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Wendy Stephenson, co-chair of the CIOMS Working Group and a highly accomplished industry expert, will release their recommendations on "Managing Safety Information from Clinical Trials" at the 2005 Clinical Trials Congress. Standardized MedDRA Queries (SMQs) that are being developed jointly by MSSO and CIOMS provide an additional method for using MedDRA to investigate drug safety issues in pharmacovigilance and clinical development. The new ALERT release continues to support international drug safety monitoring through standard reports for regulatory agencies worldwide (such as FDA 3500A MedWatch; CIOMS I & II; pharmacovigilence, US Periodic and Increased Frequency reports; VAERS form; BGA form; and MCA "Yellow Card"); as well as data structures for all commonly used pharmaceutical dictionaries. |
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