Certification EPISKIN Academy
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a dataset collected by the EU Commission in June-September 2018
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01 January 2013
Paris, Lyon, Mumbai, Shanghai, Rio de janeiro
|Description:||The certification program is a 3 pays program to OECD test guidelines for in vitro skin irritation (TG439) and eye irritation (TG 492). The 3 day workshop include1 day of conferences on scientific and regulatory context of alternative methods followed by 2 day of hands-on training in laboratory with real reconstructed human tissues: SkinEthic RHE or SkinEthic HCE models. The training is based on the OECD TG439 for in vitro skin irritation or OECD TG492 for eye irritation of chemicals. As in real situation, each trainee assesses the skin or eye irritation potential of 2 unknown products (solid, liquid, paste) compared to negative and positive controls.|
Hands-on training, Lecture, Workshops
This learning program address all scientists concerned by new approaches in toxicology who want to understand the challenges, the regulatory and scientific context. It concerns researchers in industry, CRO and academic, as well as regulators who will evaluate dossiers with such type of data. The aim is also to raise awarness of students who will represent the next generation of toxicologists.
Students, Researchers, Regulators and policy-makers
Academia, Industry, Governmental bodies, Contract Research Organizations (CROs)
University (Master), University (Doctoral education), Postdoctoral (teaching and research)
Computational methods, In vitro methods, Ethics, Legislative aspects
Full coverage (a dedicated course)
|Details on the topic or technology covered:||
The theoretical part gives an overview of the ethical, scientific and regulatory reasons explaining why there is no alternative to alternative methods. The concept of alternative method is presented and the distinction between scientifically valid and validated method is explained. Emphasize is done on the application of tissue engineering to alternative methods in toxicology. Finally, the focus is on the different valid and validated methods based on reconstructed human tissues and how they can be use in integrating approaches (IATA).
The handling sessions are devoted to OECD TG439 and TG492 with reconstructed human epidermis (RhE) and reconstituted human corneal epithelium (RhCE).
CLP Regulation (EC) No 1272/2008, REACH Regulation (EC) No 1907/2006 or equivalent, Cosmetics Regulation (EC) No 1223/2009 or equivalent, Biocidal Products Regulation (EC) No 528/2012, Medical Devices Regulation (EU) 2017/745, Test guidelines (OECD, ISO, etc.)
The learning outcomes from the courses are knowledge on:
- impact of European regulations onto the use of animal testing
- concept of alternative methods to animal testing
- different applications of reconstructed human skin and eye
From the handling session, the trainees should be able to implement in their laboratory the OECD TG 439 or 492
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