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.

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. 

In this module, you will learn more about the Ph. Eur. policy on impurity control.

In this module, you will learn about chemical reference standards used in conjunction with Ph. Eur. monographs and general chapters.

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.

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.

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.

This module addres 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.

Discover the updated EDQM guideline on how to read a CEP, review the content of CEPs and get an assessor’s viewpoint for use of CEPs.

The PDF presentations cover the main functionalities and new features of CombiStats latest release.

Through a series of case studies, this webinar explores orthogonal analytical techniques used to thoroughly characterise pharmacopoeial reference standards.

Discover the latest updates and enhancements to our platform!

Tips to boost your application for a sterile substance CEP.

Explore the principles and benefits of using medication review (MR) to enhance patient care and to discover the different types of MR, implementation strategies and best practices across Europe.

This event provided an update on the latest developments in plasma supply in Europe.

Learn more about the new general monograph on Gene therapy medicinal products for human use (3186) and the accompanying general chapter, Additional information on gene therapy medicinal products for human use (5.34).

Opportunity for CEP holders and users to enhance their understanding of the CEP procedure

Learn more about the scientific background of the project, the collaborative studies conducted and how the findings could impact the Ph. Eur. monographs related to tetanus vaccines.

Experts from the USP and the European Pharmacopoeia delve into some of the real-world challenges they face when developing pharmacopoeial reference standards and discuss the solutions they deploy to ensure they are robust.