BENEFITS OF CENTRALIZING THE LABEL UPDATE PROCESS ACROSS AN ORGANIZATION
Pharmaceutical marketing departments that centralize and standardize their approach to required label/Important Safety Information (ISI) updates, including the advance planning of upcoming labeling changes and continued optimization of their internal processes, will provide greater value to the overall organization. In addition, the benefits of cost savings, along with the consistency and transparency of a repeated process, ensures adherence to compliance policies and guidelines.
CMK Project Management Consultants organize and drive the internal label/ISI update review process to ensure completion by the set Regulatory deadline. Brand team members and brand reviewers will remain involved, kept aware of progress, and alerted to any marketing assets or programs “at risk” of not meeting the Regulatory deadline for implementing the required updates.
WHAT WE DO – Centralized Approach
We collaborate with your organization to develop a 2-year rolling plan of label updates that will need to be executed for all products across the enterprise. Our project management team will drive, manage, and make recommendations to optimize the Important Safety Information updates required for marketing materials (print, digital, web) for any impacted brands across the organization. This allows brand leads to remain focused on their products, field force, physicians, and patient needs. CMK Select can provide:
- Initial Assessment
- Development of a Master Calendar
- Management of Brand Workplan(s)
- Pre-Audit of Brand Assets
- Prioritization of Materials
- Agency and Workstream Management
- Brand and Management Status Updates
- Post-Label Update Analysis