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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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Limited Capacity seats available
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.

Chair

Meredith Y. Smith

Speaker

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


Chair
avatar for Meredith Smith

Meredith Smith

Global Risk Management Officer, Global Patient Safety, Amgen Inc.
Dr. Meredith Smith is Global Risk Management Officer in the Global Patient Safety department at Amgen. She is a social and behavioral scientist by training and has worked in the industry for approximately 15 years. She served on the CIOMS IX Working Group on Risk Minimization Toolkit and is currently the Risk Communication Co-Chair of the Benefit-Risk Assessment, Communication and Evaluation (BRACE) SIG of the International Society for... Read More →

Speakers
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 design, analysis and interpretation. Her background in professional and interpersonal communication informs the health behavior and patient-centered research she... Read More →
avatar for Elaine Morrato

Elaine Morrato

Associate Dean for Public Health Practice, Colorado School of Public Health
Elaine Morrato, DrPH MPH is the Associate Dean for Public Health Practice at the Colorado School of Public Health. Her research focuses on accelerating the translation of drug warnings into clinical practice. Dr. Morrato has contributed her expertise in numerous FDA advisory committee meetings on issues of drug safety and risk management. She also directs the Pragmatic Trials and Dissemination and Implementation Science program in the Colorado... Read More →
avatar for Gerald Dal Pan

Gerald Dal Pan

Director, Office of Surveillance and Epidemiology, CDER, FDA
He received his medical degree from Columbia University, and his Master's degree in clinical epidemiology from Johns Hopkins. He trained in Internal Medicine at the Hospital of the Univ of Pennsylvania, and in Neurology at Johns Hopkins. He is board certified in Internal Medicine and Neurology.

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