Clinical study representative

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

English to Italian translations [PRO]
Medical - Medical (general) / sinossi di protocollo clinico
English term or phrase: 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
Italy
Local time: 12:13


Summary of answers provided
3Rappresentante (europeo) degli studi clinici
Luigi Argentino


Discussion entries: 2





  

Answers


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


Explanation:
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
Italy
Local time: 12:13
Meets criteria
Specializes in field
Native speaker of: Italian
PRO pts in category: 237
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