Solution for G.k.2.2 and J2.11 Mapping Updates as per the New PMDA E2B R3 Investigational Reporting (Doc ID 2866288.1)

Last updated on OCTOBER 12, 2023

Applies to:

Purpose

The Pharmaceuticals and Medical Devices Agency (PMDA) published notifications for new investigational reporting on 31-Aug-2020.

The mandatory date for submitting investigational reports as per the updated notification is 01-Sep-2022.

To comply with the date, companies are looking for solution in their current Argus system till upgrading to Argus 8.4 that contains PMDA R3 investigational reporting functionality provided out of the box as per the updated guidance.

This document provides solution for updates required as per notification published on 07-Feb-22 – mapping updates for J2.11 Other references and G.k.2.2 Medicinal Product Name in PMDA E2B R3 investigational report.

Scope

This document provides a solution for updates required as per notification published on 07-Feb-22 – mapping updates for J2.11 Other references and G.k.2.2 Medicinal Product Name in PMDA E2B R3 investigational report.

This is tracked in Enhancement 33917092 - Logic for G.k.2.2 and J2.11 as per the new PMDA E2B R3 investigational reporting

The solution is applicable for Argus versions – 8.2.1.9, 8.2.3.1.

These are the latest versions of each code line branch. If you are using a different Argus version than above, then this solution cannot be applied.

The solution is updated in the out-of-the-box profile in the Argus 8.4 version.

Details

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