Pay Now or Pay Later: The Impact of Human Factors on Regulatory Submissions
Attend RAPS Chapter NY/NJ meeting for a special presentation
There have been significant changes in both the US and global regulatory environments affecting human factors for medical devices and combination products. While done with good intent, many of these changes have added complexity and, in some cases, confusion about how to ensure a successful human factors submission. On top of that, many may not be aware that human factors are required in most cases, and you can see why this is such an important topic. Join others from your local regulatory community to gain a better understanding of:
How human factors studies are conducted
How they differ from clinical studies
What are the most common issues that can derail a human factors submission.
Location: Porzio, Bromberg, & Newman, P.C.
100 Southgate Parkway Morristown, NJ 07960
Date: January 31, 2019
Time: 5:30pm to 8:30pm
RAPS Members: $35
During this interactive session, attendees will watch an excerpt of a human factors study to highlight the qualitative aspects of this type of research study and why it takes so long to conduct. The case study (representing both device and combination product perspectives) will showcase regulatory strategies and the purposes of the human factors study (formative/validation). It will also help participants better understand the impact that the study results have on the submission and why the impact occurred.
Understand how human factors requirements fit into the overall product development and regulatory submission schedule.
Understand how changing regulatory strategies can impact the human factors strategy.
Identify key differences between clinical studies and human factors studies.
Explore common myths associated with human factors.
This engagement activity is brought to you by the RAPS New York/New Jersey chapter and is intended to promote professional development and networking opportunities in the local regulatory community. Light refreshments will be available to all attendees and RAC holders may claim two RAC recertification credits.
Renée Bailey joined the Agilis Consulting Group in 2014 after 5 years of consulting in the medical device industry, she is now the Director of Instructional Design & Creative Solutions. Renée brings with her more than 20 years of experience designing and developing instructional materials and strategies for medical device manufacturers, pharmaceutical companies, and other high-profile companies.
As a Certified Expert Practitioner in evidence-based instructional design, Renée is part of a team dedicated to helping its clients navigate the changing landscape of product regulatory pathways, including FDA and international human factors submissions. She also serves as Faculty for AAMI’s human factors course for evaluating instructional materials and enjoys engaging with other medical field professionals on how to implement data-driven changes for improved usability and end-user performance.
As a thought leader in the industry, Renée is an active conference speaker on topics related to human factors engineering and regulatory guidance, evidence-based instructional labeling and training, post-market surveillance, and processes related to product clearance, approval and market success.
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