Label management is a complex activity that is on-going throughout the lifecycle of a pharmaceutical product. Effective labeling, from label creation and updates through to implementation, is a truly cross-functional process which spans across Pharmacovigilance, Regulatory Affairs, Medical Affairs, and Supply Chain. The need to have E2E labeling oversight is now a regulatory expectation and no longer just a future requirements. E2E tracking of status and timelines is an essential part of enabling E2E labeling oversight, i.e. from confirmation of safety signal to label implementation 'in pack'.
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- End-to-end labeling - why is it important?
- Patient Safety
- PV Compliance
- A new paradigm of E2E labeling - from signal to patient
- What does good look like? Process, Governance, and Technology
- One goal, one voice: the cross-functional paradigm (PV, RA, Supply Chain, Medical Affairs, etc.)
- The Navitas Model for Success for End-to-End Labeling