CLSI EP49 Webinar
Bridging Analytical and Clinical Performance through CLSI EP49’s Framework for Demonstrating Clinical Validity Webinar
As expectations for clinical validity continue to rise, IVD manufacturers and laboratories need a practical way to show that a test method performs as intended in real-world clinical use. This webinar on CLSI EP49 offers a clear framework for strengthening clinical validity strategies, supporting confident decision-making, and preparing for global regulatory and market expectations, including those within the European Union In Vitro Diagnostic Regulation (EU-IVDR) environment.
Led by members of the CLSI EP49 document development committee, this session translates the guideline into practical, actionable guidance for planning, evaluating, and documenting clinical validation. Attendees will learn how clinical validation is defined, what to consider when assessing clinical performance, and how to develop clinical performance study reports that support internal, customer, and regulatory needs. The session will conclude with a panel discussion that features the expertise of Dr. Christa Cobbaert, Chair of the Committee on European Regulatory Affairs for the European Federation in Laboratory Medicine (EFLM).
The webinar also covers post-launch monitoring, helping organizations maintain quality, support ongoing compliance, and stay market ready as expectations continue to evolve.
This webinar is especially valuable for:
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IVD manufacturers building or updating test methods for global markets, including the EU-IVDR environment.
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Clinical laboratories developing or validating LDTs.
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Teams developing clinical performance studies and evidence generation.
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Organizations preparing for regulatory review, internal governance, or market expansion.
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Professionals seeking alignment with internationally recognized best practices for clinical validity and performance evaluation.
Date: Wednesday, 9 September 2026 from 11:00 AM EDT - 12:00 PM EDT
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Free
{{FormatPrice(nonMemberPrice)}} List PriceLearning Objectives
- Explain the core elements of a framework for establishing evidence of the clinical validity of medical laboratory test methods.
- Review considerations for designing study protocols for the evaluation of clinical validity.
- Apply a framework using practical examples from the medical laboratory and industry perspectives.
Intermediate: Refresher course. Some basic knowledge required; for staff technologists with some years of experience.
CLSI is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program.
Learning Objectives
- Explain the core elements of a framework for establishing evidence of the clinical validity of medical laboratory test methods.
- Review considerations for designing study protocols for the evaluation of clinical validity.
- Apply a framework using practical examples from the medical laboratory and industry perspectives.
Intermediate: Refresher course. Some basic knowledge required; for staff technologists with some years of experience.
CLSI is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program.