e-Learning Resources
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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...
Joint EDQM-EPAA Event: The future of pyrogenicity testing: phasing out the rabbit pyrogen test
An international event on the future of pyrogenicity testing and an update on the scientific progress in the quest to deliver alternative and humane methods. Includes a training session on the MAT.
Microbiological Risk of Contamination Assessment tool for tissues and cells. All you need to know about the MiRCA tool.
The procurement, processing, storage and distribution of human tissues and cells (TC) intended for human application must comply with the highest standards of quality and safety, aligned with the current regulatory framework and the latest evidence-based scientific requirements, in order to...
Council of Europe Resolution on the implementation of pharmaceutical care - Implementation of pharmaceutical care in community and hospital pharmacy settings
This webinar explains the content and added value of the above resolution which defines a framework for promoting and implementing the concept of pharmaceutical care in national healthcare systems and daily practice.
Refresher on How to submit a revision application and gain rapid acceptance of proposed changes: Reminders and Updates!
This webinar is aimed at holders of a Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP). Experienced EDQM CEP Assessors explain how to maintain the validity of a CEP once it has been granted, and attendees are advised on what to include in a revision application...
Transplantation (EODD 2022)
Each year, the EDQM (Council of Europe) celebrates the European Day for Organ Donation and Transplantation (EODD) with the aim of drawing public attention to organ donation and transplantation.
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