ICH Q11 Development and Manufacture of Drug Substance

ICH Q11 Development and Manufacture of Drug Substance Current Status of Q11 ■ Step 1 EWG Consensus April 2008 - April 2011 ■ Step 2 - Signatures May 2011 ■ Step 3 - Stage 1 Public comment Target June - Sept 2011 Stage 2 Resolve comments Target 1st Quarter 2012 ■ Step 4 publication of final version ■ Step 5 Implementation March 6 telecon consensus March 2012 ICI+ Slide 12

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