Lucas-Samuel, Sophie

Overview of the Regulatory Oversight Implemented by the French Regulatory Authorities for the Clinical Investigation of Gene Therapy and Cell Therapy Products. [electronic resource] - Advances in experimental medicine and biology 2015 - 73-85 p. digital

Publication Type: Journal Article; Review

0065-2598

10.1007/978-3-319-18618-4_4 doi


Animals
Biological Products--therapeutic use
Cell- and Tissue-Based Therapy--ethics
Clinical Trials as Topic
DNA, Recombinant--therapeutic use
Drug Approval--legislation & jurisprudence
Drug and Narcotic Control--legislation & jurisprudence
France
Genetic Therapy--ethics
Genetic Vectors--therapeutic use
Humans
Investigational New Drug Application--legislation & jurisprudence
Patient Safety--legislation & jurisprudence
Practice Guidelines as Topic
Research Design
Translational Research, Biomedical--ethics