05:09 Sep 13, 2019 |
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English to Italian translations [PRO] Medical - Medical (general) / sinossi di protocollo clinico | |||||||
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Summary of answers provided | ||||
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3 | Rappresentante (europeo) degli studi clinici |
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Discussion entries: 2 | |
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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... -------------------------------------------------- Note added at 17 mins (2019-09-13 05:27:31 GMT) -------------------------------------------------- Anche "Incaricato" degli studi clinici |
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