Events

An event is a regulatory activity associated to an application. An event can be an original NDA/MAA filing or a major update such as a supplement or a variation.

When an event is created, a status schedule is also created. Status schedules are applied to every country included in the application that you chose to include in the event. The event-country status schedule consists of statuses (milestones) and lead times for planning and tracking the progress of the steps needed to complete an application. You can define lead times in days for every status and then calculate the projected dates for each status based on those lead times.

A status schedule can be developed specifically for an event or can be based on a timeline/event plan, which is essentially a template of commonly used statuses and lead times. You can individually modify status schedules for each country included in the event. You can add or revise statuses and lead times by country, which will not affect the statuses and lead times for other countries included in the event.

An event can have one or more associated sequences, which are the individual filings and amendments submitted to support a business objective. You can also create tasks and sub-tasks, references, and notifications for specific events. 

The tabs that are available when you view event attributes give you access to the countries and Calyx RIM entities (such as sequences, references, and notifications) that can be associated with an event or created through an event.