← Pharmacovigilance
Safety updates and CCDS revisions
Safety updates flow into the CCDS as they're approved with the implication for SmPCs, PILs, and country labels visible before the variation work begins.
One safety update. Forty country labels
Core Labeling is where a safety update either propagates cleanly or doesn't. Most operations maintain country labels as parallel documents, each one drifting from the global anchor at its own pace. Krevyos holds labelling as structured information, so the propagation is a property of the data not a campaign.
- Domain owner
- Head of Labeling · Labeling Operations · Artwork Manager
- Artifact types
- CCDS · SmPC · PIL · USPI · Patient Information · Carton & label artwork · Pictograms
- Regional frameworks
- EU QRD template · FDA SPL · ICH M11 (where applicable) · regional templates
Capabilities
CCDS management and versioning
The Core Company Data Sheet held as the structured anchor for every country label with version history, approval state, and the link to the safety record that drove each update, so a safety signal propagates into every territory's local label rather than waiting on a parallel maintenance cycle.
- CCDS management
- Versioning
SmPC authoring with the EU QRD template
EU SmPCs structured per the QRD template, generated from the CCDS and the country-specific extensions so a SmPC stays in step with its anchor without parallel maintenance.
- SmPC authoring
- QRD template
Patient Information Leaflet and readability testing
PILs and patient-facing labels generated from the same structured content, with readability testing tracked against the version it validates, so a label update doesn't trigger a readability re-test on the wrong document.
- Patient Information Leaflet
- Readability testing
Country localization and translation memory
Country labels held as localized projections of the CCDS with translation memory, regulatory exceptions, and country-specific safety additions tracked as structural variants rather than parallel documents.
- Country localization
- Translation memory
Artwork management and pictogram libraries
Carton and label artwork held alongside the labeling content it carries so a safety update surfaces against the artwork it implies, not as a separate creative project.
- Artwork management
- Pictograms
Label change tracking and variation linkage
Every label change connected to the variation, SmPC update, or safety event that triggered it and to the artwork, PIL, and country labels that need to follow.
- Label change tracking
- Variation linkage
Touchpoints
→ Regulatory Affairs
Label variation submissions
Label changes carry their regulatory consequence: affected territories, variation type per market, evidence package: into the regulatory operation as part of the same event.
↔ Quality Management
Artwork change control
Carton and label artwork changes flow through quality change control as part of the same record: versioning, approval, and printing release are tracked together.
→ Market Access
Indications and reimbursement labelling
Country-specific indication wording, reimbursement footnotes, and access-related label extensions feed market access without parallel maintenance.
Outcomes
- −70%(indicative)
Time from CCDS update to country labels
Country labels inherit the CCDS update as a propagation rather than a parallel project.
- 100%(indicative)
Country labels traceable to a CCDS version
Every country label carries the CCDS version it derived from: drift becomes a queryable property of the data.
- +3×(indicative)
Label updates per labeling team per quarter
The labelling team's bandwidth scales with the operation rather than the volume of paperwork around it.
Safety updates that miss a market
A CCDS update propagates to every market that needs it: by design, not by a campaign.
Figures marked indicative are directional benchmarks against comparable generics operations; per-customer numbers replace them in working sessions.
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