May 11, 2009 10:10
15 yrs ago
12 viewers *
French term
United Kingdom
BA(Hons), Dip Trans IOL, MCIL London
Native in: English
Works in: French to English, English
Unité d'essais cliniques médicaments et hors produits de santé
French to English
Medical
Medical (general)
Clinical trials; drugs; safety
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...
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...
Change log
May 11, 2009 11:43: Emanuela Galdelli changed "Term asked" from "Unite d\'essais cliniques medicaments et hors produits de sante" to "Unité d\'essais cliniques médicaments et hors produits de santé"
Proposed translations
+3
38 mins
French term (edited):
Unite d'essais cliniques medicaments et hors produits de sante
Selected
Unit for Clinical Trials on Medicinal and Non-Medicinal Products
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'.
4 KudoZ points awarded for this answer.
Comment: "Selected automatically based on peer agreement."
+1
26 mins
French term (edited):
Unite d'essais cliniques medicaments et hors produits de sante
UECM [Unit for drugs used in Clinical Trials
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
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)
--------------------------------------------------
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)
--------------------------------------------------
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
3 days 7 hrs
Clinical trials unit: trials of medicinal products and non-health products
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.
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.
Reference comments
21 mins
Reference:
[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...
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
--------------------------------------------------
Note added at 23 mins (2009-05-11 10:33:42 GMT)
--------------------------------------------------
This site is useful too:
http://209.85.229.132/search?q=cache:11UkK4vofW0J:www.afssap...
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