ICH Q11 Development and Manufacture of Drug Substance

ICH Q11 Development and Manufacture of Drug Substance What took so long? ■ Many different expectations * Traditional vs Enhanced Small vs Large * Alignment with regional guidelines and expectations ■ Many different agendas Team dynamics 25+ people ■ Only two face to face meetings per year ■ Virtual meetings ok for simple editing but not a good venue for true discussion March 2012 ICI+ Slide 13

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