FAMS

English translation: SANF - Substantial Amendment Notification Form

11:11 Aug 15, 2022
French to English translations [PRO]
Medical - Medical: Pharmaceuticals / clinical trial
French term or phrase: FAMS
This acronym appears in a text about a clinical trial. I think that it stands for "substantial amendment notification form" or "Formulaire de demande de modification(s) substantielle(s)" in French. Does anyone know the English equivalent for "FAMS"?
Maggie
Maggie Rosengarten
Local time: 14:45
English translation:SANF - Substantial Amendment Notification Form
Explanation:
Just confirming your proposal:

https://www.gmp-compliance.org/guidelines/gmp-guideline/eudr...

https://laegemiddelstyrelsen.dk/en/licensing/clinical-trials...
Substantial Amendment Notification Form:

The European Commission has drawn up a form for notification of substantial amendments that applicants can use:
Substantial Amendment Notification Form, Word – 94 KB)

--------------------------------------------------
Note added at 16 minutos (2022-08-15 11:27:52 GMT)
--------------------------------------------------

https://www.bfarm.de/SharedDocs/Downloads/DE/Service/Termine...
(substantial amendment notification form, SANF),

--------------------------------------------------
Note added at 1 hora (2022-08-15 12:16:05 GMT)
--------------------------------------------------

Regarding Phil's observation:
FAMS = Formulaire de demande de MSA (autorisation de modification substantielle)
https://archiveansm.integra.fr/var/ansm_site/storage/origina...
Page 65
Selected response from:

abe(L)solano
France
Grading comment
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4 KudoZ points were awarded for this answer



Summary of answers provided
5 +2SANF - Substantial Amendment Notification Form
abe(L)solano
4Substantial Amendment Notification Form
AKAH OKWEN ARNOLD FLORENT


  

Answers


18 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
Substantial Amendment Notification Form


Explanation:
FAMS in French is "Formulaire de demande d'autorisation de modification substantielle" used for clinical trials.


    https://health.ec.europa.eu/system/files/2016-11/substantial_amendment_notification_form__0.pdf
AKAH OKWEN ARNOLD FLORENT
Cameroon
Local time: 14:45
Specializes in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 8
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14 mins   confidence: Answerer confidence 5/5 peer agreement (net): +2
SANF - Substantial Amendment Notification Form


Explanation:
Just confirming your proposal:

https://www.gmp-compliance.org/guidelines/gmp-guideline/eudr...

https://laegemiddelstyrelsen.dk/en/licensing/clinical-trials...
Substantial Amendment Notification Form:

The European Commission has drawn up a form for notification of substantial amendments that applicants can use:
Substantial Amendment Notification Form, Word – 94 KB)

--------------------------------------------------
Note added at 16 minutos (2022-08-15 11:27:52 GMT)
--------------------------------------------------

https://www.bfarm.de/SharedDocs/Downloads/DE/Service/Termine...
(substantial amendment notification form, SANF),

--------------------------------------------------
Note added at 1 hora (2022-08-15 12:16:05 GMT)
--------------------------------------------------

Regarding Phil's observation:
FAMS = Formulaire de demande de MSA (autorisation de modification substantielle)
https://archiveansm.integra.fr/var/ansm_site/storage/origina...
Page 65


abe(L)solano
France
Specializes in field
Native speaker of: Native in SpanishSpanish
PRO pts in category: 8
Grading comment
Thank you for prompt assistance

Peer comments on this answer (and responses from the answerer)
agree  philgoddard: I don't know why it's FAMS and not FDMS. And the answer is there in the question.
30 mins
  -> thanks! true. I think it's because it's "MSA": https://ansm.sante.fr/page/essais-cliniques-demande-dautoris...

agree  Ella Rich
5 days
  -> Thank you!!
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