11:11 Aug 15, 2022 |
French to English translations [PRO] Medical - Medical: Pharmaceuticals / clinical trial | |||||||
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| Selected response from: abe(L)solano France | ||||||
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5 +2 | SANF - Substantial Amendment Notification Form |
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4 | Substantial Amendment Notification Form |
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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 |
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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 |
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