Skin Safety Assessment Training, 11-12 April 2024
Event Program
Day 1:
Introduction to skin sensitisation and the regulatory context
09:00 - 12:30
- What is skin sensitisation, mechanisms, key events, adverse outcome pathways, key event assays (DPRA, KeratinoSens, h-Clat)?
- Overview of skin sensitisation cell models and assays, including DPRA; KeratinoSens, h-Clat, SENS-IS, GARD.
- Why is regulation important?
- Overview of requirements from regulatory agencies relevant to skin safety assessment.
12.30 - 13.30 Lunch Break
Introduction to in silico modelling
13:30 - 16:00
- Introduction to SaferSkin software
- Principles behind SaferSkin models (Bayesian network, Multiple regression, SkinDoctor, etc)
- Data analysis and modelling techniques and interpretation
- Characterisation scoring using OECD 497 defined approach
- Comparison and discussion of model results
16:30 - 20:00 City tour in Basel
20:00 - 21:30 Dinner in the city
Day 2:
Principles and Best Practices (Experimental)
- 09:00 - 09:30 Recap - Q&A
- 09:30 - 10:30 Skin sensitisation assay protocols and Good Laboratory Practices (GLPs)
- 10:30 - 11:00 Coffee break
- 11:00 - 12:30 Demonstrations of sample preparation and testing protocols for h-Clat and KeratinoSens assays
- 12:30 - 13:30 Lunch
Principles and Best Practices (Experimental)
- 13.30 – 14:30 Discussion of step-by-step execution of the assay protocols by participants in small groups
Case Study Work
- 14:30 – 16:30 Advanced applications and case studies of skin sensitisation testing
- Defined Approaches including OECD guidance
- Hands-on experience with skin sensitisation tools, data analysis, and reporting
- Case studies on different compounds (Case study task sheet)
- 16:30 – 17:00 Final discussion and Q and A session