Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 11

There have been many variants on the terms and definitions used to talk about safety issues over the years. Pharmacovigilance terminology and related initialisms are somewhat confusing; commonly used terms are explained below. Table 1 contains a list of associated initialisms. For a more extensive listing of initialisms used in pharmacovigilance, see the Acronyms section of this manual.

The “official” and accepted definitions in most countries are based on the International Conference on Harmonization (ICH) E2A Guideline and are given in the following sections. Note that the ICH changed its name to International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use in 2015. They still refer to it as ICH.