About the Schedule Page | ||||||
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Milestones and Regulatory Milestones
The submission process includes a phase for completing the internal tasks to create, review, and approve all of the documents that comprise the submission dossier. After the dossier is complete and delivered to the regulatory authority, another phase occurs dictated by the regulatory authority. That phase includes milestones and phases that support the review process, including any question-and-answer (Interactive Review) phases, and ends with market authorization for the product. This phase of the submission is called the regulatory calendar, and is typically defined in theregulatory guidelines for a specific combination of regulatory context (regulatory context, regulatory context, and regulatory context) and the regulatory context (such as Initial Submission or Renewal).
The Schedule page for a submission lets you track both phases in one place. Use a Milestone task (Market Registration adds a milestone purpose attribute to the standard milestone type) during the dossier preparation phase. Use a Regulatory Milestone task during the Regulatory Calendar phase. The Regulatory Information page tab of the Regulatory Information category for a submission lists all milestones that have a purpose defined.
When you create a submission project, Market Registration automatically creates these milestones in the schedule:
| Internal Milestone Purpose Option | Description |
|---|---|
| Dossier Ready | All documents required for the dossier have been completed, reviewed, and approved. |
| Dossier Published | A ZIP or PDF containing all the documents has been generated. |
| Dossier Submitted | The dossier for the phase has been submitted to the regulatory authority. |
| Dossier Received | The regulatory authority has received the dossier. |
| Market Authorization | Authorization to market the product has been received from the Regulatory Authority. |
Do not delete these milestones. You need to complete each milestone before you can complete the next one. For example, you cannot mark the Dossier Submitted milestone complete if the Dossier Ready milestone is still in process.
For the regulatory calendar, you can define milestones with these milestone purposes:
| Regulatory Milestone Purpose Option | Description |
|---|---|
| Clock Start | The regulatory authority must respond to the submission after a specific number of days. The clock start milestone specifies the start date for that time period. |
| Question | Regulatory authority has reviewed the dossier and submitted questions based on that information. |
| Response | Answers to the above questions have been provided. |
| Assessment Report | People responsible within the regulatory authority for evaluating the dossier provide an initial assessment to the applicant. |
| Oral Explanation | The date the applicant must provide an oral explanation for any issues (question responses). |
| Procedure Go | The regulatory gives the green light (go ahead) for the submitted procedure. The product is almost approved pending some final information (such as labeling and packaging) that the applicant still needs to provide. |
If you add milestones directly to the schedule, you need to edit the properties for the milestone to set the purpose. If you use the or > Add Subtask Below commands, you can set the milestone purpose in the create dialog box.
Milestones can be defined in a submission template or a regulatory calendar template to be used by submission projects. For a milestone defined in a submission template, only a Regulatory Administrator or the owner of the submission template can edit the milestone purpose. For a milestone defined in a submission, only a Regulatory Lead or the owner of the submission project can edit this attribute.
Regulatory Milestone Checklists
Checklists can be defined for regulatory milestone tasks to track when the milestone is complete.
You can define checklists in the context of a submission template or a submission project. One checklist might contain checklist items required for a pre-submission meeting (a milestone). Another checklist could contain checklist items for an investigation plan. The checklist allows you to create a list of all the prerequisites that must be complete for that milestone to be considered complete.
The checklist items themselves vary depending on the type of submission, the requirements for that type of submission from that specific regulatory authority, and the country in which authorization is being requested. When working with submission templates and submission projects, checklist items act as prerequisites.
For each milestone in the submission schedule, you can associate one or more checklists. When a submission is created based on that template, all checklists for all milestones are copied to the individual submission project. The Regulatory Lead who owns the submission can define additional checklists and checklist items as needed for the specific circumstances of that project.
When you define a checklist item, you specify what type of response is required: Yes or No, for example. You edit the Checklists page for the regulatory milestone to enter the response.
To promote a milestone to the Complete state, all checklists for that milestone must be completed. To complete a checklist, each checklist item must have a response. The valid responses are determined when the checklist item was created.
See the checklist topics in Project Management User's Guide: Working With Gates for general information. See Working with Checklists for Milestones for information on using checklists with regulatory milestones.
Tasks
Each task is designed to deliver a document. You can add tasks to an inactive submission (on hold), but you cannot add tasks to a cancelled submission.
When creating a task for a submission project, you choose whether the task must be reviewed. The Needs Review attribute can be set to Yes or No. If you choose Yes, then when the person assigned to this task promotes it from Active to Review, the app automatically creates a review route with the submission owner assigned an approval task. Tasks that require review show the 
icon in the schedule structure.
Each task, and its deliverable, can also be associated with a volume. You can select a volume for any type of task (task, phase, gate, interactive review, or review question) but not for a milestone. The Schedule page must be in edit mode to assign tasks to volumes.
To submit the deliverable, you can use the file tools on any of these pages:
- Deliverables page for the task itself (view the WBS for the task)
- On the Schedule page tab, click the volume name for the task
- On the Schedule page tab, click + in the
column for the task
You can click the name of any task to view additional details, such as deliverables, assignees, risks, or routes associated with that task. The Deliverables page for a task includes the 
(higher revision exists) column. If the icon shows for a deliverable, then the document has been revised since it was added as a deliverable for this task. The Folders page for the submission also includes this column. You can then use the Sync Submission Dossier command on the Schedule page tab to update all documents for selected tasks to the current revision. When the Regulatory User completes a task, the app automatically syncs the dossier.
If the higher revision was also added to the task, then this icon is informative. If not, you can click to include the latest revision of a document in the deliverables list.