Online Program

Global Medical Product Safety: Harmonizing Terminology Across Nations and Languages

Monday, November 4, 2013 : 1:10 p.m. - 1:30 p.m.

Brian O'Hare, MS, Northrop Grumman Information Systems, Springfield, VA
This is a success story of how a fairly simple terminoloy standard was created and how it has a direct impact on patient safety. This presentation describes MedDRA, an electronic terminology standard supporting regulators and bio-pharmaceutical 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.

Learning Areas:

Public health or related laws, regulations, standards, or guidelines

Learning Objectives:
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): Drug Safety

Presenting author's disclosure statement:

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 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.