Signals to Labeling
The Signals-to-Labeling pipeline manages the workflow from safety signal identification through benefit-risk assessment, SmPC drafting, regulatory review, and submission. Each signal is tracked from source detection through to label update submission.
Pipeline Stages
Stage 1
Under Assessment
1
Stage 2
Expert Review
1
Stage 3
Label Review
1
Stage 4
SmPC Draft
1
Stage 5
Approved for Submission
1
Stage 6
Monitoring
1
| ID | Signal | Source | Product | Priority | Stage | Label Section | Assigned To | Created |
|---|---|---|---|---|---|---|---|---|
| STL-001 | Increased hepatotoxicity reports in post-marketing surveillance | EudraVigilance | PROD-001 | Critical | Label Review | 4.4 / 4.8 | Sarah Chen | 2025-04-12 |
| STL-002 | New drug-drug interaction identified with strong CYP3A4 inhibitors | Clinical Study KCL-INT-007 | PROD-003 | High | SmPC Draft | 4.5 | Marcus Webb | 2025-03-25 |
| STL-003 | Serious skin reactions reported across 4 markets | PSUR Q1 2025 | PROD-007 | High | Approved for Submission | 4.8 | Priya Sharma | 2025-02-18 |
| STL-004 | Off-label paediatric use pattern identified from real-world data | Healthcare claims database | PROD-012 | Medium | Under Assessment | 4.2 | James O'Brien | 2025-01-30 |
| STL-005 | Cardiac arrhythmia signal from spontaneous reports (n=12) | FDA MedWatch | PROD-004 | High | Expert Review | 4.4 / 4.8 | Aisha Okonkwo | 2025-05-02 |
| STL-006 | Benefit-risk rebalancing signal from competitor REMS program | Competitor Intelligence | PROD-006 | Low | Monitoring | 4.4 | Carlos Mendez | 2025-04-28 |