Cellular Toxicology and Predictive Toxicology
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Owner/Developer: Safety Sciences for Medicines (safe sci med)
09 April 2018
|Description:||Course Objectives In drug development the non-specific interactions of drugs substances or their metabolites pose problems on the cellular level. Therefore there is a need of experts in pre-clinical safety who interpret and understand pre-clinical and clinical data, especially in terms of evaluating the toxicological profile of a candidate drug. It is important for safety scientist to have a broad overview and the ability to understand the connections between molecular events at the cellular level upon chemical exposure and the consequences for organ functioning. The course will provide participants with a comprehensive overview how cells deal with chemical stress at the molecular and cellular level and make them familiar with the fundamentals necessary to understand cellular mechanisms of adverse drug reactions. Special emphasis is put on the recognition that during drug development the involvement of specialist scientist is often required to achieve a multidisciplinary solution. Participant will receive knowledge about the major processes in cytotoxity, become aware of technologies (use of stem cells, bioimaging, in silico modelling) to evaluate cellular stress responses and cytotoxic reactions and will be able to extrapolate the knowledge from the cellular level to the organ and human level. Key Subjects Covered by the Course - Consequences of cell injury and biochemical mechanisms - Adverse Autcome Pathway (AOPs) paradigm - Cellular defence mechanisms against cell stress - Molecular mechanisms of cellular senescence, autophagy or cell death - Intra- and intercellular signalling and mechanisms of cell injury - Translation of cell injury to in vivo models and the clinic - Molecular mechanisms of idiosyncratic drug toxicities and ADR - Stem cell technology and applications in understanding mechanisms of toxicity - Functional genomic technologies - Quantitative high content imaging of drug-induced cellular perturbation for adverse outcome prediction|
Workshops, Hands-on training, Lecture
Optional / Voluntary
MA in Life Sciences and equivalent
Students, Researchers, Regulators and policy-makers, Teachers and educators, Technicians, Scientific officers / Project managers
Academia, Industry, Governmental bodies, Contract Research Organizations (CROs), SMEs
Continuing Professional Development, University (Master)
In vitro methods, Computational methods
Partial coverage (e.g. a module)
|Course level on animal species:||
Test guidelines (OECD, ISO, etc.)
On successful completion of the course, participants will have acquired an understanding of the relevance of stem cells and other novel therapeutics for
drug safety research. More specifically, participants will be able to
- have an appreciation of basic cell biological responses to injury
-know and understand the themes and major processes in cytotoxicity
- to relate the basics of molecular toxicity to the cellular stress response
- learn about new technologies available for cytotoxicity evaluation
- extrapolate the knowledge from cell level to organ and system (human) levels
- integrate the role of in vitro cytotoxicity evaluation in the context of risk assessment
|Accreditation body and/or authority that approved the education or training:||
3 ECTS credits
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