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24 March 2020

Webinar: Aiding And Standardising Expert Review Under ICH M7

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Lhasa Webinar

In this webinar Lhasa Limited Senior Scientist, Alex Cayley, and Account Manager, Hazel Gardiner, discussed Lhasa's upcoming ICH M7 expert review functionality.

Expert review of mutagenicity predictions obtained from in silico predictive systems is an important part of the assessment process for drug impurities under ICH M7. Human assessment is particularly valuable where conflicts arise between different models and in these cases good knowledge of various areas of science as well as the strengths and limitations of the software employed are important in helping the user reach a final conclusion. There are common arguments known within industry and acknowledged in the public literature that can be used to resolve conflicts in some of these cases. However, there may inconsistency in how and when these arguments are employed.

In this webinar we discussed research undertaken at Lhasa Limited to aid users of our software in carrying out expert review and in standardising the common arguments employed. Work collaborating with our members to understand the problem will be described as well as how the findings are to be deployed in our Nexus software.

Please find recordings and slides from the webinar below.

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