Archemin

Advice & reporting for the chemical and pharmaceutical industries

e-CTD manager training for Regulatory affairs Experts on March 20-21, 2018

Tue, 20/02/2018 - 4:51pm -- Ludwig Everaert

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.

datum: 
Tuesday, 20 February, 2018