Webinar: Training on eCTD in Tunisia - Basics of electronic submissions and Tunisian Regional eCTD M1

In this webinar, in collaboration with the Tunisian National Chamber of the Pharmaceutical Industry (CNIP), we will be exploring the basics and details of the eCTD framework together with our local partner, AREMA International.  We will uncover key differences between eSubmission and eCTD as well as the current regulatory background and technical requirements in Tunisia, and will move on to general information about eCTD -  the global implementation of eCTD, file structures, XML backbones, and how eCTD validation works. 

Our expert speakers, Dr. Zina Kobbi (CEO AREMA International), Priya Krishnan and Michael Faust, will ensure you are well-equipped with valuable insights, enabling you to start creating your own eCTDs in the future - and avoid common pitfalls. You will learn effective strategies for preparing your company to transition from paper or CTD to eCTD, as well as how to plan for the upcoming IT requirements.This session provides you with actionable knowledge to prepare your company for eCTD, plan and streamline your electronic submission processes, and ensure compliance in this new digital era you are about to enter.

We will also witness a practical example of a typical publishing workflow in an eCTD software. We will conclude with an interactive Q&A part, meeting your personal clarification needs.

Please note that this webinar is mostly held in English, with summaries in French provided after each chapter.

Schedule:

Schedule in TUNISIA Time: 10:00 - 13:30 (incl. 30 min break 11:30 - 12:00)

• Part 1: 10:00 - 11:30
• Break 11:30 - 12:00
• Part 2: 12:00 - 13:30

Schedule in EU Time: 11:00 - 14:30 (incl 30 min break 12:30 - 13:00)

• Part 1: 11:00 - 12:30
• Break 12:30 - 13:00
• Part 2: 13:00 - 14:30
  

Agenda: 

• Welcome and introduction
• Current regulatory background in Tunisia
• Introduction to eCTD: the basics
• Differences between eSubmission and eCTD
• Technical requirements for eCTD
• Transitioning from paper or CTD to eCTD
• Practical example: the eCTD workflow
• Q&A session

Featuring....

	Dr. Zina Kobbi CEO Arema International
	Priya Krishnan Business Consultant