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Session 2: Defining “Risk” in the Context of Medicinal Drug Products
Session Chair(s)
Meredith Smith, PhD, MPA, FISPE
Senior Director, Implementation Science Pillar Lead
Evidera, Inc, 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).