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Which Profile Is Coherent With FDA Regulations? (Doc ID 2492215.1)

Last updated on DECEMBER 03, 2019

Applies to:

Oracle Argus Safety - Version 8.2 and later
Information in this document applies to any platform.


Oracle Argus Safety Version 8.2

Recently completed install for Argus Safety / Interchange 8.2.

Via Reporting destination noted that there are 3 standard profiles for R3: the "generic" one, the EMA one and the one for PMDA.

Which one of this is correct according to FDA regulations?


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