Search results - 7 results

The consistency approach for the substitution of in vivo testing for the quality control of established vaccines: practical considerations and progressive vision

Publication Type: Peer reviewed scientific article Authors: L. Tesolin; J.-F. Dierick; Wim Van Molle Source: Open Research Europe (2022) Keywords: human vaccines in vitro testing in vivo testing ...

Batch release of vaccines in Europe: from method transfer to first commercial batch available on the market. Straightforward approach that requires a proactive mind-set of the manufacturer.

developing Developing Countries Europe method ON vaccine vaccines WHO Abstract: According to the European Directives 200⅛3/ EC and 2004/27/ EC, EU Member States may require to test batches of immunological ...

Testing of expired Synflorix bulks: actions taken by three OMCLs and concerns raised by another OMCL.

Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: Annual OMCL meeting, EDQM, Issue EDQM, Brussels, Belgium (2015) Keywords: batch release meeting TESTING ...

Release testing by manufacturers & Ph.Eur. compliance: lessons learnt for competent authorities. A case study: the Extractable Volume

study case-study compliance meeting Release testing study TESTING Health Topics:  Vaccine batch conformity Vaccin lot conformiteit Conformité de lot de vaccin Efficacité et sécurité des vaccins, ...

Implementation over the past 20 years of the 3R's principle for batch release at the Scientific Institute of Public Health, Belgium (IPH).

medicines mice Multiple national need Network ON Order past pertussis ph PRODUCTS public public health Public-health Quality Reduction repeated routine SAFETY situation specific study Test TESTING tests ...

Testing and release of Synflorix ® monovalent conjugated bulks: update after 1 year of a complex vaccine with complex testing

Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: Annual OMCL meeting, EDQM, Issue EDQM, Split, Croatia (2010) Keywords: a meeting Release testing ...

Implementation of Synflorix® monovalent bulk testing

Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: Annual OMCL meeting, EDQM, Issue EDQM, Vienna, Austria (2009) Keywords: implementation meeting TESTING ...

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