MedDRA(Medical Dictionary for Regulatory Activities)
MedDRA or Medical Dictionary for Regulatory Activities is a clinically
validated international medical terminology used by regulatory authorities and
the regulated biopharmaceutical industry throughout the entire regulatory
process, from pre-marketing to post-marketing activities, and for data entry,
retrieval, evaluation, and presentation. In addition, it is the adverse event
classification dictionary endorsed by the International Conference on
Harmonization of Technical Requirements for Registration of Pharmaceuticals for
Human Use (ICH). MedDRA is used in the US, European Union, and Japan. Its use
is currently mandated in US, Europe and Japan for safety reporting.
MedDRA was developed by the International Conference on Harmonisation (ICH) and is owned by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) acting as trustee for the ICH steering committee.
MedDRA is managed by the MSSO (Maintenance and Support Services Organization).
Reference: ICH Guidelines
MedDRA was developed by the International Conference on Harmonisation (ICH) and is owned by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) acting as trustee for the ICH steering committee.
MedDRA is managed by the MSSO (Maintenance and Support Services Organization).
Reference: ICH Guidelines
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