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Trials, Studies and Programs: Diverse Operational Approaches to Generating Evidence in the Late-phase Environment
Session Chair(s)
Gary Coward
PAREXEL International, United Kingdom
Generating Momentum in Post-authorization Studies
Learning Objective : Identify three different operational approaches to generating real-world evidence on the usage, effectiveness, and safety of a pharmacological intervention in a late-phase environment; Discuss advantages of adopting a considered risk-based approach to site monitoring; Describe the benefits of using a managed access program; Discuss how to ensure a successful observational study outcome.
Speaker(s)
Generating Momentum in Post-authorization Studies
Gary Coward
PAREXEL International, United Kingdom
Use of Expanded Access Program (EAP) Data to Gain New Insights into Drug Efficacy and Safety
Heather L Manna
Idis Pharma, United States
Senior Manager, Regulatory Affairs
Risk-based Approach to Monitoring in Late-phase Clinical Trials
Bill Row, MBA, MS
Mapi, United States
Senior Director, Clinical Operations Americas
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