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The implementation of the ICH Q3D guideline went into full effect in the U.S. and Europe in 2018 for all products. The Q3D guideline has been applied to new drug applications in the U.S. and Europe since June 1, 2016. This workshop will provide an overview of the compliance experience since the 2017 PQRI Workshop and will review ongoing work throughout industry to resolve challenges involved in global implementation of the Elemental Impurities guidelines and standards.
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