In this webinar, experts from Cardinal Health Regulatory Sciences discuss CMC challenges and potential mitigation strategies illustrated through .. Read more multiple case studies. Cell and gene therapy developers, research scientists, regulatory and legal professionals are all encouraged to attend. Chemistry, manufacturing, and controls (CMC) is an integral aspect of cell and gene therapy development. Cell and gene therapy development presents unique CMC challenges because of inherent properties such as shorter shelf life, variability in starting and ancillary materials, manufacturing and logistical complexities, and cost. FDA cell and gene therapy information requests often contain more CMC related inquiries than traditional products. In her current role at Cardinal Health Regulatory Sciences, she focuses on providing CMC regulatory consulting and strategy in the cell and gene therapy area. Her role includes helping clients in FDA meeting preparation (INTERACT, pre-IND), authoring Module 3 quality sections, preparation of information request (IR) responses and authoring of biologics master files.
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