EDQM Virtual Training Programme: independent modules on Ph. Eur., Reference Standards and CEP Procedure
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.
Focus on chemically defined active substances and medicinal products.
Learn more about the Ph. Eur. policy on impurity control.
Learn about chemical reference standards used in conjunction with Ph. Eur. monographs and general chapters.
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.
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.
This module covers in detail how to control impurities in active substances in the context of a CEP application.
This module provides information on how EDQM inspections for API manufacturers are organised, conducted and followed up.
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