ThinkSet Podcast: Katie Norris and Heidi Sorensen - Commercialization Risk and Compliance
In this episode, we speak with BRG's Katie Norris and Heidi A. Sorensen from Foley & Lardner LLP. Katie has more than seventeen years of experience in corporate governance and compliance in the pharmaceutical, medical device, and cosmetics industries. Heidi is a healthcare attorney who focuses on healthcare fraud and abuse and compliance issues.
Katie and Heidi discuss compliance considerations companies should factor into their strategy and planning when they are entering the US market from abroad, or when they are preparing to commercialize an FDA-regulated product. They walk us through the various regulatory agencies involved in this process and provide keen insight on how to structure and implement a sustainable compliance program.