EDQM Virtual Training Programme: independent modules on the Ph. Eur., reference standards and the CEP Procedure
EDQM Training Module 1: General methods, general chapters and general monographs
This module opens with a walk-through of the structure of the Ph. Eur., recalling the general underlying concepts, including the General Notices.
EDQM Training Module 2: Individual monographs - Focus on chemically defined active substances and medicinal products containing them
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.
EDQM Training Module 3: Impurity Control in the Ph. Eur.
Dans ce module, vous en apprendrez plus sur les étalons de référence chimiques utilisés en association avec les monographies et chapitres généraux de la Ph. Eur.
EDQM Training Module 4: Ph. Eur. Reference Standards
This module, you will learn about the chemical reference standards used in conjunction with Ph. Eur. monographs and general chapters.
EDQM Training Module 5: Fundamentals of the CEP Procedure
This module gives a general presentation of the CEP Procedure.
EDQM Training Module 6: Building successful CEP dossiers: new applications
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.
EDQM Training Module 7: Building successful CEP revision applications
The module includes an introduction to the EDQM Guideline for revisions, provides the basic principles for maintaining a CEP and requirements for the content of a revision application, as well as the changes linked to the implementation of CEP 2.0.
EDQM Training Module 8: Control of impurities: CEP approach
This module addresses in detail how to control impurities in active substances in the context of a CEP application.
EDQM Training Module 9: The EDQM inspection programme
This module provides information on how EDQM inspections for API manufacturers are organised, conducted and followed up.
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
