It has only been a few years since the FDA released its guidelines for human factors and usability testing for combination products.  Compared to medical device companies, dedicated pharma and biotech companies have had to cope with a very high learning curve in order to meet regulatory expectations.  For lack of long-term experience on this subject, many companies continue to struggle to build the necessary human factors expertise, whether through outsourcing or intensive team training.

The 4th annual Human Factors Engineering & Usability Studies Summit is the most specifically focused event on the market for the regulatory and technical needs of combination product sponsors. This year’s program features never-before-heard insights and analysis of the latest FDA regulatory guidelines.