Bioequivalence and Bioavailability Forum

❝ this isn't so much about whistleblowing. It is about defining a type of deviations that require expedited reporting (analogous to SAE's) and defining who is supposed to do what and when.

IMHO the message of this guideline is fatal: EMA is not will to spent effort in the surveillance of clinical studies and has not the intellectual and personal capacities to do so. Why should the Sponsor provide the arguments which will be used to reject his study? The people who prepared this guideline live behind the moon.
Dear car driver, report any contempt against red lights and tempo Limits to your authority so that your licence can be invalidated. hahaha