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Communiqué de presse 12 2020 - Vaccins contre le COVID-19 : publication d e guidelines critiques pour le contrôle indépendant et coordonné des lots par les OMCL de l’UE - novembre 2020
La Direction européenne de la qualité du médicament & soins de santé (EDQM) a publié trois nouveaux guidelines relatifs à la libération officielle des lots par les autorités de contrôle (OCABR) énumérant les essais que les laboratoires officiels de contrôle des médicaments (OMCL) du réseau OCABR (UE) sont tenus de réaliser dans le cadre du contrôle indépendant des lots de vaccins contre le COVID-19. Ces textes ont été adoptés par l’ensemble du réseau OCABR et sont entrés en vigueur le 12 novembre 2020.
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COVID-19 vaccines: release of guidelines critical for co-ordinated independent batch control by EU OMCLs
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 independent control of pandemic COVID-19 vaccine batches. They were adopted by the full OCABR Network and are in force from 12 November 2020.
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Press release 12 2020 - COVID-19 vaccines: release of guidelines critical for co-ordinated independent batch control by EU OMCLs - November 2020
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 independent control of p andemic COVID-19 vaccine batches. They were adopted by the full OCABR Network and are in force from 12 November 2020.
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Journée européenne du don d’organes et de la greffe - 9 octobre 2021
La Journée européenne du don d’organes et de la greffe (EODD) vise à sensibiliser le public à l’importance du don d’organes, de tissus et de cellules pour améliorer et sauver des vies. La mission de l’EDQM/Conseil de l’Europe consiste à définir des normes de qualité, de sécurité et d’éthique pour le don et la transplantation d’organes, de tissus et de cellules, à destination des professionnels de santé. En organisant l’EODD dans un pays différent tous les ans, l’EDQM cherche non seulement à encourager le débat public et à favoriser une réflexion sur cette question, mais également à amener la communauté médicale et les responsables politiques de toute l’Europe à réfléchir à l’importance de ce traitement salvateur.
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European Day for Organ Donation and Transplantation - 9 october 2021
The European Day for Organ Donation and Transplantation (EODD) is held to raise awareness of the importance of organ, tissue and cell donation as a way to improve and save lives. The mission of the EDQM/Council of Europe is to set quality, safety and ethical standards for organ, tissue and cell donation and transplantation for health professionals. By organising the EODD in a different country every year, the EDQM seeks not only to encourage public debate and reflection on this topic, but also to invite the medical community and policy makers across Europe to reflect on the importance of this life-saving therapy.
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OCABR Guideline 36 - Human Papillomavirus (rDNA) Vaccine
EU Official Control Authority Batch Release Human Vaccines Guideline for Human Papillomavirus (rDNA) Vaccine This version in force from 31/08/2020 Replacing version in force from 01/01/2019
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OCABR Guideline 35 - Hepatitis B (rDNA) Vaccine
EU Official Control Authority Batch Release Human Vaccines Guideline for Hepatitis B (rDNA) Vaccine This version in force from 31/08/2020 Replacing version in force from 01/01/2019
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OCABR Guideline 34 - Hepatitis A (Virosomal) Vaccine
EU Official Control Authority Batch Release Human Vaccines Guideline for Hepatitis A (Virosomal) Vaccine This version in force from 01/01/2019 Replacing version in force from 01/06/2015
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OCABR Guideline 33 - Hepatitis A Vaccine (Inactivated, Adsorbed)
EU Official Control Authority Batch Release Human Vaccines Guideline for Hepatitis A Vaccine (Inactivated, Adsorbed) This version in force from 31/08/2020 Replacing version in force from 01/01/2019
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OCABR Guideline 32 - Hepatitis A (Inactivated) and Typhoid Polysaccharide Combined Vaccine (Adsorbed) for Mix-At-Use Format Products
EU Official Control Authority Batch Release Human Vaccines Guideline for Hepatitis A (Inactivated) and Typhoid Polysaccharide Combined Vaccine (Adsorbed) for Mix-at-Use Format Products This version in force from 01/01/2020 Replacing version in force from 01/01/2019