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 the co-existence of CEP 2.0, “hybrid look” CEPs and “old look” CEPs and their respective contents. The recording includes a Q&A session.
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Target audience
The module is of interest to all personnel involved in drug development, R&D, pharmaceutical quality assurance and quality control, as well as those working in regulatory affairs.
It is ideal for those looking to build a solid foundation knowledge of both the Ph. Eur. and the Certification procedure, such as recent graduates or early-career professionals.
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Duration: 1 hour, 40 minutes.
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