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ICH has produced a comprehensive set of safety Guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity. A recent breakthrough has been a non-clinical testing strategy for assessing the QT interval prolongation liability: the single most important cause of drug withdrawals in recent years.
Welcome to the ICH Official Website. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines.
global community. ICH is committed to stakeholder engagement and transparency in the development of its guidelines. ICH E6 Good Clinical Practice (GCP) Guideline is widely used by clinical trial researchers beyond the membership and regional representation of ICH itself and has a significant impact on trial participants and patients.
Oct 14, 2019 · The ICH E2D guideline provides guidance on definitions and standards for post-approval individual case safety reporting, as well as good case management practices. This revised guideline is proposed to clarify the management of post-approval safety information from new or increasingly used data sources including the need to adapt definitions and standards.
Electronic Standards (ESTRI) Reflection Papers & Discussion Groups. Consideration Documents. CIOMS Glossary of ICH Terms & Definitions. ICH PQKM Task Force. ICH Calendar. Assembly. Management Committee. ICH Public Events.
Welcome to the ICH Official Website. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines.
This guideline should be read in conjunction with other ICH guidelines relevant to the conduct of clinical trials (e.g., E2A (clinical safety data management), E3 (clinical study reporting), E7 (geriatric populations), E8 (general considerations for clinical trials), E9
