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Long-Term Safety of Approved Medicines: Approaches for Identifying, Characterizing, and Quantifying Delayed Adverse Events
Session Chair(s)
Steven M. Weisman, PHD
Global President, Clinical and Regulatory, Lumanity Inc, United States
This forum will hear from regulators, industry, vendors, and the academic community on how each has approached the generation of long-term safety data on a hypothetical approved medicine with a risk of delayed adverse events.
Learning Objective : Compare strengths and weaknesses of different approaches for evaluating long-term safety particularly when delayed adverse events are a potential risk; Identify fit-for-purpose, longitudinal data sources to answer regulator research objectives for long-term follow-up studies.
Speaker(s)
Panelist
Senior Director, GPS Pharmacoepidemiology, Eli Lilly and Company, United States
Panelist
General Manager, PHARMO Institute, Netherlands
Panelist
Professor, Department of Clinical Medicine, Dept of Clinical Epidemiology, Aarhus University, Denmark
Panelist
Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
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