Drug Development is a knowledge-intensive, Risk-intensive endeavor, and we target to establish a very high-quality manufacturing standard.
So Knowledge, Risk and Quality are interwoven into every step of the day (this is not a typo).
In this beautiful short piece, Lipa, O'Donnell and Greene present the application of Knowledge management and Quality Risk Management as dual enablers of ICH Q10, and how these processes feed into each other in an infinite cycle.
The most significant works are short and sharp as a razor, and I highly recommend you take a few minutes to read it:
(or a more elaborate version here: https://arrow.tudublin.ie/level3/vol15/iss2/4/)
This work and many publications that followed by the same group have influenced my strategic thinking on our path in Drug Development.
I start every webinar and course I run with this slide, and if you want a quick sneak-peek into one of the lectures, see link in comments...
Did you encounter a risk in your project (or in your day-to-day), that could be mitigated with additional knowledge? Would love to hear about it in the comments….
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