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EDQM (Europe) (EU) 10/19/2020 05:27
19 October 2020. Strasbourg, France. The Committee of Ministers of the Council of Europe has adopted a new resolution on the safety and quality of materials and articles for contact with food. This instrument is expected to improve the protection of consumers from contaminants (metals, antioxidants, stabilisers, colorants, plasticisers, etc.) potentially released by material in contact with food, such as containers, work surfaces or packaging.
EDQM (Europe) (EU) 10/08/2020 08:08
08 October 2020. Strasbourg, France. The Committee of Ministers of the Council of Europe has adopted a recommendation1 calling on member states to take measures to protect the health of donors of haematopoietic progenitor cells (HPCs). These cells are used as a lifesaving treatment for patients with severe blood diseases and are the most frequently donated cells for transplantation.
EDQM (Europe) (EU) 10/08/2020 05:58
08 October 2020. Strasbourg, France. The Committee of Ministers of the Council of Europe has adopted two new recommendations, calling on member states to ensure that quality and safety standards for the donation and transplantation or human application of organs, tissues and cells are respected in accordance with the technical guides published by the European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe.
EDQM (Europe) (EU) 10/08/2020 04:36
08 October 2020. Strasbourg, France. Organ, tissue and cell transplantation is one of the great medical success stories of modern times. In many cases, it is the only life-saving treatment for patients with end-stage organ failure, devastating burn injuries or blood cancers, and in many others it can significantly improve the quality of life of patients, for example, by restoring their sight. On average, 41 000 organ transplantations are performed in Europe[1] every year, and 48 000 new patients are added at some time to a waiting lists.
EDQM (Europe) (EU) 09/29/2020 10:24
01 October 2020. Strasbourg, France. As health systems worldwide continue to cope with the impact of the COVID-19 pandemic, the EDQM/Council of Europe publishes this year’s issue of the Newsletter Transplant. The timely release of this issue is proof of the EDQM’s dedication to the international medical community and all those involved in the preparation of this publication.
EDQM (Europe) (EU) 09/21/2020 05:04
21 September 2020. Strasbourg, France. The EDQM/Council of Europe will implement the “Reorganisation of the Romanian Blood System” project. The project aims to support Romania in setting up a fit-for-purpose and efficient blood transfusion system aligned with European Union and EDQM standards. The EDQM is therefore seeking experienced professionals in the field of blood transfusion to provide consultancy services in order to:. develop action plans to restructure the national blood transfusion service and the regulatory oversight system, including developing requirements for an IT system; develop a 5-year investment plan (covering building infrastructure, material, equipment and transportation logistics); develop an action plan for education an.
EDQM (Europe) (EU) 09/08/2020 09:24
08 September 2020. Strasbourg, France. The approach to the elaboration of European Pharmacopoeia (Ph. Eur.) monographs for biotherapeutics has significantly evolved in recent years. In particular, where monographs on complex biotherapeutics are concerned, the emphasis is now placed on allowing greater flexibility as a means of better addressing the structural complexity and naturally occurring heterogeneity of these substances, and the potential diversity of the preparation resulting from different manufacturing processes.
EDQM (Europe) (EU) 08/31/2020 05:51
31 August 2020. Strasbourg, France. The content and layout of the current Certificate of Suitability (CEP) remains very similar to the original created in 1992. The EDQM is nonetheless well aware of the far-reaching effects that globalisation, the rise of digital technology and many other major regulatory and scientific developments have had on the pharmaceutical industry and competent authorities over the last three decades and, in response, is launching a project to design the CEP of the future.

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