Jamie Skipper, BSN, PhD, joined IQVIA in 2021 to leads assessments of the technical and operational requirements of clinical data registries for not-for-profit clients. She serves as a senior expert for client-centric design of innovative solutions and for client registry program strategic planning. She is also a senior expert on thought leadership around IQVIA’s agile registry and integrated health platform solutions.Prior to IQVIA, Jamie served as a federal official at HHS where she directed research funding at NIH, helped craft FDA guidance around the use of EHRs in research, and created the ONC PCOR program to create policies and technical requirements for the use of EHI in research
FDA's draft guidances on real-world data do not provide strict requirements for industry stakeholders to abide by, but they offer patient advocacy organizations with a clearer understanding of how to model their registries to have a more substantial impact for their patient communities.