Unité d'essais cliniques médicaments et hors produits de santé

English translation: Unit for Clinical Trials on Medicinal and Non-Medicinal Products

10:10 May 11, 2009
French to English translations [PRO]
Medical - Medical (general) / Clinical trials; drugs; safety
French term or phrase: Unité d'essais cliniques médicaments et hors produits de santé
Having researched it, understand what this means, but am not sure how best to translate it into English. The website below (AFSSAPS) explains what this department deals with:

suivi des essais cliniques ne portant pas sur un produit mentionné à l'article L.5311-1 du code de la santé publique appelés communément "essais cliniques hors produits de santé"

but this is a bit of a mouthful and I at the moment I can't think how to get it into a more concise phrase to describe the actual department or 'unit'. Any helpful suggestions? Clearly this is very specific in terms of what drugs or health products it excludes - but I have not managed to find any reference to it in English. Thanks in advance for any help.

http://www.afssaps.fr/Activites/Essais-cliniques/Essais-clin...
French2English
United Kingdom
Local time: 16:33
English translation:Unit for Clinical Trials on Medicinal and Non-Medicinal Products
Explanation:
The Unit seems to have responsibility for BOTH kinds of clinical trial - so 'medicinal and non-medicinal' would cover all eventualities. I don't think you necessarily need to get into the definition with respect to the Code de la Santé - the list of products that are classed as 'produits de santé' is a long and inclusive one, so I think 'non-medicinal' is a fair translation for 'hors produits de santé'.
Selected response from:

Charlotte Allen
United Kingdom
Local time: 16:33
Grading comment
Selected automatically based on peer agreement.
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Summary of answers provided
3 +3Unit for Clinical Trials on Medicinal and Non-Medicinal Products
Charlotte Allen
3 +1UECM [Unit for drugs used in Clinical Trials
liz askew
3Clinical trials unit: trials of medicinal products and non-health products
Helen Genevier
Summary of reference entries provided
liz askew

  

Answers


26 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +1
Unite d'essais cliniques medicaments et hors produits de sante
UECM [Unit for drugs used in Clinical Trials


Explanation:
a starter only

still thinking about the second part

http://209.85.229.132/search?q=cache:11UkK4vofW0J:www.afssap...

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Note added at 29 mins (2009-05-11 10:39:22 GMT)
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is
the "hors produits de santé

non-medical products

see

[PDF]
Safety testing (of non-medical products) (1)
File Format: PDF/Adobe Acrobat
(of non-medical products) (1) factsheet. What is safety testing? Using animals to test the safety of chemicals is a very controversial issue that has ...
www.rspca.org.uk/servlet/Satellite?blobcol=urlblob&blobhead... - Similar pages

??

Good luck!

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Note added at 32 mins (2009-05-11 10:42:32 GMT)
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apologies
I think that should =

non-MedICINAL products

[PDF]
Sale of Non-Medicinal Products
File Format: PDF/Adobe Acrobat - View as HTML
all non-medicinal products that can be available from clinics, the SMA ... the sale of non-medicinal products from medical clinics, an excellent paper on ...
sma.org.sg/sma_news/3311/advisory.pdf - Similar pages

liz askew
United Kingdom
Local time: 16:33
Specializes in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 3189

Peer comments on this answer (and responses from the answerer)
agree  Nikki Scott-Despaigne: and parapharmaceutical products?
2 hrs
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38 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +3
Unite d'essais cliniques medicaments et hors produits de sante
Unit for Clinical Trials on Medicinal and Non-Medicinal Products


Explanation:
The Unit seems to have responsibility for BOTH kinds of clinical trial - so 'medicinal and non-medicinal' would cover all eventualities. I don't think you necessarily need to get into the definition with respect to the Code de la Santé - the list of products that are classed as 'produits de santé' is a long and inclusive one, so I think 'non-medicinal' is a fair translation for 'hors produits de santé'.

Charlotte Allen
United Kingdom
Local time: 16:33
Native speaker of: English
PRO pts in category: 16
Grading comment
Selected automatically based on peer agreement.

Peer comments on this answer (and responses from the answerer)
agree  Kate Hudson (X)
49 mins

agree  Omar Lima Quintana
1 hr

agree  Raya Mansour
9 hrs
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3 days 7 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5
Clinical trials unit: trials of medicinal products and non-health products


Explanation:
I don't feel that non-medicinal products will cover it, because when you look at the list of "produit mentionné à l'article L.5311-1 du code de la santé publique" it already includes a lot of products that are not medicines eg biologics, cosmetics, devices, diagnostic tests.

This looks like a clue to me:
http://www.afssaps.fr/var/afssaps_site/storage/original/appl...
"Deux autorités administratives (compétence nationale)
- l ’AFSSAPS pour les recherches concernant les produits de santé (L. 5311-1) : 70% des recherches biomédicales
- le Ministre chargé de la santé (Direction générale de la santé) pour les autres recherches (physiologie et physiopathologie, génétique, produits nutritionnels, ….) : 30% des recherches."

My suggestion of Clinical trials unit: trials of medicinal products and non-health products is still not great, because it now leaves out non-medicinal products such as medical devices from the spectrum, but IMO that's a pretty direct translation of the French.

Helen Genevier
France
Local time: 17:33
Specializes in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 529
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Reference comments


21 mins
Reference

Reference information:
[PDF]
European Perspectives on Advanced Therapy Medicinal Products
File Format: PDF/Adobe Acrobat
Products. •. Proprietary medicinal products. •. Non proprietary med products. •. Clinical trials. Afssaps Responsabilities ...
www.pmda.go.jp/english/past/pdf/03.Dr.Zorzi.pdf - Similar pages

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Note added at 23 mins (2009-05-11 10:33:42 GMT)
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This site is useful too:

http://209.85.229.132/search?q=cache:11UkK4vofW0J:www.afssap...

liz askew
United Kingdom
Specializes in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 3189
Login to enter a peer comment (or grade)



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