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Implementing the New EU Legislation on Advanced Therapy Medicinal Products

This article was originally published in SRA

Executive Summary

The large number of people who attended the European Medicines Agency’s first workshop on advanced therapy medicinal products reflects the interest of stakeholders for this rapidly evolving field. Around 160 individuals from regulatory authorities, industry and academia attended the much anticipated meeting, which took place in London on 3 April, a month after having been postponed due to severe weather conditions. Delegates from the EMEA and representatives from the EMEA’s new Committee for Advanced Therapies presented the key implementation aspects surrounding the relevant legislation, Regulation (EC) No 1394/2007 on Advanced Therapy Medicinal Products, which has been in force since 30 December 2008.

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