`Maîtriser le format eCTD & les nouvelles procédures réglementaires en Tunisie : atelier de 2 jours`


22 & 23 septembre 2026
Golden Tulip El Mechtel, Tunis, Tunisie
1,800 DT excl. tax / participant

Animé par : Dr Zina Kobbi, Docteur en Pharmacie avec PhD en pharmacologie, avec une expertise de plus de 20 ans en Affaires Règlementaire et partenaire de Extedo accompagnant les industriels dans leur transition eCTD.

Avec la participation de notre experte Publishing de EXTEDO : Mme Sylvie Colin, qui interviendra lors d'une courte session de questions-réponses pour partager son expertise et répondre à vos questions.

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Objectifs :

- Structurer les Modules 1 à 5 selon les exigences de l'ANMPS (notamment le Module 1 spécifique à la Tunisie).

- Préparer et générer le « Trigger File ».

- Maîtriser le processus de soumission eCTD demandé par l'ANMPS.

- Baseline : exigences de l'ANMPS, avec un exemple théorique et pratique de préparation.

- Gérer le cycle de vie des dossiers (séquences et variations post-AMM), à partir d'exemples théoriques et pratiques.

- Éviter les erreurs de validation courantes afin de ne pas retarder l'octroi des AMM.




Download the training programme (PDF)
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