Clinical study representative

05:09 Sep 13, 2019
This question was closed without grading. Reason: Altro

Traduzioni da Inglese a Italiano [PRO]
Medical - Medicina (generale) / sinossi di protocollo clinico
Termine o frase Inglese: Clinical study representative
The IMC will include the Roche Medical Monitor, at least one other medical doctor or Clinical Science representative who is not directly involved in the study, and a representative from Safety Science and Biostatistics.

Non trovo molte ricorrenze. Una in particolare è questa
https://www.roche.com/de/careers/jobs/jobsearch/job.htm?id=2...
che mi induce a pensare si tratti di una figura identificata con il termine all'interno della casa farmaceutica stessa (sponsor dello studio)
stefania milano
Italia
Local time: 01:43


Riepilogo di tutte le risposte fornite
3Rappresentante (europeo) degli studi clinici
Luigi Argentino


Voci della discussione: 2





  

Risposte


16 min   Affidabilità: Answerer confidence 3/5Answerer confidence 3/5
clinical study representative
Rappresentante (europeo) degli studi clinici


Spiegazione:
Directive 2007/47/EC defines an Authorized Representative as “any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter’s obligations under this Directive.” According to the Directive, the designation of an Authorized Representative is required if a non-EU manufacturer of medical devices plans on conducting trials in the EU.

https://www.namsa.com/european-market/the-need-for-an-author...

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Note added at 17 mins (2019-09-13 05:27:31 GMT)
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Anche "Incaricato" degli studi clinici

Luigi Argentino
Italia
Local time: 01:43
Soddisfa i criteri
Specializzato nell'area
Madrelingua: Italiano
Punti PRO nella categoria: 237
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