Back EDQM Training Module 5: Fundamentals of the CEP Procedure

EUROPEAN PHARMACOPOEIA 09/12/2024 ON-DEMAND WEBINAR
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EDQM Training Module 5: Fundamentals of the CEP Procedure

This module gives a general presentation of the CEP procedure. The background and scope of the CEP procedure is explained in detail, and a comparison with the Active Substance Master File (ASMF) procedure is made. The second part of the module provides tools and tips on how to read a CEP and understand its content, and gives details on how to use it in a marketing authorisation application. This part also addresses address the recently implemented CEP 2.0. The recording includes a Q&A session.  

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Target audience

The module is of interest to all individuals involved in drug development, R&D, pharmaceutical quality assurance and quality control, as well as those working in regulatory affairs.

It is ideal for anyone looking to build a solid foundation knowledge of both the Ph. Eur. and the CEP Procedure, such as recent graduates or early-career professionals.

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Duration: 1 hour, 50 minutes.

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Suggested viewing and reading

The EDQM recommends participants watch and read the pre-training materials listed below before joining a training module. The materials will help participants familiarise themselves with some basic concepts and topics which will not be covered in detail in the webinar sessions.

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