Label management is a complex activity that is on-going through the lifecycle of a pharmaceutical product. At Navitas, we recognise that effective labeling, from label text creation and updates through to implementation, is a truly cross-functional process which spans across Pharmacovigilance, Regulatory Affairs, Medical Affairs and Supply Chain. It requires specialist input and careful co-ordination across an organisation, and involve expert resources from Headquarters, regional and local operations. Coupled with the need to meet the diverse and shifting regulatory requirements across global markets, it is no surprise that achieving effective label management remains a major challenge for many Pharma companies.
Navitas Model for Success for effective labeling
Our model for success addresses these challenges and aligns across functions to deliver a compliant, label management process. In terms of labeling process design we ensure:
- A consistent global process to initiate and approve label changes with shared understanding of terms and definitions
- Clear governance with metrics and target timelines by category
- Common tools and templates; with visible tracking from initiation to implementation
- Robust Quality Management System to ensure compliance
- A single, accessible repository for label information and workflow tools
- Clear owners and responsibilities across the end-to-end process
Latest insights in the labeling space
- The Company Core Datasheet (CCDS) is an essential document for global label management, particularly in upholding label consistencies across diverse markets. Clearly defined processes for the creation, update and version management of the CCDS, alongside a clear policy for regional/local implementation, are required to ensure that accurate and consistent benefit-risk information is communicated to the end-users in an effective and timely manner.
- The need to have End-to-End labeling oversight is now a regulatory expectation and no longer just a future requirement. End-to-End tracking of status and timelines is an essential part of enabling End-to-End labeling oversight i.e. from confirmation of safety signal to label implementation ‘in pack’.
- Effective management and governance of local label deviations drive global consistency of messages and provide oversight and assurance of labeling compliance in the global operating environment.
- A proactive labeling intelligence strategy will become increasingly important in enabling companies to adapt and respond to the rapidly changing regulatory environment and the growing presence and importance of emerging markets.
- The focus for labeling of the future will shift from simply ‘staying compliant’ to improving operational efficiency and adding value, via deployment of new technologies tailored to the needs of labeling, new paradigms in managing product information/label content (e.g. structured content, IDMP), and smart applications of labeling (e.g. eLabeling).
Established in 2011, labelnet provides a neutral platform for Heads of Labeling and labeling professionals to network, share insights and experiences, benchmark performance, develop best practices across the full lifecycle of labeling, from the definition of company positions (CCDS, CCSI) to local/regional labeling (SmPC, USPI, reference labels, etc.) and ultimately to label implementation (artwork, packaging, electronic media).
In light of the increasingly pivotal role labeling plays in improving patient safety and as a key channel for Benefit-Risk communications, together with the increasing emphasis regulators place on labeling as an integral part of a PV system, we aim to develop compelling, yet practical solutions to meet ever shifting regulatory requirements, whilst providing business value and meeting the needs of patients and prescribers. The philosophy behind labelnet is to:
- Provide a platform for industry peers to network, share and learn from one another in an secure yet open environment
- Deliver benchmark information to compare and measure operational and organisational performance
- Identify key issues facing labeling organisations with “hot topics” addressed by action teams
- Create a network to develop best practices to define the future of labeling
- Provide access to the latest labeling insights through forums, working groups, webcasts, and community exchanges