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· the 13 principles of ich e6 (r2) have been rearranged to produce 11 more detailed principles consisting of a statement and sub-points designed to provide a flexible framework for trial conduct. The international council for harmonisation of technical requirements for pharmaceuticals for human use (ich) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ich guidelines. The introduction of the m4q (r1) guidelines on the common technical document (ctd) in 2002 harmonised the. The international council for harmonisation of technical requirements for pharmaceuticals for human use (ich) is an initiative that brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration. · the new ich m4q (r2) guideline will revise and update the current ich m4q (r1) guidelines. The european medicines agency publishes scientific guidelines on human medicines that are harmonised by the international council for harmonisation of technical requirements for registration of pharmaceuticals for human use (ich).