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PRAC following conclusion of the PAM procedure

Italian translation: e del PRAC dopo la conclusione della procedura PAM

11:12 May 20, 2019
English to Italian translations [PRO]
Medical - Medical (general)
English term or phrase: PRAC following conclusion of the PAM procedure
Clinical study

Importantly, the study will not be initiated until there is concurrent approval on the protocol from National Competent Authorities, Ethics Committee, and the PRAC following conclusion of the PAM procedure.

Non mi è chiaro se PRAC (Comitato di valutazione dei rischi per la farmacovigilanza) sia retto da "approval on the protocol from". Approvazione da parte delle autorità competenti, … e del PRAC dopo la conclusione della procedura PAM"
Antonella Vallicelli
Italy
Local time: 01:10
Italian translation:e del PRAC dopo la conclusione della procedura PAM
Explanation:
Quello che pensi è corretto. Il PRAC deve esprimere un parere favorevole sul protocollo prima che lo studio possa essere iniziato, per assicurare che tutte le necessarie misure di gestione del rischio siano incluse.
Selected response from:

Serena Arduini
Ireland
Local time: 00:10
Grading comment
2 KudoZ points were awarded for this answer



Summary of answers provided
4e del PRAC dopo la conclusione della procedura PAM
Serena Arduini


  

Answers


16 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
prac following conclusion of the pam procedure
e del PRAC dopo la conclusione della procedura PAM


Explanation:
Quello che pensi è corretto. Il PRAC deve esprimere un parere favorevole sul protocollo prima che lo studio possa essere iniziato, per assicurare che tutte le necessarie misure di gestione del rischio siano incluse.

Serena Arduini
Ireland
Local time: 00:10
Specializes in field
Native speaker of: Native in ItalianItalian
PRO pts in category: 374
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