EN FR

Scientific Assistant – Scientific Procurement

EDQM Deadline for applications: 10 April 2024 Strasbourg, France

We are looking for a motivated and dynamic candidate who is able to quickly adapt to our established structures and be immediately operational at the level required for this post.

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EN FR

How CEP holders can avoid the rejection of notifications

EDQM 28/03/2024 Strasbourg, France

In order to facilitate the acceptance of proposed changes in a timely manner, CEP holders are reminded that the European Directorate for the Quality of Medicines & HealthCare (EDQM) Guideline on requirements for revision/renewal of Certificates of Suitability to the European Pharmacopoeia...

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EN FR

First OMCL analytical procedures for determination of nitrosamine drug substance-related impurities (NDSRIs) and intermediate-related contaminants published

EDQM 28/03/2024 Strasbourg, France

The official medicines control laboratories (OMCLs) of the General European OMCL Network (GEON) began developing procedures for the determination of N-nitrosamine contaminants in 2018. The resulting procedures have been published for information on the website of the European Directorate for the...

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EN FR

Public Procurement Assistant

EDQ|M Deadline for applications: 10/04/2024 Strasbourg, France

We are looking for a motivated and dynamic candidate who is able to quickly adapt to our existing structures and be immediately operational at the level required for this post.

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EN FR

29 March to 1 April 2024

Public holiday: EDQM offices closed from Friday 29 March to 1 April 2024

Due to a public holiday in France, the European Directorate for the Quality of Medicines & HealthCare (EDQM) will be closed from Friday 29 March to Monday 1 April 2024.

Normal business hours will resume on Tuesday 2 April 2024.

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EN FR

Head of Publications Section

EDQM Deadline for applications: 15/04/2024 Strasbourg, France

Do you have the necessary experience in the publications sector and the skills required to oversee and co-ordinate the production of the EDQM’s scientific texts (both print and electronic) to a very high-quality standard?

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EN FR

Stakeholder consultation – New draft technical guide on FCM compliance

EDQM 19/03/2024 Strasbourg, France

Stakeholder consultation – New draft technical guide on FCM compliance A new draft technical guide on documentation supporting compliance and safety of food contact materials and articles is now open for comment. The European Directorate for the Quality of Medicines & HealthCare (EDQM) invites...

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EN FR

The template of Quality Overall Summary (QOS) to be submitted for Certification applications has been adapted to the current needs!

EDQM 25/01/2024 Strasbourg, France

A new version of the QOS template is now available. It may be used from January 2024 and will become mandatory as of April 2024. The QOS (eCTD Module 2) has to be provided along with an initial submission since it is essential in the review of a new CEP application. This updated template gives...

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EN FR

Certification monthly report of activities: End of February 2024

EDQM 05/03/2024 Strasbourg, France

The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of February 2024 Certification Monthly Report For more information, access the Certification Database.

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EN FR

Survey on strategy for Ph. Eur. quality standards for monoclonal antibodies

EDQM 06/03/2024 Strasbourg, France

In 2014, the European Pharmacopoeia Commission (EPC) launched a pilot phase on setting public standards for therapeutic monoclonal antibodies (mAbs) (“MAB pilot phase”). This pilot phase was intended to explore the feasibility of establishing individual monographs for multi-source mAbs, as well...

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EN FR

1 new Ph. Eur. reference standard and 15 replacement batches released in February 2024

EDQM 01/03/2024 Strasbourg, France

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...

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EN FR

Two new monographs published in European Paediatric Formulary

EDQM 29/02/2024 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has added two new monographs Clonidine hydrochloride 10 µg/mL oral solution and Furosemide 2 mg/mL oral solution, to the European Paediatric Formulary after a successful public consultation phase. The Formulary now...

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EN FR

Stakeholder consultation – Draft documents to support safe and correct use of herbal food supplements

EDQM 29/02/2024 Strasbourg, France

From 23 February 2024 to 5 April 2024, the European Directorate for the Quality of Medicines & HealthCare (EDQM) is undertaking a targeted consultation to seek the opinions of interested parties on a draft guidance document for healthcare professionals and a draft leaflet for patients/consumers...

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EN FR

Save the date: webinar on CEP 2.0

EDQM 26/02/2024 Strasbourg, France

The EDQM invites CEP holders and users to participate in a public webinar on the 9th April 2024 to share their experiences on the use of CEP 2.0. More info at: https://www.edqm.eu/en/cep-2-0-fresh-feedback-from-stakeholders

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EN FR

Certification monthly report of activities: End of January 2024

EDQM 09/02/2024 Strasbourg, France

The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of January 2024 Certification Monthly Report For more information, access the Certification Database.

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EN FR

Read the top 10 deficiencies observed in new CEP applications for chemical purity assessed in 2023 to improve the quality of your applications!

EDQM 08/02/2024 Strasbourg, France

This document is a summary of the top ten deficiencies identified after the initial evaluation of new applications for Certificates of Suitability (CEP) for chemical purity. The content of this document is intended to help applicants to build their application in conjunction with the EDQM...

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EN FR

EDQM’s ISO 9001:2015 certification maintained

EDQM 08/02/2024 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare’s (EDQM) ISO 9001:2015 certificate has been maintained following the second surveillance audit of its quality management system on 28 and 29 November 2023 by the official French standardisation body Association française de...

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EN FR

Save the date: EDQM conference celebrating 60 years of excellence in public health protection

EDQM 18/01/2024 Strasbourg, France

In 2024, the European Directorate for the Quality of Medicines & HealthCare (EDQM) is celebrating 60 years of excellence in the protection and promotion of public health. We are delighted to announce the organisation of a conference to mark this occasion, on 11 and 12 June 2024, in Strasbourg...

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EN FR

1 new Ph. Eur. reference standard and 29 replacement batches released in January 2024

EDQM 01/02/2024 Strasbourg, France

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...

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EN FR

BSP study outcome published in Pharmeuropa Bio & Scientific Notes – Human tetanus immunoglobulin BRP batch 2

EDQM 29/01/2024 Strasbourg, France

The outcome of the Biological Standardisation Programme study BSP140 to establish the European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for Human tetanus immunoglobulin batch 2 has been published in the online journal Pharmeuropa Bio & Scientific Notes of the European...

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