CER Critical Concepts: Effectively Telling the Story of the Clinical Evaluation Report

#clinicalevaluation #safteymeasures #performancemeasures #acceptancecriteria #clinicalbenefits #riskbenefit
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)
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Who is this webinar 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.
Speaker
Laurie Mitchell
Founder/President of Criterion Edge, a global regulatory writing services firm serving the medical device, pharmaceutical, and biotech industries. She has over 25 years experience in medical writing, pharmacovigilance management, and regulatory reporting. Prior to Criterion Edge, Laurie founded Mitchell Research Group, a successful site management organization, and acted as a Clinical Safety consultant for Abbott Vascular for almost a decade. Laurie brings extensive experience creating and training Data Safety Monitoring Boards and Clinical Event Committees and working with global cross-functional teams. Having worked for three of the four major medical device sponsors, she maintains expertise in many therapeutic areas. She holds a BS in Nursing and an MS as a Cardiopulmonary Clinical Nurse Specialist from UCLA.