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Wednesday, June 27 • 8:00am - 9:15am
#302: Risk Communication and Patient Safety: Recent Learnings and New Approaches

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-623-L04-P; CME 1.25; IACET 1.25; RN 1.25

While the product label represents the primary source of information about a medicine’s risks, numerous other types of risk communication measures have been used or required by regulatory authorities to date, including Dear Healthcare Provider Letters, Medication Guides, educational brochures, monographs, reminder and/or alert cards, and checklists. Such materials are typically intended for a diverse audience (e.g., healthcare professionals, patients, informal care providers, general public) and for use in a diverse array of settings, ranging from hospital and outpatient clinics to home-based. Increasingly, regulatory authorities are seeking to incorporate new learnings from the science of risk communication to support more effective tools and methods for reaching these audiences, including patient-centered approaches, shared decision-making techniques, electronic medical records, and other digital-based forms of communication.
The purpose of this session is present highlights from recent risk communication initiatives at the European Medicines Agency (EMA) and US Food and Drug Administration (FDA), and to illustrate how learnings from the emerging field of implementation science can be used to enhance the effectiveness of risk communication by both regulators as well as sponsors.

Learning Objectives

Describe recent efforts by a major regulatory authority (the European Medicines Agency) to improve the quality of therapeutic risk communication via partnership and engagement with patients and healthcare professionals; Identify how to implement therapeutic risk communication programs; Discuss new types of risk communication tools that the FDA has developed for sponsors to use when communicating medicinal product risks to healthcare professionals and patients.


Meredith Y. Smith


Engaging Patients and Healthcare Professionals in Evaluating Risk Minimization Measures: How Can Regulators Best Listen to Medicine Users for Improved Regulatory Decision Making and Risk Communication
Juan Garcia-Burgos, MD

New Risk Communication Approaches for Patients: The FDA's Benefit-Risk Counseling Framework and Other Tools
Michael S. Wolf, PhD, MA, MPH

Prescription Medication Information and Adherence: New Research and Future Directions
Marina Serper, MD, MS

avatar for Juan Garcia-Burgos

Juan Garcia-Burgos

Head of Public and Stakeholders Engagement, European Medicines Agency, Netherlands
Juan Garcia Burgos is a Qualified Medical Doctor from Autonoma University in Madrid, specialised in urology. Juan worked as a urologist surgeon at the Maranon hospital in Madrid. He joined the European Medicines Agency in 2002 and was responsible for coordinating the preparation of... Read More →

Marina Serper

Assistant Professor of Medicine in Gastroenterology, University of Pennsylvania School of Medicine
Dr. Serper is a transplant hepatologist, health services investigator, and Assistant Professor of Medicine at the University of Pennsylvania Perelman School of Medicine. Dr. Serper’s research focuses on designing behavioral and health-system interventions utilizing health technology... Read More →
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 →

Michael Wolf

Associate Professor, Medicine and Learning Sciences, Associate Division Chief, Northwestern University
Dr. Wolf is Professor of Medicine at the Feinberg School of Medicine at Northwestern University. He serves as both Vice Chair for Research for the Department of Medicine, as well as Associate Division Chief for General Internal Medicine. Dr. Wolf is a health services researcher and... Read More →

Wednesday June 27, 2018 8:00am - 9:15am EDT
Room 253AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  01: ClinSafety-PV, Session