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Le Pharmacien Responsable : quelles obligations pour maintenir un haut niveau de qualité et de sécurité en France ?
Mémoire de Master / Thèse d'exercice   Open Access

Le Pharmacien Responsable : quelles obligations pour maintenir un haut niveau de qualité et de sécurité en France ?

Yann Guerre-Chaley
Masters , Université de Montpellier
10/01/2024

Résumé

Réglementation Produit de santé Pharmaciens responsables Médicaments -- Droit européen Soins médicaux -- Qualité -- Contrôle Pharmaciens Législation pharmaceutique Sécurité des patients Industrie pharmaceutique Contrôle de qualité
The healthcare sector is constantly expanding, and the pharmaceutical industry even more so. Following the health disasters and political scandals of the 20th century, it became clear that legible and comprehensive regulations were needed to ensure the quality of health products, their safety for patients and public health, and the effectiveness of the therapies on offer. Pharmaceutical regulations, first national and then community (European) rapidly introduced the concept of the qualified person: far from being the only person in charge of operations within the laboratory, the Responsible Pharmacist remains a French exception. In this thesis, we seek to highlight the role of the Responsible Pharmacist, as well as all the obligations incumbent upon this position. As the pinnacle of pharmaceutical activities, we discuss how this role represents the regulatory safeguard of the laboratory's activities, the guarantee of a high level of quality and safety, and a guardian of the ethics of the pharmaceutical world.

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