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Interpreting ICH Q11: A Risk Assessment Tool for Assessing Starting Material Acceptability

Wigman L;

Presented as part of the 2017 Lhasa Limited vICGM series.

Larry Wigman, Principal Scientific Manager at Genentech, discussed the selection of Regulatory Starting Materials based on the EMA Reflection Paper and ICH Q11 Q&A documentation, the disclosure of more Synthetic Steps and more highly reactive, potentially genotoxic intermediates, and leveraging M7 Control Options and Purging Rationale.


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