In the last months, the eCTD format became mandatory for CEP submissions to the EDQM and for DMFs for Health Canada.
Therefore we decided to offer this complimentary webinar, which is focussed on Active Pharmaceutical Ingredient (API) manufacturers.
Frank Dickert (Business Consultant, EXTEDO) will explain what a CEP is, how it can be submitted to the EDQM via the CESP portal and he will highlight the advantages compared to ASMF/DMF.
He will show, how a CEP and a DMF in eCTD format can be easily created using EXTEDO's eCTDmanager submission management software.
Following the presentation, Frank will answer your questions in the Q&A session.
1. EXTEDO Corporate Intro
2. Mandatory eCTD submissions for CEP and CA DMF
- What is a CEP?
- Submission to EDQM via CESP
- CEP in eCTD
- CEP compared to ASMF/CA DMF
3. eCTDmanager demo: How to create a CEP / CA DMF in eCTD format
4. Q&A Session
Details and Registration
Tuesday, 23 June 2020
09:00 am BST (London, Lisbon)
10:00 am CEST (Madrid, Berlin)
01:30 pm IST (Mumbai)
04:00 pm CST (Beijing)
Duration: 40 Minutes
Participation is free of charge. Register at https://register.gotowebinar.com/register/1048880624501398283