Human Factors Session Spotlight: USA Regulatory Expectations for the Application of Human Factors Engineering for the Development of Drug Delivery Combination Products

Understanding the requirements of human factors studies is critical to accelerate your product through the regulatory process and getting it to market quickly. It is important for drug and device developers alike to align their product development efforts with the regulatory expectations.  This May at the Human Factors for Drug-Device Combination Products, we'll give you the tools to gain insights into success factors and methods for human factors studies, as well as ideas that will help you avoid potential pitfalls in the process.  In the session USA Regulatory Expectations for the Application of Human Factors Engineering for the Development of Drug Delivery Combination Products,  we will provide regulatory perspectives from FDA representatives regarding the growing importance of human factors studies for drug-device combination products.

For more information on this session or the rest of the program, 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 to join us and mention code HF2013JP, you'll save 20% off the standard rate!

Featured Session: USA Regulatory Expectations for the Application of Human Factors Engineering for the Development of Drug Delivery Combination Products

Featured FDA Speaker: QuynhNhu Nguyen, Lieutenant, U.S. Public Health Service, Biomedical Engineer/Combination Products Human Factors Specialist, Center for Devices and Radiological Health, US FDA

What the session will focus on:

• - 2011 Draft Guidance - incorporating human factors in risk management of medical devices
• - What are the regulatory expectations with regards to human factors?

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