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The Role of Labeling in Successful Human Factors Studies
Session Chair(s)
Eileen Kahn, BSN, MSc
Sr. Manager, Global Regulatory Labeling, Consultant, United States
A key component of well-designed, successful human factors studies is having clear and concise labeling so the patient can use the device safely and effectively. This forum will provide some industry perspectives in how this can be accomplished.
Learning Objective : Discuss how to develop patient labeling in correlation with the device development in order to have a successful human factors (HF) study; Explain how to implement labeling changes resulting from the HF study; Identify what labeling changes can be made without affecting the validity of the HF study including what choices are available if it does, such as a bridging study.
Speaker(s)
Panelist
Renee Bailey
Director, Instructional Design & Creative Solutions, Agilis Consulting Group, LLC, United States
Panelist
Molly Follette Story, PhD, MS
Senior Advisor, Medical Device Development Unit, Sanofi , United States
Panelist
Irene Z. Chan, PharmD
Director (Acting), Division of Medication Error Prevention and Analysis 1, OSE, , FDA, United States
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