Ask the Expert: Understanding Clinical Data Sufficiency and Limited Clinical and Performance Data



Published
#clinicalevaluation #clinicaldata #cer #gspr #mdr

This session's topic: Understanding Clinical Data Sufficiency and Strategies to Address Limited Clinical and Performance Data

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.

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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 Clinical Evaluation Reports for EU MDR submissions, or anyone interested in learning more about MDR data requirements.

Speakers
Sarah Chavez, PhD

Dr. Sarah Chavez has worked on medical and regulatory writing for three years and has a BS in Biochemistry and a PhD in Molecular and Cellular Biology, with 25 years of laboratory bench experience. She has a strong understanding of a wide range of laboratory techniques, and has taught Genetics, General Biology, Cancer Immunology, and Global Health at the University level for the past 15 years. Prior to joining Criterion Edge, Sarah had extensive scientific writing experience in an academic environment, having written many large institutional research grants, regulatory documents, clinical trials protocols, book chapters, and manuscripts, as well as textbook chapters and educational materials 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.


Stacie Beecham

Stacie Beecham is a Principal Medical Writer with Criterion Edge. Stacie has a BS in Biology and a MS in Human Physiology, with extensive experience in regulatory writing and 10 years of experience in international regulatory affairs. Stacie was a medical researcher prior to entering the regulatory space, where she worked with physicians, scientists, and hospital pharmacists at Mayo Clinic in Minnesota. Stacie's expertise in regulatory affairs, submission writing, clinical research, and regulatory consulting for medical device, biopharma, and biotech makes her a valuable asset to the Criterion Edge team.
Category
Health
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