Non-Japanese license name displays in PMDA E2B (R3) paper report
(Doc ID 2492445.1)
Last updated on FEBRUARY 11, 2019
Applies to:Oracle Argus Safety Japan - Version 8.1.2 and later
Information in this document applies to any platform.
When printing PMDA E2B (R3) paper report to Japan MKT license from the foreign case, non-Japanese license name displays in the “販売名 / 治験成分記号” column.
PRODUCT (A) has the following 2 licenses
- US license "US-MKT-001" (Japanese trade name is "US-MKT-001(J)")
- JP license "JP-MKT-001" (Japanese trade name is "JP-MKT-001(J)")
1. Create a new case with COI is USA and select US license "US-MKT-001"
2. Set the mandatory information for PMDA E2B (R3)
3. Schedule PMDA E2B (R3) to the Japan license "JP-MKT-001"
4. Click the draft link and view the PMDA paper report
5. In the “販売名 / 治験成分記号” column, US license name "US-MKT-001" in the case product tab displays. Instead, Japanese trade name for Japan license "JP-MKT-001" displays here.
To view full details, sign in with your My Oracle Support account.
Don't have a My Oracle Support account? Click to get started!
In this Document