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EDQM Training Module 9: The EDQM Inspection Programme
This module provides information on how EDQM inspections for API manufacturers are organised, conducted and followed up.
EDQM Training Module 8: Control of impurities: CEP approach
This module addres in detail how to control impurities in active substances in the context of a CEP application.
EDQM Training Module 7: Building successful CEP revision applications
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.
EDQM Training Module 6: Building successful CEP dossiers
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.
EDQM Training Module 5: Fundamentals of the CEP Procedure
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.
EDQM Training Module 4: Ph. Eur. Reference Standards
In this module, you will learn about chemical reference standards used in conjunction with Ph. Eur. monographs and general chapters.
EDQM Training Module 3: Impurity Control in the Ph. Eur.
In this module, you will learn more about the Ph. Eur. policy on impurity control.
EDQM Training Module 2: Individual monographs - Focus on chemically defined active substances and medicinal products containing chemically defined active substances
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.
Advancements in gene therapy: the European Pharmacopoeia’s new approach
Several gene therapy medicinal products (GTMPs) have been approved in recent years and it appears likely that ongoing clinical trials will result in more reaching the market. The European Pharmacopoeia Commission (EPC) has responded by defining a new approach to these promising and innovative...
EDQM Training Module 1: General methods, general chapters & general monographs
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.
CombiStats Online – Training
CombiStats is a software application developed by the EDQM to perform calculations as described in European Pharmacopoeia General Chapter 5.3. Statistical analysis of results of biological assays and tests. CombiStats Online was released on 4 July 2024. This brand new version offers a flexible...
Everything you've always wanted to know about the certification (CEP) procedure
The aim of this webinar was to facilitate the understanding of the Certification Procedure including its GMP inspection programme but also to share the difficulties encountered with the preparation of CEP applications, the use of CEPs, as well as with finding and interpreting EDQM guidance....
BINACLE Assay for Tetanus Neurotoxin: Outcomes of Project BSP136
The testing procedure in the European Pharmacopoeia (Ph. Eur.) for demonstrating the absence of tetanus toxin from toxoids used in the manufacture of both human and veterinary vaccines currently consists of an in vivo test in guinea pigs. In accordance with the 3Rs policy of the EDQM, project...
Joint EDQM-USP Webinar on “Overcoming obstacles in establishing pharmacopoeial reference standards: insights from case studies”
Real-world challenges and solutions in developing robust pharmacopoeial reference standards.
Pharmacopoeial Discussion Group (PDG) stakeholder event - The PDG is going global
Discover the latest PDG insights, recent milestones in its expansion programme, and global harmonisation efforts.
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: European Pharmacopoeia texts related to Biologicals and on Microbiology chapters - Module 4: Microbiology
In this module, we dive into the Ph. Eur. world of microbiology, starting with the conventional tests such as the test for sterility, the chapters for microbial examination of non-sterile products and the mycoplasma chapter. We then cover the field of rapid microbiological...
