About a decade ago, I talked with my niece and shared this conundrum: “How do you know that the red I see is the red you see?” To this day, I remember her reaction. Her eyes widened, and she said, ...
In 2020, the International Council for Harmonisation (ICH) published a concept paper (1) that outlined a limited revision to the published guideline ICH Q9 Quality Risk Management (QRM) (2) to address ...
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