Individual monographs are the core texts of the Ph. Eur., covering active substances, excipients and also medicinal products. This module provides an overview of the general principles, the link between individual and general monographs and general chapters, and the structure of monographs on active pharmaceutical ingredients (APIs), excipients and medicinal products containing chemically defined active substances. It describes the different sections of individual monographs with a focus on the policy for medicinal product monographs (including titles and the dissolution test).
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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, 06 minutes
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Other Events / Training Sessions
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