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.