Ask the Expert: Clinical Data for IVD - What Is It and How Do I Find It? скачать в хорошем качестве

Ask the Expert: Clinical Data for IVD - What Is It and How Do I Find It?

#clinicaldata #ClinicalPerformanceReport #datacollection #IVDR #InVitroDiagnostics This session's topic: Clinical Data for In Vitro Diagnostics Companies This webinar answers questions regarding sources of data, data sufficiency, sample size, demonstrating clinical performance, conducting clinical studies, effective data presentation in your Performance Evaluation Report, IVDR data requirements, and more. Have more questions? Reach out to us at info@criterionedge.com. Want to be notified of future webinar postings? https://go.criterionedge.com/webinar_... ///Who should watch/// Those Regulatory, Quality and Clinical leaders and teams who are tasked with the development, writing, review or approval of Performance Evaluation Reports for EU IVDR submissions, or anyone interested in learning more about IVDR data requirements. ///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 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.