Type IB Variation Submission Plan 48
This submission plan coordinates owners, milestone dependencies, and readiness controls for Pancrexan. 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-048
Application
Target Date
2025-02-11
Status
Draft
Owner
Lieselotte van der Berg
Created
2022-06-26
Readiness Score
10/100
Calculated from 2 approved of 20 linked content components.
Blockers
10 components are missing approval snapshots.
6 components still have unresolved review comments.
Cross-market label harmonisation open
Quality review gate not passed
Milestone Dependency Strip
Quality review
Data cutoff
CSR review
Dispatch submission
QC check
Authority acknowledgement expected
CSR draft
| Milestone | Due Date | Owner | Dependencies | Dependency Indicators | Completed |
|---|---|---|---|---|---|
| Quality review | 2025-01-23 | Tomoko Ikeda | None | Independent | No |
| Data cutoff | 2025-03-16 | Lieselotte van der Berg | None | Independent | No |
| CSR review | 2025-04-12 | Marcus Webb | None | Independent | No |
| Dispatch submission | 2025-05-21 | Sarah Chen | PLAN-048-MS-003 | Dependent | No |
| QC check | 2025-06-24 | Lieselotte van der Berg | PLAN-048-MS-004 | Dependent | Yes |
| Authority acknowledgement expected | 2025-08-02 | Nadia Petrova | None | Independent | No |
| CSR draft | 2025-08-28 | Carlos Mendez | PLAN-048-MS-006 | Dependent | Yes |