Global Medical Product Safety: Harmonizing Terminology Across Nations and Languages
Learning Areas:Public health or related laws, regulations, standards, or guidelines
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
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.