A network for labeling professionals, focused on developing best practices for End-to-End labeling compliance, enhancing operational efficiency and excellence, and creating value-adding labeling
London: 06 November, 2019 | New York: 13 November, 2019
The labelnet November agenda is themed around Intelligent Labeling – realizing our full potential and will focus on the following:
- Early involvement, framework, TPP, TPLs interface between labeling and regulatory strategy leader
- Talent and capability – map key roles (early strategists, digital data science, labeling intelligence, vendor management) and feedback from working group
- Patients in labeling – patient centricity, RWE alternative data sources. Apps are devices in combination with medicinal products
- Digital and automation – mapping the end-to-end process looking for opportunities for automation
Established in 2011, labelnet provides an open, yet confidential, platform to network, share insights and experiences, benchmark performance and develop best practices across the full lifecycle of labeling. Forum members discuss subjects ranging from the definition of company positions (CCDS, CCSI), to local and regional labeling requirements (including SmPC, USPI, Reference labeling, Local labeling Deviations Management, etc.). This network focuses on labeling implementation for patient/product leaflets, artwork, packaging, and electronic media and other product information in the public domain for which the Marketing Authorization Holder is ultimately accountable.
Labeling plays an increasingly pivotal role in improving patient safety, as a key channel for Benefit-Risk communications. Regulators are placing an increasing emphasis on labeling as an integral part of PV systems. labelnet helps develop compelling yet practical solutions to meet ever shifting regulatory requirements, whilst providing business value and meeting the needs of patients and prescribers.
-
Peer to Peer Network
and Insight Exchange
-
Discuss and Develop Strategies
and Best Practices
-
Build Profile and
Industry Voice
Who should join labelnet?
Heads of Labeling and Labeling Professionals
Why join labelnet?
-
Future Proof
Your Systems
-
Engage with
Global Peers
-
Compare and
Improve Performance
Be part of the only global labeling network with exclusive access to:
- Spring and autumn in person meetings in US and Europe providing industry leading insights with a strategic focus
- Technology showcase events driven by member cases to discover cutting edge utilization of technology, new approaches and collaborations
- Annual benchmark, with 1-1 meetings to explore insights, relative performance and improvement opportunities
- Hot topic based industry working groups, think tanks and webcasts
- Live scientific community discussion board: connect with other members, post and answer questions on latest labeling topics
- Member-only platform for collaboration and resource hub – a secure portal to connect and collaborate with peers and share the latest documented insights
- Routine publications including white papers, benchmark report, discussion summaries
- Unique networking with access to Subject Matter Experts within Navitas Life Sciences
Latest Insights in the Labeling Space
- The Company Core Datasheet (CCDS) is an essential document for global labeling 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 labeling implementation ‘in pack’.
- Effective management and governance of local labeling 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 is shifting 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 ).
For further information, or to register your interest, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.