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Key points covered include ICH's history and members, as well as descriptions of ICH's organization, process for guideline development, and several quality, safety, efficacy and multidisciplinary guidelines.
Sep 30, 2014 · ICH guidelines cover quality, efficacy, safety, and multidisciplinary topics. The process for developing ICH guidelines involves working groups developing a draft which undergoes review and approval by ICH members and regions.
Jan 6, 2019 · The document presents an overview of ICH guidelines. It discusses that ICH was created in 1990 to harmonize pharmaceutical regulations between Europe, Japan, and the US. ICH has developed over 45 guidelines divided into quality, safety, efficacy, and multidisciplinary categories.
Well-defined objectives: To improve efficiency of new drug development and registration process. To promote public health, prevent duplication of clinical trials in humans and minimize the use of animal testing without compromising safety and effectiveness.
Training materials developed by ICH Working Groups, ICH Training Associates and external Training Providers can be found in the below Training Library and under respective ICH Guideline as they become available.
This guideline is being developed to encourage thoughtful consideration and planning to address specific and potentially unique aspects of an individual clinical trial. The principles are intended to support improved and more efficient approaches to trial design and conduct.
Objectives of the Guideline. To meet the objectives, ICH Q10 augments Good Manufacturing Practices which are generally not repeated within the Guideline. Achieve product realisation. Establish and maintain a state of control. Facilitate continual improvement. Scope of Guideline. applies...throughout the product lifecycle.
