The network for Labelling professionals of life science companies
Established in 2011, labelnet provides a neutral platform for Heads of Labelling and labelling professionals to network, share insights and experiences, benchmark performance, develop best practices across the full lifecycle of labelling, from the definition of company positions (CCDS, CCSI) to local/regional labelling (SmPC, USPI, reference labels, etc.) and, ultimately, to label implementation (artwork, packaging, and electronic media).
In light of the increasingly pivotal role labelling plays in improving patient safety and as a key channel for Benefit-Risk communications, together with the increasing emphasis regulators place on labelling 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 labelling organisations with “hot topics” addressed by action teams
- Create a network to develop best practices to define the future of labelling
- Provide access to the latest labelling insights through forums, working groups, webcasts, and community exchanges
Latest insights in the labelling 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 labelling 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 labelling 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 labelling compliance in the global operating environment.
- A proactive labelling 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 labelling 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 labelling, new paradigms in managing product information/label content (e.g. structured content, IDMP), and smart applications of labelling (e.g. eLabelling).