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Departamento de Registros / expedientes de registro

English translation: Regulatory Affairs department / Regulatory Affairs files OR Marketing Authorisation dossiers

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GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
Spanish term or phrase:Departamento de Registros / expedientes de registro
English translation:Regulatory Affairs department / Regulatory Affairs files OR Marketing Authorisation dossiers
Entered by: alidalc
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19:27 Feb 2, 2009
Spanish to English translations [PRO]
Tech/Engineering - Medical: Pharmaceuticals
Spanish term or phrase: Departamento de Registros / expedientes de registro
Hello, I'm translating a CV to English and one of the jobs that was held was as "Assistant del ", where the individual was in charge of "trascripción de documentación técnica de los (nuevos registros, modificaciones y revalidaciones).

I am a bit confused as to the meaning of "registro(s)". Is she talking about the laboratory 'records' or is the meaning here a 'registry' or even 'recordings'?

"Expedientes de registro" is also confusing. Does anyone know what these are?

Any help is much appreciated. Thank you.
Alison Imms
Regulatory Affairs department / Regulatory Affairs files
Explanation:
That's the definition in English for the pharmaceutical Industry!
:-)
Selected response from:

Ivan Nieves
Switzerland
Local time: 05:49
Grading comment
Thanks for your help and for the explanatory comments from the "agrees".
4 KudoZ points were awarded for this answer

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Summary of answers provided
4 +3Regulatory Affairs department / Regulatory Affairs files
Ivan Nieves
4 +1registration department / registration filesmargaret caulfield
4Regulatory Affairs Department/Technical Registration Dossier
Susana Legradi
3 +1Department of laboratory recordsliz askew
4Records Department/files
Remy Arce
Summary of reference entries provided
"expedientes de registro"
Emma Goldsmith

Discussion entries: 1





  

Answers


3 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
departamento de registros / expedientes de registro
Records Department/files


Explanation:
my experience

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Note added at 12 mins (2009-02-02 19:39:35 GMT)
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I am adding the word "record" to read "record files"; thanks for pointing out this omission.

Remy Arce
United States
Local time: 23:49
Specializes in field
Native speaker of: Native in SpanishSpanish
PRO pts in category: 39
Notes to answerer
Asker: Hello, so you think that "expedientes de registro" are just "files", then? I know expedientes are files or reports, but what happened to the "de registro"?


Peer comments on this answer (and responses from the answerer)
neutral  L Villarino: En algunos países a veces se denomina Departamento de Registro a los asuntos regulatorios, o sea, los trámites ante las autoridades sanitarias. Probablemente se refiera a esto el texto, pero también podría referirse a la documentación interna de la empres
15 hrs
  -> de acuerdo contigo, mi respuests se basa en mi experiencia en el los laboratorios farmacéuticos en Puerto Rico y Estados Unidos. Probablemente para España, el sistema es diferente. Por acá la empresas tienen Departamentos de Cumplimiento o Asuntos Regula
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16 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +1
departamento de registros / expedientes de registro
Department of laboratory records


Explanation:
[PDF]
(Microsoft Word - Laboratory Records and Evidence Control Clerk ...
File Format: PDF/Adobe Acrobat - View as HTML
telephone inquiries, typing and maintaining various laboratory records and files, etc.). An. employee in this position will come in contact with ...
www.mshp.dps.mo.gov/MSHPWeb/PatrolDivisions/HRD/Civilian/..... - Similar pages

--------------------------------------------------
Note added at 17 mins (2009-02-02 19:45:09 GMT)
--------------------------------------------------

here

expedientes de registro = log files

http://209.85.229.132/search?q=cache:VkYkH1CJPwsJ:americanpu...

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Note added at 19 mins (2009-02-02 19:47:02 GMT)
--------------------------------------------------

Or

just "files"

[PDF]
QM Section 13 Page 1 of 4 Records 13.0 Records
File Format: PDF/Adobe Acrobat - View as HTML
the laboratory records are kept in locked cabinets and access to the files are limited to the. laboratory staff. Records include information required by ...
ts.nist.gov/WeightsAndMeasures/upload/Section_13_Rev7-03.pdf - Similar pages

liz askew
United Kingdom
Local time: 04:49
Works in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 651

Peer comments on this answer (and responses from the answerer)
agree  ES > EN (US)
1 hr
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33 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
departamento de registros / expedientes de registro
registration department / registration files


Explanation:
.

margaret caulfield
Local time: 05:49
Specializes in field
Native speaker of: Native in EnglishEnglish, Native in SpanishSpanish
PRO pts in category: 28

Peer comments on this answer (and responses from the answerer)
agree  M.Helia Alarcon
25 mins
  -> Thanks, Merhelia!
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1 hr   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +3
Regulatory Affairs department / Regulatory Affairs files


Explanation:
That's the definition in English for the pharmaceutical Industry!
:-)

Ivan Nieves
Switzerland
Local time: 05:49
Specializes in field
Native speaker of: Native in GermanGerman, Native in SpanishSpanish
PRO pts in category: 8
Grading comment
Thanks for your help and for the explanatory comments from the "agrees".

Peer comments on this answer (and responses from the answerer)
agree  Emma Goldsmith: This is definitely the right one. It's all about marketing authorisations, renewals, etc. etc.
17 mins
  -> Thank you Emma!! :-)

agree  Carmen Valentín
40 mins
  -> Muchas gracias Carmen!! :-)

agree  John Cutler: I work at a Pharmaceutical company on a regular basis. This is DEFINITELY what it's called in English.
46 mins
  -> Thanks a lot John!!
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2 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5
Regulatory Affairs Department/Technical Registration Dossier


Explanation:
registration dossiers [expedientes de registro] are used to submit product information as part of an application for a marketing authorization to the Regulatory Agencies

Susana Legradi
Chile
Local time: 00:49
Specializes in field
Native speaker of: Spanish
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Reference comments


1 hr
Reference: "expedientes de registro"

Reference information:
If this is a pharmaceutical company (called "laboratorio X") then it will be researching new drugs, and bringing them onto the market. To do so, they have to submit a marketing authorisation dossier in the form of a "common technical document" to the EU regulatory authorities.

<<<expedientes de registro>>> (nuevos registros, modificaciones y revalidaciones).
marketing authorisation dossiers (new authorisations, modifications and renewals).

http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-...


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Note added at 2 hrs (2009-02-02 21:50:53 GMT)
--------------------------------------------------

In short (as I don't think I made it very clear):

"expedientes de registro" = marketing authorisation dossiers

Emma Goldsmith
Spain
Specializes in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 240
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Changes made by editors
Feb 2, 2009 - Changes made by Sandra Cifuentes Dowling:
Language pairEnglish to Spanish » Spanish to English


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