Accurate and scientifically justified first-in-human (FIH) dose selection is a critical component of drug development and fundamental to patient safety. This Continuing Education course will provide a comprehensive and integrated overview of approaches used to translate nonclinical findings into safe and pharmacologically relevant FIH...

This Continuing Education (CE) further expands the training course on AI presented in 2025 with a focus on Agentic AI and will introduce toxicologists and safety scientists to the emerging field of Agentic Artificial Intelligence (AI) not covered in the 2025 ACT CE course, and its transformative potential in predictive, translational, and clinical...

This Continuing Education (CE) course aims to discuss the principles applied to plan, deliver, and communicate embryofetal testing for pharmaceuticals in clinical development. The why, when, and how to conduct these studies and the rationale for decisions made in study design, conduct, and interpretation will be addressed. This is a...

At the 2025 ACT Annual Meeting, a basic/practical mini-symposium was held on best practices for optimizing FDA interactions. Building on this foundation, the proposed advanced/practical Continuing Education (CE) course will delve deeper into the regulatory interactions, with presentations from pharma and regulatory on numerous interactive...

As the pharma industry evolves toward more ethical, efficient, and human-relevant practices, New Approach Methodologies (NAMs) are reshaping the landscape of drug discovery and safety assessment. This course explores the scientific, regulatory, and technological dimensions of NAMs, including in vitro systems, computational...

Immunotherapies constitute a rapidly growing class of pharmaceuticals which have significant potential benefit for numerous indications. The nonclinical development of immunotherapeutics requires a variety of scientific experts, including immunologists, pathologists, toxicologists, and regulatory personnel working together to ensure...

Genetic toxicology is integral to pharmaceutical development, providing a scientific framework for the identification and mitigation of genotoxic risks associated with new chemical entities, metabolites, and impurities. This course critically examines the implementation of genotoxicity risk assessment throughout the drug development...

Quantitative Structure-Activity Relationship (QSAR) approaches are integral to modern toxicology. They enable predictive hazard assessment, prioritization, and regulatory decision-making without reliance on animal testing. However, many toxicologists have little experience or hands-on familiarity with how QSAR tools work or how...