Glossary entry

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
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!
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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 :)
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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.
Note from asker:
Thank you :)
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