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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CPC Injector Systems Working Group: Comments on the FDA Draft Guidance

Yesterday, we looked at the Human Factors session that will help you interpret the draft guidance recently put forth by the FDA.  The CPC Injector Systems Working Group has taken the time to set out several of the key issues they have with this draft guidance.

According to the document, they are:

>Bridging Strategies for presentation switches

• - Applicable data requirements
• - Application requirements

> Human Factors Studies

• - When are they required
• - Use in supporting promotional claims

 >Coordination between centers

• - Timing with respect to submission review, specifically, timing of labeling review  by non-primary Centers
• - Guidance development

> Submission requirements

• - Post-approval changes to combination products
• - Evaluation of submission types for generic drugs marketed in an injector (e.g., 505(b)(1) vs. 505(b)(2) vs. ANDA)

 > Consistency between FDA’s Technical Guidance for Injectors and ISO standards including the 11608 series> Analytical release testing requirements for the combination product (e.g., functional testing requirements)

> Consistent application of FDA and ICH guidance allowing fulfillment of chemical/drug stability requirements of “bare” container closure when injector/device does not provide additional protection.

Read the complete comments here: Comments on the Draft Guidance.

For your opportunity to discuss this draft guidance in depth with other professionals who have a stake in it's interpretation, join us at the Human Factors for Drug Device Combination Products event taking place May 14-15, 2013 in Bethesda, Maryland.   Download the brochure to find out more about the session Interpretation and Clarification of the Guidance Document – What Constitutes Human Factors Engineering Success in the Regulator’s Perspective? and the rest of the program.  As a reader of this blog when you register to join us, mention code FF13JP and save 20% off the standard rate! 

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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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