Regulatory and Safety Toxicology

This session focuses on the principles, guidelines, and practices of regulatory and safety toxicology, which are critical for ensuring the safe development, approval, and use of pharmaceutical and chemical products. Emphasis will be placed on the integration of biological, pharmacological, and toxicological information to evaluate the risk–benefit profile of new and existing drugs, biologics, and chemical substances. Participants will gain insight into preclinical safety testing, including in vitro and in vivo toxicology studies, dose-response assessment, organ-specific toxicity, genotoxicity, carcinogenicity, reproductive toxicity, and immunotoxicity, as well as the translation of these findings to human risk assessment. The session will explore regulatory frameworks and guidelines from global agencies such as the FDA, EMA, ICH, and WHO, highlighting the requirements for data submission, safety evaluation, and pharmacovigilance. Case studies will illustrate how safety toxicology informs clinical trial design, dose selection, monitoring of adverse effects, and post-marketing surveillance. Emerging methodologies such as alternative testing models, high-throughput screening, computational toxicology, and predictive biomarkers will be discussed for their potential to enhance efficiency, reduce animal use, and improve predictive accuracy. By linking biological and mechanistic understanding with regulatory standards and clinical safety considerations, this session aims to equip participants with the knowledge and practical approaches necessary to conduct robust safety evaluations, ensure compliance with global regulations, and support the development of safe and effective therapeutics.

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