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Approaches to Postapproval Pediatric Safety Surveillance
Program Code:
117
Date:
Monday, June 25, 2012
Time:
10:00 AM to 11:30 AM
EST
CHAIR
:
Robert Reynolds is Vice President, Epidemiology at Pfizer. He is also an Adjunct Associate Professor at Tulane & serves on the Board of the International Society for Pharmacoepidemiology (ISPE). He holds degrees from Bard College and the Harvard School of Public Health.
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PRESENTER
(S):
Susan Oliveria, EpiSource, United States
John March, Duke Clinical Research Institute, United States
Dr. Sobel is a pharmacoepidemiologist who obtained her doctorate in public health from Columbia University and has over 12 yrs of industry experience. Prior to joining Pfizer, she managed an autoimmune disease registry at the Hospital For Special Surgery/Cornell Med Ctr in NYC.
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Description
This session describes the use of observational data sources and methods, including electronic health care data, cohorts and registries to conduct postapproval safety surveillance in pediatric populations.
Learning Objectives:
Summarize observational methods of postapproval data collection to assess the safety of medicines in children
Compare the feasibility of these approaches under varying scientific and operational circumstances
Apply this knowledge to specific research questions about pediatric medicine safety.