#IVD #regulatorywriting #invitrodiagnostics #AAMIFDABSI #clinicaldata #IVDR
What is this webinar about?
The In Vitro Diagnostics Regulation (IVDR) took effect in May 2022 and has introduced substantial changes in the regulatory framework for in vitro diagnostic medical devices (IVDs) in Europe. IVD manufacturers are expected to meet more rigorous standards for clinical evidence, with up to 80% of IVDs requiring Notified Body certificates under IVDR.
In October 2022, the AAMI/FDA/BSI Annual Conference sought to discuss current knowledge and practical strategies to meet these new clinical evidence requirements. Dr. Sarah Chavez, Criterion Edge Director of IVD Writing Services, was honored to be an invited speaker and join with other regulatory, notified body and industry leaders as panelists at the pre-conference workshop “New Requirements for In Vitro Diagnostics”.
Attendees to this Criterion Edge webinar will benefit from key insider insights gleaned from this meeting, as Sarah shares and discusses the key take-aways from the Symposium, including clinical evidence requirements and strategies to keep your report writing and data collection on track. Most companies are in the early stages of planning for IVDR, so the goal of this webinar is to provide helpful suggestions for IVDR planning and preparation from the perspective of experienced regulatory writers.
Have more questions? Reach out to us at info@criterionedge.com.
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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 IVDR submissions.
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.