ICH Q11, the anticipated guideline from the International Conference on Harmonization (ICH) titled Development and Manufacture of Drug Substances, has achieved international consensus. ICH Q11, the ...
AUSTIN, Texas & GENEVA–(BUSINESS WIRE)–The International Council for Harmonisation (ICH) M11 Expert Working Group (EWG) (Clinical electronic Structured Harmonized Protocol (CeSHarP) has developed a ...
Pharmaceutical Technology talks to FDA's Justina A. Molzon about current discussions with international regulators, and how, after 20 years of harmonization activities and the common technical ...
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