Search results - 18 results

Belgian recommendations for analytical verification and validation of immunohistochemical tests in laboratories of anatomic pathology

a quality management system in anatomic pathology laboratories has been reviewed to meet this demand and additionally to prepare the laboratories for the EU  —  IVD revised regulations (IVDR). This paper ...

Proposal for 3R reporting for Official Control Authority Batch Release

Publication Type: Scientific poster, presentation or proceeding Authors: Source: OMLC Annual meeting 2021- Common OCABR session, EDQM (extranet), Strasbourg, France (2021) Keywords: 3Rs EU reporting ...

Praktijkrichtlijn voor het opzetten van een kwaliteitssysteem in de erkende laboratoria voor pathologische anatomie werkzaam binnen het kader van het Erkenningsbesluit

cytologie pathologique” (SH GRA 03 – rév 00 ; Cofrac) De IVDR (Europese Verordening EU  2017/746) Het KB van 28 april 2017 tot vaststelling van boek I-X van de codex over het welzijn op het werk  Wet van 22 ...

Directive Pratique pour la mise en place d'un système qualité dans les laboratoires d'anatomie pathologique agréés dans le cadre de l'Arrêté d'agrément

clinique agréés dans le cadre de l’Arrêté d’agrément (version 3 :2017) ; L’ IVDR (Règlement européen EU  2017/746) L’ AR du 28 avril 2017 établissant le livre I-X du Codex sur le bien-être au travail La loi ...

Development of a multiplex immunoassay for simultaneous detection of antigens in DTaP vaccines

In this context, the VAC2VAC project is a public-private consortium of 22 partners funded by EU. Its main objective is to reduce the number of animal used for batch testing by developing immunoassays ...

Guideline for Pandemic COVID-19 Vaccine (mRNA)

https://www.edqm.eu/en/ocabr-activities-related-covid-19-vaccines#guidelines File:  Version:  Published Full text access:  Public Access Full text language:  English Category:  E42 FOS Classification:  3.04 Medical biotechnology ...

Guideline for Pandemic COVID-19 Vaccine (Non-replicating Adenovirus-vectored vaccine)

Kwaliteit van vaccins en bloedproducten Quality of vaccines and blood products Manuscript versions:  DOI:  https://www.edqm.eu/en/ocabr-activities-related-covid-19-vaccines#guidelines File:  Version:  ...

Panel discussion on CMC in 'Risk- based strategies to support current health emergency

Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: World Vaccine Conference (EU), Terrapinn, Web based (2020) Health Topics:  Effectiveness and safety of ...

Vaxelis (PR5I): another fully liquid hexavalent vaccine on the EU market in 2016.

Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: Annual OMCL meeting, EDQM, Issue EDQM, Brussels, Belgium (2015) Keywords: EU meeting ON vaccine Health ...

Infanrix Hexa supply situation within EU and related issues

Publication Type: Scientific poster, presentation or proceeding Authors: L. Tesolin Source: Annual OMCL meeting, NA, Issue EDQM, NA (2011) Keywords: EU meeting situation Health Topics:  ...

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