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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)
Kathleen Johnson
Associate Director - Global Regulatory Affairs - Global Core Labeling, Eli Lilly and Company, United States
Human Factors Testing to Core Device Label - Case Study
Mark Jakubowski
Global Labeling Strategist, Bayer Corporation, United States
Speaker
Young Ji Chun, PHD
Principal Research Engineer, Human Factors, Combination Product Development, AbbVie, United States
Speaker
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