Non-Japanese license name displays in PMDA E2B (R3) paper report
(Doc ID 2492445.1)
Last updated on JULY 13, 2023
Applies to:
Oracle Life Sciences Argus Safety Japan - Version 8.1.2 and laterInformation in this document applies to any platform.
Symptoms
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.
Sample Scenario:
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)")
Steps:
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.
Cause
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In this Document
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