Regulation of Advanced Therapy Medicinal Products in Europe, from Clinic to Approval

?Advanced Therapy Medicinal Products?, first defined in EU Directive 2003/63/EC, cover gene, somatic cell and human tissue-engineered products. In response to scientific progress a regulatory basis has been developed in the EU, including, for the first time, tissue-engineered products. A dedicated review group, the Committee for Advanced Therapies (CAT) has been instituted at the European Medicines Agency (EMEA) to deal specifically with this class of product. This course will address the regulation of ?Advanced Therapy Medicinal Products? in the EU and provide practical advice relating to
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?Advanced Therapy Medicinal Products?, first defined in EU Directive 2003/63/EC, cover gene, somatic cell and human tissue-engineered products. In response to scientific progress a regulatory basis has been developed in the EU, including, for the first time, tissue-engineered products. A dedicated review group, the Committee for Advanced Therapies (CAT) has been instituted at the European Medicines Agency (EMEA) to deal specifically with this class of product. This course will address the regulation of ?Advanced Therapy Medicinal Products? in the EU and provide practical advice relating to the CMC, preclinical and clinical development of these products from the European perspective. The opportunities in the European regulatory environment and future trends will also be discussed. For those not familiar with the topic in Europe this will provide a sound overview. For those already working in the field this session would bring the individuals right up to date with recent developments.