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PMDA Follow-up E2B Is Scheduled Differently By 'Allow Multiple Reports For Marketed/Investigational Drugs' Checkbox (Doc ID 2112672.1)

Last updated on AUGUST 11, 2020

Applies to:

Oracle Argus Safety Japan - Version 7.0.3 and later
Information in this document applies to any platform.

Goal

After PMDA E2B has been submitted for a license of Product X and case product is changed from Product X to Product Y,
follow-up E2B is auto scheduled differently depending on the 'Allow Multiple Reports for Marketed/Investigational Drugs' checkbox of the agency at Reporting Destination code list.

If that checkbox is not checked, Follow-up E2B for Product Y is scheduled.

However, if that checkbox is checked, Nullification E2B for Product X and Initial E2B for Product Y are scheduled.

Is this report schedule behavior a bug or expected?

Solution

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In this Document
Goal
Solution


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