Mastering the eCTD Format & New Regulatory Procedures in Tunisia: 2-Day Workshop

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

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.

Download the training programme (PDF)

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AREMA - Pharmaceutical and healthcare regulatory affairs