A Practical Guide: Conducting Systematic Literature Reviews in Support of IVDR Readiness

#systematicliteraturereviews #SLR #IVDR #IVD #SVR #scientificvalidityreport #clinicalperformancereport #invitrodiagnostics

With the implementation of IVDR requirements, IVD manufacturers have been challenged to align their internal processes and systems to comply with these rigorous regulations. Companies realize the need to review published literature for device-specific clinical data to establish the state of the art (scientific validity) and clinical performance of their products, however many manufacturers may not be familiar with or have the capability to perform rigorous, IVDR-compliant systematic literature reviews (SLR), screening, selection and data extraction.

In this practical presentation, Criterion Edge breaks down the steps of the SLR process and takes a wholistic approach to conducting an IVDR-compliant SLR. Using case studies, the presentation illustrates the effective use of SLR-derived data to develop the Scientific Validity Report (SVR) and the Clinical Performance Report (CPR).

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////Key Takeaways////
Review the essential steps for conducting a robust, methodologically-sound systematic literature review
Using a typical case study scenario, learn how to effectively search, identify, screen, review and extract critical published clinical data on your subject IVD device to support the development of the Scientific Validity and Clinical Performance Reports.

////Who should watch this?////
Those Regulatory, Quality and Clinical leaders and regulatory writers 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.

///Speakers///
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.

Dr. Sarah Chavez is a Principal Medical Writer 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.