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May 2, 2012 · 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.
- ICH AND ICH GUIDELINES | PPT - SlideShare
This document provides an overview of ICH guidelines. ICH is...
- ICH AND ICH GUIDELINES | PPT - SlideShare
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 · This document provides an overview of ICH guidelines. ICH is an international non-profit organization that brings together regulatory authorities and pharmaceutical industries from Europe, Japan, and the US to discuss technical requirements for drug development and registration.
A presentation by the European Medicines Agency (EMA) on the International Conference on Harmonisation (ICH) and the European regulation of medicinal products. It covers the background, structure, process, outcomes and implementation of ICH guidelines and standards, as well as the role of EMA and other regional harmonisation initiatives.
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.
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Objective of ICH: Technical and scientific harmonisation between Japan, Europe and USA. Scope: New chemical entities and biotechnology derived products. Sponsors: Regulators: EU, FDA, MHLW. Industry: EFPIA, JPMA, PhRMA. Observers: EFTA, Health Canada, WHO, IFPMA. Steering Committee. ICH : 20 years process (2) 1990: Pharmacopoeial Discussion Group.
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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.
