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MEDICAMENTS > CYCLE DE VIE DU MEDOC > Flashcards

CYCLE DE VIE DU MEDOC Flashcards

1
Q

par qui les essais cliniques sont autorisés en france

A

ANSM et CPP

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2
Q

auprès de qui l’industriel fait la demande d’une visa

A

ANSM

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3
Q

qui exerce un controle de la publicité avant la diffusion du médoc

A

ANSM

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4
Q

sui détermine le service médical rendu et son amélioration

A

la commission de transparence de HAS

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5
Q

le prix du médoc remboursé est issu d’une négociation entre l’industriel et qui

A

CEPS

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6
Q

les établissements pharmaceutiques doivent avoir une autorisation d’ouverture délivrée par

A

ANSM

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7
Q

le but de la phase 1 des essais cliniques

A

etude de tolérance

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8
Q

le but de la phase 2 des essais cliniques

A

etude pharmacologique : pharmacocinetique ou pharmacodynamique

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9
Q

le but de la phase 3 des essais cliniques

A

etude de securite et efficacite

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10
Q

En france , le dossier de demande d’AMM nationale doit obligatoirement etre déposé auprès de qui

A

ANSM

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MEDICAMENTS (2 decks)

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