In vitro cell- and tissue models
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a dataset collected by the EU Commission in June-September 2018
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Owner/Developer: University of Tampere (UTA)
05 June 2018
3-weeks coiurse (4ECT) including lectures on GLP, in vitro models in general, acceptance of in vitro models in regulatory dossiers, in vitro disease models, disease moldel homework and laboratory training on performing acute cytotoxicity test under GLP.
No´directly from the course
Hands-on training, Lecture
Optional / Voluntary
4 ECDs during 3 weeks period
B.Sc. in natural sciences and cell culture education and training
Academia, Industry, Governmental bodies, Contract Research Organizations (CROs), Consulting, SMEs
In vitro methods, Legislative aspects
Full coverage (a dedicated course)
No species is addressed specifically
|Details on the topic or technology covered:||
Lectures: General principles of in vitro models, How to ensure relevance and quality of in vitro models, Assessing safety and efficacy with in vitro models, In vitro vasculature model, Intestinal models, In vitro models for ocular barriers, In vitro neuronal models, stem cell differentiation, cardio, GLP; Home work: selected organ focused assessement on the use of in vitro method, hands-on-training on acute toxicity testing under GLP
Directive 2010/63/EU or equivalent, CLP Regulation (EC) No 1272/2008, REACH Regulation (EC) No 1907/2006 or equivalent, Cosmetics Regulation (EC) No 1223/2009 or equivalent, Plant Protection Products Regulation (EC) No 1107/2009, Biocidal Products Regulation (EC) No 528/2012, Medical Devices Regulation (EU) 2017/745, In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), Food Safety (EC) No 178/2002 or equivalent, Test guidelines (OECD, ISO, etc.)
GLP-level study report from the laboratory hands-on-training
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