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Session 6 - Post-Approval Benefit-Risk Assessment
Session Chair(s)
Qi Jiang, PHD
Executive Director, Global Biostatistical Science
Amgen Inc., United States
This session will address the ongoing collection and use of benefit-risk information for specific applications such as PBRERS and PSURs, as well as more general safety surveillance of post-marketed products. Information will be relevant for mature products, vaccines, and devices.
Speaker(s)
Adaptive Licensing
John G. Ferguson, MD
Novartis Vaccines, United States
Vice President, Global Head of Pharmacovigilance and Medical Safety
Benefit-risk Balance Assessment During the Lifecycle of Medicinal Products
Robert Ball, MD, MPH, MSC
FDA, United States
Deputy Director, Office of Surveillance and Epidemiology, CDER
Capturing Benefits and Risks in the Post-approval Phase-Practical and Regulatory Challenges
Marilyn A. Metcalf, PHD
GlaxoSmithKline, United States
Senior Director, Patient Focused Development, Global Medical
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