinar walks through what it takes to meet combined IVDR and WHO requirements, using an HPV case study to ground the discussion in real-world practice. We'll cover the regulatory landscape for combined studies, then bring in an external scientific perspective through a case study on HPV diagnostics and clinical study execution in Africa, drawing on the University of Ghent's partnership with AML and its sample-access network across the region.

    Agenda

    45 minutes presentation + 10 to 15 minutes live Q&A via chat

    • The regulatory landscape — what IVDR and WHO PQ each require for combined clinical performance studies
    • Where requirements overlap and diverge — building one lean strategy instead of two parallel ones
    • HPV case study — study design and execution across multiple sites in Africa
    • Local networks and sample access — how the QbD Group and AML collaboration accelerates multi-site studies
    • Practical considerations — for IVD manufacturers targeting IVDR, WHO PQ, or both

    What You'll Learn

    • What IVDR and WHO PQ each require for combined clinical performance studies, and where the requirements overlap or diverge
    • How to build a lean, regulator-ready clinical strategy for high-complexity assays like HPV and STI panels
    • What a real-world HPV case study looks like in practice, including study design and execution across multiple sites
    • How local network and sample-access partnerships, such as the QbD Group and AML collaboration in Africa, can accelerate multi-site studies
    • Practical considerations for IVD manufacturers targeting IVDR, WHO PQ, or both

    Speakers

    An external scientific expert and a QbD Group specialist bring together deep HPV research experience with hands-on regulatory and clinical execution.

    Sara Peeters

    Senior Consultant IVD CRO, QbD Group

    Sara Peeters brings over 15 years of experience in point-of-care and IVD development, with international expertise in assay development, surface chemistry, and molecular diagnostics. She specializes in biosensors, assay optimization, and performance evaluation studies, and manages analytical and clinical performance studies across a wide range of IVD products.

    Professor Davy Vanden Broeck

    University of Ghent

    Professor Davy Vanden Broeck

    Davy Vanden Broeck is a biochemist with a professional journey in academia and healthcare industry. With a passion for advancing science, he completed a PhD in the field of Molecular Biology, followed by two consecutive post-doctoral positions focused on the HPV virology and cervical cancer development. Today, he holds the position of a professor at Ghent University, in parallel to his role at Sonic Healthcare Benelux as Molecular Biologist, demonstrating leadership in both routine diagnostics and the management of multiple clinical trials, where he plays a vital role in validating diagnostic tests and ensuring stringent quality assurance measures for accredited test laboratories. He has a publication record of over 100 peer-reviewed papers, books, and a patent.

    Who Should Attend

    This session is built for clinical, regulatory, and product teams navigating combined IVDR and WHO requirements for infectious disease diagnostics.

    • C-Level executives at IVD companies shaping strategy for HPV, STI, or infectious disease portfolios and weighing IVDR and WHO PQ market entry.
    • Heads of Clinical Affairs / Clinical Development planning combined clinical performance studies and looking to streamline execution across multiple sites.
    • Regulatory Affairs leads responsible for building IVDR and WHO PQ submission strategies for high-complexity assays.
    • Product specialists and R&D leads translating assay design choices into regulator-ready evidence for global markets.
    • IVD manufacturers developing HPV, STI, or multiplex infectious disease assays, particularly those targeting IVDR and/or WHO PQ approval for the African market.