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Session 7: Human Factors Testing to Core Device Label - Case Study
Session Chair(s)
Gina Monteiro
Senior Director, Global Regulatory Affairs – Global Core Labeling
Eli Lilly and Company, United States
Mary Beth Wilusz
Head, Regulatory Labeling Operations and Compliance
Daiichi Sankyo, Inc., United States
This session presents a case study of the development of labeling for a drug-device combination product, followed by a panel discussion consisting of experts in Global Regulatory Labeling and Human Factors engineering. The case study discusses an end-to-end process improvement project spanning from human factors testing through labeling development, submission, and implementation, focusing on ways to enhance collaboration between human factors engineers and global regulatory labeling colleagues during core device labeling development. The panel will provide both labeling and human factors engineer perspectives on potential areas of process challenges and ways to address them.
Learning Objective : - Explain high level human factors testing for device constituent of drug led combination product Instructions for use, quick reference guide, carton and/or container label
- Describe optimized collaboration between a labeling department and human factor engineers to develop core device labeling
- Discuss a case study handling governance and early Ministry of Health (MOH) feedback to draft device constituent core device labeling
Speaker(s)
Device Constituent of Drug Led Combination Product Labeling Optimization Project – Case Study
Kathleen S. Johnson
Eli Lilly and Company, United States
Associate Director, Global Regulatory Affairs – Global Core Labeling
Speaker
Mark Jakubowski
Bayer Corporation, United States
Regulatory Labeling Strategist
Speaker
Young Ji Chun, PhD
AbbVie, United States
Principal Research Engineer, Human Factors, Combination Product Development
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