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Making a significant difference – 2023 EDQM annual report published in new engaging digital format
The European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe has published its 2023 annual report. For the first time, the report is completely digital, with a new, intuitive design and interactive features, facilitating your discovery journey and making it...
New general chapter on Extractable elements in plastic materials for pharmaceutical use (2.4.35) adopted
With the implementation of the ICH Q3D guideline on elemental impurities, the control of elemental impurities has undergone a shift in paradigm, moving away from pure substance-based testing towards a holistic control strategy at the medicinal product level. Parts of the Introduction and Scope of...
Call for abstracts for the EDQM Blood Conference – Innovation in Blood Establishment Processes
The EDQM Blood Conference entitled “Innovation in Blood Establishment Processes” will take place in Strasbourg, France, on 14 and 15 January 2025. Do you deal with topics related to blood donation and blood component processes in your professional activity? Why not take an active part in...
European Paediatric Formulary: Amiodarone hydrochloride capsules (5 mg-200 mg) monograph in public consultation
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just released Issue 9 of Pharmeuropa PaedForm, containing the 11th monograph of the PaedF Working Party, Amiodarone hydrochloride capsules (5 mg-200 mg) for public consultation. The deadline for comments is 30 September...
Certification monthly report of activities: End of May 2024
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of May 2024 Certification Monthly Report For more information, access the Certification Database.
Pharmacopoeial Discussion Group achievements
The Pharmacopoeial Discussion Group (PDG) held its interim videoconference on 15 April 2024. The primary topic of the meeting was the lessons learned from the PDG expansion pilot programme that was launched in 2022 and ended in October 2023 with the inclusion of the Indian Pharmacopoeia...
5 new Ph. Eur. reference standard and 13 replacement batches released in May 2024
New Ph. Eur. reference standards and Replacement batches for Ph. Eur. reference standards Distribution quota Removal Future removal Change of sales units Information on change of amount per unit Information on change of price Change of EDQM storage/shipping conditions Information on International...
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....
30th anniversary of the OMCL Network – Celebrating the success of international collaboration for safe medicines at the 29th GEON meeting
The 29th Annual Meeting of the General European Official Medicines Control Laboratories Network (GEON) was held from 13 to 17 May 2024 in Ohrid (North Macedonia). Over 230 participants representing 63 official medicines control laboratories (OMCLs) from 38 countries attended this meeting, which...
Save the date – Get ready to join our webinar on 12 November 2024
BINACLE Assay for Tetanus Neurotoxin: Outcomes of Collaborative Study 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...
NEW 4th Training Course on Quality Management for Tissue Establishments
A robust quality management system (QMS) is key to ensuring the efficacy, quality and safety of tissues and cells for human application. Tissue establishments (TEs) need to implement a QMS to ensure that tissues and cells for human application comply with the applicable technical and legal...
Draft guideline on ‘Content of the dossier for sterile substances’ released for public consultation
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has drafted a guideline ‘Content of the dossier for sterile substances’ (PA/PH/CEP (23) 54). The draft document is now available for public consultation in the consultation space. The consultation deadline for this document...
European Pharmacopoeia Supplements 11.6 to 11.8 – 2025 subscriptions now open!
The 2025 subscriptions to the European Pharmacopoeia (Ph. Eur.), including the Supplements 11.6 to 11.8, are now available for purchase in the WebStore of the European Directorate for the Quality of Medicines & HealthCare (EDQM). Two subscription formats are available. Both include access to all...
Cosmetics – Joint meeting of OCCL Network and CD-P-COS
The 13th meeting of the Network of Official Cosmetics Control Laboratories (OCCLs) was held in Strasbourg on 19 and 20 March 2024. This joint session brought together network members and experts from the European Committee for Cosmetics and Consumer Health (CD-P-COS). Participants from 26...
Public consultation on new general texts on mRNA vaccines in Pharmeuropa 36.2
The European Pharmacopoeia (Ph. Eur.) is seeking stakeholder feedback on a series of three new general texts on mRNA vaccines, published in this quarter’s issue of Pharmeuropa 36.2 for comment. The mRNA vaccine field has developed rapidly in the past few years and continues to evolve into an...
Public consultation on new general chapter on High-throughput sequencing for the detection of viral extraneous agents in Pharmeuropa 36.2
The European Pharmacopoeia (Ph. Eur.) is seeking stakeholder feedback on its new general chapter, HTS for the detection of viral extraneous agents (2.6.41), published in this quarter’s issue of Pharmeuropa (36.2) for comment. High-Throughput Sequencing (HTS, also known as Next-Generation...
Specialist - Nuclear magnetic resonance (NMR)
Grade: A1/2 Salary: from €5 536 to €7 074 per month (gross) Location: Strasbourg (France) Reference: Vacancy Notice n° e25/2024 Deadline for applications: 27/05/2024 Apply here Do you have practical/hands-on laboratory experience of nuclear magnetic...
Public consultation on Traceability of Medicines in Hospital Settings
The European Directorate for the Quality of Medicines & HealthCare is seeking comments from interested parties on a draft guidance document on the topic of “Traceability of Medicines in Hospital Settings”. The objective of this project is to provide regulatory authorities and stakeholders with a...
Certification monthly report of activities: End of April 2024
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of April 2024 Certification Monthly Report For more information, access the Certification Database.
Don’t miss your chance to comment: HPTLC fingerprinting in two monographs on homoeopathic preparations
The first two monographs, Calendula for homoeopathic preparations (2492) and Chamomilla for homoeopathic preparations (2493), resulting from the pilot study on the use of semi-quantitative high-performance thin-layer chromatography (HPTLC) fingerprinting for homoeopathic preparations containing...
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