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Physicochemical characterization and genotoxicity assessment of nanomaterials using new approach methodologies
protection products. Manufacturers bringing food-based nanotechnology applications to the European market must comply with the European Union’s regulatory framework, including a nanospecific risk ...
10 years of organizing L. monocytogenes enumeration proficiency testing in food matrices at the Belgian national reference laboratory.
reliability of the participant’s results. The NRL organizes L. monocytogenes enumeration PT once a year, using one food matrix. The methods used by the participants must belong to a list of methods approved by ...
Analyzing the airborne birch and grass pollen monitoring network in Belgium
monitoring stations must be evaluated. Materials & Methods We explored the network quality (i) and coverage (ii) of the five current pollen monitoring stations in Belgium using the methodology developed ...
Pediatric diabetes centres rated parental responsibility and family support as most important determinants of HbA1c using a 17-item questionnaire: a pilot study
different centers. In order to have a proper comparison, consideration must be taken for those external factors’ impact on HbA1c levels (i.e. risk-adjustment). Based on a pilot project, we wanted to identify ...
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.
release testing that must be carried out by the manufacturer for each single batch. The Directives require Member States to recognize Official Control Authority Batch Release carried out by other Member ...
Risk assessment for contained use of GMOs
specific containment, protective measures and safe work practices.For each contained use, the precise nature and scale of risks are not fully known in advance and the risk involved must be assessed on ...
Regulatory issues regarding manufacture and control of vaccine adjuvants. The EU situation.
testing with the adjuvant alone and in combination with the antigen should be thoroughly studied and documented. Finally, regarding clinical studies, the inclusion of an adjuvant in a vaccine must always be ...
How to report central line-associated bloodstream infections in surveillance? A comparison of three classifications in Belgium.
CLABSI incidence and trends. Materials/methods: To be considered as CLABSI in the Belgian bloodstream infection surveillance, a CLABSI must first meet the surveillance definition for hospital-associated ...
Batch release of vaccines in Europe: from method transfer to first commercial batch available on the market. Straightforward approach that requires a proactive mindset of the manufacturer.
“Official Control Authority Batch Release” (OCABR) and consists of analytical controls and document review which are additional to the routine release testing that must be carried out by the manufacturer for ...
Combined untargeted screenings of substances migrating from emerging food contact materials
reed) are examples of substitute materials, and they must comply with Regulation (EC) No 1935/2004. However, specific harmonized legislation is only available for plastic FCM, and the understanding of ...