Draft Icon >> E2B shows Error after Initial E2B was Submitted
(Doc ID 1615658.1)
Last updated on JULY 13, 2023
Applies to:
Oracle Life Sciences Argus Safety Japan - Version 7.0.2 to 8.1 [Release 7.0.0 to 8.1]Information in this document applies to any platform.
Goal
After Initial E2B is submitted to PMDA agency, unable to Generate E2B using [Draft] icon >> E2B with PMDA ICSR Validation report.
Error on PMDA ICSR Validation report:
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J.4b MHLWADMICSRCASENUMB
Case Form / Analysis / PMDA Info / General / PMDA Number of Suspected License
Though J.4b (MHLWADMICSRCASENUMB) value cannot exist in Initial report, the value exists [Domestic specific information : PMDA number]
Solution
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In this Document
| Goal |
| Solution |
| References |