Gestion pharmaceutique des études cliniques de thérapie génique en France

GMO-drugs belong to the advanced therapy medicinal products category, whose manipulation, considering their intrinsic biological properties, is liable to potential risks. They are subjected to strict European and French national regulations. In France, the use of GMO-drugs requires beforehand an assessment of these potential risks and a definition, by the Haut Conseil des biotechnologies, of a suitable level containment. For the pharmacist, in clinical trials using GMO-medications, the compliance with the regulations and protocol requirements requires an adequate organization and structures. The implementation of a clinical trial with GMOs requires an upstream feasibility study, which is required to be able to anticipate all the constraints (technical, organizational and human) and any subsequent risks, in order to ensure the efficiency and safety of the pharmaceutical circuit of these therapeutic. The pharmacist's responsibility is great, and must ultimately ensure the safety of the exposed patients, the healthcare professionals and the environment.