Event
FDA Convening
FDA's Enterprise Data Modernization
Materials
Agenda_FDA's Enterprise Data Modernization.pdf (294.31 KB)Discussion Guide_FDA's Enterprise Data Modernization.pdf (340.86 KB)
Participant List_FDA's Enterprise Data Modernization Workshop.pdf (446.01 KB)
Slide Deck_FDA's Enterprise Data Modernization_v1.pdf (925.26 KB)
Summary_FDA's Enterprise Data Modernization.pdf (566.51 KB)
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

Rachele Hendricks-Sturrup, DHSc, MSc, MA
Research Director, Real-World Evidence
Senior Team Member

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