Final Agenda


專題介紹

Tsyabri: Practical case studies in REMS, EU RMPs; unifying the European RMP with the FDA REMS

Carmen Bozic, M.D., Vice President and Global Head, Drug Safety and Risk Management, Biogen Idec Inc.

Designing and Analyzing a Randomized Control Trial for Detecting and Understanding Safety

Ralph B. D'Agostino Sr., Ph.D., Professor of Mathematics, Statistics, and Public Health, Boston University

Optimizing the Allocation of an Organization's Product Safety and Risk Management

Jill Robinson, R.Ph., M.B.A., Vice President, Global Safety Surveillance & Epidemiology, Wyeth

Suicidality: Defining and Studying Suicidality in CNS and Beyond: What Do We Really Know and Where are We Going?

Kelly Posner, Ph.D., Principal Investigator, Columbia/FDA Classification Project for Drug Safety Analyses, Director of the Center for Suicide Risk Assessment, Columbia University

Designing an Epidemiologic Research Strategy to Support Risk Management

Nicolle Gatto, Ph.D., Senior Director, Oncology BU Group Head, Epidemiology, Safety and Risk Management, Pfizer Inc

Plotting a Strategy for the Best Benefit-Risk Ratio

John Ferguson, M.D., Ph.D., Vice President & Global Head, Pharmacovigilance & Medical Safety, Novartis Vaccines & Diagnostics

案例研究研討會

Pragmatic Approaches to FDAAA: A Decision Tree Approach to Successful REMS Creation and Risk Assessement Studies

Hosted by United BioSource Corporation (UBC)

Practical Approaches to Lifecycle Signal Detection

Hosted by Drug Safety Alliance (DSA)