ICH Guidelines referring to electronic reporting in pharmacovigilance

• What is ICH?
• What is the impact of ICH on adverse reaction reporting in the frame of pharmacovigilance
• ICH Clinical Safety Guidance Documents

Several guidelines and technical documents produced by ICH are relevant to the electronic transfer of safety data for pharmacovigilance. Here are the links to the relevant sections of the ICH website where all these documents can be found.

• Efficacy Guidelines
• Multidisciplinary Guidelines
• Quality Guidelines
• Safety Guidelines

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Last update: Friday, 11 January 2013.