DRUG SAFETY-RELATED LABELING CHANGES (SrLC) – PART II by CMK SELECT CMK SELECT CMK SELECT
CMK SELECT CMK SELECT CMK SELECT
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
CMK SELECT
43 Route 46 East, Suite 705 Pine Brook, NJ 07058 USA
Rachel Phone: (973) 244-6060

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DRUG SAFETY-RELATED LABELING CHANGES (SrLC) – PART II

by CMK SELECT / /
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Male,Mature,Caucasian,Ceo,Businessman,Leader,With,Diverse,Coworkers,Team,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

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CMK SELECT

DRUG SAFETY-RELATED LABELING CHANGES (SrLC) – PART II

AUTHOR: CMK SELECT

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…
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CMK SELECT

DRUG SAFETY-RELATED LABELING CHANGES (SrLC) – PART I

AUTHOR: CMK SELECT

EFFICENTLY MANAGING REVISIONS TO MARKETING MATERIALS At any time during the active marketing of a pharmaceutical product, there is a high probability of having to implement a safety label update, impacting the Important Safety Information (ISI) that is highlighted in…
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