Building a Core Labeling Process - Drug Information Association

Electronic Tools
• Document Management System
– Securityy
– Version Control
– Formats
– Workflows
• Proof- reading tool
– To verify absence and differences between documents if needed
• Issuance System
– Web based design (global accessibility)
– Password protected
• CCDS tracking tool
– Tracking of key milestones, submission to MOH, Approval of
labeling submission
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The Communication Plan
• “The single biggest problem in communication is the
illusion that it has taken place” place George Bernard Shaw
• Your SOP is not an effective communication tool to drive change and
acceptance of a process
• Interactive training is needed for all stake holders in the process
– Road show to all the region
– Testing of the participants’ knowledge of their roles and responsibilities
– Testing of implementation activities
• Regular meeting with the Regional Coordinators
• Regular meetings with Global Pharmacovigilance
– Attendance to Signal detection meetings
• Regular meeting regarding the IT tools and their functionality
• Communication of Labeling guidance's to the broader organization
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10/20/2011
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