Purpose of PMDA R2 Profiles
(Doc ID 2967775.1)
Last updated on AUGUST 16, 2023
Applies to:Oracle Life Sciences Argus Safety - Version 8.4 and later
Information in this document applies to any platform.
When are the following PMDA OOB R2 profiles used?
ICH-ICSR V2.1 MESSAGE TEMPLATE - PMDA - J
ICH-ICSR V2.1 MESSAGE TEMPLATE - PMDA - I
ICH-ICSR V2.1 MESSAGE TEMPLATE - PMDA - PIP
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