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Session 2C: Drug/Device – Part 1: Human Factors Studies
Session Chair(s)
Andrew Chang, PHD
Sr. Quality and Regulatory Compliance Director, Novo Nordisk A/S, United States
This session will address the current regulatory landscape of Human Factors usability testing for drug/device combination products. The development of advanced drug delivery technologies is bringing new regulations and technical requirements with regards to usability of these devices. Last year, the FDA and the MHRA published draft guidelines for Human Factors studies. The session will provide recommendations/expectations for Human Factors analysis and testing, based also on experience with the existing CDRH FDA HFE Guide from 2016 and IEC62366-1 Usability for Medical Devices.
Speaker(s)
Irene Z. Chan, PHARMD
Director (Acting), Division of Medication Error Prevention and Analysis 1, OSE, , FDA, United States
Session Co-Chair
Peter Boge
Senior R&D Engineer, Design and Controls, Novo Nordisk, Denmark
Usability and Human Factors Engineering: Integration with Risk Management and Design Controls
Becky Leibowitz, PHD
Associate Director, Reg Affairs, CMC Medical Devices & Combination Products, Janssen Research & Development, United States
Regulatory Perspectives on Planning Human Factors Studies of Combination Products
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