Global Labeling Conference

Join speakers from around the world sharing their labeling – Germany, Japan, Belgium, UK, Canada and more!

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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 Inc., 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)

What To Track? Timeline Compliance and Content Deviations

Megann Looker

Jazz Pharmaceuticals, United Kingdom

Executive Director, Head of Global Labeling

BMS End-to-End Labeling Process Implemented Across Regulatory and Supply Chain

Wanda Rosado

Bristol Myers-Squibb, United States

E2E Labeling Process Lead

U.S. Regulations Leveraging Product Labeling

Tracy Nasarenko, MBA

GS1 US, United States

Vice President of Community Engagement, Healthcare