The manufacture, promotion ( publicity and training of the medical sales visit), medical Information, pharmacovigilance, batch follow-up (including the management of complaints, batch recalls, etc.), distribution (including transport conditions), importation and exportation of the concerned medicines, products, objects or articles as well as the correspondent storage operations and labelling operations.5124-36 CSP).Īctivities under the responsibility of the exploitant Chief pharmaceutical officer in France The Qualified Person (the exploitant Chief pharmaceutical officer) organises and supervises all the pharmaceutical operations of the company (article R. The Qualified Person is the guarantor of the respect of the French Health Code (CSP) inside the pharmaceutical company, and more generally, of medicines' safety. Placed at the heart of the board of directors of the French pharmaceutical companies, the QP accumulates several responsabilités and is the privileged interlocutor of the Health authorities. The Qualified Person is a privileged function in France. ![]() Advice and interpretation of the French regulations.Interaction and meetings with the French Authorities (ANSM, CEPS, HAS…). ![]() Evaluation of Product Quality Reviews (PQR).Preparation of new procedures (SOPs) and updating existing ones.DMOS (French gift law) and transparency of interests.Management of the local pharmacovigilance.Pharmacovigilance services, including EU QPPV and local QPPV. ![]()
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