Thursday, 15 November 2018
5:30-8:30 pm EDT
Porzio, Bromberg & Newman, PC
100 Southgate Parkway
Morristown, NJ 07962-1997
+1 973 538 1690
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.
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.
The 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.
Renee Bailey, Agilis Consulting Group, LLC
Prior to 8 November 2018
RAPS Members: $35
On or after 8 November 2018
RAPS Members: $45
Nonmembers : $60