September 8, 2010
Risk Communications An essential part of every REMS or benefit-risk management program is effective communications of risk. Importantly, this is far more complex than writing, printing, and distributing Dear Healthcare Provider Letters or Medication Guides.
An essential part of every REMS or benefit-risk management program is effective communications of risk. Importantly, this is far more complex than writing, printing, and distributing Dear Healthcare Provider Letters or Medication Guides. Risk communication requires an understanding of how humans hear, read, comprehend, and perceive risk. New sciences of neuro-communications and neural decision-making are providing some much needed insight in this area, but much remains to be learned.
In this program, our speakers will review the principles and best practices of risk communication. Starting with the fundamentals of definitions and relevant FDA guidance, we will review the requirements for risk communication in REMS. A presentation of recent surveys of various stakeholders will uncover some preferences and gaps that need to be addressed in the construction of risk communications. In addition, we will consider some recent case examples of risk communications as practical application of the principles. This will include consideration of ways to extend outreach to the point of care to inform decision making and behaviors. Finally, we will preview some of the emerging sciences and methods that will inform the next generation of risk communications.
Ken Hornbuckle, Senior Epidemiology Advisor, Office of Risk Management and Pharmacoepidemiology, Eli Lilly and Company
Rebecca Vermeulen, Senior Director, Global Medical Regulatory and Safety, Eli Lilly and Company
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