ICH’s M2 Expert Working Group, which was established in 1994 “to facilitate international electronic communication by evaluating and recommending, open and non-proprietary— to the extent possible—Electronic Standards for the Transfer of Regulatory Information (ESTRI) that will meet the requirements of the pharmaceutical companies and regulatory authorities.” The group works on standardizing electronic communications including the use of the common technical document (CTD). In 2010, ICH moved responsibility for the electronic common technical document (eCTRD) to a new committee called the M8 Expert Working Group. The M8 group is working to develop framework for developing technical solutions in relations to ICH E2B (Re) (clinical data safety management) and M5 (data elements and drug dictionaries).
For More Information please click here: ICH Reports on Latest Activities (Electronic standards)
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