Pharmeuropa 34.3 just released

EDQM 07/07/2022 Strasbourg, France

All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 34.3 is 30 September 2022. Users and interested parties are welcome to comment on these drafts. It...

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Implementation of the 11th Edition of European Pharmacopoeia – Notification for CEP holders

EDQM 07/07/2022 Strasbourg, France

The 11th Edition of the European Pharmacopoeia (Ph. Eur.) is now available. Holders of Certificates of suitability to the monographs of the Ph. Eur. (CEPs) are invited to update their applications according to the revised monographs that will be implemented on 1 January 2023, and to follow the...

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CEP holders invited to comment on draft monographs published in Pharmeuropa 34.3

EDQM 05/07/2022 Strasbourg, France

Holders of Certificates of suitability to the monographs of the European Pharmacopoeia (CEPs) are requested to consult the list of substances for which draft revised monographs of the European Pharmacopoeia (Ph. Eur.) have been published in Pharmeuropa 34.3. The table below lists the substances...

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Revision of Heparin sodium (0333) and Heparin calcium (0332) monographs – feedback required

EDQM 30/06/2022 Strasbourg, France

First published in the 1980s, the monographs on unfractionated heparin are some of the earliest texts of the European Pharmacopoeia (Ph. Eur.). Since then, significant effort has been expended by the Ph. Eur. experts to regularly revise these texts, with the most significant series of revisions...

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OMCL Annual Meeting 2022: European Strategies for Work Sharing and Collaboration in Testing of Medicines

EDQM 29/06/2022 Strasbourg, France

The 27th Annual Meeting of the European Network of Official Medicines Control Laboratories (OMCLs) was held from 13 to 17 June 2022 at the Council of Europe, in Strasbourg (France). Over 230 participants – from 36 countries and representing 60 OMCLs – attended this meeting organised by the...

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Pharmacopoeial Discussion Group videoconference meeting

EDQM 28/06/2022 Strasbourg, France

The Pharmacopoeial Discussion Group (PDG), which brings together the European Pharmacopoeia, the Japanese Pharmacopoeia and the United States Pharmacopeia with WHO as observer, held its interim videoconference in two sessions on 15 and 28 March 2022. During this videoconference, the PDG discussed...

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BSP study publication: Somatropin/desamidosomatropin resolution mixture CRS 2

EDQM 27/06/2022 Strasbourg, France

An article on the outcome of the Biological Standardisation Programme (BSP) study for the establishment of the European Pharmacopoeia (Ph. Eur.) Somatropin/desamidosomatropin resolution mixture Chemical Reference Substance batch 2 is now available free online. The article has been published in...

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Call for experts: join the Ph. Eur. network

EDQM 23/06/2022 Strasbourg, France

Quality control of inorganic substances and synthetic and semi-synthetic organic substances

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EDQM ISO 9001:2015 certification renewed

EDQM 24/06/2022 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) successfully obtained the renewal of its certification according to the ISO 9001:2015 standard from the AFNOR certification body, confirming the compliance of the Quality Management System of the EDQM with this standard....

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NEW 5th European Training Course on Quality Management for Blood Establishments

EDQM Registration closing date: 15 July 2022 online

The European Directorate for the Quality of Medicines & HealthCare (EDQM)/Council of Europe (CoE) is organising a FREE training course on audit practices for blood establishments, with the support of the European Commission. Auditing, in addition to being a key driver in the continual improvement...

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Pharmeuropa Bio & Scientific Notes now accessible without registration

EDQM 14/06/2022 Strasbourg, France

Pharmeuropa Bio & Scientific Notes, a free online journal of the European Directorate for the Quality of Medicines & HealthCare (EDQM) indexed in Medline/PubMed®, can be consulted without prior registration as of 13 June 2022. The journal seeks to disseminate knowledge on methods of analysis...

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2021 Highlights – EDQM annual report now available

EDQM 14/06/2022 Strasbourg, France

Download: 2021 Highlights – EDQM annual report The 2021 annual report of the European Directorate for the Quality of Medicines & HealthCare (EDQM) is now available, providing a comprehensive overview of its activities and achievements. New to this edition is a four-page summary of key facts and...

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New option for shipments to Ukraine and the Republic of Moldova

EDQM 13/06/2022 Strasbourg, France

The EDQM is now able to offer a new option for shipments to Ukraine and the Republic of Moldova. Ukrainian and Moldovan users will receive a dedicated e-mail explaining how to proceed. If you would like more information, please contact us through our HelpDesk.

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Certification monthly report of activities: End of May 2022

EDQM 08/06/2022 Strasbourg, France

The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of May Certification Monthly Report For more information, access the Certification Database.

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OMCLs participate in international regulatory collaboration on the analysis of nitrosamines in metformin‑containing medicines

EDQM 31/05/2022 Strasbourg, France

In 2020, batches of metformin-containing medicines were recalled because they contained N-nitrosodimethylamine (NDMA), a probable human carcinogen, above the acceptable daily intake (AI) of 96 ng/day. Prior to the recalls, Official Medicines Control Laboratories (OMCLs) from the OMCL Network...

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Register now for our upcoming training programme on the Ph. Eur., reference standards and CEPs

EDQM 31/05/2022 Strasbourg, France

8 independent modules – 8 topics – 8 Q&A sessions – All LIVE! This 100% virtual training will focus on chemically defined active substances and cover all the fundamentals related to the use of the European Pharmacopoeia and its reference standards, as well as the procedure for Certification of...

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Temporary job offer: Assistant

EDQM 23/05/2022 Strasbourg, France

Salary: from €2 460 (netto/month) Contract type: temporary (until end of 2022, renewable in 2023) Place: Strasbourg (France) We're looking for several individuals to operate secretarial duties, highly motivated and who can quickly slot in to our existing structure and immediately operate...

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Call for experts: join the Ph. Eur. network!

EDQM 06/04/2022 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) is seeking independent scientific experts to join its groups of experts and working parties. Professionals from national authorities (e.g. pharmacopoeial authorities, official medicines control laboratories, licensing authorities and inspectorates), the...

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Ph. Eur. Commission adopts first “horizontal standard” for monoclonal antibodies

EDQM 18/05/2022 Strasbourg, France

At its 172nd session in March 2022, the European Pharmacopoeia (Ph. Eur.) Commission adopted a new general chapter, Cell-based assay for potency determination of TNF-alpha antagonists (2.7.26), the first of three planned new horizontal standards for monoclonal antibodies (mAbs). The adoption of...

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European Pharmacopoeia 11th Edition (11.0-11.2) – Subscriptions now open!

EDQM 26/04/2022 Strasbourg, France

The 2023 subscriptions to the European Pharmacopoeia (Ph. Eur.), including the initial release (11.0) and the first two supplements (11.1-11.2), are now available for sale in the WebStore of the European Directorate for the Quality of Medicines & HealthCare (EDQM). Subscribers may choose either...

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