Zoekresultaten - 288 results

The Role of EDQM and OMCLs

Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: Responsable des affaires réglementaires, Issue Culture in vivo ASBL (2021) Health Topics:  ...

CBD oils on the Belgian market: A validated MRM GC-MS/MS method for routine quality control using QuEChERS sample clean up

that the β-expectation tolerance intervals did not exceed the acceptance limits of 20%, meaning that 90% of future measurements will be included within this error range. Health Topics:  Effectiveness and ...

Deepening of In Silico Evaluation of SARS-CoV-2 Detection RT-qPCR Assays in the Context of New Variants

Health Topics:  Efficacité et sécurité des vaccins, médicaments et produits de santé- Qualité des laboratoires médicaux Coronavirus Santé et environnement Effectiveness and safety of vaccines, medicines ...

Identification of flavouring substances of genotoxic concern present in e-cigarette refills

establish a screening strategy to prioritize the flavouring substances of highest concern for human health. In the present study, a prioritization strategy combining analytical screening, in silico tools and ...

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 ...

Vaccine quality control in Europe: monitoring the quality of vaccines after licensing

Publication Type: Scientific poster, presentation or proceeding Authors: Lieke Maria van der Aa Source: Immunity for Health, Flanders Vaccine, Issue Flanders Vaccine, Antwerp, Belgium (2020) ...

The EMA PRIME procedure in an accelerated assessment environment for vaccine licensure: Experiences from quality (CMC) assessors. A case study for Ebola vaccine.

BioManufacturing (2020) Health Topics:  Effectiveness and safety of vaccines, medicines and health products- Quality of medical laboratories Efficacité et sécurité des vaccins, médicaments et produits de santé- ...

Use of Whole Genome Sequencing Data for a First in Silico Specificity Evaluation of the RT-qPCR Assays Used for SARS-CoV-2 Detection.

of future RT-qPCR tests, as well as verifying that the former methods are still capable of detecting circulating SARS-CoV-2 variants. Health Topics:  Effectiveness and safety of vaccines, medicines and ...

Human challenge trial workshop: Focus on quality requirements for challenge agents, Langen, Germany, October 22, 2019.

for early exchange with regulators to ensure acceptability of strain selection and manufacturing for later drug development; sharing of models and challenge agents. Health Topics:  Effectiveness and ...

Sciensano Jaarverslag 2019

Publication Type: Popular-science publication (vulgarising publication) Authors: Sciensano Source: (2020) Health Topics:  Health and environment Food consumption and food safety Health and disease ...

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