Online training
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...
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...
EDQM upgrades CombiStats to web version
CombiStats is getting an upgrade. The new version of this powerful statistical analysis tool for data from biological dilution assays or potency assays, maintained by the European Directorate for the Quality of Medicines & HealthCare (EDQM), will be launched as a web application on 4 July 2024....
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.
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.
Conference: Collaboration, Innovation and Scientific Excellence: the European Pharmacopoeia 11th Edition
This hybrid conference brought together leading experts in the quality of medicines to exchange their views and share their experiences, with the objective of gathering feedback on how best to tackle future challenges.
Training: Quality Management for Tissue Establishments
Within the framework of the Grant Agreement between the European Commission and the EDQM/Council of Europe, this training course was organised to provide tissue establishments in Europe with the tools required for the successful implementation of a quality management system (QMS).
Prospective harmonisation of quality standards: A model for pharmacopoeial convergence
This webinar explains how the Ph. Eur. and the USP work together to align their quality standards for selected active substances and medicinal products that are not yet available in either pharmacopoeia. It also highlights the benefits and advantages of this collaboration.
Supporting contingency and emergency planning for blood
The EDQM has developed practical tools to assist European countries in establishing or strengthening contingency and emergency plans for blood supply. Learn more about the Blood Supply Contingency and Emergency Plan (B-SCEP)...
Getting the big picture: what has changed in the Ph. Eur. General Notices
This webinar provides an overview of the revised version of the Ph. Eur. General Notices (as of Supplement 10.7).
How to communicate efficiently with the EDQM on CEP applications
This webinar covers the new electronic application forms (eAF), advice on their completion as well as how the new DCEP IT sharing tool should be used.
Webinar: Data Particulate contamination in parenteral preparations: what’s new in the Ph. Eur.? Are monoclonal antibodies a special case?
This webinar covers the major changes made to the general monograph, in particular where the testing and evaluation of particulate contamination is concerned. It also provides an insight into the draft general monograph on Monoclonal antibodies for human use (2031) that has been revised to bring...
Training: Quality Management for Tissue Establishments
Within the framework of the Grant Agreement between the European Commission and the EDQM/Council of Europe, this training course was organised to provide tissue establishments in Europe with the tools required for the successful implementation of a quality management system (QMS).
Training Course on Biovigilance for Tissues and Cells
Training course on biovigilance and on reporting of Serious Adverse Reactions and Events (SARE) in the field of tissues and cells organised within the framework of the Grant Agreement between the European Commission and the EDQM/Council of Europe.
Webinar: the Council of Europe Resolution on good reconstitution practices - A major contribution to the safety of patients receiving reconstituted medicines
This webinar provides some practical examples of how the provisions set out in the resolution can be transposed into national legislation and implemented in a hospital pharmacy setting.
Approaches for CEPs and the Ph. Eur. strategy with regard to nitrosamine control: current guidance and practical implementation
This webinar provides an update and detailed overview of the approaches for CEPs and the Ph. Eur. strategy with regard to controlling these impurities.
Webinar: Using recombinant factor C for bacterial endotoxin testing in the European Pharmacopoeia: how far have we come, how far have we to go?
This webinar is aimed at facilitating understanding of the Ph. Eur. approach to the use of recombinant factor C (rFC) as a reagent for bacterial endotoxin testing.
Workshop Webinars: Quality Control of Veterinary Vaccines
The EDQM, in collaboration with the EPAA and JRC, organised a virtual workshop (webinar sessions) on ‘Novel in vitro model as alternative to in vivo toxoid vaccines testing: Clostridium septicum vaccine as a proof of concept’.
Webinar: Data Protection in the Blood Sector - Impact & Challenges for Blood Establishments
This webinar covers data protection and how it applies to blood transfusion; the responsibilities, challenges and strategies used by blood establishments in managing the various types of data they process.
Webinar: N-Nitrosamine impurities: Latest update on the Ph. Eur. approach
Focus on the new general chapter on the analysis of N-nitrosamine impurities in active substances.
