Regulatory ICH Guidelines with Nonclinical Impact

This lecture series provides an overview of key International Council for Harmonisation (ICH) guidelines that guide the nonclinical development of human pharmaceuticals, highlighting the harmonisation of regulatory requirements across Europe, the United States, Japan and other partners within ICH. It covers the scientific and regulatory principles of nonclinical safety evaluation,... read moreincluding areas such as safety pharmacology, pharmacokinetics, toxicology, immunotoxicity, carcinogenicity, and emerging fields like gene and biotechnology-derived therapies. The series also offers practical insights into study design, reduction of animal use (3Rs), risk assessment, and how nonclinical data support staging in clinical trials and regulatory decision-making.