#StateOfTheArt # SOA #ScientificValidityReport #SVR #PerformanceEvaluationReport #PER
In this practical presentation, Criterion Edge’s Principal Medical Writer, Dr. Sarah Chavez, will present focused strategies on building an IVDR-aligned State-of-the-Art (SOA) section within the Scientific Validity Report (SVR). She will also talk about the critical role of the SVR as it relates to the overall performance evaluation process. In addition, you will learn how to assess your SVR project for unanticipated roadblocks and delays, and how indecision or incomplete supporting documents can negatively impact SOA (and therefore, SVR) quality and timelines.
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Key Takeaways:
(1) The foundational role of the SOA in the SVR
(2) The required components of the SOA such as the safety and performance objectives
(3) The importance of a robust systematic literature review (SLR) to support your SOA
Who Should Watch?
Those Regulatory, Quality and Clinical leaders, regulatory writers, and teams who are tasked with the development, writing, review or approval of Performance Evaluation Reports for EU IVDR submission, or anyone interested in learning more about IVDR requirements for PERs.
Speaker
Dr. Sarah Chavez
Principal Medical Writer with Criterion Edge with a BS in Biochemistry and a PhD in Molecular and Cellular Biology. Sarah has 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.
Негізгі бет How to Establish the State-of-the-Art Within the Scientific Validity Report
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