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How terminology standards can positively impact patient safety
The Medical Dictionary for Regulatory Activities (MedDRA) was developed to address the need for a rigorous medical standard to support electronic submissions, multiple sources of product safety data (e.g., clinical trials, spontaneous reports from patients and healthcare professionals, literature reports), types of data (e.g., adverse reactions, medical history, product indications), and product types (e.g., drugs, biologics, vaccines, health effects of medical devices).
Objective/purpose: This is a success story of how a simple terminology standard was created and how it has a direct impact on patient safety. This presentation describes MedDRA, an electronic terminology standard supporting regulators and biopharmaceutical companies in analyzing medical product safety data. Available in 11 languages, MedDRA is used globally by over 3000 organizations including US FDA, CDC, the European Medicines Agency (EMA), and other regulatory agencies, academic institutions, and pharmaceutical companies. The objective of the presentation is to:
- Explain MedDRA’s role in the global medical product safety regulatory arena
- Describe the relationship of MedDRA with standard medical terminologies (e.g., ICD-9/10, SNOMED-CT)
- Describe the goals of the MedDRA maintenance and development organization
The presentation will describe the how MedDRA is applied during the clinical trial process and post marketing of pharmaceutical products.
The presentation will provide examples of how regulatory authorities use MedDRA to monitor the safety of medicinal products.
A well-developed and maintained terminology standard can positively impact patient safety.
Learning Areas:
Clinical medicine applied in public healthCommunication and informatics
Learning Objectives:
Demonstrate how the application of standard terminologies in varied research and reporting scenarios may have a positive impact on public health.
Explain MedDRA’s role in the global medical product safety regulatory arena
Describe the relationship of MedDRA to other standard medical terminologies (such as ICD-9/10, SNOMED-CT)
Describe the goals of the MedDRA maintenance and development organization
Keyword(s): Information Technology, Clinical Trials
Qualified on the content I am responsible for because: I am the terminology maintenance manager responsible for the Medical Dictionary for Regulatory Activities (MedDRA) change request process, the biannual MedDRA release and help manage MedDRA related software development projects. I am familiar with how MedDRA is is used and how it supports public health. I work with regulators (e.g., FDA and the European Medicines Agency) and the pharmaceutical industry to enhance the utility of MedDRA in adverse event reporting.
Any relevant financial relationships? No
I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.