142nd APHA Annual Meeting and Exposition

Annual Meeting Recordings are now available for purchase

Global Medical Product Safety: Harmonizing Terminology Across Nations and Languages

142nd APHA Annual Meeting and Exposition (November 15 - November 19, 2014): http://www.apha.org/events-and-meetings/annual
Tuesday, November 18, 2014 : 3:10 PM - 3:30 PM

Brian OHare, MS Information Systems , MedDRA Maintenance and Support Services Organization, Northrop Grumman Health IT, McLean, VA
This is a success story of how a fairly 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.

Learning Areas:

Other professions or practice related to public health

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.

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 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.