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1. [Poster] The marketing authorisation of advanced therapy medicinal products under the regulation of the European Union

   … a single application to the European Medicines Agency (EMA) and its scientific assessment by the Committee for … Almost half of them benefited from expediting pathways or regulatory support schemes for (innovative) medicines to be …

2. Research and Innovation

   … or metabolic actions of the manipulated cells. An EMA-approved example is using properties of MSCs … but results from these studies provide information for regulatory agencies to determine whether the product should … advices (EMA/HTA, EMA/FDA)  . There are also early support regulatory schemes from national competent …