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 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. The recording includes a Q&A session.
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, for example, newly graduated or early-career professionals.
Duration: 1 hour, 30 minutes.
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