Label Update Submission Plan 55
This submission plan coordinates owners, milestone dependencies, and readiness controls for Tisavance. Teams use it to monitor timeline health, resolve blockers, and decide whether content is publish-ready for sequence assembly. Readiness is calculated from deterministic component approval status across linked dossiers, rather than manual estimates. Use the edit and content assembly actions to move directly into corrective work.
Plan ID
PLAN-055
Application
Target Date
2025-06-17
Status
Completed
Owner
Tomoko Ikeda
Created
2022-01-05
Readiness Score
10/100
Calculated from 2 approved of 20 linked content components.
Blockers
13 components are missing approval snapshots.
8 components still have unresolved review comments.
Authority clarification needed on comparator study
Cross-market label harmonisation open
Phase III data reconciliation ongoing
Milestone Dependency Strip
CSR review
Protocol finalization
Regulatory review
Quality review
Publishing start
| Milestone | Due Date | Owner | Dependencies | Dependency Indicators | Completed |
|---|---|---|---|---|---|
| CSR review | 2025-02-02 | Priya Sharma | None | Independent | No |
| Protocol finalization | 2025-03-04 | Nadia Petrova | None | Independent | No |
| Regulatory review | 2025-04-07 | James O'Brien | PLAN-055-MS-002 | Dependent | Yes |
| Quality review | 2025-05-04 | Priya Sharma | PLAN-055-MS-003 | Dependent | No |
| Publishing start | 2025-06-07 | Dmitri Volkov | None | Independent | No |