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Session 2: Defining “Risk” in the Context of Medicinal Drug Products
Session Chair(s)
Meredith Yearsley Smith, PHD, MPA, FISPE
Fellow and faculty member
USC Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences, United States
- What do we mean when we say a drug carries a specific risk? How does the perception of risk vary depending on whether one is a regulator, patient, caregiver or healthcare professional? What types of risks may need to be communicated, and how might they vary across the lifecycle of a medicinal product?
Several case studies will be introduced to illustrate specific types of risk communication challenges (e.g., communicating for awareness; communicating uncertainties in the evidence and in the benefits; dynamic risks; potential risks in the context of well-established benefits).
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