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Genotoxic Impurities - Methods to Identify and Control

4-week online academy | 2 hours per week

Next intake begins 1 October 2019

Online Academy

Course Content Summary

All modules are approximately 1 hour in duration

Historical perspective on the development of guidelines relating to genotoxic impurities and their relevance/relationship to ICH M7

What does ICH M7 mean? Should I be worried?

Practical implementation

Structural analysis of impurities and data interpretation

Safety testing – pre-clinical evaluation of MI related risk

Safety testing – pre-clinical evaluation of MI related risk

How to efficiently analyse mutagenic impurities – strategies to minimise development times and appropriate focus of testing