Current safety management practices are centered on spontaneous adverse events reported by healthcare professionals, caregivers, and patients. While existing processes have been instrumental in identifying new and unsuspected safety concerns in the past, the availability of longitudinal Real-World Data and modern digital technologies offers a new paradigm in enhancing our knowledge of drug safety. Through the Sentinel Initiative, the FDA has built a robust system for gleaning intelligence from claims data and electronic medical records.
This webinar is designed to help professionals in the field of pharmacovigilance, epidemiology, and medical affairs understand how they can harness the power of active safety surveillance for themselves. Attendees will gain insights into:
- The FDA’s Active Risk Identification and Analysis (ARIA) system How TreeScan methodology can be used for safety signal detection
- How one Top 10 Pharma company is using Saama’s pioneering Active Safety Analytics for Pharma (ASAP) solution
Dr. Judith Maro, PhD
Dr. Maro is an Assistant Professor in the Department of Population Medicine at Harvard Medical School and the Harvard Pilgrim Health Care Institute. She is also the Operations Lead for the FDA’s Sentinel Operations Center, which is responsible for the coordination of data curation, management, and utilization activities among multiple data partner sites covering hundreds of millions of patients. Dr. Maro also consults on safety signal detection approaches through the Reagan-Udall Foundation for the FDA, an independent 501(c)(3) organization created by Congress to advance the mission of the FDA to modernize product development, accelerate innovation, and enhance product safety. Dr. Maro received her doctorate in Engineering Systems at the Massachusetts Institute of Technology (MIT). Her main research interest is the implementation of pharmacovigilance techniques, particularly continuous, near-real time sequential statistical analysis methods and data-mining/signal identification methods in distributed longitudinal databases.
Carla Rodriguez-Watson, PhD, MPH
Dr. Rodriguez-Watson is the Scientific Director of the Innovation in Medical Evidence Development and Surveillance (IMEDS) program at the Reagan-Udall Foundation for the FDA. A transformational public-private partnership, IMEDS mobilizes data providers, drug manufacturers, researchers, and the FDA to accelerate research and answer critical patient safety and public health questions. Dr. Rodriguez-Watson has more than 25 years of experience in public health research in local, national, and international settings. An epidemiologist, Dr. Rodriguez-Watson’s research focuses on the use of Real-World Data for public health surveillance and the epidemiology of viral hepatitis and HIV, influenza, substance abuse, and liver and kidney disease. Her methodological areas of focus include the development and evaluation of surveillance systems, comparative effectiveness, multi-level modeling, predictive modeling, and test accuracy.
Ram is the Sr. Director of Life Sciences Solutions at Saama Technologies. He is the Product Owner of Active Safety Analytics for Pharma (ASAP), a solution co-built with Gilead Sciences to enable active safety surveillance using Real-World Data. Ram has more than 20 years of experience in defining business processes and building innovative technology solutions that enhance business efficiency and effectiveness across various domains in the life sciences industry. Ram is a postgraduate from the Indian Institute of Management in Ahmedabad, India.