Human Factors Engineering and Usability Studies CongressImproving User Experience and Regulatory Success through Innovative Designs of Medical Devices, Combination Products, and IFUs
The Human Factors Engineering & Usability Studies Congress is the only event specifically focused on the needs of medical device and combination product professionals responsible for avoiding use errors and medication errors while building a positive user experience. As your combination product matures, are you ready to address more involved questions of practical design, troubleshooting, and answering involved questions from regulators? This unique event will empower HF professionals to grow more confident in their skills, guide their teams toward the right insource/outsource decisions, and set new strategies for device software.
About the Chairperson
Dr. Matthew T. Roe has been a faculty member at Duke University School of Medine and the Duke Clinical Research Institute (DCRI) since 1999. As a senior investigator at the DCRI, he has been the principal investigator for numerous phase II-IV cardiovascular clinical trials and is currently a co-principal investigator for the ADAPTABLE trial—the first large-scale pragmatic trials being conducted in the PCORnet network. He has also served in leadership roles for several observational registries focusing upon the treatment and outcomes of patients with cardiovascular disease and has served as the Director of the DCRI Clinical Research Fellowship since 2010.
Head of Clinical Innovation
Chief Executive Officer
Managing Director, Life Sciences Strategy and Operations, R&D Practice
General Counsel & Chief Privacy Officer
Doctor on Demand
- Latest updates on domestic and international regulatory developments
- Ideal metrics for judging the ROI in human factors engineering and usability testing
- Innovative methods for selecting the best comparator devices and study designs
- Detailed insight on the design, testing, updating, and cybersecurity precautions required for medical device software and apps
- Unequaled access and networking opportunities with the life science industry’s leaders in usability testing
Who is Attending?
This conference is designed for senior leaders and executives in pharmaceutical, biotech, and medical device companies responsible for:
- Human Factors / Human Factors Engineer
- User Experience / User Interface / UX / UI
- Patient Experience
- Customer Experience
- Medical Device
- Combination Products
- Device Development / Device Technology
- Design Assurance Engineer
- Product Development
- Device Design
- Industrial Design
- Design Controls
- Software Engineering
- Quality / Quality Control / Quality Assurance / Quality Engineer
October 19th, 2020 | Day 1
8:00 AM - 9:00 AM
Registration & Continental Breakfast
9:00 AM - 9:15 AM
Conference Opening Remarks
9:15 AM - 10:00 AM
Paper to Hybrid to eTMF – Best Practices for Selecting, Implementing, Transitioning and Assuring Compliance from Day One
Maha Saad, Ph.D., MBA - Americas Pharmacovigilance Head, Bioresearch Quality and Compliance, Quality Assurance
JOHNSON & JOHNSON
10:00 AM - 10:45 AM
Moving Toward a Risk-based eTMF Operating Model
Laura Naranjo - Associate Director, TMF Operations
DAIICHI SANKYO, INC.
10:45 AM - 11:00 AM
Morning Networking Break
11:00 AM - 12:00 PM
Using Metrics to Optimize Business Decisions
REGENERON PHARMACEUTICALS, INC.
12:00 PM - 1:00 PM
1:00 PM - 1:45 PM
1:45 PM - 2:45 PM
TMF Inspection Readiness
2:45 PM - 3:00 PM
Afternoon Networking Break
3:00 PM - 4:00 PM
Best Practices for Compliant eTMF Archiving
REGENERON PHARMACEUTICALS, INC.
4:00 PM - 4:45 PM
4:45 PM - 5:00 PM
Day 1 Closing Remarks
Joan A. ChambersThe Center for Information & Study on Clinical Research Participation (CISCRP)
Senior Director, Marketing & Outreach
Senior Vice President and Head of Pharmacoepidemiology and Risk Management
Super Early Bird
Conference + Workshop$2,196
Register by 9/11/20
Conference + Workshop$2,396
Register by 10/9/20
Conference + Workshop$2,596
Register before event
Conference + Workshop$2,796
Register at event
Register 2 Attendees, Get 1 Complimentary Registration*!
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