The eCTD standard for electronic submissions is becoming mandatory or at least accepted in more and more countries or regions, such as GCC, Jordan, South Africa, Europe, North America and China. EXTEDO supported many of these agencies with their eCTD projects. In the MENA region, many additional regulatory authorities plan to implement this standard in the next years as well.
We invite you to our complimentary webinar about eCTD, NeeS and CTD submissions. This webinar is dedicated to Regulatory Affairs professionals, who would like to get an overview about the three submission standards and see, how an eCTD submission can easily be created and validated using a submission management software.
We are very happy to welcome a local regulatory expert, based in Egypt, as a speaker: Asmaa Khalil, who already ran many training courses on CTD, NeeS and eCTD will present in this webinar. The software demo will be done by Maren Müller, EXTEDO's product manager for eCTDmanager, the most advanced eCTD software solution which is supporting nearly all global standards for electronic submissions including the validation of submissions.
- What is the difference between CTD, NeeS and eCTD?
- How is the drug approval process at an agency such as Saudi FDA structured?
- What are the advantages of electronic submissions and where in the world are there accepted/required?
- What is necessary to create and validate an eCTD submission and how is this done?
These and other questions will be answered in our complimentary webinar.
1. EXTEDO company overview (Thomas Kessler, EXTEDO)
2. Introduction to CTD, NeeS and eCTD Submissions (Asmaa Khalil, Boston Biopharma)
- Differences between submission standards
- Drug licensing process at a Regulatory Authority (Saudi FDA)
- Advantages of CTD, NeeS and eCTD
- Global acceptance of electronic submissions overview
3. How to create an eCTD submission (Maren Müller, EXTEDO)
4. Questions & Answers
- Asmaa Khalil, MENA RA Manager, Boston Biopharma Limited
- Maren Müller, Product Manager, EXTEDO GmbH
Details and Registration
Date: Wednesday, 29 January 2020
10:00 h CET (Madrid, Berlin)
11:00 h EET (Cairo)
Duration: 60 Minutes
Participation is free of charge.