Ennov Registrations

Ennov InSight Registrations

Ennov InSight Registrations Entity Diagram

Manage Entities in Ennov InSight Registrations

Package Set Registrations

Product Registrations

Product Families

Creating Product Families

Modify a Product Family

Modify the Active Ingredients Order

Product Family Attributes

View a Product Family

Delete a Product Family

Clinical Trial Shared Data

Active Ingredients

Reference Active Ingredients

Create a Product

Product Attributes

Modify a Product

Delete a Product

Pharmaceutical Product

Country Specific Detail

Active Ingredients and Reference Active Ingredients

Associate an Active Ingredient

Associate a Reference Active Ingredient

Substances and Reference Substances

Associate a Substance

To associate a reference substance:

Associate a Substance or Reference Substance from Substance Search

Create Application Wizard

Create an Application from the Product Family Attributes Page

Application Attributes

Modify an Application

Use the Update Application Wizard

Application Countries

Add a Country to an Application

Application Country Attributes

Modify an Application Country

Remove Application Countries

Copy Applications

Event Attributes

Copy an Application

Copy Application Attributes

Copied Application Attribute Results

Copied PDS Attribute Results

View an Application

Import an eCTD Application

Associate or Disassociate a Product to an Application

Delete an Application

Medicinal Product

Create a Medicinal Product

Medicinal Product Attributes

Modify a Medicinal Product

Delete a Medicinal Product

Medicinal Product Action

Create a Medicinal Product Name

Medicinal Product Name Attributes

Modify a Medicinal Product Name

Delete a Medicinal Product Name

Product Cross-References

Product Cross-Reference Attributes

PMSID Attributes

MPID Attributes

Associate a Pharmaceutical Product to a Medicinal Product

Disassociate a Pharmaceutical Product from a Medicinal Product

Medicinal Product Action

Create a Medicinal Product Action

Sender-defined Keywords

Orphan Designation

Ennov InSight XEVMPD

XEVMPD Submission Wizard

XEVMPD Acknowledgement Wizard

XEVMPD Error Message for Authorised Product

Auto Upload and Process Acknowledgement Files

XEVMPD Data Administration Sections Correspondence

XEVMPD Entities

Create an Event

Event Attributes

Modifying an Event

Associate or Disassociate a Product and an Event

About Associating or Disassociating Clinical Trial Shared Data

Remove Countries from an Event

Pending Changes

Delete an Event

Event-Country Statuses, Actual Dates, Projected Dates, and Lead Times

Approved Status Views

Global Project Planning

Create a Project

Project Attributes

Modify a Project

Update Multiple Events from a Project

Update Multiple Sequences from a Project

Create Product Registrations for Project Events

Delete GPP Projects

Update Project Event-Country Statuses and Dates

Calculate Projected Event-Country Status Dates for a Project

Associate or Disassociate an Event with or from a Project

Create a Reference for Project Events or Sequences

Associate Workflows to Events or Sequences

Associate Change Details

Product Detail Sets (PDS)

Create a PDS from a PDS Template

Flu Vaccine PDS

Associate or Disassociate PDSs and Events

Updating MedDRA Version

QC Status for a PDS Detail

Create a Sequence from the Application Attributes Page

Create a Sequence from the Event Attributes Page

Create a Sequence from the Project Attributes Page

Sequence Attributes

Modify a Sequence

View a Sequence

Delete a Sequence

Projected Status Dates for Sequences

Change Submittal Status Wizard

Registration Types

Create a Package Set Registration

Create a Product Registration

Associate a Dosage Form to an Entity

Modify Registrations

About the Copy Package Set Registrations Wizard

Use the Update Status Wizard

View a Registration

Delete a Registration

Full Product Presentation

Registration Attachment

Registration FPP Attachment

FPP Pharmaceutical Products

FPP Previous EV Code

Notification Specifications

Notification Types

Concerned Parties

Tasks and Sub-tasks

Create a Sub-task

View Tasks and Sub-tasks

Update Tasks and Sub-tasks

Copy a Task and Associated Sub-tasks

Delete a Task or Sub-task

Projected Status Dates for Tasks

Task Attributes

Create a Reference

Reference Attributes

Modify a Reference

View a Reference

Delete a Reference

Projected Status Dates

Add a Projected Status Date

Projected Status Date Attributes

Modify a Status Date

Delete a Projected Status Date

Create a Change

Use the Change Management Wizard

Delete a Change

Create Change Details

Change Attributes

Modify Change Attributes

Associate or Disassociate Change Details and Events

Generate a Query

Registered Document Analysis Queries

Product Detail Management Queries

Registration Planning and Tracking Queries

Submission Planning and Tracking Queries

Administration Queries

Entity Audit Trail

Modify a Custom Query

Entity History Query

Activities Associated with Ennov InSight Registrations Entities

View Activities Associated with Ennov InSight Registrations Entities

View Activities List Filters

List of Ennov InSight Registrations Entities

Ennov InSight Registrations Best Practices