Did you know that a revised version of the EDQM guideline “How to read a CEP” has recently been released? Would you like to learn more about the content of a CEP? How much do you know about the differences between the three CEP formats (CEP 2.0, Hybrid CEP and old-format CEP)?
Get answers to these questions and many more! The agenda included presentations on the content of a CEP and how to read it, and on a quality assessor’s point of view on how best to use a CEP in marketing authorisation applications in Europe.
The presentation was followed by a Q&A session.
Target audience
This webinar is of interest to CEP applicants, holders and users, including manufacturers and competent authorities.
Register to watch the recording
Duration : 2 hours, 4 minutes
Download the presentations
- How to read a CEP - Nimet FILIZ
- How to use a CEP in MAA/MAV - Olaf LUDEK
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