Presentation
Addressing Risk for Standalone Drug Products at the Source
DescriptionIn recent years, many pharmaceutical companies have formed robust human factors teams to address changing regulatory requirements for application of human factors engineering to medical devices and combination products. Since devices are the primary regulatory focus, stand-alone drug products often get overlooked, and the potential for serious, use-related risk can go unnoticed. Using a successful case study of applying human factors to the user interface of a standalone drug product, this presentation will demonstrate the importance of human factors even when not strictly required by health authorities, and will also identify critical inputs for determining the scale of human factors work and normalizing it with stakeholders that may have little exposure to human factors science.
Contributor
Event Type
Case Study
Industry/Practitioner Content
Lecture
TimeTuesday, October 14th11:30am - 11:50am CDT
LocationGrand C/D North
Health Care
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