Event Date/Time: Nov 21, 2007
End Date/Time: Nov 22, 2007
This workshop aims to provide a comprehensive overview on all aspects of photosafety evaluation of drugs. Starting from basic considerations on photochemistry and physics, experts will cover extensively the fields of pre-clinical and clinical photosafety assessment. Special emphasis will be placed on the health authority perspective and the implication on current testing practice and clinical risk assessment. The workshop will lead to a discussion on how to achieve the best practice in photosafety evaluation and the possible impact on guideline development. Both the FDA and EMEA have released guidance documents on photosafety evaluation, with the aim to provide recommendations for appropriate testing procedures and interpretation of test results. Four major areas of testing are addressed in these documents: phototoxicity (photoirritation), photoallergy, photogenotoxicty and photocarcenogenicity. A validated test exists for in vitro phototoxicity (3T3 PT NRU assay) as summarised in the OECD TG 432.