In August of 2008, company representatives from Abbott, Amgen, Eli Lilly, Genentech, GSK, MedImmune and Pfizer were brought together to help advance the principles contained in ICH Q8 (R2), Q9 and Q10, focusing on the principles of Quality by design. Through a series of inter-company and regulatory interactions, the group set out to create a study that would stimulate discussion around how the core principles contained in these guidelines would be applied to product realization programs, with a multitude of real-world scenarios, as opposed to a singular approach. Learn More

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