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Joint EDQM-AESAN symposium on “Recent developments in food contact materials and articles”
Joint symposium organised by the EDQM and the Spanish Agency for Food Safety and Nutrition (AESAN) covering the latest updates in the field of food contact materials and articles (FCMs).
Introduction to CombiStats web application
CombiStats is a computer programme for the statistical analysis of data from biological dilution assays or potency assays. The software was developed at the EDQM and can perform calculations according to Chapter 5.3 of the European Pharmacopoeia (10th Edition). This webinar presents the new...
CEP 2.0: Fresh feedback from stakeholders
The CEP 2.0 was rolled-out in September 2023 to better meet the current needs of stakeholders (enhanced user-friendliness and greater transparency of the information conveyed). The EDQM has invited CEP holders and users to participate in a public webinar to share their experiences on the use of...
Joint EDQM-USP webinar on “Ethylene glycol and diethylene glycol testing”
Ethylene glycol (EG) and diethylene glycol (DEG) contamination has been discovered in several medicinal products in African and Asian countries over the last 2 years (see WHO alerts). For example, confirmed cases of propylene glycol adulterated with EG led to over 190 fatalities in Indonesia.1 In...
2024 EDQM Virtual Training Programme: 4 independent modules on European Pharmacopoeia texts related to Biologicals and on Microbiology chapters
4 modules covering Biologicals and Microbiology Ph. Eur. Chapters as well as Ph. Eur. Reference standards for biologicals.
Webinar on new general chapter Comparability of alternative analytical procedures (5.27)
A new general chapter on Comparability of alternative analytical procedures (5.27) has been published in Supplement 11.5 of the European Pharmacopoeia (Ph. Eur.) in January 2024. While this text does not introduce any new requirements, it does provide valuable information on how users wishing to...
Webinar on the new Ph. Eur. Cannabis flower monograph (3028)
The new monograph Cannabis flower (3028) was adopted at the 176th session of the European Pharmacopoeia (Ph. Eur.) Commission in June 2023. It will be published in Ph. Eur. Supplement 11.5 and will become the legally binding standard in Europe for cannabis flower on 1 July 2024. In response to...
Anti-D Immunoglobulin: Exploring collection, production and alternatives
When a mother with RhD-negative blood is pregnant with a baby that has RhD-positive blood, there is a risk her immune system will create antibodies that go on to attack the red blood cells of her next RhD-positive baby. This is known as “Rhesus Disease”, which can have serious and potentially...
Joint EDQM-USP Webinar on “Secondary standards - Considerations in traceability to pharmacopeial standards"
Information to help users reduce the risks and avoid pitfalls when using secondary standards.
EDQM Training Module 1: General methods, general chapters & general monographs
EDQM Training Module 2: 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
This module gives a general presentation of the CEP procedure. The background and scope of the CEP procedure is explained in detail, and a comparison with the Active Substance Master File (ASMF) procedure is made. The second part of the module provides tools and tips on how to read a CEP and...
EDQM Training Module 6: Building successful CEP dossiers
The first part of this module explains how to build a good application for a new CEP and how to avoid deficiencies. The module is based on the top 10 most frequently asked questions after the initial evaluation of new CEP applications, along with expectations and recommendations on how to...
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. The participants receive information to facilitate efficient preparation for the inspection, in particular with regard to obligations/communications ahead of time. An...
The CEP 2.0 – Webinar for CEP holders and CEP users
In 2020, the European Directorate for the Quality of Medicines & HealthCare (EDQM) launched the “CEP of the future” project to design a “new-look” CEP to better meet the current needs of stakeholders, offer enhanced user-friendliness and provide greater information transparency. This project is...
European Pharmacopoeia: specific chapters for herbal substances, herbal preparations and herbal medicinal products.
This webinar is designed to provide participants with detailed knowledge and understanding of the relevant European Pharmacopoeia texts in the field of herbal medicinal products. It presents the general structure of the different general texts and general monographs and explains their...