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Marriott Wardman Park Hotel

27 ene 2020 7:00 a.m. - 29 ene 2020 4:15 p.m.

2660 Woodley Road, NW, , Washington, DC 20008 , USA

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, PhD, FISPE

Annette Stemhagen, DrPH, PhD, FISPE

Chief Science 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

Speaker(s)

Paula  Rausch, PhD, RN

Health Risk Communication

Paula Rausch, PhD, RN

FDA, United States

Director, Division of Health Communications, Office of Communications, CDER

Donella  Fitzgerald, PharmD

Communication of REMS Over Time

Donella Fitzgerald, PharmD

FDA, United States

Risk Management Analyst, Team Leader

Jamie  Wilkins, PharmD

Speaker

Jamie Wilkins, PharmD

Pfizer Inc, United States

Head- Risk Management Center of Excellence

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