Timeline for a Regulatory Calendar Page

The Timeline page tab in the Regulatory Calendar page lists all schedule items within regulatory calendar phases.

The regulatory calendar is added to the schedule using the Add Regulatory Calendar or Add Existing Calendar From Template commands on the schedule page for the submission project.

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To access this page:

  1. Open the required submission project.
  2. In the navigation pane, click Schedule.
  3. Click the Regulatory Calendar page tab.
  4. View the Timeline tab.

This topic describes:

This page discusses:

See Also
About Regulatory Calendars
About the Interactive Review Phase

Columns

SectionColumn NameDescription
NameThe automatically generated name of the item. The first row always shows the submission project. Rows can be expanded to show the global regulatory calendar and all milestones and phases.
TypeThe type of item on this line. The first line shows the submission, subsequent lines can show any of these types:
  • Regulatory Calendar
  • Regulatory Milestone
  • Interactive Review
Regulatory CalendarScopeShows a value only for regulatory calendar phases: Global or Local.
Esc. LevelShows a value only for regulatory calendar phases: the escalation level.
CountryFor local calendars, the country the calendar is associated with.
Regulatory MilestonePivotYes or No to indicate if an escalation calendar can be added to this milestone.
ConnectionYes or No to indicate if a local calendar can be added to this milestone.
PurposeThe regulatory purpose for the milestone. See Regulatory Milestones.
If shows in a row, the interactive review phase acts as a clock stop. This icon does not show in rows for regulatory calendars or regulatory milestones.
IdThe sequence number.
DependencyThe dependency for this milestone or phase. See Project Management User's Guide : Using WBS Task Dependencies
Icon indicating the current status for this milestone or phase.

IconDescription
(blank)The milestone or phase is not complete but there is more than 5 days remaining before the due date.
The milestone or phase is complete.


The milestone or phase is not complete and there are less than 5 days remaining before the due date.
The milestone or phase is not complete and the current date is after the due date.

StateThe current lifecycle state for the milestone or phase.
Constraint TypeConstraint type used for scheduling. See Project Management User's Guide : About Tasks: About Task Constraints.
DateConstraint date used for scheduling.
EstimatedDurationThe estimated duration in days or hours for the milestone or phase.
Start DateThe estimated start date of the milestone or phase.
End DateThe estimated completion date of the milestone or phase.
ActualDurationThe actual duration of the milestone or phase.
Start DateThe actual start date of the milestone or phase.
End DateThe actual completion date of the milestone or phase.
OwnerOwner of the milestone or phase.
WBSThe item's order in the hierarchy. Integers represent top-level items. Second-level items have one decimal, third-level items have two decimals, and so on.

Actions/Toolbar Commands

See Project Management User's Guide : Listing WBS Tasks within a Project or Task for information on the Edit menu.

These actions are only available when the calendar is not in the Complete or Archived states.

Required access roles: Submission Lead with Regulatory User or Regulatory Lead role, or submission owner

Action NameDescriptionFor More Information
Add Local CalendarAdds a local calendar to the schedule.-
Add Escalation CalendarAdds the next level of escalation calendar defined by the regulatory calendar template to a selected pivot milestone using an FS+0D dependency.

Adding an escalation calendar changes all subsequent milestones and local calendars to optional. That is, any milestones and calendars that were on the timeline after the selected pivot milestone are effectually deleted because the project now follows the timeline for the escalation calendar.

If the escalation calendar contains connection milestones, then a local calendar for each country is also added to the timeline.

You cannot add an escalation calendar if the schedule is in an interactive review phase with the clock stopped.

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Add Interactive ReviewInserts an interactive review phase into the timeline after the selected milestone or interactive review phase.

You must be the Regulatory Lead for the submission project.

You cannot add an interactive review phase to the timeline if another interactive review is in process.

After adding the interactive review phase, add review questions as defined by the regulatory authority. You cannot add the questions on this page: Click the name of interactive review phase and add them on the schedule page that opens.

Defining Review Question Tasks
Add Clock StopStops the calendar timer and adds the clock stop icon to the selected interactive review phase.-
Enable Edit Toggles the page into the edit mode. In edit mode, you can use the Edit menu and quick action toolbar.

If you added a regulatory calendar template, columns controlled by the template cannot be edited here.

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Disable Edit Toggles the page into the view mode.-