eVAERS GENC2 Regulatory Updates November 2020
(Doc ID 2812878.1)
Last updated on OCTOBER 30, 2024
Applies to:
Oracle Life Sciences Argus Safety - Version 8.2 to 8.4.3.2 [Release 8.2 to 8.4]Oracle Life Sciences Argus Interchange - Version 8.2 to 8.4.3.2 [Release 8.2 to 8.4]
Oracle Life Sciences Argus Safety Cloud Service - Version 8.2 to 8.4.3.2 [Release 8.2 to 8.4]
Information in this document applies to any platform.
Goal
The purpose of this document is to generate eVAERS reports with GENC2 codes for the COUNTRY code list as per CBER guidance published in November 2020.
You can refer to the updated guideline using the URL:
https://www.fda.gov/media/138670/download
These requirements are logged as an Argus enhancement request Enh 33415880 - 'eVAERS GENC2 Regulatory Updates November 2020'
Solution
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In this Document
Goal |
Solution |
References |