In close collaboration with Extedo, Archemin organises an “e-CTD manager” training. EXTEDO’s eCTD manager is an off-the-shelf electronic submission management solution that satisfies your requirements for eCTD and non-eCTD submissions, whether electronic or paper.
The training will be given by an Extedo expert and will be held at the Archemin offices in Mechelen.
It will be a practical and interactive session with a focus on the following key topics:
- Elementary terminology
- EU M1 v. 3.0.1 (same structure as 3.0.3), the upgrade of submissions from EU M1 v. 2.0
- Creation of dossier including addition of “electronic Application Form”
- Submission of lifecycle
- Creation of hyperlinks •Export/import eCTD of submissions
- MRP/DCP principles and tools
- NeeS vs eCTD
- IMP - Investigational Medical Products
- Additional functionalities (document viewer, tools on document level, reviewing,…)
Target audience: Regulatory Affairs managers and Regulatory Affairs Officers who already have a sound theoretical and practical background and who wish to progress within their profession. The training is intended both as an initial and as a refresher training.
For more details and in case of questions, please contact ra [at] archemin.eu.