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Xtalks, Online
2025-11-13
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.
Keywords: China, Clinical Research, Clinical Trial Regulations, Clinical Trials, Companion Diagnostics, CRO, Diagnostic Assays, Diagnostics, Drug Development, European Union, In Vitro, In Vitro Diagnostics, Medical Device Regulation, Patient Safety, Precision Medicine, Quality, Regulatory, Regulatory Affairs, Regulatory Compliance
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Organized by:
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Xtalks |
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Invited Speakers:
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Dr. Caoifa Dougan, Global Clinical Trial Monitoring Team Leader, Almac Diagnostic Services
Dr. Charlene Robb, Global IVD Regulatory Affairs Manager, Almac Diagnostic Services
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Deadline for Abstracts:
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2025-11-13
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Registration:
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Free Registration
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E-mail:
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tristan@xtalks.com
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