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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
Claudia Salinas, PhD
Eli Lilly and Company, United States
Senior Director, GPS Pharmacoepidemiology
Panelist
Naomi Boxall, PhD
PHARMO Institute, Netherlands
General Manager
Panelist
Vera Ehrenstein, DrSc, MPH
Aarhus University, Denmark
Professor, Department of Clinical Medicine, Dept of Clinical Epidemiology
Panelist
Gerald Dal Pan, MD, MHS
FDA, United States
Director, Office of Surveillance and Epidemiology, CDER
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