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
EDQM Training Module 2: Focus on chemically defined active substances and medicinal products
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
EDQM Training Module 6: Building successful CEP dossiers
EDQM Training Module 7: Control of impurities: CEP approach
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 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: 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
Joint EDQM-EPAA Event: The future of pyrogenicity testing: phasing out the rabbit pyrogen test
