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Great RBM Webinar on ICH GCP Changes

By Penny Manasco - June 12, 2016

I heard a great webinar presentation by Gareth Adams discussing the new ICH revisions to GCP.  ( liked the differentiation Gareth made between the FDA Guidance that is focused on monitoring while the new ICH Guidance has a much broader scope—focusing on a Comprehensive Risk Based Quality Management approach.  He discussed the timelines for finalization of the Guidance which will occur this year. 
The second part of the presentation, by Brion Regan from ERT gave me pause and launched my recent post “A Plea to RBM Tech Vendors”.  In Brion’s presentation, he recommended standardization of Key Risk Indicators (KRI), which is great for the vendors and will provide useful information BUT it doesn’t address our very real need—to be able to efficiently and effectively review data specific to a protocol’s conduct.  While KRI’s are great, we HAVE to be able to evaluate the High Risk data and processes that are protocol specific and are identified during Risk Assessment—which means that we need ad hoc reporting capabilities, not just a standard set of reports.
I recommend listening to Gareth’s presentation.  The MANA RBM team was thrilled to be able to confirm that our processes are in full alignment with the ICH GCP draft guidance.  We are making our processes, work instructions, plans, and technology specifications available to the industry to make the transition to these large changes in process required to adopt the new ICH GCP Guidelines.  For more information, please contact me at