141st APHA Annual Meeting

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294591
Global Medical Product Safety: Harmonizing Terminology Across Nations and Languages

Monday, November 4, 2013 : 1:10 PM - 1:30 PM

Patricia Mozzicato, MD , Northrop Grumman Information Systems Health IT Programs, Chantilly, 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

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: I was one of the first pharmacovigilance experts to use MedDRA when it was first developed over a decade ago. I am currently the Chief Medical Officer of the sole maintenance and content development organization for MedDRA and am generally responsible for overseeing its content and appropriate use by pharmacovigilance professionals and other stakeholders in public health.
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.

Back to: 3245.0: Advances in Public Health and Healthcare informatics: Northrop Grumman Innovations and Solutions - Part 2
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