MedDRA Points to Consider

The MedDRA Points to Consider documents are ICH-endorsed guides for MedDRA users. They are designed to be updated based on MedDRA changes, and are companion documents to the MedDRA terminology. They are developed and maintained by a working group charged by the ICH Steering Committee consisting of regulatory and industry representatives of the European Union, Japan and the United States, as well as representatives from Canada, the MedDRA Maintenance and Support Services Organisation (MSSO), and Japanese Maintenance Organisation (JMO).

The MedDRA Points to Consider documents are available on the following website: http://www.meddramsso.com/subscriber_library_ptc.asp

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Last update: Wednesday, 30 November 2011.