Michael Hoey will discuss the regulatory process and execution of Medical Device trials in Colombia, South America. Colombia has an unique regulatory environment in South America that allows trials to start quickly. Mike will discuss how to execute these trials in such a way that clinical data may be submitted to the FDA.
Michael got his start working for Accenture in their pharmaceutical practice in the 90’s. With a focus on regulatory publishing, Michael later went to work as the CTO for a submission publishing startup called ESPS. Five years later, ESPS had a dominant market share in pharmaceutical publishing and exited with a successful IPO.
Following ESPS, Michael helped start a knowledge management company that specialized in unstructured data analysis with a significant development presence in Colombia.
Michael also has been involved in advising a number of different start up companies over the years in both the software and pharmaceutical regulatory spaces.