ICH Q11 Development and Manufacture of Drug Substance slide image

ICH Q11 Development and Manufacture of Drug Substance

ICH Q11 Development and Manufacture of Drug Substance Step 1 ■ 6 Face-to-face EWG meetings ■ Many teleconferences and net meetings ■ Many drafts (10 + depending on how you count) Draft 0 - 4 (June 2008 – November 2010) ■ Examples Remember: This is a negotiated consensus process . No party gets everything they want! March 2012 ICH 77 Slide 7
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