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  • ICH Official web site : ICH
    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
  • ICH Official web site : ICH
    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)
  • ICH HARMONISED GUIDELINE GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R3)
    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
  • ICH Official web site : ICH
    You can explore in the below table the index of all ICH Guidelines, finalised or under development, on the topics of Quality, Safety, Efficacy and Multidisciplinary
  • ICH Official web site : ICH
    The International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation (ICH) held the inaugural Assembly meetings on 23 October 2015 establishing ICH as an international association, a legal entity under Swiss law
  • ICH Official web site : ICH
    The ICH E6 (R3) “Good Clinical Practice” Guideline provides a unified standard to facilitate the mutual acceptance of clinical trial data for ICH member countries and regions by applicable regulatory authorities
  • ICH Official web site : ICH
    The ICH Harmonised Guideline was finalised under Step 4 in February 2002 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
  • ICH Official web site : ICH
    In order to facilitate the implementation of the CTD General (M4) Guideline, the ICH Experts have developed a series of Q As The document which reached Step 4 of the ICH Process in June 2004, intends to clarify the key issues regarding the CTD




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