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The Elephant in the Room: Meaningful Communication of Near Synonyms as Suspected Adverse Reactions
Session Chair(s)
Judith Jones
Principal Consultant, Pharmacovigilance, Epidemiology, and Risk Management
PharmaLex, United States
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 Objective : 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.
Speaker(s)
Dynamic Trends for Value and Meaningful Product Safety Labeling in Asia, Including Japan
Rie Matsui, RPh
Pfizer R&D Japan G.K., Japan
Senior Director, Regional Labeling Head for APAC, International Labeling
A Perspicacious CIOMS View of a Sometimes Tangled Mass of Adverse Reaction Communication Challenges
William Gregory, PhD
Pfizer Inc, United States
Senior Director, Safety and Risk Management
MedDRA Labeling Groupings (MLGs): A New CIOMS Initiative
Sonja Brajovic, MD
FDA, United States
Medical Officer, OSE, CDER
MedDRA Labeling Groupings (MLGs): Practical Examples Underscore Feasibility
Ilona Grosse-Michaelis, DrMed, MD
Bayer AG, Germany
Senior Medical Dictionary Expert
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