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Thursday, June 18 • 5:00pm - 6:00pm
#503 OD: ON DEMAND - MedDRA® Labeling Groupings for Enhanced Communication of Safety Concepts: Cinderella’s Glass Slipper?

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Component Type: Forum
Level: Intermediate

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 Objectives

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.

Chair

William Gregory, PhD

Speaker

Background and Rationale for MedDRA Labeling Groupings
William Gregory, PhD

Near-Synonymous MedDRA Preferred Terms
Scott Proestel, MD

CIOMS Working Group Effort to Develop MedDRA PT Label Groupings
Sonja Brajovic, MD

An Industry Approach to Applying MedDRA in Labeling
Ilona Grosse-Michaelis, DrMed, MD


Speakers
avatar for William Gregory

William Gregory

Senior Director, Safety and Risk Management, 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 Sonja Brajovic

Sonja Brajovic

Medical Officer, OSE, 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 Scott Proestel

Scott Proestel

Acting Associate Director, Biomedical Informatics and Regulatory Review Science,, FDA, United States
Scott Proestel, MD, is Acting Associate Director of Biomedical Informatics and Regulatory Review Science at the US FDA’s Center for Drug Evaluation and Research. He completed his internal medicine training at Johns Hopkins Hospital and obtained his medical degree from Columbia University... Read More →
avatar for Ilona Grosse-Michaelis

Ilona Grosse-Michaelis

Senior 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 →

Thursday June 18, 2020 5:00pm - 6:00pm EDT
TBD Virtual Event Horsham, PA 19044
  01: ClinSafety-PV, Forum