Ennov InSight Registrations 7.1

Create an Event

You create an event for an application to show a key business objective or regulatory action.

When you create an event, you specify important event attributes, including event name, event code, event type, PSUR information, and status dates. You also choose which countries and which products included in the application can be included in the event and choose whether to use an event plan to create the status schedules.
Note: Withdrawn application countries with the Withdraw Date value equal to today’s date or earlier, are not available for selection in the Countries multi-select field on the Create Event page. This is applicable only to applications of Mutual Recognition (MRP) or Decentralised Procedure (DCP) types.

When you create an event, Ennov InSight automatically associates the event schedule to each country selected for inclusion in the event.

An event is automatically created and associated with the submission entities when you use the Create Submission wizard to create an initial application or a major update.
Note: At this time, Ennov InSight will not prevent you from associating non-veterinary events to projects with veterinary product families. Under this scenario, you will not see the non-veterinary details, however, they will be stored in the database and appear in related queries.
To create an event:
  1. Click a link for the application for which you want to create an event.
    The Application Attributes page opens.
  2. Click Events.
  3. Click Create.
    The Create Event page appears.
  4. Select and enter the event attributes.
  5. Save.
  6. Choose the applicable procedure to enter an electronic signature for entities:
    Scenario Steps
    When electronic signature is enabled
    1. Select a reason and enter comments for the reason.
    2. Select Save.
    3. Validate your identity by entering your user credentials in the dialog box.