EDQM Virtual Training Programme: independent modules on Ph. Eur., Reference Standards and 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.
EDQM Training Module 3: Impurity Control in the Ph. Eur.
Learn more about the Ph. Eur. policy on impurity control.
EDQM Training Module 4: Ph. Eur. Reference Standards
Learn about chemical reference standards used in conjunction with Ph. Eur. monographs and general chapters.
EDQM Training Module 5: Fundamentals of the CEP Procedure
The background and scope of the CEP procedure is explained, as well as details on how to read a CEP and use it in a MAA application.
EDQM Training Module 6: Building successful CEP dossiers
This module is intended to help applicants to improve the quality of their dossiers. It also explains the basic principles for preparing a revision application.
EDQM Training Module 7: Control of impurities: CEP approach
This module covers in detail how to control impurities in active substances in the context of a CEP application.
EDQM Training Module 8: The EDQM Inspection Programme
This module provides information on how EDQM inspections for API manufacturers are organised, conducted and followed up.
Suggested Viewing/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: 30 minutes
- General concepts in the European Pharmacopoeia - Duration: 30 minutes
- How to participate in the Elaboration of the European Pharmacopoeia - Duration: 20 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: 20 minutes
- The Certification procedure: Fact sheet
Collaboration, Innovation and Scientific Excellence: the European Pharmacopoeia 11th Edition
