IVD Study Steps for Success: Safety and Quality of Global IVD Clinical Performance Studies, Upcoming Webinar Hosted by Xtalks

In this free webinar, gain insight into global IVD clinical performance study monitoring. Attendees will learn the common findings raised by global regulators and the impact on IVD clinical performance studies and clinical trials. The featured speakers will discuss the importance of alignment with quality and safety requirements in global IVD clinical performance studies, and how this can be operationalized in practice. The speakers will also share practical strategies for supporting global IVD clinical performance studies.

TORONTO, Oct. 28, 2025 /PRNewswire/ -- In the field of precision medicine, in vitro diagnostic devices (IVDs), such as companion diagnostics (CDx) and clinical trial assays (CTA), are vital for biomarker-driven subject eligibility, enabling targeted treatment of malignancies and chronic diseases.

Global IVD clinical performance studies facilitate the use of CDx and CTAs in precision medicine to be accurate and reliable, as they enable data collection from diverse patient populations simultaneously. However, the regulatory and ethical requirements for global IVD clinical performance studies are constantly changing, with each country requiring different criteria to be met.

Therefore, the quality management system, which supports the IVD clinical performance study, may need to comply with multiple standards including the International Council for Harmonisation – Good Clinical Practice (ICH GCP), Good Clinical Laboratory Practice (GCLP), In Vitro Diagnostic Regulation (IVDR), Investigational Device Exemption (IDE), International Organization for Standardization (ISO) 20916 and Human Genetic Resources Administration of China (HGRAC). Furthermore, because regulatory authorities may evaluate the IVD clinical performance study data only at the time of marketing submission, it is important to maintain strong quality systems and conduct regular audits to ensure successful marketing approvals and protect the interests of the pharmaceutical or diagnostic sponsor.

This webinar explores the 'Steps for Success' in implementing global IVD clinical performance studies. The featured speakers will discuss common findings raised by international regulators in IVD clinical performance studies, and the steps needed to ensure the quality, safety and success of these studies.

Register for this webinar to learn how global IVD studies can meet regulatory expectations while maintaining safety and data integrity.

Join experts from Almac Diagnostic Services, Dr. Caoifa Dougan, Global Clinical Trial Monitoring Team Leader; and Dr. Charlene Robb, Global IVD Regulatory Affairs Manager, for the live webinar on Thursday, November 13, 2025, at 11am EST (5pm CET/EU-Central).

For more information, or to register for this event, visit IVD Study Steps for Success: Safety and Quality of Global IVD Clinical Performance Studies.

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