Ennov InSight 7.2 Data Migration Documentation

Ennov InSight 7.2 Medicinal Product Updates

New features and fields are included in Ennov InSight 7.2 to conform to the regulatory requirements.

Medicinal Product

To support IDMP, Ennov InSight 7.2 includes the following changes for the medicinal product:
  • The Medicinal Product entity and all the associated child entities are moved from the Registration to the Application level.
  • The Medicinal Product tab is added to the Application Attributes page.
  • The PMSID field is removed from the Medicinal Product Attributes page.
  • The PMSIDs tab is added to the Medicinal Product Attributes page.
  • The following fields are added to the Medicinal Product Attributes page:
    • Full Indication Text
    • Full Indication Language
    • Country
    • Registrations
    • License Root Number
  • The following columns are now displayed for the Medicinal Product tab:
    • Registration Country
    • Product
    • PMSID
    • MPID
    • License Root Number
    • Related Registration(s)
Ennov InSight 7.2 includes the ability to track Pending Changes for the entities at the Event level and select attributes for Pending Changes in a wizard. The new Pending Changes tab on the Event Attributespage displays the Pending Changes attributes. The following fields are tracked for medicinal product:
  • Pediatric Use Indicator
  • Full Indication Text

The Full Indication Language attribute was added to medicinal product to correspond with Full Indication Text. However, this new attribute will not be tracked with the Pending Changes functionality.

MPIDs

To support IDMP, Ennov InSight 7.2 includes the following changes for the MPIDs:
  • The MPIDs tab is editable now.
  • The Country field is added to the MPID Attributes. This field is available if the application procedure type is CP and includes the values: European Union , Iceland , Liechtenstein , Norway .
  • The MPIDs tab now includes the Country column.