Ennov InSight 7.2 Release Notes (Cumulative)

Entity Fields and Columns Updated: Ennov InSight 7.2

The following tables describe fields that were modified in this release.

Product Family

Field/Option Name Field Type Description Business Rules
Product Family Indication Multi-select, read-only text (populated automatically) This field is renamed to Product Family Indication(s) on the Product Family Attributes page. For Veterinary Product Family Type, this field is still Product Family Indications/Intended Use.
Product Family Comorbidity Multi-select, read-only text (populated automatically) This field is renamed to Product Family Comorbidity(s) on the Product Family Attributes page.
Active Ingredients Selection widget The selection widget for this field is modified to display XEVMPD Code and SMS Term ID columns on the Product Family Attributes page.

You can now associate or disassociate the Active Ingredients on the Product Family Attributes page if a Product Family has associated Products with no Components, PDSs, or PDS Templates related to these Products.

Registrations

Field/Option Name Field Type Description Business Rules
Status Read-only text This field is renamed to PDS Package Set Status on the Registration-Package Sets Attributes page.
Status Date Read-only text This field is renamed to PDS Package Status Date on the Registration-Package Sets Attributes page.
Currently Marketed in this country? Drop-down list This check box for this option is now changed to a drop-down list and includes the values Registration Maintenance > Marketing Status Values in Data Administration.
Package Description Description Text field This field is renamed to Package Description on the Package Set- Package Description Attributes page.

Component

Field/Option Name Field Type Description Business Rules
IDMP Concentration Measure Type Drop-down list This field is moved under IDMP Presentation Strength section on the Component > Active Ingredient Attributes and Reference Active Ingredient Attributes pages and renamed to Concentration Measure Type. When Equal is selected for this field, Equal is no longer shown in XEVMPD Strength, IDMP Presentation Strength , IDMP Concentration Strength columns on the Active Ingredients and Reference Active Ingredients tabs.

Pharmaceutical Product

Field/Option Name Field Type Description Business Rules
IDMP Concentration Measure Type Drop-down list This field is renamed to Concentration Measure Type and moved under IDMP Presentation Strength section for the following pages:
  • Pharmaceutical Product > Active Ingredient Attributes and Reference Active Ingredient Attributes
  • Pharmaceutical Product > Substance Attributes and Reference Substance Attributes.
When Equal is selected for this field, Equal is no longer shown in XEVMPD Strength, IDMP Presentation Strength , IDMP Concentration Strength columns on the Active Ingredients and Reference Active Ingredients tabs, and also on Substances and Reference Substances tabs.

Product Detail Sets

Field/Option Name Field Type Description Business Rules
Packaging MI Quantity Text field This field is updated to include both integer and non-integer values on the Package Detail Attributes page.
IDMP Concentration Measure Type Drop-down list This field is renamed to Concentration Measure Type and moved under IDMP Presentation Strength section for the following pages:
  • Product Detail Set > Substance Detail Attributes
  • Product Detail Set Template > Substance Detail Attributes
  • Product Detail Set > Flu Strain Attributes
  • Product Detail Set Template > Flu Strain Attributes
All the active values from Data Administration > Other > Concentration Measure Type Values are displayed for this field.

Manufactured Item

Field/Option Name Field Type Description Business Rules
Manufactured Item Quantity Text field This field is updated from required to optional on the Manufactured Item Attributes page and may include both integer and non-integer values.
Manufactured Item Quantity Unit Drop-down list This field is updated from required to optional on the Manufactured Item Attributes page.
IDMP Concentration Measure Type Drop-down list This field is moved under IDMP Presentation Strength section on the Manufactured Item > Active Ingredient Attributes and Reference Active Ingredient Attributes pages and renamed to Concentration Measure Type. When Equal is selected for this field, Equal is no longer shown in XEVMPD Strength, IDMP Presentation Strength , IDMP Concentration Strength columns on the Active Ingredients and Reference Active Ingredients tabs, and also on Substances and Reference Substances tabs.

Medicinal Product

Field/Option Name Field Type Description Business Rules
Full Indication Text Text field This field is now available for all the EU procedure types and not restricted to just to Centralised Procedure (CP) on the Medicinal Product Attributes page.
  • Application Code
  • Application Name
  • Medicinal Product Name
  • MPID
  • Country
  • Version
  • Version Date
Hyperlink, drop-down list, text field, date. The MPIDs tab is editable now and includes the respective fields.

Medicinal Product Name

Field/Option Name Field Type Description Business Rules
Country Multi-select, read-only text (populated automatically) The Medicinal Product Name Attributes page is updated to include European Union for the Country field for applications with Centralized Procedure (CP). A country can be created or modified for Medicinal Product Name for applications with Centralized Procedure (CP) only.

Medicinal Product Action

Field/Option Name Field Type Description Business Rules
Sequence Drop-down list This field is updated to display a concatenation of the Sequence Name and Sequence Code values on the Medicinal Product Actions page.

Wizards

Table 1. Create Application
Field/Option Name Field Type Description Business Rules
Countries N/A The wizard is updated to select only European Union when an Event is created for EU CP application. European Union is selected in the Selected. All other countries are in the Available box. N/A
Table 2. Global Project Plan
Field/Option Name Field Type Description Business Rules
EU Clinical Trial Regulation Read-only text (populated automatically) The Application Type field is updated with the EU Clinical Trial Regulation option in the Available box on the Global Project Plan > Select Filter Criteria page. N/A