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Glossary entry

Spanish term or phrase:

Departamento de Registros / expedientes de registro

English translation:

Regulatory Affairs department / Regulatory Affairs files OR Marketing Authorisation dossiers

Added to glossary by alidalc
Feb 2, 2009 19:27
15 yrs ago
36 viewers *
Spanish term

Departamento de Registros / expedientes de registro

Spanish to English Tech/Engineering Medical: Pharmaceuticals
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.
Proposed translations (English)
4 +3 Regulatory Affairs department / Regulatory Affairs files
4 +1 registration department / registration files
4 Records Department/files
3 +1 Department of laboratory records
4 Regulatory Affairs Department/Technical Registration Dossier
References
"expedientes de registro"
Change log

Feb 2, 2009 20:32: Sandra Cifuentes Dowling changed "Language pair" from "English to Spanish" to "Spanish to English"

Discussion

Natalia Pedrosa (X) Feb 2, 2009:
En respuesta a lo de expedientes de registro, creo que es lo mismo que expediente, ya que todos quedan registrados para su posterior consulta.

Proposed translations

+3
1 hr
Selected

Regulatory Affairs department / Regulatory Affairs files

That's the definition in English for the pharmaceutical Industry!
:-)
Peer comment(s):
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 Valentin-Rodriguez
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!!
Something went wrong...
4 KudoZ points awarded for this answer. Comment: "Thanks for your help and for the explanatory comments from the "agrees". "
3 mins

Records Department/files

my experience

--------------------------------------------------
Note added at 12 mins (2009-02-02 19:39:35 GMT)
--------------------------------------------------

I am adding the word "record" to read "record files"; thanks for pointing out this omission.
Note from 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 comment(s):
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
Something went wrong...
+1
16 mins

Department of laboratory records

[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...

--------------------------------------------------
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
Peer comment(s):
agree Consult Couture
1 hr
Something went wrong...
+1
33 mins

registration department / registration files

.
Peer comment(s):
agree M.Helia Alarcon
25 mins
Thanks, Merhelia!
Something went wrong...
2 hrs

Regulatory Affairs Department/Technical Registration Dossier

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

Reference comments

1 hr
Reference:

"expedientes de registro"

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-...


--------------------------------------------------
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
Something went wrong...
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