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Session 6: End-to-end Labeling Part 2: The Implementation Phase
Session Chair(s)
Gerrit Nijveldt, MS, MSC
Global Labeling Consultant , Opus Regulatory, United States
This session aims to address the critical need for streamlined processes, enhanced traceability, and improved safety in the development of medicinal products information. Explore the significance and challenges of end-to-end tracking in ensuring product integrity, patient safety, and regulatory compliance across the internal content development processes and into the supply chain.
Learning Objective : At the conclusion of this session, participants should be able to:- Recognize the regional requirements for compliant management of iterative product information, including the role of audit and inspection
- Appraise the various industry approaches for tracking label content and content deviations
- Interpret the importance and impact to patients and caregivers
Speaker(s)
Megann Looker
Executive Director, Head of Global Labeling, Jazz Pharmaceuticals, United Kingdom
What To Track? Timeline Compliance and Content Deviations
Wanda Rosado
E2E Labeling Process Lead, Bristol Myers-Squibb, United States
BMS End-to-End Labeling Process Implemented Across Regulatory and Supply Chain
Tracy Nasarenko, MBA
Vice President of Community Engagement, Healthcare, GS1 US, United States
U.S. Regulations Leveraging Product Labeling
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