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département inspection des essais, de la pharmacovigilance et de la sécurité

English translation: Department for the validation of clinical trials, pharmacovigilance, and safety (usually drugs)

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GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
French term or phrase:département inspection des essais, de la pharmacovigilance et de la sécurité
English translation:Department for the validation of clinical trials, pharmacovigilance, and safety (usually drugs)
Entered by: Drmanu49
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11:13 Dec 8, 2010
French to English translations [PRO]
Medical - Medical: Pharmaceuticals / AFSSAP
French term or phrase: département inspection des essais, de la pharmacovigilance et de la sécurité
AFSSAPS (agence francaise de securite sanitaire des produits de sante)
Direction de l'Inspection et des Etablissements
Departement inspection des Essais, de la pharmacovigilance et de la securite
Elene P.
Georgia
Local time: 03:36
Department for the validation of clinical trials, pharmacovigilance, and safety (usually drugs)
Explanation:
I have a member of the department sitting with me!
Selected response from:

Drmanu49
France
Local time: 00:36
Grading comment
thanks!
4 KudoZ points were awarded for this answer

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Summary of answers provided
4 +5Department for the validation of clinical trials, pharmacovigilance, and safety (usually drugs)
Drmanu49
4 +4Clinical trial, pharmacovigilance and drug safety inspectorate
SJLD
3Drugs Monitoring and Safety Department
schevallier
Summary of reference entries provided
liz askew

  

Answers


14 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +5
Departement inspection des Essais, de la pharmacovigilance et de la securite
Department for the validation of clinical trials, pharmacovigilance, and safety (usually drugs)


Explanation:
I have a member of the department sitting with me!

Drmanu49
France
Local time: 00:36
Specializes in field
Native speaker of: Native in EnglishEnglish, Native in FrenchFrench
PRO pts in category: 1029
Grading comment
thanks!

Peer comments on this answer (and responses from the answerer)
agree  Simon Cole: equivalent to UK unit, but 'validation' is not in the title or the French text
7 mins
  -> Thank you Simon. I know but that is what Pr Stahl told me to write and he is a member!

agree  Vicky Valla: i would say .....and drug safety (take out the parentheses)
11 mins
  -> OK. Thank you Vicky.

neutral  liz askew: I would question "validation" here.
18 mins
  -> Well question the specialist! LOL

agree  Bashiqa: Validation isn't there but Inspection is. I would opt for validation. Very common word in pharma doc.
40 mins
  -> Thank you.

agree  xxxLionel_M: It is validation and this is what asks EMA; not to confound with "clinical trial assessment" which is the "évaluation" and not "validation"
2 hrs
  -> Thank you Lionel.

agree  philgoddard: Mainly because you were first, but also because you have it straight from the horse's mouth!
6 hrs
  -> Thank you Phil! ;-)
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23 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5
Departement inspection des Essais, de la pharmacovigilance et de la securite
Drugs Monitoring and Safety Department


Explanation:
ou "Dept."


IMO :)

schevallier
Local time: 00:36
Native speaker of: Native in FrenchFrench
PRO pts in category: 4
Login to enter a peer comment (or grade)

52 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +4
Departement inspection des Essais, de la pharmacovigilance et de la securite
Clinical trial, pharmacovigilance and drug safety inspectorate


Explanation:
use "pharmacovigilance" for EU text, "postmarketing surveillance" for US.

http://books.google.fr/books?id=21NOPftshHEC&pg=PA497&lpg=PA...

SJLD
Local time: 00:36
Specializes in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 258

Peer comments on this answer (and responses from the answerer)
agree  liz askew: yes.
24 mins

agree  mimi 254: .... and Safety Unit - adediem.com/docs/ArmelleMIJONNET_%252... - Cached - Similar, slide 11
36 mins

agree  Zareh Darakjian Ph.D.
2 hrs

agree  Anne C
3 hrs
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Reference comments


30 mins
Reference

Reference information:
Findings only
[PDF]
Revue du Cadre réglementaire Fr et EU des essais cliniques ...
- [ Translate this page ]
File Format: PDF/Adobe Acrobat - Quick View
Unité inspection sécurité et pharmacovigilance, Magda DAUDIN .... authorities for authorisation of a clinical trial on a medicinal product for human use, ...
www.afssaps.fr/var/afssaps.../4a700882a2f832555e1da19b3db32...
• [PDF]
Workshop on the Guideline for First-In-Man Clinical Trials for ...
File Format: PDF/Adobe Acrobat - Quick View
Phase I (F.I.M.) clinical trials. Pierre Henri BERTOYE. Clinical Trials Inspection Unit. French Health Products Safety Agency ...
www.ema.europa.eu/pdfs/conferenceflyers/.../08-P_Bertoye_Af...
• Good Clinical Practice : MHRA
1 Jul 2010 ... The MHRA's Good Clinical Practice (GCP) Inspectorate is part of the ... It assesses the compliance of organisations conducting clinical trials using ... This section outlines the Good Clinical Practice inspection process ...
www.mhra.gov.uk/.../Inspectionandstandards/GoodClinicalPrac... - Cached - Similar
• Inspection Strategy for Clinical Trials [Health Canada, 2002]
8 Apr 2002 ... As part of the regulatory amendments to the Food and Drug Regulations on clinical trials, an inspection function for clinical trials was ...
www.hc-sc.gc.ca › ... › Guidance Documents - Cached - Similar

liz askew
United Kingdom
Works in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 413
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Changes made by editors
Dec 15, 2010 - Changes made by Drmanu49:
Edited KOG entry<a href="/profile/92264">Elene P.'s</a> old entry - "département inspection des essais, de la pharmacovigilance et de la sécurité" » "Department for the validation of clinical trials, pharmacovigilance, and safety (usually drugs)"
Dec 8, 2010 - Changes made by Stéphanie Soudais:
Term askedDepartement inspection des Essais, de la pharmacovigilance et de la securite » département inspection des essais, de la pharmacovigilance et de la sécurité


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