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Update on the review of CEP applications for sartans and the availability of test methods for nitrosamines

17/10/2018 Strasbourg, France

Following the detection of the impurity NDMA (N-nitrosodimethylamine) in valsartan at the end of June, the EDQM has conducted a complete review of the manufacturing information submitted in all Certificate of suitability (CEP) applications for valsartan and other structurally related active...

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EDQM launches public consultation on first pilot monographs for European Paediatric Formulary

16/10/2018 Strasbourg, France

The EDQM has launched a public consultation on the first two pilot monographs and on two general texts for its European Paediatric Formulary. Pharmacists and paediatricians across Europe are called to provide their feedback on the draft monographs on Hydrochlorothiazide oral solution and on...

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Quality of gene therapy products: EDQM listens to stakeholders’ needs

08/10/2018 Strasbourg, France

The EDQM is the Directorate of the Council of Europe responsible for supporting the basic human right of access to good quality medicines and health care in Europe. With its European Pharmacopoeia (Ph. Eur.), the EDQM sets requirements for the quality of medicines, including those in the field...

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EDQM issues recommendations for sustainable, cost-effective quality management in Europe’s blood sector

28/09/2018 Strasbourg, France

The EDQM has issued a set of recommendations for the development of cost-effective and sustainable Quality Management Systems (QMSs) in Blood Establishments (BEs) across Europe. The document follows on from the European Conference on “Sharing best practices: Quality Risk Management, Change...

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Just released: 2017 international figures for organ donation and transplantation

25/09/2018 Strasbourg, France

Monitoring of practices in the field of organ donation and transplantation allows strengthened transparency, as well as international benchmarking. The Newsletter Transplant, which is issued by the EDQM/Council of Europe every year in coordination with the National Transplant Organisation in...

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