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Virtual

Nov 09, 2020 9:00 AM - Nov 11, 2020 2:00 PM

Safety Risk Communication for Medical Products

In this virtual training course, learn how to enhance the effectiveness of safety risk communication in light of evolving regulatory expectations.

Session 2: Defining “Risk” in the Context of Medicinal Drug Products

Session Chair(s)

Meredith  Smith, PhD, MPA, FISPE

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).

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