Method Evaluation

CLSI EP43 Webinar

Implementing a Laboratory Test Under Emergency Use Conditions

Tune in to this on-demand webinar to learn about: 

  • Best practices for implementation based on EP19?A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures.
  • Understand the use of Emergency Use Authorization (EUA) during a Public Health Emergency (PHE) and non-US equivalents.
  • Show examples from both Ebola and COVID-19 (SARS-CoV-2).
     
October 19, 2021

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Scope

Learning Objectives

At the conclusion of this on-demand webinar, the learner will: 

  • Describe the use of Emergency Use Authorization (EUA) during a Public Health Emergency (PHE).
  • Explain the ways the Test Life Phases Model (CLSI EP19) can be applied to implementing an assay granted EUA.
  • Discuss how implementation of an EUA may differ from implementation of a cleared/approved test.
  • Identify some of the unique challenges in implementation of an EUA.

 

Speakers
Marcia L. Zucker, PhD, FAACC, Co-chairholder of EP43
Scope

Learning Objectives

At the conclusion of this on-demand webinar, the learner will: 

  • Describe the use of Emergency Use Authorization (EUA) during a Public Health Emergency (PHE).
  • Explain the ways the Test Life Phases Model (CLSI EP19) can be applied to implementing an assay granted EUA.
  • Discuss how implementation of an EUA may differ from implementation of a cleared/approved test.
  • Identify some of the unique challenges in implementation of an EUA.

 

Speakers
Marcia L. Zucker, PhD, FAACC, Co-chairholder of EP43