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Session 13: REMS: Opportunities to Improve Communication of Risk Information in the 21st Century
Session Chair(s)
Annette Stemhagen, DrPH, PhD, FISPE
Chief Science Officer
UBC, United States
Ingrid N. Chapman, PharmD
Senior Risk Management Analyst, DRM, OMEPRM, OSE, CDER
FDA, United States
This session will highlight some of the challenges with communicating risk information, specifically within risk evaluation and mitigating strategies (REMS) programs. This session delves into how to communicate health risk and/or risk information to change behavior and ultimately integrate these behaviors into the healthcare system as standard of care. Current and potentially innovative mechanisms to communicate risk that could be applied to REMS will also be discussed.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Define key components of effective health risk messaging
- Identify current mechanisms to communicate risk messages through REMS
- Discuss innovative ways to communicate health risk and/or risk information to various healthcare providers and patients
Speaker(s)
Health Risk Communication
Paula Rausch, PhD, RN
FDA, United States
Director, Division of Health Communications, Office of Communications, CDER
Communication of REMS Over Time
Donella Fitzgerald, PharmD
FDA, United States
Risk Management Analyst, Team Leader
Speaker
Jamie Wilkins, PharmD
Pfizer Inc, United States
Head- Risk Management Center of Excellence