Abstract: With recent technological advances and availability of new data sources, we are experiencing exciting changes to the human medical product regulatory landscape. While these new areas have created challenges, they also present opportunities. This presentation will review the various FDA initiatives in Real World Data/Real World Evidence, Complex Innovative Designs, digital health technology, and COVID-19 and highlight the areas for which statisticians play a key strategic role in efficiently addressing current and future medical product development and evaluation challenges. Statisticians need to be effective leaders and communicators in interdisciplinary teams.
Speaker: Matilde Kam
Affiliation: FDA
Title: Challenges in an Evolving Regulatory Landscape: How Statisticians Can Contribute
Abstract_Sanitzed: With recent technological advances and availability of new data sources, we are experiencing exciting changes to the human medical product regulatory landscape. While these new areas have created challenges, they also present opportunities. This presentation will review the various FDA initiatives in Real World Data/Real World Evidence, Complex Innovative Designs, digital health technology, and COVID-19 and highlight the areas for which statisticians play a key strategic role in efficiently addressing current and future medical product development and evaluation challenges. Statisticians need to be effective leaders and communicators in interdisciplinary teams.