294591
Global Medical Product Safety: Harmonizing Terminology Across Nations and Languages
Learning Areas:
Public health or related laws, regulations, standards, or guidelinesLearning 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
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.