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 The FDA’s 2011 Draft Guidance on Applying Human Factors and Usability Engineering to Optimize Medical Device Design, was intended to assist industry in conducting appropriate human factors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.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?
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