The first part of this module explains how to build a good application for a new CEP and avoid deficiencies in order to facilitate and speed up the granting of a CEP.
The module is based on the recently revised EDQM guideline “Content of the dossier for chemical purity and microbiological quality”, the use of SPOR OMS_IDs for companies and other essential documents such as the QOS template and “top 10 deficiencies”.
This module also addresses the preparation of sections 3.2.S.4.1 and 3.2.S.4.2 in line with CEP 2.0.
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.
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Duration: 1 hour, 30 minutes
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Other Events / Training Sessions
- EDQM Virtual Training Programme: independent modules on the Ph. Eur., reference standards and the CEP Procedure
- How to read a CEP webinar
- Sterile substance CEP webinar
- Everything you've always wanted to know about the certification (CEP) procedure
On-Demand Webinars
Suggested viewing and reading
The EDQM recommends participants watch and read the pre-training materials listed below before watching a training module. The materials will help participants familiarise themselves with some basic concepts and topics which are not covered in detail in the webinar sessions.
- European regulations for medicines: Place and role of the EDQM and the European Pharmacopoeia (Ph. Eur.) - Duration: 27 minutes
- General concepts in the European Pharmacopoeia - Duration: 28 minutes
- How to participate in the elaboration of the European Pharmacopoeia - Duration: 24 minutes
- Find your way in the new Ph. Eur. Online platform: new features, advanced navigation and efficient searching - Duration: 51 minutes
- Find your way in Pharmeuropa – Duration: 12 minutes
- Find your way in the Knowledge database – Duration: 6 minutes
- Ph. Eur. Reference Standards: General Aspects - Duration: 22 minutes
- CEP at a glance
Suggested viewing and reading