“Polypharmacy and ageing” – EDQM participation in ESCP symposium in Prague

EDQM 15/11/2022 Strasbourg, France

Representatives of the European Directorate for the Quality of Medicines & HealthCare (EDQM) participated in the 50th European Society of Clinical Pharmacy (ESCP) Symposium, entitled “Polypharmacy and ageing – individualized, person-centered care”, held in Prague from 19 to 21 October 2022....

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Full OCABR guideline for Pandemic COVID-19 vaccine, Inactivated, now available

EDQM 29/11/2022 Strasbourg, France

The guideline for Pandemic COVID-19 vaccine, Inactivated, in force since 4 May 2022, contains the list of tests to be carried out by an Official Medicines Control Laboratory (OMCL) for Official Control Authority Batch Release (OCABR). It has now been updated to include a model protocol for the...

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Scientific Programme Manager – Blood transfusion activities

EDQM Deadline for applications: 14/12/2022  Strasbourg, France

Grade: A1/2 Salary: €6 376 per month (A2 Grade) Contract Type: Renewable fixed term contract Location: Strasbourg (France) Reference: Vacancy Notice n° e46/2022 Deadline for applications: 14/12/2022 Are you a dynamic scientist specialised in the field of quality control, regulation or inspection...

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Contribute to shaping the future EDQM strategy – Stakeholder survey

EDQM 23/11/2022 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) is conducting a survey to seek the input of its stakeholders, including the (wider) public. Your input will help shape our upcoming four-year strategy (2024-2027) and contribute to ensuring the EDQM continuously meets your...

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EDQM order and shipment deadlines and end-of-year closure

EDQM 15/11/2022 Strasbourg, France

Order and shipment deadlines have been established for publications and reference standards, taking into account the closure of the European Directorate for the Quality of Medicines & HealthCare (EDQM) offices from 22 December 2022 (12 noon CET) to 2 January 2023 (8 a.m. CET). The dates by type...

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European Paediatric Formulary: Revised Phosphate Oral Solution monograph published

EDQM 15/11/2022 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just published the revised monograph Phosphate 60 mg/mL Oral Solution in the European Paediatric Formulary (PaedForm). This revised monograph (the first PaedForm text to undergo revision) was published in Issue 4 of...

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Certification monthly report of activities: End of October 2022

EDQM 08/11/2022 Strasbourg, France

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

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7 new Ph. Eur. reference standards and 14 replacement batches released in October 2022

EDQM 03/11/2022 Strasbourg, France

New Ph. Eur. reference standards Replacement batches for Ph. Eur. reference standards Removal Future removal Change of sales units Technical information Information on change of price Change of EDQM storage/shipping conditions See also: Content of the Ph. Eur. RS catalogue How to place an RS...

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The Council of Europe/EDQM and the European Union conclude an agreement expanding the scope of their co-operation in the field of substances of human origin

EDQM 28/10/2022 Strasbourg, France

The Council of Europe/European Directorate for the Quality of Medicines & HealthCare (EDQM) and the European Union (EU), through the European Commission, have concluded a new contribution agreement, with equal financing, which will run until 2024. This agreement further enhances their already...

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SAVE THE DATE! Joint EDQM–EPAA event on the future of pyrogenicity testing: phasing out the rabbit pyrogen test

EDQM 14 to 16 February 2023 Brussels, Belgium

In June 2021, the European Pharmacopoeia (Ph. Eur.) Commission took the decision to engage on a path that should ultimately lead to the complete replacement of the rabbit pyrogen test (RPT) in the Ph. Eur. within approximately 5 years. There are a number of Ph. Eur. texts – covering a variety of...

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“CEP of the future”: second project update

EDQM 21/10/2022 Strasbourg, France

Since conducting a wide public survey on the Certification of suitability to the European Pharmacopoeia monographs (CEP), the European Directorate for the Quality of Medicines & HealthCare (EDQM) has been working on the design of the CEP of the future. Different aspects were presented to...

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CEP holders invited to comment on draft monographs published in Pharmeuropa 34.4

EDQM 21/10/2022 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 34.4. The table below lists the substances...

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EDQM changes CEP policy regarding chemical applications for polymorphs

EDQM 18/10/2022 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has recently modified its policy on chemical applications for polymorphs. A request for a Certificate of suitability to the European Pharmacopoeia monographs (CEP) for a specific polymorphic form (as a grade) is now...

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Ph. Eur. publishes Cannabis flos draft monograph in Pharmeuropa for comment

EDQM 13/10/2022 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) is seeking feedback on its new draft monograph on Cannabis flos (3028). The draft text covers the herbal drug defined as dried, whole or fragmented, fully developed shoot apices of female cultivars of Cannabis sativa L. It is to be read in conjunction with...

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General chapter 2.2.46. Chromatographic separation techniques: comparison of requirements in the Ph. Eur. 10th and 11th Editions

EDQM 13/10/2022 Strasbourg, France

A new document has been added to the Knowledge database page for revised general chapter 2.2.46, under Additional information. This document provides a useful and easy reference guide to the main changes made to the general chapter recently published in the 11th Edition of the European...

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Ph. Eur. publishes key harmonised monographs on Paraffin, white soft and Paraffin, yellow soft

EDQM 12/10/2022 Strasbourg, France

The recently published (July 2022) 11th Edition of the European Pharmacopoeia (Ph. Eur.) includes the two revised harmonised monographs Paraffin, white soft (1799), and Paraffin, yellow soft (1554). The publication of these two texts marks an important step forward in the international...

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Pharmeuropa 34.4 just released

EDQM 11/10/2022 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 34.4 is 31 December 2022. Users and interested parties are welcome to comment on these drafts. It should...

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Certification monthly report of activities: End of September 2022

EDQM 07/10/2022 Strasbourg, France

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

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The EDQM participated in a conference on Next Generation Sequencing

EDQM 07/10/2022 Strasbourg, France

On 27-28 September, representatives of the EDQM participated in the 3rd Conference on Next Generation Sequencing for Adventitious Virus Detection in Biologics for Humans and Animals organised by the International Alliance for Biological Standardization (IABS) in Rockville, Maryland, U.S.A. At the...

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European Day for Organ Donation and Transplantation 2022 – Become an “influencer for life” and share what’s most precious

EDQM 07/10/2022 Strasbourg, France

In recent years, great strides have been made in the field of organ, tissue and cell transplantation and human application, making it one of the great medical success stories of modern times. Transplantation is in many cases the only viable treatment for reclaiming essential functions and...

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