Mastering the eCTD Format & New Regulatory Procedures in Tunisia: 2-Day Workshop
AREMA is organizing a two-day training workshop dedicated to the eCTD format and the new regulatory procedures in Tunisia. A must-attend event for Regulatory Affairs professionals looking to master the current requirements of the ANMPS.
Dates: September 22–23, 2026
Venue: Golden Tulip El Mechtel, Tunis, Tunisia
Registration fee: 1,800 TND (excl. VAT) per participant (10% discount for two or more participants)
Speakers
The workshop will be led by Dr. Zina Kobbi, Doctor of Pharmacy with a PhD in Pharmacology, who brings over 20 years of experience in Regulatory Affairs and is an Extedo partner supporting manufacturers through their eCTD transition.
The session will also feature Ms. Sylvie Colin, Publishing Expert at EXTEDO, who will lead a dedicated Q&A session to address participants’ specific questions and share her expertise.
Workshop Objectives
This workshop is designed to help participants structure Modules 1 to 5 in line with ANMPS requirements, with particular focus on Module 1, which is specific to Tunisia, as well as prepare and generate the “Trigger File.” Participants will learn to master the eCTD submission process required by the ANMPS and gain a clear understanding of the regulatory baseline through a theoretical and practical preparation example. The training will also cover dossier lifecycle management, including sequences and post-marketing authorization variations, illustrated with concrete case studies. Finally, special attention will be given to the most common validation errors, in order to avoid delays in obtaining marketing authorizations.
Registration
Places are limited to ensure quality support for all participants.