Back to Agenda
Session 4: Signal Detection/Data Mining/Risk Assessment/Risk Management/Risk Minimization
Session Chair(s)
Andre Daniels, MD, MS
Executive Director, Global Regulatory Affairs and Safety
Amgen, Inc., United States
This presentation will describe methods for the detection and prioritization of signals from multiple data sources and the use of data mining in association with case by case evaluation for signal confirmation. Evidence available for risk assessment associated with the prescribing of medications will be discussed. Methods and challenges in evaluating risk management and risk minimization programs including REMS will be considered.
Speaker(s)
Detection, Evaluation, Mitigation and Reporting of Safety Issues through the Product Life Cycle
Joanna Haas, MD, MSc, FACP, FISPE
Haas and Partners LLC, United States
Founding Partner
The Growing Use of Observational Studies in Risk Management Strategy
J. Michael Sprafka, PhD, MPH
Amgen Inc., United States
Executive Director, General Medicine, Inflammation & Bone TA Lead
Methods and Challenges in Evaluating Risk Management and Risk Minimization Programs
Paul J. Seligman, MD, MPH
Amgen Inc., United States
Executive Director, Global Regulatory and R&D Policy
Have an account?