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Trainings on toxicological or quality aspects, can be requested by filling in the contact form. Courses typically consist out of a theoretical part and a practical part (e.g. task, exercises or case studies). The content can be adapted based on the customer’s need. Examples of training topics are:
Scientific principles and guidelines; toxicokinetics, acute toxicity, skin/eye irritation, skin sensitisation, genotoxicity, repeated dose toxicity, carcinogenicity, reproductive and developmental toxicity; – 1 day
Scientific principles and guidelines; genetic toxicity, alternative cancer studies, acute toxicity, local tolerance (skin/eye irritation, skin sensitisation, phototoxicity), reproductive/developmental toxicity, organ toxicity; – 1 day
(Q)SAR models, OECD Principles of (Q)SAR validation, (Q)SAR lifecycle, applications of (Q)SARs, (Q)SAR documentation (QMRF and QPRF), demonstration of (Q)SAR models, read-across, case studies mutagenicity and skin sensitisation; – 1 day
Training course can be focused on risk assessment of extractables & leachables (E&L) of container closure systems (PQRI) or of medical devices (ISO-10993-17)
Basic principles of toxicology, risk assessment: hazard identification, hazard characterization, exposure assessment, risk characterization
in vivo and in vitro toxicology studies
Interpretation of (Q)SAR models, selection of read-across substances, calculation of lifetime and less-than-lifetime safety limits, calculation of margin of safety.
Discussion on and planning of (incl. timelines) the test facility organization and personnel, quality assurance program, facilities, equipment, materials and reagents, test system, test & reference item, standard operating procedures, performance of the study, reporting of study results, storage and retention of records and materials.
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