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Tuesday, June 25 • 4:15pm - 5:30pm
#282: The Elephant in the Room: Meaningful Communication of Near Synonyms as Suspected Adverse Reactions

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-628-L04-P; CME 1.25; IACET 1.25; RN 1.25

This forum-style enquiry session is designed as a panel discussion driven by audience participation. Speakers will present prepared summary comments on effective communication of safety and risk concepts in reference safety information (RSI). These short, introductory statements will prepare the audience for discussion of the evolving product labeling landscape, using Japan and Asia as examples. Additional comments will describe the existing regulatory guidance from Canada, the EU, and the US that supports simplification of suspected adverse reactions in RSI. To facilitate convergence of several independent efforts aimed at grouping near-synonymous medical concepts, CIOMS has formed an exploratory working group to assess the feasibility of developing internationally harmonized consensus principles for “MedDRA® Labeling Groupings” (MLGs). If developed, these principles could be available for consideration when the existing MedDRA hierarchy does not support the desired groupings. Practical examples of current challenges will be discussed in the context of enhancing understandability of medical concepts by the health care community. Join the Clinical Safety & Pharmacovigilance Community for a follow up Round Table discussion on Wednesday, June 26, 2:00-3:00PM in the DIA Community Zone 2, Sails Pavilion.

Learning Objectives

Describe regional safety labeling requirements in Japan and Asia and their international implications (for the benefit of patients); Identify existing regulatory guidance that supports simplification of RSI; Define practical examples of medical concepts that are nearly synonymous from a clinical perspective and which might be appropriate candidates for application of MLGs; Explain the new CIOMS initiative that is exploring feasibility of developing principles for MLGs.

Chair

Judith Jones

Speaker

Dynamic Trends for Value and Meaningful Product Safety Labeling in Asia, Including Japan
Rie Matsui, RPh

A Perspicacious CIOMS View of a Sometimes Tangled Mass of Adverse Reaction Communication Challenges
William Gregory, PhD

MedDRA Labeling Groupings (MLGs): A New CIOMS Initiative
Sonja Brajovic, MD

MedDRA Labeling Groupings (MLGs): Practical Examples Underscore Feasibility
Ilona Grosse-Michaelis, MD, PharmD



Speakers
avatar for William Gregory

William Gregory

Worldwide Medical and Safety, Pfizer Inc
He received formal training in infectious diseases and molecular mechanisms of pathogenesis and has more than 15 years of experience directing global product development and registration programs. He also has extensive experience in pharmacovigilance and health informatics as well... Read More →
avatar for Judith Jones

Judith Jones

Principal Consultant, Pharmacovigilance, Epidemiology, and Risk Management, PharmaLex
Dr. Jones is a clinical pharmacologist/pharmacoepidemiologist trained in geriatrics and internal medicine with a longstanding interest in the study of adverse drug reactions, drug utilization, and drug development and regulation. She received her medical training at Baylor College... Read More →
avatar for Rie Matsui

Rie Matsui

Director, International Labeling Asia, Regulatory Affairs, Pfizer R&D Japan
Rie Matsui is currently Director, Regional Labeling Head for APAC, International Labeling Group, Worldwide Safety & Regulatory, Pfizer Japan. She is the founder of Asia Labeling Hub at Pfizer which was established in July 2012. The Asia Labeling Hub has created various local label... Read More →
avatar for Sonja Brajovic

Sonja Brajovic

Medical Officer, Office of Surveillance and Epidemiology, CDER, FDA
Sonja Brajovic is a Medical officer in the Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). She is responsible for coordination of projects related to the Medical Dictionary for Regulatory Activities... Read More →
avatar for Ilona Grosse-Michaelis

Ilona Grosse-Michaelis

Medical Dictionary Expert, Bayer AG
Dr. Große-Michaelis is a clinical pharmacologist trained in internal medicine and pharmacology/ toxicology with a longstanding interest in the risk-benefit profile of drugs, and drug development. She obtained her medical degree from the Humboldt University of Berlin, Germany. The... Read More →


Tuesday June 25, 2019 4:15pm - 5:30pm
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA