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demande de déclaration de pharmacovigilance

English translation: pharmacovigilance report order / reporting form order

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GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
French term or phrase:demande de déclaration de pharmacovigilance
English translation:pharmacovigilance report order / reporting form order
Entered by: Drmanu49
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00:25 Dec 31, 2010
French to English translations [PRO]
Medical - Medical (general)
French term or phrase: demande de déclaration de pharmacovigilance
Après identification des cas non préalablement déclarés par les médecins et relevant de la procédure de pharmacovigilance, XXX adressait aux médecins enquêteurs une demande de déclaration de pharmacovigilance à envoyer au laboratoire concerné.
xxxjeantrans
pharmacovigilance report order / reporting form order
Explanation:
Challenges in Pharmacovigilance: Pragmatic Approaches (Report of CIOMS ... (Report of CIOMS Working Group VII published by CIOMS Geneva) ...
www.cioms.ch/.../frame_available_publications.htm

The National Pharmacovigilance Centre is responsible for providing reporting forms, collecting, evaluating and communicating the findings from ADR reports ...
www.nafdacnigeria.org/pharmacovigilance.html

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Note added at 12 hrs (2010-12-31 12:42:38 GMT)
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Pharmacovigilance is definitely used in the USA

#
12 May 2010 ... Pharmacovigilance in United States- Here pharmacovigilance has a multi faceted approach. Three branches of pharmacovigilance in the USA can ...
www.pharmaceutical-drug-manufacturers.com/.../pharmacovigil... - En cache

#
Pharmacovigilance and reporting oversight in US FDA fast-track ...
- [ Traduire cette page ]
de BJ Edwards - 2008 - Cité 34 fois - Autres articles
Pharmacovigilance and reporting oversight in US FDA fast-track process: bisphosphonates and osteonecrosis of the jaw. By - Beatrice J Edwards MD, ...
www.thelancet.com/.../PIIS1470-2045(08)70305-X

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Note added at 12 hrs (2010-12-31 12:43:26 GMT)
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Good Pharmacovigilance Practices and Pharmacoepidemiologic. Assessment. This ...
www.fda.gov/downloads/.../Guidances/UCM126834.pdf -

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Note added at 12 hrs (2010-12-31 12:57:46 GMT)
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And Pharmacovigilance is obviously used by the FDA.

Suspected Adverse Drug Reaction. (SADR) Proposed Rule. • Adverse Event Reporting System. (AERS). • Pharmacovigilance Practice at FDA ...
www.fda.gov/downloads/AboutFDA/.../ucm119101.pdf

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Note added at 1 day13 hrs (2011-01-01 13:35:54 GMT)
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To send physicians a request/order for pharmacovigilance report makes perfect sense.
After identifying an adverse effect or event, a request or order was sent to the investigating physician for a pharmacovigilance report to be filled out.
Selected response from:

Drmanu49
France
Local time: 20:18
Grading comment
Thanks for all the good answers. I decided to go with this one for this text.
4 KudoZ points were awarded for this answer

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Summary of answers provided
4pharmacovigilance report order / reporting form order
Drmanu49
3 +1request for a report of adverse reactionscc in nyc
4pharmacovigilance report application
Nikki Scott-Despaigne
4drug safety surveillance report form
SJLD


Discussion entries: 1





  

Answers


7 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5
drug safety surveillance report form


Explanation:
as a generic term for the US where pharmacovigilance is not used I believe.
In fact it's an adverse event report form. The study doctors/physicians have been sent these forms to be returned to the drug manufacturer (laboratoire).

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInforma...

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInforma...

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Note added at 12 hrs (2010-12-31 12:53:57 GMT)
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Interesting site here:
http://www.genomicglossaries.com/content/printpage.asp?REF=/...

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Note added at 12 hrs (2010-12-31 13:02:04 GMT)
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In fact the more I think of it, the more I would tend to use "adverse event report(ing) form", because that's exactly what a "déclaration de pharmacovigilance" is.

http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms...

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Note added at 12 hrs (2010-12-31 13:05:08 GMT)
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http://adiph.org/protocole_PVG.pdf

4. Comment déclarer ?
Les déclarations de pharmacovigilance sont réalisées sur les fiches CERFA réglementaires dont un
exemplaire est joint en annexe.

And here is the "fiche"
http://www.invs.sante.fr/surveillance/coqueluche/repevax_pro...

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Note added at 12 hrs (2010-12-31 13:06:33 GMT)
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It is called:
DÉCLARATION D'EFFET INDÉSIRABLE
SUSCEPTIBLE D'ÊTRE DÛ À UN
MÉDICAMENT OU PRODUIT

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Note added at 12 hrs (2010-12-31 13:08:22 GMT)
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IMO this is what the doctors have been sent. It's not an order or an application.

--------------------------------------------------
Note added at 12 hrs (2010-12-31 13:20:22 GMT)
--------------------------------------------------

Furthermore, if you google "pharmacovigilance report", you will see it does not refer to an adverse event case report form.

SJLD
Local time: 20:18
Specializes in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 1923

Peer comments on this answer (and responses from the answerer)
neutral  Nikki Scott-Despaigne: Yes, except that the term is for a "demande" for this form, thus an application, request, order, whatever.// I see what you are getting at but "demande" cannot be redundant. XXX has sent a "demande de déclaration-", the application/order for the form itse
5 hrs
  -> I think "demande" is redundant here - the doctors have been sent the forms enabling them to make a report of an adverse drug event/ No, I don't think so. They already know who needs to make a report. They are sending the report forms.

disagree  Drmanu49: It is used in the USA www.fda.gov/downloads/.../Guidances/UCM126834.pdf - Your statement "pharmacovigilance is not used I believe" is wrong indeed.
5 hrs
  -> so that makes my answer wrong? Perhaps we should inform the FDA? / but that doesn't make my translation wrong - postmarketing surveillance is obviously the term used by the FDA

agree  Tony M: Surely it's simply a 'request for a declaration to be made', which seems to be the name of the form, I don't quite see where the idea of 'asking for a copy of the form' has crept in from?
11 hrs
  -> nor do I - and I would be very surprised if a request to make a report were sent without including the actual form needed to do it! Happy New Year Tony!
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12 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5
pharmacovigilance report application


Explanation:
A candidate molecule is identified, then there are pre-clinical and clinical developments and trials which have to satisfy a whole series of requirements before going onto the market.

Once the new molecule has gone onto the market, there is an infinite period of surveillance on a large scale covering undesirable effects. A network of pharmacologists, doctors and so on report.

It is important to bear in mind here that the asker's term includes the word "demande". There is an application being put in here, a request.

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Note added at 13 hrs (2010-12-31 13:36:06 GMT)
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FYI, "Pharmacovigilance" is used by the FDA :
http://www.fda.gov/downloads/RegulatoryInformation/Guidances...

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Note added at 13 hrs (2010-12-31 13:37:46 GMT)
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Oh well, back to my revision. Neuropharmacology exam on Tuesday... great way to spend a New Year ;-(

Nikki Scott-Despaigne
Local time: 20:18
Native speaker of: Native in EnglishEnglish
PRO pts in category: 96

Peer comments on this answer (and responses from the answerer)
neutral  SJLD: OK we all agree "pharmacovigilance" is used in the US, but not in this particular instance - what is a "pharmacovigilance report" in the US (or elsewhere)?
1 hr
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15 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +1
request for a report of adverse reactions


Explanation:
But I would probably verb it, something like: "XXX asked the [study doctors] to report adverse reactions..."

I found the (English-language) reference helpful.

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Note added at 15 hrs (2010-12-31 15:44:31 GMT)
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To clarify: I'm not sure the form itself is the issue.


    Reference: http://www.dkma.dk/1024/visUKLSArtikel.asp?artikelID=749
cc in nyc
Local time: 14:18
Native speaker of: English
PRO pts in category: 50

Peer comments on this answer (and responses from the answerer)
agree  SJLD: that is another possibility that I mentioned in my reply to Nikki but later deleted for lack of room - glad you didn't call it a pharmacovigilance report ;-)
54 mins
  -> Thank you for your comment and Happy New Year :-)
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4 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
pharmacovigilance report order / reporting form order


Explanation:
Challenges in Pharmacovigilance: Pragmatic Approaches (Report of CIOMS ... (Report of CIOMS Working Group VII published by CIOMS Geneva) ...
www.cioms.ch/.../frame_available_publications.htm

The National Pharmacovigilance Centre is responsible for providing reporting forms, collecting, evaluating and communicating the findings from ADR reports ...
www.nafdacnigeria.org/pharmacovigilance.html

--------------------------------------------------
Note added at 12 hrs (2010-12-31 12:42:38 GMT)
--------------------------------------------------

Pharmacovigilance is definitely used in the USA

#
12 May 2010 ... Pharmacovigilance in United States- Here pharmacovigilance has a multi faceted approach. Three branches of pharmacovigilance in the USA can ...
www.pharmaceutical-drug-manufacturers.com/.../pharmacovigil... - En cache

#
Pharmacovigilance and reporting oversight in US FDA fast-track ...
- [ Traduire cette page ]
de BJ Edwards - 2008 - Cité 34 fois - Autres articles
Pharmacovigilance and reporting oversight in US FDA fast-track process: bisphosphonates and osteonecrosis of the jaw. By - Beatrice J Edwards MD, ...
www.thelancet.com/.../PIIS1470-2045(08)70305-X

--------------------------------------------------
Note added at 12 hrs (2010-12-31 12:43:26 GMT)
--------------------------------------------------

Good Pharmacovigilance Practices and Pharmacoepidemiologic. Assessment. This ...
www.fda.gov/downloads/.../Guidances/UCM126834.pdf -

--------------------------------------------------
Note added at 12 hrs (2010-12-31 12:57:46 GMT)
--------------------------------------------------

And Pharmacovigilance is obviously used by the FDA.

Suspected Adverse Drug Reaction. (SADR) Proposed Rule. • Adverse Event Reporting System. (AERS). • Pharmacovigilance Practice at FDA ...
www.fda.gov/downloads/AboutFDA/.../ucm119101.pdf

--------------------------------------------------
Note added at 1 day13 hrs (2011-01-01 13:35:54 GMT)
--------------------------------------------------

To send physicians a request/order for pharmacovigilance report makes perfect sense.
After identifying an adverse effect or event, a request or order was sent to the investigating physician for a pharmacovigilance report to be filled out.

Drmanu49
France
Local time: 20:18
Specializes in field
Native speaker of: Native in EnglishEnglish, Native in FrenchFrench
PRO pts in category: 4064
Grading comment
Thanks for all the good answers. I decided to go with this one for this text.

Peer comments on this answer (and responses from the answerer)
agree  Nikki Scott-Despaigne: Pardon, je veins de me rendre compte que vous avez couvert le terme "demande" avec "order"... ma propal n'a pas d'utilité!!!
12 hrs
  -> Thank you Nikki.

disagree  SJLD: OK "pharmacovigilance" is used in the US, but not in this particular instance - what is a "pharmacovigilance report" in the US (or elsewhere)? / the only problem is it's not called a pharmacovigilance report in English
13 hrs
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Changes made by editors
Jan 5, 2011 - Changes made by Drmanu49:
Edited KOG entry<a href="/profile/1136990">xxxjeantrans's</a> old entry - "demande de déclaration de pharmacovigilance " » "pharmacovigilance report order / reporting form order"


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