FDA's Enterprise Data Modernization

Event

FDA Convening

FDA's Enterprise Data Modernization

Workshop Objective:

This two-day workshop is intended to address the data infrastructure needs for two critical FDA driver initiatives: non-clinical trial data, such as real-world data (RWD), and supply chain. The objective of this workshop is to leverage specific use cases from FDA Centers to identify key challenges to ingesting data, address supply chain issues affecting public health, and propose solutions (short and long-term) to improve the FDA's data infrastructure, processes and systems. While policy is important and critical to FDA's success, this is not a policy focused discussion. This is a discussion on the data infrastructure to support these key initiatives. 

Duke-Margolis Team

Dr. Rachele Hendricks-Sturrup, Research Director, Real World Evidence

Rachele Hendricks-Sturrup, DHSc, MSc, MA

Research Director, Real-World Evidence
Senior Team Member

silcox

Christina Silcox, PhD

Research Director, Digital Health
Adjunct Assistant Professor
Senior Team Member
Margolis Core Faculty