ICH Q11 Development and Manufacture of Drug Substance

ICH Q11 Development and Manufacture of Drug Substance Is ICH worth the effort? Top Four Reasons. 4. Allows discussion / debate of draft and proposed expectations face-to-face with regulators 3. Allows all parties to hear each other's concerns including probable unintended consequences. 2. Allows debating specific wording with regulators and hearing underlying meaning of specific words 1. Reduces regional specific guidance March 2012 Disclaimer: Also MY opinion ICH Slide 37

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