first stage Qualified Person (QP) release

Russian translation: Первичное одобрение уполномоченного по качеству

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:first stage Qualified Person (QP) release
Russian translation:Первичное одобрение уполномоченного по качеству
Entered by: Elene P.

17:06 Jan 7, 2012
English to Russian translations [PRO]
Medical - Medical (general) / clinical trials
English term or phrase: first stage Qualified Person (QP) release
The blinding process and first stage Qualified Person (QP) release will be done by the designated clinical trial supply company.
Elene P.
Georgia
Первичное одобрение уполномоченного по качеству
Explanation:
Qualified Person (QP) is a technical term used in European Union pharmaceutical regulation (Directive 2001/83/EC for Medicinal products for human use).

http://en.wikipedia.org/wiki/Qualified_Person

http://health-ua.com/articles/1055.html

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Note added at 19 мин (2012-01-07 17:25:32 GMT)
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http://www.trialsjournal.com/content/11/1/40

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Note added at 26 мин (2012-01-07 17:32:36 GMT)
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Уполномоченное лицо (Qualified Person): см. Приложение 16 к настоящему стандарту.

"ГОСТ Р 52249-2009 GMP Приложение 3 Производство радиофармацевтических препаратов - Термины и определения"

http://tinyurl.com/7l6yt5j
Selected response from:

Alexander Vorobyev
Local time: 14:24
Grading comment
thx
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +3Первичное одобрение уполномоченного по качеству
Alexander Vorobyev


  

Answers


17 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +3
first stage qualified person (qp) release
Первичное одобрение уполномоченного по качеству


Explanation:
Qualified Person (QP) is a technical term used in European Union pharmaceutical regulation (Directive 2001/83/EC for Medicinal products for human use).

http://en.wikipedia.org/wiki/Qualified_Person

http://health-ua.com/articles/1055.html

--------------------------------------------------
Note added at 19 мин (2012-01-07 17:25:32 GMT)
--------------------------------------------------

http://www.trialsjournal.com/content/11/1/40

--------------------------------------------------
Note added at 26 мин (2012-01-07 17:32:36 GMT)
--------------------------------------------------

Уполномоченное лицо (Qualified Person): см. Приложение 16 к настоящему стандарту.

"ГОСТ Р 52249-2009 GMP Приложение 3 Производство радиофармацевтических препаратов - Термины и определения"

http://tinyurl.com/7l6yt5j

Alexander Vorobyev
Local time: 14:24
Specializes in field
Native speaker of: Russian
PRO pts in category: 444
Grading comment
thx

Peer comments on this answer (and responses from the answerer)
agree  Vladyslav Golovaty
1 hr
  -> Спасибо!

agree  Pavel Nikonorkin
1 hr
  -> Спасибо!

agree  NikFil
6 hrs
  -> Спасибо!
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