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Phasing out animal testing for in-process control of veterinary vaccines

24/03/2021 Strasbourg, France

On 9 and 10 March 2021, a workshop aimed at facilitating the implementation of replacement in vitro toxicity and antigenicity assays for Clostridium septicum vaccine antigens was jointly held by the European Directorate for the Quality of Medicines & HealthCare (EDQM/Council of Europe),...

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Control of N-nitrosamine impurities in sartans: revision and rapid implementation of five Ph. Eur. monographs

23/02/2021 Strasbourg, France

On 9 July 2020, the EMA’s Committee for Medicinal Products for Human Use (CHMP) published its opinion pursuant to Article 5(3) of Regulation (EC) No 726/2004 regarding the detection, management and prevention of the presence of N-nitrosamines in medicinal products for human use (see the report...

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Outcome of the 168th session of the European Pharmacopoeia Commission

04/12/2020 Strasbourg, France

The 168th session of the European Pharmacopoeia (Ph. Eur.) Commission took place on 24 and 25 November 2020.

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EDQM and EC build on 10 years of co-operation to support a more sustainable blood supply and resilient blood sector

03/12/2020 Strasbourg, France

A conference celebrating 10 years of co-operation between the European Directorate for the Quality of Medicines & HealthCare (EDQM) and the European Commission (EC) in the field of blood transfusion shed light on the challenges faced by blood establishments (BEs) in securing sustainable...

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COVID-19 vaccines: release of guidelines critical for co-ordinated independent batch control by EU OMCLs

12/11/2020 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published three new Official Control Authority Batch Release (OCABR) guidelines outlining the tests to be performed by Official Medicines Control Laboratories (OMCLs) in the EU OCABR Network as part of the...

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