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Ask the Writers: A Comparison of Critical Elements of the SVR versus the CER State-of-the-Art and Best Practice Writing Strategies
In this highly interactive question-and-answer session, Criterion Edge experts Laurie Mitchell, President, and Dr. Sarah Chavez, Director of IVD and Scientific Writing Services, will outline the must-have elements for two very similar regulatory reports: the State-of-the-Art section of an EU MDR-compliant Clinical Evaluation Report (CER) and the EU IVDR Scientific Validity Report (SVR).

Participants will understand the required and critical content that is common to both documents and learn best-practice writing strategies to support successful completion of these challenging projects. Come with your questions ready to get feedback from our experts!

Please submit your questions ahead of time while registering for this session so we have ample time to answer them thoughtfully. Also, please be aware that answers will be limited to 3 minutes per question.

This forum will answer questions on a first come first serve basis, so please submit all your questions when you register for this event.

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 Scientific Validity Reports for IVDR submissions. Anyone interested in learning more about the requirements for these reports is also welcome to attend.

May 18, 2022 11:00 AM in Pacific Time (US and Canada)

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Speakers

Dr. Sarah Chavez
Director, IVD and Scientific Writing Services @Criterion Edge
Dr. Sarah Chavez is the Director of IVD and Scientific Writing Services 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.​
Laurie Mitchell
President @Criterion Edge
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.