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How to Establish the Competitive Landscape Within the Scientific Validity Report
In this practical presentation, Criterion Edge’s Principal Medical Writer, Dr. Sarah Chavez, will present a detailed outline of the State-of-the-Art (SOA) search within the Performance Evaluation Report (PER). She will distinguish between the purpose and scope of the SOA search and the Competitor search, in terms of the SLR approach, data screening, and data presentation.

Key Takeaways:
• The importance of the State-of-the-Art in the Systematic Literature Review for providing background and general information
• How data will be used to establish acceptance criteria
• How to assess the safety and performance of your IVD with a systematic approach to the Competitor SLR process

Who should attend?
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.

Sep 15, 2021 11:00 AM in Pacific Time (US and Canada)

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