Updating the European guidance on genetically modified cells. Exploring how novel scientific and regulatory approaches might be used to make advanced therapy medicinal products (ATMPs) more readily available to patients. Reflecting on the current practice of defining the benefit-risk balance of ATMPs and whether too much emphasis is placed on risks and not enough on expected but realistic benefits.
These are some of the objectives in the 2017 work plan of the European Medicines Agency’s Committee for...
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