|
- 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
ICH has produced a comprehensive set of safety Guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity A recent breakthrough has been a non-clinical testing strategy for assessing the QT interval prolongation liability: the single most important cause of drug withdrawals in recent years
- 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
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
- 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 drug registration
- Welcome to the ICH Official Website | 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
|
|
|