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date_range October 15, 2025
MedDRA Labeling Groupings Webinar
This free webinar focused on proposed recommendations to improve safety communication to patients and healthcare providers and support the urgent need for a harmonized international approach to the creation and use of MedDRA Labeling Groupings (MLGs) and/or groups of MedDRA terms.
This webinar introduced and explained the main concepts of the report.
About the event
- mic 6 Speakers
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The Medical Dictionary for Regulatory Activities (MedDRA) is a terminology developed by the International Council for Harmonisation (ICH). While it is useful for precise coding of adverse events of medicines for data analysis, its high granularity can obscure the safety communication in product labeling for healthcare practitioners. Many sponsors and regulators have therefore begun to develop their own approaches to clustering similar adverse reaction terms in medical product prescribing information on a product-by-product basis. However, there are no agreed-upon conventions that describe which adverse reaction terms may be appropriate to group together. The CIOMS Expert Working Group for MedDRA Labeling Groupings (MLG) proposed the consensus recommendations on principles and points to consider in the development of MLGs in the 2024 report:
Introduction to MedDRA Labeling Grouping (MLG): A standardized approach to grouping adverse reactions in product safety labels. https://doi.org/10.56759/hmku5307
Webinar presentations: Download PDF
Webinar recording: https://vimeo.com/1128765950/cfef7c1660?share=copy&fl=sv&fe=ci
Speakers and Panelists
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Lembit Rägo
Secretary-General, CIOMS, Switzerland
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Aniello Santoro
Signal Management Lead, European Medicines Agency
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Radhika Rao
Medical Director, Global Patient Safety, Abbvie, United States
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Ilona Grosse-Michaelis
Independent Senior Medical Consultant (formerly Senior Medical Dictionary Expert at Bayer), Germany
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Silvia Bader-Weder
Senior Medical Safety Director, Product Development Safety, Roche, Switzerland
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Scott Proestel
Vice President, Medical Informatics, Medpace, (formerly with FDA) United States
Webinar programme
Introduction
Lembit Rägo
Background
Aniello Santoro
MLG Characteristics, Objectives, Principles and Conventions
Radhika Rao
Benefits of MLGs and Unexplored Potential Applications, Labeling Considerations with Illustrations
Ilona Grosse-Michaelis
MLG Examples, Comparison of SMQ and MLG
Silvia Bader-Weder
MLG Limitations/Conclusion and Future Considerations
Scott Proestel
Panel discussion
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