The committee for advanced therapies' of the European Medicines Agency reflection paper on management of clinical risks deriving from insertional mutagenesis
| Autor: | Giulio Cossu, Axel Stahlbom, Christian Schneider, Caroline Voltz-Girolt, Gopalan Narayanan, Maria Cristina Galli, Alessandro Aiuti, Pablo de Felipe, Matthias Renner |
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| Přispěvatelé: | Aiuti, Alessandro, Cossu, Giulio, de Felipe, Pablo, Galli Maria, Cristina, Narayanan, Gopalan, Renner, Matthia, Stahlbom, Axel, Schneider Christian, K, Voltz Girolt, Caroline |
| Jazyk: | angličtina |
| Rok vydání: | 2013 |
| Předmět: |
medicine.medical_specialty
Reflection (computer programming) Genetic Vectors Alternative medicine Cell- and Tissue-Based Therapy Bioinformatics Marketing authorization Insertional mutagenesis Mice Risk Factors Agency (sociology) medicine media_common.cataloged_instance Animals Humans European Union Transgenes European union Genetics (clinical) media_common Clinical Trials as Topic Leukemia Tissue Engineering business.industry Genetic Therapy Transplantation Mutagenesis Insertional Engineering ethics business |
| Popis: | In the European Union, the Committee for Advanced Therapies of the European Medicines Agency takes the lead in the scientific assessment for marketing authorization applications for advanced therapy medicinal products, which include gene therapy medicinal products, somatic cell therapy medicinal products, and tissue-engineered products. The Committee for Advanced Therapies also takes the lead in defining the scientific framework for the quality, nonclinical and clinical development of such products. This reflection paper represents the Committee's current thinking on management of clinical risks deriving from insertional mutagenesis. A multidisciplinary approach to insertional mutagenesis is provided. This reflection paper has been adopted by the committee in its April 2013 meeting. |
| Databáze: | OpenAIRE |
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