It includes the ich medical terminology (meddra), the common technical document (ctd) and the development of electronic standards for the transfer of regulatory information (estri). This document is intended to address recommendations on the application of bracketing and matrixing to stability studies conducted in accordance with principles outlined in the main stability guideline. 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 objective of this ich gcp guideline is to provide a unified standard to facilitate the mutual acceptance of clinical trial data for ich member countries and regions by applicable regulatory authorities. The ich harmonised guideline was finalised under step 4 in february 2002. Funding ich award work with ich organisational chart members & observers value of membership application process articles & procedures work plans & reports process of harmonisation public consultations guideline implementation all guidelines quality guidelines safety guidelines multidisciplinary guidelines index of guidelines efficacy.
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It includes the ich medical terminology (meddra), the common technical document (ctd) and the development of electronic standards for the transfer of regulatory information (estri)....
