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Tuesday, June 28 • 2:00pm - 3:15pm
#248: Mind the Gaps: The Science of Designing, Implementing, and Evaluating Benefit-Risk Communication for Medicinal Products

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Component Type: Forum
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-580-L04-P; CME 1.25; IACET 1.25; RN 1.25

Effective benefit-risk communication is central to ensuring safe and appropriate use of medicinal drug products. Additionally, regulatory authorities across the globe are now demanding evidence of the effectiveness of risk communication measures included as part of formal risk management programs. Currently, however, the design, dissemination and application of best practices in benefit-risk communication have been limited. This forum seeks to highlight the main gaps in the design, implementation, and evaluation of benefit-risk communication for medicinal products, to identify best practices in those areas, and to explore ways to reduce those gaps moving forward.

Learning Objectives

Identify the main facilitators and barriers in the design of current benefit-risk communications; Describe the key gaps in the translation and implementation of benefit-risk communication best practices into real-world practices (e.g., at the community level, and across cultures, health care systems and regulatory authority jurisdictions); Discuss the major gaps in the evaluation of risk communication, and how these gaps can be effectively addressed.


Meredith Y. Smith


Communicating Risk Information to Patients: Gaps in Current Approaches and How Health Literacy and Information Orientation Measures Can Improve Effectiveness
Kristina Birnbrauer, PhD

Gaps and Best Practices in Designing Risk Minimization Communication Campaigns
Elaine H Morrato, DrPH, MPH

Evaluating Effectiveness of Benefit-Risk Communication
Gerald J. Dal Pan, MD

avatar for Meredith Smith

Meredith Smith

Global Risk Management Officer, Global Patient Safety, Amgen Inc.
Meredith Smith is Global Risk Management Officer at Amgen, Inc. where she leads a team of 6 scientists responsible for medicinal product benefit-risk assessment and risk management. She is a behavioral scientist and health services researcher by training with over 15 years of experience... Read More →

avatar for Kristina Birnbrauer

Kristina Birnbrauer

Sr. Research Consultant, MSP Analytics
Kristina Birnbrauer is a health communication and research professional with expertise in patient and healthcare provider education and health behavior interventions. Kristina found her niche after a life-threatening mosquito borne virus in 2010. She is experienced in study and survey... Read More →
avatar for Elaine Morrato

Elaine Morrato

Professor Health Systems, Management and Policy, Colorado School of Public Health
Elaine Morrato, DrPH MPH is a Professor in Health Systems, Management and Policy and Associate Dean for Public Health Practice at the Colorado School of Public Health. Her research focuses on accelerating the translation of drug warnings into practice, and she has contributed her... Read More →
avatar for Gerald Dal Pan

Gerald Dal Pan

Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
Gerald J. Dal Pan, MD, MHS, is Director of the Office of Surveillance & Epidemiology in FDA’s Center for Drug Evaluation and Research, where he oversees adverse event surveillance and analysis, pharmacoepidemiology, risk management, and medication error prevention. A member of the... Read More →

Tuesday June 28, 2016 2:00pm - 3:15pm EDT
113C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 14: Clin Safety-PV, Forum