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Meeting on the Med 2021 | Challenges with ATMP clinical trials in Europe

Ana Hidalgo-Simon, MD, PhD, European Medicines Agency, Amsterdam, Netherlands, discusses some of the key challenges associated with clinical trials for advanced therapies in Europe, including current genetically modified organisms (GMO) legislation for gene therapies, issues with heterogenicity, as well as communication difficulties across European Union member states. Dr Hidalgo-Simon highlights the importance of improving international harmonization and collaboration between developers, regulators and patients in order to speed up the clinical trial process and subsequent approval of advanced therapies in Europe. This interview took place during the Cell & Gene Meeting on the Mediterranean 2021 virtual conference.