Search results - 14 results

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

performance characteristics to be evaluated, (iii) the objective acceptance criteria, (iv) the evaluation method for the obtained results and (v) how and when to revalidate. A literature study and a risk ...

A roadmap for regulatory implementation of in vitro models for evaluation of vaccine efficacy

Publication Type: Scientific poster, presentation or proceeding Authors: R. J. Vandebriel; L. Tesolin; K. Veenstra; K. Huber Source: EVI, Niagara falls, Canada (2023) Keywords: in vitro model Regulatory roadmap Vaccine Efficacy Health Topics:  Effectivene ...

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

Virtual (2021) Keywords: 3R Vaccine Potency Abstract: Routine batch quality testing before vaccine release, notably for potency evaluation, still relies on animal use for several animal and human vaccines. ...

Characterization and hazard identification of substandard and falsified antimicrobials encountered in Belgium

characterization of SF-antimicrobials, collected samples were also evaluated in terms of impurities and dissolution. The impurities were analyzed based on the methods of the European Pharmacopoeia (Ph. Eur.) and the ...

Identification of Flavouring Substances of Genotoxic Concern Present in E-Cigarette Refills

alert for genotoxicity in at least one of the two (Q) SAR models. For these substances, genotoxicity data was collected from previous European safety evaluations in different regulatory domains (e.g. by ...

OMCL's role in OOS evaluation and communication with partners (network, MAH and beyond) and tools available

HealthCare (EDQM),Council of Europe, NA (2016) Keywords: Communication EVALUATION meeting Network Role Health Topics:  Effectiveness and safety of vaccines, medicines and health products- Quality of medical ...

First Belgian national EQA for special stains in histopathology

consistentand accurate results that, ultimately, impact a patient diagnosis. They enable laboratories to evaluate theirperformance and methods compared with that of their peers or with the whole laboratory ...

Evolution of the implementation of a quality management system in the Belgian laboratories for anatomic pathology

Standard Operating Procedures (SOP s)  and validity  date. In the course of 2015, during a second evaluation step, the laboratories were asked to actualize the table presented in the survey of 2014.  In ...

Evaluation externe de la qualité pour la détection de Toxoplasma gondii par des méthodes de biologie moléculaire

NA (2015) Keywords: 0 2008 a ce conditions de detection Diagnostic moléculaire EEQ EN ET EVALUATION Evaluation externe de la qualité i LE PAR Participation Patient patients performance qualité santé ...

Quality control of polio vaccines at WIV-ISP

Publication Type: Scientific poster, presentation or proceeding Authors: M Janssen Source: First International Workshop to Assess the utility of Deep Sequencing for the evaluation of the genetic ...

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