Regulators are changing the way they look at labeling. The emphasis is on ensuring Marketing Authorization Holders have a linked up End-to-End (E2E) process...

January 17, 2017 Princeton, New Jersey:Navitas Life Sciences Launches Labeling Assessment Express to improve End-to-End labeling process and business performance

Why focus on End-to-End Labeling?

Regulators are changing the way they look at labeling. The emphasis is on ensuring Marketing Authorization Holders have a linked up End-to-End (E2E) process that delivers accurate, quality labeling information to the patient in a timely manner. This represents a paradigm shift from Drug Safety to Patient Safety, transforming labeling from a compliance focused activity to become one of the key mechanisms of getting timely benefit-risk information to patients and prescribers in a user friendly way.

Labeling is one of the most common areas for critical inspection findings. An effective E2E labeling process is essentially to safe guarding patient safety, ensuring regulatory compliance and protecting the company’s reputation through the avoidance of fines and unwanted media attention.

What is Labeling Assessment Express?

Labeling Assessment Express is a highly cost-effective diagnostic tool which provides a rapid read-out of the health of an E2E labeling system, without a long drawn-out project and with minimum disruption to the business.

The multi-dimensional read-out provides valuable insights on key E2E health indicators:

  • Process completeness and robustness
  • Governance
  • Organizational structure
  • Capabilities and capacity
  • Data management
  • Technologies
  • Inspection readiness

Our insights are driven through our extensive labeling experience and from Navitas’ labelnet®, a network of labeling professionals focused on best practices development for E2E labeling.

The output from Labeling Assessment Express is a report that includes:

  • A prioritized list of current gaps
  • A compliance Heatmap
  • Opportunities for improvement, including quick-wins and longer term initiatives
  • A shared, cross-functional vision for the future and roadmap for improvement

What does Labeling Assessment Express involve?

Labeling Assessment Express is an insight-led, cross-functional assessment by our experienced labeling consultants covering all relevant E2E labeling functions, including Pharmacovigilance, Regulatory Affairs, Artwork, Supply Chain, Quality, Medical Affairs and Commercial. Our experience working with stakeholders across multiple functions, and our ability to ‘speak the language’ and understand business challenges across different domains, enables us to conduct a comprehensive and holistic analysis in a compact timeframe.

Labeling Assessment Express is delivered through a combination of focused stakeholder interviews and discussions, and a single cross-functional alignment and process improvement workshop, to minimize the impact on your business.

Labeling Assessment Express generates the roadmap and the case for action, which defines the high level strategy, firms up the roadmap for implementation and builds the business case for change.

About Navitas:
The Navitas Life Sciences team has been assembled bringing together the proven expert teams of TAKE Life Sciences and WCI Consulting and, adding to this core, a range of experts from the worlds of Regulatory Affairs, Pharmacovigilance, Clinical Development, Technology, and Consulting.

We have built the Navitas Life Sciences team specifically to deliver subject matter expertise and insights to our clients, to develop pragmatic solutions together, and to support their deployment and operation. We deliver advice, process and technology solutions, and outsourcing services in Regulatory, Safety and Clinical.

We are proud that our legacy businesses have served the sector for over 20 years and have allowed us to work with 100 of the top Life Science companies. Our team has now grown to over 500 staff. For more information, visit www.navitas.net

Navitas Life Sciences also hosts labelnet, the industry’s unique and leading network for labeling professionals. labelnet focuses on the full lifecycle of label creation and maintenance; from core company information through to local and regional product information, artwork and distribution. labelnet is comprised of over 100 industry labeling executives from 28 leading pharmaceutical and biotechnology companies in the world. labelnet’s vision is to shape the future of labeling through community discussions, working groups, and bi-annual forums, supported by regular benchmarking of member performance and best practice sharing. labelnet guides the industry’s development of compelling, yet practical solutions to meet ever shifting regulatory requirements, while creating business value and meeting the needs of patients and prescribers. For more information, visit www.navitas.net/labelnet

 

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