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Session 2C: Drug/Device – Part 1: Human Factors Studies
Session Chair(s)
Andrew Chang, PhD
Vice President, Quality and Regulatory Compliance
Novo Nordisk, 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)
Session Co-Chair
Irene Z. Chan, PharmD
FDA, United States
Director (Acting), Division of Medication Error Prevention and Analysis 1, OSE,
Usability and Human Factors Engineering: Integration with Risk Management and Design Controls
Peter Boge
Novo Nordisk, Denmark
Senior R&D Engineer, Design and Controls
Regulatory Perspectives on Planning Human Factors Studies of Combination Products
Becky Leibowitz, PhD
Janssen Research & Development, United States
Associate Director, Reg Affairs, CMC Medical Devices & Combination Products