EDQM Virtual Training Programme: independent modules on the Ph. Eur., reference standards and the CEP Procedure
EDQM Training Module 1: General methods, general chapters & general monographs
This module starts with a walk-through of the structure of the Ph. Eur. and explains the scope and correct use of General Monographs and Dosage Form Monographs as well as General Chapters.
EDQM Training Module 2: Individual monographs - Focus on chemically defined active substances and medicinal products containing chemically defined active substances
This module provides an overview of the general principles, explains the link between individual and general monographs and general chapters, and the structure of monographs.
EDQM Training Module 3: Impurity Control in the Ph. Eur.
In this module, you will learn more about the Ph. Eur. policy on impurity control.
EDQM Training Module 4: Ph. Eur. Reference Standards
In this module, you will learn about 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. Its background and scope is explained in detail, and a comparison with the ASMF procedure is made. It also provides tools and tips on how to read a CEP and understand its content.
EDQM Training Module 6: Building successful CEP dossiers
This module explains how to build a good application for a new CEP and how to avoid deficiencies in order to facilitate and speed up the granting of a CEP.
EDQM Training Module 7: Building successful CEP revision applications
This 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 addres 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 joining a training module. The materials will help participants familiarise themselves with some basic concepts and topics which will not be 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 Pharmeuropa, the Knowledge database & Ph. Eur. Online: Useful hints and other practicalities - Duration: 25 minutes
- Ph. Eur. Reference Standards: General Aspects - Duration: 22 minutes
- CEP at a glance
