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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...
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 1: General concepts. Biotherapeutics and ATMPs
This module begins with a review of the structure of the Ph. Eur., recalling the general underlying concepts, including the General Notices. It covers new and recently revised general chapters and texts that are relevant to biologicals ...
2024 EDQM Virtual Training Programme: European Pharmacopoeia texts related to Biologicals and on Microbiology chapters - Module 2: Plasma-derived products and vaccines for human use
This module focuses on plasma-derived products, the associated class and individual monographs, and the recent revisions made with a view to continuously improving the quality and safety of these biological products.
2024 EDQM Virtual Training Programme: European Pharmacopoeia texts related to Biologicals and on Microbiology chapters - Module 3: Ph. Eur. Reference standards for biologicals
In this module, you will learn about reference standards used in conjunction with Ph. Eur. monographs and general chapters to ensure the quality of biologicals. It covers the basis of their scientific establishment, provides additional information on their use and address questions that you...
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...
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
