Human Factors Session Spotlight: Linking HF to Clinical Trials – Can Clinical Trials Be a Source of Human Factors Information, or Not?

Clinical studies on the drug component of many drug-device combination products are conducted simultaneously, yet independently of the human factors studies. If there is a delay on one of these studies, the market launch of the combination product can be delayed.  This May in Bethesda, Maryland, experts from P/L Biomedical, MannKind Corporation and Hospira gather to discuss the  interface between the clinical drug study and the human factors device study to see where there are opportunities for greater synergy and efficiency.

The Human Factors for Drug-Device Combination Products Summit will take place May 14-15, 2013.  For more information on this session and the rest of the agenda, download the brochure.  If you'd like to join us in Maryland, as a reader of this blog when you register to join us and mention code HFJP13, you'l save 20% off the standard rate!

Featured Session: Linking HF to Clinical Trials – Can Clinical Trials Be a Source of Human Factors Information, or Not?

Participants:
Moderator: Lee H. Leichter, RAC, MBA, President, P/L Biomedical
Panelists: Chad Smutney, Senior Director, Device Technology, MannKind Corporation
Seema Kumbhat, MD., Medical Director, Drug Device Development, Hospira

About the session:
• How are clinical studies affected? Should they be conducted at the same time as when you’re conducting HF usability studies?
• What data can/cannot be collected effectively in a clinical trial?
• Can you link clinical trials to human factors studies to come up with elements during trials to show that you’ve probed patient user usage and that residual error is acceptable?
• Medical / clinical perspective on leading human factors programs at corporations: strengths/pitfalls

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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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Introducing the Human Factors for Drug-Device Combination Products

Human Factors Are NOW a Major Risk Factor for the Pharmaceutical Industry.  The FDA’s 2011 Draft Guidance on Applying Human Factors and Usability Engineering to Optimize Medical Device Design, was intended to assist industry in conducting appropriate human factors testing and identifying device features that manufacturers should optimize throughout the total product life cycle. The recommendations in the were intended to improve the usability of devices and to reduce use error, injuries from medical devices, and product recalls. But numerous questions and implementation challenges exist on the part of drug developers and device makers who are charged with responding to FDA recommendations.

Download the agenda to find out more about

Human Factors for Drug-Device Combination Products

IBC’s Human Factors for Drug-Device Combination Products, taking place May 14-15, 2013,  brings FDA representatives together with drug and device developers to share best practices and case studies in these areas:

Implementing Successful Human Factors Studies to Accelerate Regulatory Approvals

• • Incorporate Human Factors Engineering into Development Programs
• Hear case studies and best practices from the top pharma/biotech companies: Genentech, Novartis, Abbott, Hospira, etc.
• • Find Out How to Get Your Company's Drug-Device Combination Product FDA Compliant
• Learn from the leading practitioners and implementers of human factors: Cambridge Consultants, Team Consulting, Design Science, etc.

Avoiding the Risk of Adverse Events Due to Use Errors or Faulty Devices

Participate in these exciting panel discussions and get important questions answered:

• • Linking HF to Clinical Trials - Can Clinical Trials Be a Source of Human Factors Information, or Not?
• • Understanding HF Methodologies - Their Applications and Limitations
• • Interpretation and Clarification of the FDA Guidance Document - What Constitutes Human Factors Engineering Success in the Regulator's Perspective?

If you'd like to join us, as a reader of this blog when you register to join us, mention code HFJP13 and save 20% off the standard rate.  Feel free to email Jennifer Pereira with any questions!

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