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Using Real World Data to Develop a Safety Monitoring Program and Ensure Pre- and Post-Market Continuity
Session Chair(s)
Jeremy A Rassen, DrSc, MS
Co-Founder and President
Aetion, United States
This session will discuss proactively planning and pilot-testing high-quality safety monitoring programs in the pre-marketing phase to ensure timely implementation of monitoring programs and post-marketing safety studies.
Learning Objective : Describe the role of real world data in active safety monitoring, strengths, and limitations of real world data, and basic pharmacoepidemiological study design considerations; Recognize analytic and logistical considerations in planning and testing a safety monitoring program based on use case examples and translate lessons learned to your own pharmacovigilance team.
Speaker(s)
Academia Perspective
Noelle Cocoros, DrSc, MPH
Harvard Medical School, United States
Research Scientist, Department of Population Medicine
Industry Perspective
Kimberly Brodovicz, DrPH
Boehringer Ingelheim, United States
Executive Director of Global Epidemiology
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