Interesting question. If no one here can answer it, and you know anyone who is an ACRP member, you might ask them to post it to the ACRP forum, too. There are some folks there who try to stay on top of FDA stuff, especially BIMO-related.
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com------------------------------
Original Message:
Sent: 14-Mar-2019 10:17
From: Michael Trapani
Subject: Training of FDA investigators-bioresearch monitoring
At the end of 2017, FDA announced a realignment of the Office of Bioresearch Monitoring Operations and the development of a specialized training program for field investigators conducting GCP and GLP inspections. I have been unable to obtain information regarding the training program nor additional information on which FDA investigators have been assigned to perform BIMO inspections in the USA and internationally. Any information on the training program and investigators would be helpful.
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Michael Trapani
Senior Consultant
Monroe Township NJ
United States
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