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Ask the Expert: The Role of RA in the Clinical and Performance Evaluation Report Process



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#PER #IVDR #MDR #CER #clinicalevaluation #stateoftheart #regulatoryaffairs #scientificvalidity #clinicaldata

This session's topic: The Role of Regulatory Affairs in the Clinical and Performance Evaluation Report Process

This webinar answers questions regarding (1) how Regulatory Affairs can lead critical decision-making throughout the planning, preparation and writing of the Clinical Evaluation Report (CER), (2) the critical components of the CER process that influence project success, and (3) how to overcome roadblocks and drive to on-time submission.

Have more questions? Reach out to us at [email protected].

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///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.
Category
Health
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