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Wednesday, November 3, 2010

ICH - Multidisciplinary Topics

Multidisciplinary topics are categorized in to five types:

ICH M1: MedDRA(Medical Dictionary)

ICH M2: ESTRI(Electronic Standards for the Transfer of Regulatory Information)

ICH M3:  Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorisation for Pharmaceuticals

ICH M4: CTD(Common Technical Document)

ICH M5: Data Elements and Standards for Drug Dictionaries

Source: http://www.ich.org/UrlGrpServer.jser?@_ID=2196&@_FORCETEMPLATE=272

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