Back to Agendas
Novel Data Sources and Tools for Pharmacovigilance
Session Chair(s)
Rave Harpaz, PhD
Senior Research Scientist
Oracle Health Sciences, United States
The session will discuss the use of new data sources and tools for pharmacovigilance, including: (1) A real-time system that integrates and analyzes safety evidence from FDA's adverse event reporting system (FAERS), electronic health records (EHRs), and the social media, with application to the safety profiling of tumor necrosis factor alpha (TNFa) inhibitors; (2) The openFDA website, its application programming interface, and a novel graphical user interface called the Adverse Event Explorer, which allows easy access to and query of the safety information contained in openFDA; and (3) Holistic signal detection—approaches and challenges associated with detecting, evaluating, and combining safety signals from multiple data sources such as FAERS, EHRs, the biomedical literature, and the logs of health information seeking activities on the Web.
Learning Objective : Discuss new data sources and approaches for holistic pharmacovigilance; Describe how patient-generated data from social media can be used to improve pharmacovigilance; Describe the openFDA web site, its application programming interface, and a novel interactive tool that provides access to the information in openFDA.
Speaker(s)
Real-World Data-Driven Drug Safety Evaluation: Tumor Necrosis Factor Alpha (TNFa) Inhibitors Case Study
Ran Balicer, MD, PhD, MPH
Data2life and Clalit Research Institute, Israel
Advisory Board of Data2Life
Interactive Web-Based Exploration of the 3.8 Million Adverse Event Reports in the OpenFDA Database
Jeremy Wildfire, MSc
Gilead Sciences, United States
Director, Biostatistics
Have an account?