QTLs at SCOPE 2023
QTLs are not specifically called out in ICH E6 (R3), so do QTLs still have a place in the Quality Management System (QMS)? And if so, how do you best implement QTLs to ensure regulatory compliance, quality trial data and subject safety. These questions will be discussed in detail at SCOPE, but in the meantime, here's our view.
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