Including CMC requirements for marketing authorisation applications
Webcode 26122646
anytime
anytime
online
online
Event - 590€ plus tax
The fee for a single account that is valid for 90 days is €590 (excluding German VAT). You can access the modules as often as you want during this time. You will be awarded a certificate of completion at the end.
Event - 590€ plus tax
The fee for a single account that is valid for 90 days is €590 (excluding German VAT). You can access the modules as often as you want during this time. You will be awarded a certificate of completion at the end.
Jean-Marie Bayhurst
Conference Manager
+49 6221 500-685
j.bayhurst@forum-institut.de
Do you need know how regarding CTD/eCTD & CMC? Then this e-learning programme is the fast track to becoming knowledgeable in this field. No prior dossier experience is required.
This e-Learning programme will provide you with detailed knowledge on the structure and content of the (electronic) common technical document - the only valid dossier format for marketing authorisation applications for human pharmaceuticals in the ICH region.
It will address full as well as abridged dossier application formats, enabling participants to select the data necessary for each application type.
Module 3 requirements will be addressed in depth (drug substance and drug product data requirements).
This e-Learning was completely revised in August 2025.
