Back Module 5: Fundamentals of the CEP Procedure

Certification 9 December 2024 - 10:00-11:45 (CET, France) live webinar
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Module 5: Fundamentals of the CEP Procedure

This module will give a general presentation of the CEP Procedure. The background and scope of the CEP Procedure will be explained in detail, and a comparison with the Active Substance Master File (ASMF) procedure will be made. The second part of the module will provide tools and tips on how to read a CEP and understand its content, and give details on how to use it in a marketing authorisation application. This part will also address the recently implemented CEP 2.0.

The presentations will be followed by a live Q&A session.

Programme (subject to change):

10:00-10:30 General overview of the CEP Procedure

10:30-11:15 Use of a CEP

11:15-11:45 Live Q&A session

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