Last month, Christina Mendat, PhD, Managing Director for Human Factors MD, was an invited speaker at the annual DIA Combination Products Conference. This virtual event took place on October 15th and 16th and included professionals from regulatory agencies, pharmaceutical companies, and consultancies from around the world.
Christina participated in the Panel Discussion on Human Factors for Combination Product Development session, which included Shannon Hoste, MS (Enable Injections, Inc), Paul Blowers, MA (AbbVie, Inc), and Irene Chan, PharmD (CDER FDA). Topics addressed in the one-hour session included the importance of using formative studies to drive optimal combination product design and tips for designing and executing successful validation tests. One of the key takeaways was the importance of developing a solid Use-Related Risk Analysis (URRA) to drive the program in order to develop devices that are safe and effective.