Category Lead, Safety Evidence for Regulators
IQVIA
University of North Carolina at Chapel Hill
Durham, United States
Dr. Emily Bratton has been in the pharmaceutical industry 15 years, contributing to late-phase
observational epidemiology research teams. As Category Lead of Safety Evidence for Regulators, Emily
works across our Real World Solutions business to ensure our customers are connect with the right
people and design the right solution for their research needs -- particularly evidence for regulators. Prior
to her current role, Emily was part of Global Epidemiology at IQVIA. She led the development, analysis,
and interpretation of observational studies (both retrospective and prospective) and low interventional
clinical trials.
Emily's areas of specialization and interest include: PASS, pregnancy studies, drug safety and
surveillance, natural history studies, disease and drug registries, and comparative effectiveness research.
She provides scientific and operational cross-functional support across IQVIA (e.g., Regulatory, PV and
Safety, and Medical Affairs). Dr. Bratton often consults with early clinical R&D programs in shaping RWE
needs and goals within regulatory expectations. Her analytic capabilities range from descriptive to more
advanced epidemiologic methods.
At IQVIA, she has been involved in the design and execution of non-interventional and low interventional
studies and pragmatic trials. The majority of her work focuses on treatment effectiveness and safety, with
emphasis on patient registries (notably pregnancy and rare disease registries). She has extensive
experience in post-marketing regulatory requirements (ie, PASS, PMRs) including protocols, reports, and
regulatory response documents. Her knowledge and experience span both chronic and infectious
therapeutic areas and diverse patient populations.
Emily received her MSPH in Epidemiology (2008) and PhD in Infectious Disease Epidemiology (2012)
from the University of North Carolina at Chapel Hill where she now holds an adjunct assistant professor
position. Before her graduate studies, Dr. Bratton studied evolutionary biology, molecular genetics and
microbiology (Colgate University, Duke University Medical Center). She is based in Research Triangle
Park, NC (USA).
Disclosure information not submitted.
Real-World Evidence (RWE) Generation for Rare Disease Drug Development and Orphan Drug Approvals
Wednesday, August 23, 2023
2:00 PM – 6:00 PM ADT
Friday, August 25, 2023
3:30 PM – 5:00 PM ADT
