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ON DEMAND - MedDRA® Labeling Groupings for Enhanced Communication of Safety Concepts: Cinderella’s Glass Slipper?
Session Chair(s)
William Gregory, PhD
Senior Director, Safety and Risk Management
Pfizer Inc, United States
MedDRA terms are often used de novo in safety information, but certain related terms appear in unrelated parts of the hierarchy. CIOMS is developing principles to facilitate global convergence of various independent safety communication initiatives.
Learning Objective : Describe rationale for the initial stratification of safety information by CIOMS into three categories; Discuss the importance of regulatory mandates to simplify communication of medical concepts in safety information; Explain goals of CIOMS in developing consensus principles for grouping terms in safety information.
Speaker(s)
Background and Rationale for MedDRA Labeling Groupings
William Gregory, PhD
Pfizer Inc, United States
Senior Director, Safety and Risk Management
Near-Synonymous MedDRA Preferred Terms
Scott Proestel, MD
FDA, United States
Senior Medical Officer, ODES, OND, CDER, FDA
CIOMS Working Group Effort to Develop MedDRA PT Label Groupings
Sonja Brajovic, MD
FDA, United States
Medical Officer, OSE, CDER
An Industry Approach to Applying MedDRA in Labeling
Ilona Grosse-Michaelis, DrMed, MD
Bayer AG, Germany
Senior Medical Dictionary Expert
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