AREMA is organizing a two-day training workshop on 22 and 23 September 2026 in Tunis, dedicated to the eCTD format and new regulatory procedures in Tunisia.
Title
“Mastering eCTD Format & New Regulatory Procedures in Tunisia: 2-Day Training Workshop”
Trainer
Dr. Zina Kobbi, Doctor of Pharmacy, holding a PhD in Pharmacology, with more than 20 years of experience in Regulatory Affairs and a partner of EXTEDO, supporting pharmaceutical companies in their transition to eCTD.
The workshop will also feature Ms. Sylvie Colin, EXTEDO Publishing Expert, who will participate in a short Q&A session to share her expertise and answer participants’ questions.
Objectives
- Structure Modules 1 to 5 in accordance with ANMPS requirements, particularly the Tunisia-specific Module 1.
- Prepare and generate the “Trigger File.”
- Master the eCTD submission process required by ANMPS.
- Understand baseline requirements according to ANMPS through a theoretical and practical preparation example.
- Manage the lifecycle of regulatory dossiers, including sequences and post-marketing authorization variations, through theoretical and practical examples.
- Avoid common validation errors that could delay the granting of marketing authorizations.
Practical Information
Dates: 22 & 23 September 2026
Location: Golden Tulip El Mechtel, Tunis, Tunisia
Registration fee: TND 1,800 excl. VAT per participant
10% discount for registrations of 2 participants or more
Reserve Your Place
Places are limited to ensure high-quality guidance and interaction with participants.
📩 Register now at contact@arema-international.com or through our online registration form.
Mastering the eCTD Format & New Regulatory Procedures in Tunisia: 2-Day Workshop
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.
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AREMA - Pharmaceutical and healthcare regulatory affairs