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 will provide 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 recently implemented CEP 2.0.
The recording includes a Q&A session.
Download the virtual training agenda.
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.
Register to watch the recording
Duration: 1 hour, 36 minutes
Download the presentation
Other Events / Training Sessions

