CLSI EP49 Webinar
Bridging Analytical and Clinical Performance through CLSI EP49’s Framework for Demonstrating Clinical Validity Webinar
Members of the document development team will highlight key concepts from the guideline, including how clinical validation is defined and the factors that should be considered when evaluating a test method’s clinical performance. The session will also cover the development of clinical performance study reports and best practices for monitoring clinical validity post-launch. A panel discussion will follow.
This content is relevant for developers (both manufacturers and laboratories that create laboratory-developed tests) evaluating the clinical performance of quantitative, semi-quantitative, and qualitative test methods.
This webinar is intended for:
- IVD manufacturers developing or updating test methods
- Clinical laboratories developing establishing or validating LDTs
- Teams responsible for clinical performance studies and evidence generation
- Organizations preparing for regulatory review or internal governance
- Professionals seeking alignment with internationally recognized best practices
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.