In our complimentary webinar, we will share the basics of eCTD submissions, South Africa specific details as well as the current timelines in South Africa. Additionally, we will look at the current eCTD structure.
In the live demo following the theoretical part, you will see how a South African eCTD submission is created using eCTDmanager and how it can be reviewed using eSUBmanager.
1. EXTEDO Company Overview (Thomas Kessler, EXTEDO)
2. Introduction to eCTD submissions in South Africa (Frank Dickert, EXTEDO)
• Introduction to eCTD and benefits of the standard
• Timelines in South Africa
• The South African eCTD Module 1 in detail
• Workflow of an eCTD submission
• Validation criteria of a South African eCTD dossier
3. Live Demo: Creation and Validation of an eCTD Dossier using eCTDmanager (Maren Müller, EXTEDO)
4. Live Demo: Review of an eCTD Dossier using eSUBmanager (Maren Müller, EXTEDO)
5. Questions & Answers
Date: Thursday, 14 October 2021 | 14:00h GMT (London, Lisbon) | 15:00h CEST (Berlin, Paris)
Duration: 60 Minutes | If the time does not fit for you, register anyway and we will send you the link to the recording.