Elizabeth Andrews

Dr. Elizabeth Andrews, VP of Pharmacoepidemiology and Risk Management, will be presenting at the IIR Signal Detection & Risk Management Conference. Below is an overview of her presentation, entitled, “Evaluating the Effectiveness of Risk Management Programs.”

Evaluating the Effectiveness of Risk Management Programs

The goal of a risk management plan (RMP) is to reduce risks to patients while preserving access to treatment. Critical to meeting that goal is to implement an on-going evaluation of the RMP that provides real-world evidence on how well the program elements are working to modify behavior of healthcare professionals and patients and to maintain risks at an acceptable level. Effective evaluation of RMPs allows sponsors to modify the programs and in some cases eliminate them altogether. The presentation will provide insight on:

• The changing risk management landscape
• How to select appropriate risk management tools,
• Methods and data sources for evaluating the impact of risk management tools, and
• Program evaluation frameworks and processes that can facilitate the introduction of modifications to risk management programs

Each method will be described using relevant case examples from US and European experiences. A hypothetical risk management program will be described in cases where experiences are not available in the public domain

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