Reference Safety Information (RSI)

Spanish translation: información de seguridad de referencia

13:57 Dec 31, 2018
English to Spanish translations [PRO]
Medical - Medical: Pharmaceuticals / Literature case
English term or phrase: Reference Safety Information (RSI)
Context:

The event is assessed as serious (hospitalization) and unlisted as per the current RSI.

Is this 'Información de seguridad de referencia' or 'Información de referencia de seguridad'?

Thanks
Maria Iglesia Ramos
Spain
Spanish translation:información de seguridad de referencia
Explanation:
https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:...

Concretamente, precisará en qué parte del expediente de solicitud figura la información de seguridad de referencia para evaluar si una reacción adversa constituye una sospecha de reacción adversa grave e imprevista («SUSAR»).

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Note added at 1 hr (2018-12-31 15:13:48 GMT)
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Hope it works for you!
Selected response from:

Lydianette Soza
Belize
Local time: 08:26
Grading comment
excelente
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +1información de seguridad de referencia
Lydianette Soza


  

Answers


1 hr   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
reference safety information (rsi)
información de seguridad de referencia


Explanation:
https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:...

Concretamente, precisará en qué parte del expediente de solicitud figura la información de seguridad de referencia para evaluar si una reacción adversa constituye una sospecha de reacción adversa grave e imprevista («SUSAR»).

--------------------------------------------------
Note added at 1 hr (2018-12-31 15:13:48 GMT)
--------------------------------------------------

Hope it works for you!


    https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2010:082:0001:0019:ES:PDF
Lydianette Soza
Belize
Local time: 08:26
PRO pts in category: 4
Grading comment
excelente

Peer comments on this answer (and responses from the answerer)
agree  Nelson Soares
37 mins
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