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MedDRA European language translations free for MSSO subscribers.

The MedDRA Management Board announced that the $850 charge for additional European language translations of MedDRA will be abolished for MSSO MSSO Maintenance and Support Services Organization
MSSO Multiple Source Simple Output
MSSO Munich Symphonic Sound Orchestra
MSSO MILSATCOM Systems Sustainment Office
MSSO Multi-Stage Self-Organizing
MSSO Mission Services and Support Office
MSSO Mean Squared Soft Output
 subscribers from January 2008. Previously, only one free European language translation was included in each subscription.

This fee reduction follows those announced in a press release on Sept. 18. For the third consecutive year there will be a significant reduction for lower revenue subscribers and no increases to other subscription levels. In addition, access to MedDRA is now free for academic organizations, hospitals, healthcare providers, and other users involved in non-commercial activities. The MSSO also offers free MedDRA training for all new Basic, Core 0, and Core 1 subscribers.

These recent fee reductions are likely to have contributed to a 20% increase in the number of MSSO subscribers in the first nine months of 2007. The Board also noted an increase in the number of users of the Japanese version.

With the latest release of MedDRA, 55 Standardized MedDRA Queries (SMQs) are now available to support more uniform and effective safety surveillance. The Board commended the excellent work of the members of the Council for the International Organization of Medical Sciences (CIOMS CIOMS Council for International Organizations of Medical Sciences ) SMQ SMQ Sunday Morning Quarterback
SMQ Surface Mount Quality (DKL Metals Ltd E-Qual)
SMQ Standardised MedDRA Query
SMQ Statement of Minimum Qualification
SMQ String Missing Quote
SMQ Split Matrix Quantization
 working group. Medical device terms have been reviewed and the Board has endorsed the addition of new terms to support safety surveillance of medical devices and combination products. The first batch of new terms is anticipated in March 2008 (version 11.0). The terms will follow lists from FDA's Center for Devices and the Global Harmonization Task Force “GHTF” redirects here. For other uses, see GHTF (disambiguation).

The Global Harmonization Task Force (GHTF) is “a voluntary group of representatives from national medical device regulatory authorities (such as the FDA) and the members of the medical
 (GHTF GHTF Global Harmonization Task Force ) for medical devices.

The Board has endorsed a proposal from European regulators to create a gender-specific list of terms and a list of pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children.

pe·di·at·ric
adj.
Of or relating to pediatrics.
 adverse event terms. The provisional lists will be placed on the MSSO website early in 2008 for subscriber comment. These lists will assist data quality control (for example, a male patient cannot develop uterine cancer uterine cancer

Malignant tumour of the uterus. Cancers affecting the lining of the uterus (endometrium) are the most common cancers of the female reproductive tract.
) and assist pharmacovigilance for these sub-populations. Both lists are considered recommendations only, and organizations may wish to modify the lists for their own requirements.

The next scheduled meeting of the Board will be on May 31-June 1, 2008, in Portland, OR.
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Title Annotation:AE Reporting; Medical Dictionary for Regulatory Activities; Maintenance and Support Services Organization
Publication:Adverse Event Reporting News
Geographic Code:1USA
Date:Nov 5, 2007
Words:353
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