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 3^rd 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.

Top Five Reasons to Attend

1. Updates on the latest regulatory developments, including how to proceed when CDER and CDRH reviewers seem to disagree
2. Best practice for sequencing validation studies within the product testing life cycle to avoid severe late-stage errors
3. Device instruction and labeling optimization strategies that reduce user error
4. Case studies on selecting and working with both trained and untrained user populations
5. Methods for cultivating in-house expertise on human factors and usability test protocol design

Who Should Attend

This event is designed for pharmaceutical, biotech and medical device professionals with responsibilities in the following areas: