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Session 2: Tracking and Compliance
Session Chair(s)
Theresa Brunone, MLS, MS
Head-Labelling Compliance and Implementation, Global Labeling
GlaxoSmithKline, United States
Paula Hudson, RPh, RAC
Director, Global Labeling
Eli Lilly and Company, United States
End to end tracking of labeling submissions is a pharmacovigilance activity [tracking from signal identification/validation through regulatory submission/approval and finally through the creation of production packaging artwork and product distribution] and a source of many potential areas for opportunities for miscommunications and delays to product availability in the hands of the patients. A wide variety of solutions exist across the pharmaceutical, biologics, and device industries. We will look at what is implemented in various companies for governance and tracking, and where the pain points are for future improvements in tracking and labeling compliance.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Identify milestones commonly used in end-to-end labeling tracking and compliance
- Define deviations including types, use, and value of capturing
- Discuss the types of regulatory complicane metrics, when each may be effective, and considerations for selection for use
Speaker(s)
Connected Labeling: The Final Frontier in Content Management
David Gwyn, MBA
fme US, United States
VP, Business Consulting Services
Labeling Tracking
Nya Feldthus, MS
Eli Lilly and Company, Denmark
Associate Director - Gobal Labeling Implementation
Timely Implementation Monitoring
Shannon Leber, MBA
Janssen Pharmaceuticals, United States
Associate Director, GRA Quality & Compliance
Timely Implementation Monitoring
Kathleen Salazar, MA, MBA
Johnson & Johnson Innovative Medicine, United States
Head, Global Labeling Implementation
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