Informer et former les professionnels aux spécificités des essais thérapeutiques sur les maladies rares, dans le but de pouvoir participer, concevoir et conduire un essai thérapeutique dans le domaine des maladies rares.
Compétences développées
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Débouchés
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Organisation de la formation
Savoir comment construire et mener un essai thérapeutique pour les maladies rares :
– connaitre l’environnement des maladies rares et des essais thérapeutiques
-savoir analyser et critiquer un protocole
-connaitre les méthodologies et outils utiles (types d’essai, outils statistiques, etc.) pour la construction d’un essai
-comprendre les étapes qui mènent de la recherche fondamentale à la recherche clinique
-connaitre les bases règlementaires liées aux essais thérapeutiques dans les MR (autorisation, enregistrement, surveillance) et les spécificités pédiatriques
-être sensibilisé au financement (budget) pour la conduite d’un essai clinique
-connaître les outils pour l’évaluation médico-économique (viabilité clinique et économique)
-être sensibilisé au repositionnement de médicament dans les MR
-être sensibilisé à la dimension éthique et sociétale liée à la recherche sur les MR, (essai pédiatriques, coût d’un médicament, etc.)
Contrôle de connaissances
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Condition admission / Public cible
Médecins, pharmaciens, internes en médecine ou en pharmacie
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