Human Factors Session Spotlight: Interpretation and Clarification of the Guidance Document – What Constitutes Human Factors Engineering Success in the Regulator’s Perspective?

At Human Factors for Drug Device Combination Products, we present a panel discussion of industry experts who are active in developing and implementing human factors studies for drug-device combination products, to share strategies and best practices in the field. The biggest obstacle to successful human factors studies is clear guidance from regulators on study requirements. This session will attempt to interpret the FDA’s draft guidance on human factors to better prepare you to conduct human factors studies for your products.

For more information on this session and the rest of Human Factors for Drug Device Combination Products event, download the agenda.  If you'd like to join us May 14-15, 2013 in Bethesda, Maryland as a reader of this blog, when you register mention code HF13JP and you'll save 20% off the standard rate!  If you have any questions, feel free to reach out to me at jpereira@iirusa.com.

Featured Session: Interpretation and Clarification of the Guidance Document – What Constitutes Human Factors Engineering Success in the Regulator’s Perspective?

Featured Moderator & Panelists:

• - Robert North, Ph.D., Chief Scientist, Human Centered Strategies, Moderator
• - Steve B. Wilcox, Ph.D., Principal, Design Science
• - Sherri Biondi, Ph.D., Associate Director, Device Development, Genentech
• - Edmond W. Israelski, Ph.D., CHFP, Director, Quality and Regulatory, Abbott
• - Douglas Mead, Director – RA-CMC, Johnson and Johnson
• - Michael E. Wiklund, PE, CHFP, General Manager, Human Factors Engineering, UL-Wiklund R&D
• - John K. Towns, Ph.D., Fellow, Global Regulatory Affairs, Eli Lilly and Company

About the session:
Definition of Critical Errors:

• • Assessing critical tasks
• • Usability goals for drug-delivery combination products

• ➢ Are comparative studies to marketed configurations a problem or a solution?
• ➢ Can we agree that drug delivery devices do require a degree of 'patient responsibility’ to pay attention to the instructions for use?
• ➢ Can we agree that the occasional failure to receive a dose with a delivery device is no worse (and therefore no less acceptable) than a typical oral medication?
• ➢ When you’re trying to offer an alternative route of administration – how do you compare? How do you benchmark? eg: inhaler vs injector – how do you comment on the errors or make comparison?

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