#PER #performanceevaluation #regulatoryaffairs #regulatorywriting #IVD #invitrodiagnostics #CER #clinicalevaluationreport #clinicalwriting #IVDR #ivdrcompliance
What is this webinar about?
With the implementation of IVDR requirements, IVD manufacturers have been challenged to align their internal processes and systems to comply with these rigorous regulations. In this practical presentation, Criterion Edge uncovers what we have learned from our experience in writing MDR-compliant CERs, and how urgently applicable some of these key learnings are in preparing a robust Performance Evaluation Report (PER).
This presentation provides practical tips on how to assess for hidden traps and unexpected roadblocks that could impact the success of writing an IVDR-compliant PER. By performing a gap analysis and assessing the readiness and availability of critical resources, documents and expertise, you will be able to avoid project delays and discover efficiencies that will enable the on-time completion of a successful, IVDR-compliant PER.
Learning Objectives:
- The importance of scoping your PER project in advance
- The critical inputs needed to enable the success of your PER and the impact to the project if these inputs are not available or incomplete
- How to identify those hidden gaps in resources and information and the steps to take to mitigate them
What is this Webinar About?
Those Regulatory, Quality and Clinical leaders and teams who are tasked with the development, writing, review or approval of performance evaluation reports for IVDR submissions.
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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.
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.