Current safety management practices are largely centered on the review and analysis of spontaneous adverse events reported by healthcare professionals, caregivers and patients. While existing processes have been instrumental in identifying new unsuspected safety concerns in the past, the availability of longitudinal real world data and modern digital technologies offers a new paradigm in enhancing knowledge of drug safety. Through the Sentinel Initiative, the FDA has built a robust system for gleaning intelligence from real world data. The FDA is now actively using the Sentinel System and Active Risk Identification and Analysis (ARIA) system to review safety concerns for several drugs.
This webinar is designed to help professionals in the field of Pharmacovigilance, Epidemiology and Medical Affairs to understand how they can harness the power of active safety surveillance for themselves.
Dr. Judith Maro, PhD, Assistant Professor in the Department of Population Medicine, Harvard Medical School and the Harvard Pilgrim Health Care Institute
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 Sentinel Operations Center as part of the U.S. Food and Drug Administration’s Sentinel System. Dr. Maro also consults on safety signal detection approaches through the Reagan-Udall Foundation for the Food and Drug Administration. Dr. Maro received her doctorate in Engineering Systems from the Massachusetts Institute of Technology (MIT) and her main research interest is implementation of pharmacovigilance techniques, particularly continuous near-real time sequential statistical analysis methods and data-mining/signal identification methods in distributed longitudinal databases.Message Presenter
Dr. Carla Rodriguez-Watson, PhD, MPH, IMEDS Scientific Director, Reagan-Udall Foundation for the FDA
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. Dr. Rodriguez-Watson has over 25 years of experience in public health research in local, national, and international settings. An epidemiologist, Dr. Rodriguez-Watson’s research focus is on the use of real-world, big-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.Message Presenter
Ramprasad Keshavamurthy, MBA, Sr. Director of Life Sciences Solutions, Saama Technologies
Ramprasad Keshavamurthy 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. Keshavamurthy has over 20 years of experience in defining business processes and building innovative technology solutions that enhance business efficiency and effectiveness for the Life Sciences industry. Keshavamurthy is a post-graduate from the Indian Institute of Management, Ahmedabad, India.Message Presenter
Who Should Attend?
- Medical Affairs
- Data Science
What You Will Learn
Attendees will gain insights into:
- How the FDA is utilizing the Sentinel and ARIA systems for active safety surveillance
- How the TreeScan methodology can be used for safety signal detection
- How pharmaceutical companies can incorporate active safety signal detection in their safety surveillance program
Saama is the #1 AI clinical analytics platform company, enabling the life sciences industry to conduct faster and safer clinical development and regulatory programs. Today, 50 biotech companies use Saama’s award-winning Life Science Analytics Cloud (LSAC) platform on over 1,500 studies, including many of the top 20 pharmaceutical companies. LSAC’s rich applications facilitate an unprecedented, authoritative oversight of comprehensive clinical research data, enabling companies to file New Drug Applications (NDAs) more efficiently and bring drugs to market faster. Discover more at www.saama.com and follow Saama @SaamaTechInc