How to Establish the Competitive Landscape Within the Scientific Validity Report

#PerformanceEvaluationReport #ScientificValidity #StateoftheArt #SafetyandPerformance #AcceptanceCriteria #ClinicalData

This session will review the scope and purpose of the Scientific Validity Report (SVR), particularly how the SVR establishes the competitive landscape and acceptance criteria within the state-of-the-art.

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Key Takeaways
• Why the SVR must include a clear discussion of “state-of-the-art” (SOA)
• Where to identify relevant performance objectives for your IVD
• What data can and should be included in the competitive landscape
• When to include detailed screening and appraisals of the articles identified
• How to present the data to determine the acceptable range

Who should watch?
Those Regulatory, Quality and Clinical leaders and regulatory writers who are tasked with the development, writing, review or approval of Scientific Validity Reports for EU IVDR submission, or anyone interested in learning more about the competitive landscape within the SVR.

Speaker
Dr. Sarah Chavez, PhD

Dr. Sarah Chavez is the Director of IVD and Scientific Writing
Services with Criterion Edge. Sarah has a BS in Biochemistry and a
PhD in Molecular and Cellular Biology, with 25 years of laboratory
bench experience and has taught at the University level for the past
15 years.

She has extensive scientific writing experience in an academic
environment, as well as for several large textbook publishers.
Sarah’s strong background in basic research and her extensive
experience with regulatory writing will allow her to assist companies
with IVDR readiness as part of the Criterion Edge team.