Maria Amaya

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Lead External Advocacy North America (Quality Policy)

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Post-approval Change Management for Cell and Gene Therapy Products
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Post-Approval Change Management for Cell and Gene Therapy Products

Cell and gene therapy (C&GT) products represent a significant step forward in patient treatment and often offer unique patient benefits. However, product developers face significant hurdles within the regulatory landscape. The tools laid out in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q12 guideline: “Technical and...