E1: Clinical Safety for Drugs used in Long Term Treatment E1: The Extent Of Population Exposure To Assess Clinical Safety for Drugs intended for long term treatment of non-life threatening conditions. E2A-E2F: Pharmacovigilance E2A: Clinical Safety Data Management: Definitions and…
Tag: ICH Guidelines
ICH, or the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, is what the acronym stands for. ICH is a collaborative effort in which regulators from Europe, Japan, and the United States participate in…