With the release of a Roadmap to reduce animal testing in preclinical safety studies by the FDA in April 2025 and the EMA’s release of the Reflection paper on the current regulatory testing requirements for human medicinal products and opportunities for implementation of the 3Rs for consultation in February 2025, there is an urgent need to develop, validate and understand the place of New Approach Methodologies (NAMs) in the drug development paradigm.
Human Research Ethics Committees (HRECs) oversee First-In-Human (FIH) trials and are responsible for ensuring both the ethical acceptability and the scientific integrity of human research. HRECs also need to remain aware of regulatory changes driving innovation in the nonclinical development of new medicines. This workshop will provide participants with initial skills in examining NAMs as supportive methods for FIH clinical studies.
