Glossary entry (derived from question below)
French term or phrase:
argumentaire du demandeur
English translation:
the applicant's arguments
Added to glossary by
Conor McAuley
Jun 16, 2021 08:39
2 yrs ago
24 viewers *
French term
argumentaire du demandeur
French to English
Medical
Medical (general)
avis scientifique
Hello,
I was wondering whether "demandeur" here is called "applicant" ? or something else in this pharmacological context
This "avis scientifique" includes questions by "demandeurs" who ask various questions about the efficacy of the product that is being tested. The "demandeur" provides an extensive answer here.
Thank you
I was wondering whether "demandeur" here is called "applicant" ? or something else in this pharmacological context
This "avis scientifique" includes questions by "demandeurs" who ask various questions about the efficacy of the product that is being tested. The "demandeur" provides an extensive answer here.
Thank you
Proposed translations
(English)
2 | the applicant's arguments | Conor McAuley |
4 | applicant's rationale/reasoning | liz askew |
3 | developer | Samuël Buysschaert |
Change log
Jun 23, 2021 09:54: Conor McAuley Created KOG entry
Proposed translations
4 hrs
Selected
the applicant's arguments
This text indicates that a "demandeur" is an applicant for an "AMM" (Autorisation de Mise sur le Marché).
"Avis aux demandeurs et titulaires d’AMM
Autorisation de Mise sur le Marché de Médicaments à usage humain (AMM) - les bases réglementaires"
https://ansm.sante.fr/documents/reference/reglementation-rel...
*Marketing authorisation* | European Medicines Agencyhttps://www.ema.europa.eu › human-regulatory › mark...
Once granted by the European Commission, the centralised marketing authorisation is valid in all European Union (EU) Member States, Iceland, Norway and ...
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Note added at 7 days (2021-06-23 09:52:45 GMT) Post-grading
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To Louisa: you're welcome!
"Avis aux demandeurs et titulaires d’AMM
Autorisation de Mise sur le Marché de Médicaments à usage humain (AMM) - les bases réglementaires"
https://ansm.sante.fr/documents/reference/reglementation-rel...
*Marketing authorisation* | European Medicines Agencyhttps://www.ema.europa.eu › human-regulatory › mark...
Once granted by the European Commission, the centralised marketing authorisation is valid in all European Union (EU) Member States, Iceland, Norway and ...
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Note added at 7 days (2021-06-23 09:52:45 GMT) Post-grading
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To Louisa: you're welcome!
4 KudoZ points awarded for this answer.
Comment: "Thank you Conor!"
2 days 7 hrs
applicant's rationale/reasoning
/
Note from asker:
Thank you Liz :) |
3 hrs
French term (edited):
demandeur
developer
Just a suggestion,
"How scientific advice works
EMA gives scientific advice by responding to specific questions posed by the medicine developer on the development of a particular medicine.
The developer of a medicine presents the way it plans to develop its medicine and identifies questions and possible solutions. EMA then gives advice on the developer’s proposals."
https://www.ema.europa.eu/en/human-regulatory/research-devel...
https://www.nice.org.uk/about/what-we-do/life-sciences/scien...
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Note added at 4 heures (2021-06-16 12:43:16 GMT)
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détails du processus (en français) p.11
https://www.ema.europa.eu/en/documents/other/laboratory-pati...
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Note added at 6 jours (2021-06-23 08:33:11 GMT) Post-grading
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Thanks, glad to help.
"How scientific advice works
EMA gives scientific advice by responding to specific questions posed by the medicine developer on the development of a particular medicine.
The developer of a medicine presents the way it plans to develop its medicine and identifies questions and possible solutions. EMA then gives advice on the developer’s proposals."
https://www.ema.europa.eu/en/human-regulatory/research-devel...
https://www.nice.org.uk/about/what-we-do/life-sciences/scien...
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Note added at 4 heures (2021-06-16 12:43:16 GMT)
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détails du processus (en français) p.11
https://www.ema.europa.eu/en/documents/other/laboratory-pati...
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Note added at 6 jours (2021-06-23 08:33:11 GMT) Post-grading
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Thanks, glad to help.
Note from asker:
Thank you :) |
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