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CER Critical Concepts: Effectively Telling the Story of the CER - Focus on S&P Objectives, Acceptance Criteria, Clinical Benefits and Risk-Benefit Analysis
Safety and performance objectives…..clinical outcomes…..clinical benefits…..acceptance criteria…..risk-benefit ratio. These terms represent key foundational concepts of the Clinical Evaluation Report (CER), yet confusion still exists on how to effectively identify, present and analyze these parameters within the context of an MDR-compliant CER. How do they tie together? How do they help you “tell the story” of the CER?

Presented from the point of view of seasoned MDR-compliant CER medical writers, this session will take a practical approach to:

• Define each of these concepts and their relationship to each other
• Develop MDR-aligned safety and performance objectives
• How clinical outcomes are leveraged in the CER and how they are different from S&P objectives
• Tying it all together in the Risk-Benefit section of the CER (hint: this section is where it all comes together)

There will be time at the end of this session to ask questions. Please submit your questions ahead of time while registering for this session so we have ample time to answer them thoughtfully. You may choose to send in your questions during the presentation as well.

Who is this forum for?
Those Regulatory, Quality and Clinical leaders and teams who are tasked with the development, writing, review, or approval of clinical evaluation reports for MDR submissions, or anyone interested in learning more about MDR requirements for CERs. We encourage professionals from the IVD industry to attend as well, as the content is also relevant to IVDR requirements, which align closely with MDR.

Sep 28, 2022 11:00 AM in Pacific Time (US and Canada)

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Webinar is over, you cannot register now. If you have any questions, please contact Webinar host: Olivia Miele.