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 REGLEMENTATION SPECIFIQUE DES SOLUTIONS INJECTABLES HOSPITALIERES. Particularites de ces solutions et consequences de l'evolution de la reglementation en France
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REGLEMENTATION SPECIFIQUE DES SOLUTIONS INJECTABLES HOSPITALIERES. Particularites de ces solutions et consequences de l'evolution de la reglementation en France

автор Dominique R. издательство Книга по Требованию Книги
Cтраниц 92        мягкая обложка       
Аннотация:Le present document a pour but de mettre en lumiere les specificites reglementaires des solutions injectables "generiques" a usage hospitalier ainsi que les consequences de l'evolution de la reglementation sur ces medicaments en France. Ce travail est issu de deux ans d'experience au sein du service Affaires Reglementaires Medicaments de B Braun Medical France. Le caractere injectable et a usage hospitalier ainsi que l'aspect "generique" de ces medicaments influencent a la fois les strategies et le contenu des dossiers d'enregistrement mais aussi le contenu de documents tels que le Resume des Caracteristiques du produit, le dossier de demande d'agrement aux collectivites et les documents publicitaires. Un chapitre est consacre a ces aspects particuliers. Enfin, la reglementation francaise etant en pleine evolution, le dernier chapitre s'attache a etudier les consequences sur les medicaments commercialises par B Braun Medical France et les actions a mettre en place.
Автор: Dominique R.
Издательство: Книга по Требованию
Год:2011
Цена:
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