The Technical Reference Manual (TRM) for the Pharmaceuticals and Medical Devices Agency (PMDA) R3 Profile Has Incorrect Information for elements (G.k.4.r.10.2a, G.k.4.r.10.2b, G.k.4.r.11.2a, G.k.4.r.11.2b)
(Doc ID 3042913.1)
Last updated on SEPTEMBER 06, 2024
Applies to:
Oracle Life Sciences Argus Safety - Version 8.4.1 and laterInformation in this document applies to any platform.
Goal
The Technical Reference Manual (TRM) for the Pharmaceuticals and Medical Devices Agency (PMDA) R3 Profile "ArgusInterchange841_PMDA E2B (R3) Export Import Mappings.xlsx" does not have correct logic for import of Route of Administration elements (G.k.4.r.10.2a, G.k.4.r.10.2b, G.k.4.r.11.2a, G.k.4.r.11.2b). There is no mention of the European Directorate for the Quality of Medicines & HealthCare (EDQM) terms handling.
Looking at actual import logic, the system looks at the EDQM repository to import these elements.
Solution
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In this Document
| Goal |
| Solution |
| References |