Agilis is a proud sponsor!

The Association of Food and Drug Officials (AFDO) and the Regulatory Affairs Professionals Society (RAPS) have come together to support sharing, collaboration, and learning across the global healthcare products community. With a focus on fostering open discussions of the most pressing issues facing the industry, the AFDO/RAPS Healthcare Products Collaborative will carry on Xavier Heath’s legacy of delivering the Combination Products Summit.

Shannon will be presenting with her colleague, Shannon Clark from Userwise:

Leveraging Data in Human Factors Validation - Biopharmaceutical companies often leverage the same device technology for multiple drug products, though there is concern about the consistency with which FDA reviews a submission for a new drug using that same technology.