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Pharmacovigilance and Risk Management Strategies Conference

Session 13: REMS: Opportunities to Improve Communication of Risk Information in the 21st Century

Session Chair(s)

Annette  Stemhagen, DrPH, FISPE

Annette Stemhagen, DrPH, FISPE

  • Senior Vice President and Chief Scientific Officer
  • UBC, United States
Ingrid N. Chapman, PharmD

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


Paula  Rausch, PhD, RN

Health Risk Communication

Paula Rausch, PhD, RN

  • Director, Division of Health Communications, Office of Communications, CDER
  • FDA, United States
Donella  Fitzgerald, PharmD

Communication of REMS Over Time

Donella Fitzgerald, PharmD

  • Risk Management Analyst, Team Leader
  • FDA, United States
Jamie  Wilkins, PharmD


Jamie Wilkins, PharmD

  • Director, Risk Management Product Lead
  • Pfizer Inc, United States