Schedule Page for a Regulatory Calendar Template

The Schedule page for a regulatory calendar template defines the phases and milestones that occur after the dossier is submitted, through the regulatory authorization.

Required access role: Regulatory Administrator

When created, the schedule automatically includes a regulatory calendar phase (Scope: Global and Esc. Level: 0), with regulatory milestones for the Clock Stop and Market Authorization purposes. Although you can remove these rows from the schedule, you cannot promote the regulatory calendar template to active without them.

To access this page, open the required regulatory calendar template. Schedule is the default page for the category with the template name.

This topic describes:

This page discusses:

Columns

SectionColumn NameDescription
Task NameThe name of the item. Click to open the default page for that item. You can expand and collapse the structure to view the regulatory calendar phases in the template, and the regulatory milestones within the calendar phases.
TypeThe type of item. The calendar can include these item types:
  • Regulatory Calendar Template
  • Regulatory Calendar
  • Regulatory Milestone
  • Interactive Review
Regulatory CalendarScopeGlobal or Local for rows that define a regulatory calendar. Blank for all other rows.

You cannot define more than one regulatory calendar with the same combination of Scope and Esc. Level.

In the schedule for the template, you add additional global or local calendars as children of the template (the first row of the schedule) regardless of when they would occur during the submission process.

For a submission project that uses this regulatory calendar template, you would add the local calendar to a regulatory milestone with Yes for the Connection value. You would add an escalated global calendar to a regulatory milestone with Yes for the Pivot value.

Esc. LevelThe escalation level. For the global scope, all escalation values must start from 0, and increment by 1 without any gaps.

The escalation for a global calendar might not have an equivalent escalation for the local calendar.

Regulatory MilestonePivotYes or No to indicate if this milestone allows an escalation calendar to be added to it.

If the schedule includes global calendars for any number of escalations, you need to include regulatory milestones for each escalation, not including the 0 escalation. For example, if your schedule includes these regulatory calendars:

  • Scope=Global and Esc. Level=0
  • Scope=Global and Esc. Level=1
  • Scope=Global and Esc. Level=2

You need at least two regulatory milestones with Yes for the Pivot value. These milestones define the places in the schedule where the escalated calendars can be attached in the schedule for a submission project.

ConnectionYes or No to indicate if this milestone allows a local calendar to be connected to it.

If the schedule includes local calendars for any number of escalations, you need to include regulatory milestones for each escalation. For example, if your schedule includes these regulatory calendars:

  • Scope=Local and Esc. Level=0
  • Scope=Local and Esc. Level=1
  • Scope=Local and Esc. Level=2

You need at least three regulatory milestones with Yes for the Connection value. These milestones define the places in the schedule where local calendars can be attached in the schedule for a submission project.

PurposeThe regulatory purpose for this milestone. See Regulatory Milestones for information about the options.
For the Interactive Review phase only. If shows for the row, then the submission timer is in clock stop.
IdThe schedule sequence for this regulatory calendar phase, interactive review phase, or regulatory milestone.
DependencyThe dependency for this milestone. See Project Management User's Guide: About Task Dependencies for information.
EstimatedDurationDuration in days or hours for the item on this row
WBS The phase or milestone's order in the hierarchy. Integers represent the top level. Second level items have one decimal, third level tasks have two decimals, and so on.
DescriptionDescriptive information about the activity.

Edit Menu

Required access role: Regulatory Administrator

When adding a regulatory calendar phase to the schedule, you must add it at level 1. That is, the regulatory calendar template must be the parent of all phases. You cannot nest phases. In addition, regulatory milestones and interactive review phases can only be added to regulatory calendar phases, not as direct children of the regulatory calendar template.

Edit OptionDescriptionFor More Information
UndoReverts changes to existing values on the selected row. Click OK to confirm.Project Management User's Guide : Listing WBS Tasks within a Project or Task
CutMarks the selected row for removal from the current location and keeps it in memory (for use with one of the Paste actions). You can cut multiple rows at a time. The text in the row is crossed-out in red to indicate it is marked for removal.
CopyCopies the selected rows for use with one of the Paste actions.
Paste As ChildInserts rows cut or copied as children of the selected row. If you need to define an order for child rows, use the Paste Above action.
Paste AboveInsert rows cut or copied above the selected row as child objects to the selected row's parent object. Pasted rows show in green if the row was cut or copied from a different parent object, or orange if the pasted rows were cut (not copied) from a different location in the list of that parent object. Orange indicates a re-sequencing of rows.

Actions/Toolbar Commands

Required access role: Regulatory Administrator

Action NameDescriptionFor More Information
Enable Edit Toggles the page into the edit mode. In edit mode, you can add and remove rows, and edit values.

The calendar template must be in the Inactive state.

Project Management User's Guide: Editing the WBS
Disable Edit Toggles the page into the view mode. -
Delete Selected Deletes selected rows. Click OK to confirm.

The calendar template must be in the Inactive state.

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Quick creation toolbarAdds the specified number of the shown type above or below a selected row.

The calendar template must be in the Inactive state.

You can only add these types to the template:

  • Regulatory Calendar
  • Regulatory Milestone
  • Interactive Review

When adding a regulatory phase to the schedule, you must add it at level 1. That is, the regulatory calendar template must be the parent of all regulatory phases. You cannot nest phases. In addition, regulatory milestones and interactive review phases can only be added to regulatory calendar phases, not as direct children of the regulatory calendar template.

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