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Margot J. Borgel, PhD

Diagnostic Regulatory Strategy Lead
Astellas, South Carolina

Margot Borgel is an expert in the technical and regulatory requirements of in vitro diagnostics (IVDs) with 15 years of experience in both the US and EU markets. Her current role involves diagnostic regulatory support for precision medicine projects, and she previously worked as a regulatory and clinical consultant as well as within a Botified Body. Margot holds a BSc and Ph.D. in Chemistry A strategic thinker and collaborator, she has an extensive scientific background in assay development, IVD manufacturing, process improvement, regulatory requirements, and quality management systems. She is a subject matter expert for performance evaluation and clinical requirements, international standards, and guidance documents for IVDs.

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