Report Scheduling

As part of the PMDA E2B (R3) implementation, the application is enhanced for the reporting related requirements.

• Urgent Report flag: You can schedule an Urgent report for a Product License based on the value of Case form > Analysis Tab > PMDA Information Tab > General Tab > Urgent Report Checkbox for that License.
• Aware Date: You can schedule a report for an Aware Date based on the value selected in the Case form > Analysis Tab > PMDA Information Tab > Comments Tab > Start date of reporting timeframe drop-down for that License.
• Downgrade/Nullification flag: Determines whether the report is Nullification or Downgrade. The preference is given to the manually selected value Case form > Analysis Tab > PMDA Information Tab > Comments Tab > Downgrade Report flag drop-down for that License.

  Besides, the logic to schedule Nullification report in case Investigation license for Event invalidation scenarios is updated to be in synchronization with Marketed Report.

• Nullification Against changed Reporting Category: Enables you to schedule both R2/R3 as Nullification report against a License for which Reporting Category was changed. The new "Justification" field is used as the Nullification reason.
• Aware Date/Due Date of a downgrade/Nullification reports: Schedules a Downgrade/Nullification report based on the Aware date and Due Date as per the latest case data rather than copying from previous report.
• Nullification Report Distribution flag: Enable you to maintain Downgrade/Nullification report status (to not always mark the schedule Downgrade/Nullification report) for Auto Transmission, and follows a regular follow-up report workflow (as configured).