Date & Time
Starts
Apr 30, 2026 10:00am CST
Ends
11:00am CST
Location
Online
Language
English
There are many important nuances in regulators’ expectations for applying human factors engineering (HFE) throughout the development of combination products, which are therapeutic or diagnostic products that integrate drugs, devices and/or biological components. Teams developing these products often have practical questions about how to structure, execute and document their HFE activities to align with regulators’ rapidly- evolving expectations.
What topics will be covered?
In this open forum webinar, experts from Emergo by UL’s Human Factors Research & Design (HFR&D) team will address questions on applying HFE to drug-device combination products, covering topics such as:
- Developing a comprehensive HFE strategy for multiple indications and/or device types
- Conducting use-related risk analyses and identifying critical tasks
- Selecting appropriate user groups and sample sizes, including justifying proxy participants in cases of a rare end-user population
- Sequencing HFE work amidst clinical trials
- Planning and executing formative and HF validation tests
- Performing threshold analyses and comparative use HF tests for proposed generic products
- Determining when it may be possible to forgo HF validation testing
Save your spot now — space is limited.
This interactive session will provide participants with practical guidance to help them navigate today’s HFE best practices and regulatory landscape.
Please submit your questions to emergomarketing@ul.com by April 23, before the webinar, to give the presenters time to organize the questions and answer as many as possible during the event.
Speakers
Save your spot now — space is limited.
Join us on Apr.30 from 10 a.m. –11 a.m. CT