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Assessment of Impact and Effectiveness of Risk Management and Minimization in the EU and US

Track:
Clinical Safety and Pharmacovigilance

Day & Time:
June 16, 11:00AM - 12:30PM (Pacific Standard Time)

Session Number:
139

Room Number:
6D

Level:
Intermediate

Type:
Symposium

Title:
Assessment of Impact and Effectiveness of Risk Management and Minimization in the EU and US

Chair(s):
Saad A.W. Shakir, MD, FFPM, FISPE, FRCP
Director
Drug Safety Research Unit (DSRU), United Kingdom

Description:
This symposium will provide insights, information about tools used, and approaches to assess and measure the effectiveness and impact of risk management and minimization methods in the EU and US.

Learning Objective(s):
Discuss methods used to assess the impact and effectiveness of risk management and minimization methods; Identify the application of some of the tools used to examine the effectiveness of risk management and minimization.

Presentation(s) & Speaker(s):
Evaluating Risk Evaluation and Mitigation Strategies Effectiveness Using Existing Tools
Annette Stemhagen, DrPH, FISPE
Senior Vice President, Safety, Epidemiology, Registries and Risk Management
UBC: An Express Scripts Company , United States

Impacts of Safety Warning and Risk Evaluation and Mitigation Strategies on Drug Utilization and Clinical Outcome
Jason C. Hsu
Assistant Professor, Institute of Clinical Pharmacy and Pharmaceutical Sciences
National Cheng Kung University, Taiwan

Monitoring and Studying the Effectiveness of Risk Management and Minimization in the EU
Saad A.W. Shakir, MD, FFPM, FISPE, FRCP
Director
Drug Safety Research Unit (DSRU), United Kingdom