FDA & Intellectual Property

2.0 credits

This interactive course will offer students exposure to intellectual property (IP), patenting processes and regulatory pathways for new medical innovations. Students will learn the terminology, processes and challenges involved in FDA regulations, and the protection and evaluation of intellectual property for medical innovations. Differences between Regulatory Affairs and Regulatory Science will be highlighted with opportunities to work on Regulatory Science in a project setting. An emphasis will be placed on ways that knowledge of prior art and regulatory barriers can optimize concept selection, and early phase project planning to best identify projects suitable for commercialization.