Preclinical & Laboratory Foundations Learning Path

The Preclinical & Laboratory Foundations Learning Path is designed to equip professionals with the essential regulatory, quality, and safety knowledge required to operate effectively in preclinical research and laboratory environments. Covering Good Laboratory Practice (GLP) under both ICH principles and FDA 21 CFR Part 58, laboratory safety, ISO/IEC 17025 accreditation, computer system validation, equipment qualification, cleaning validation, and GMP foundations, this programme provides a structured pathway from laboratory basics through to compliance readiness.

Participants will develop a thorough understanding of nonclinical study conduct, laboratory quality systems, data integrity requirements, and the validation frameworks essential for regulated laboratory environments. The programme ensures learners are prepared to support preclinical activities that feed directly into clinical development programmes, regulatory submissions, and product approval processes.

How this differs from the Phase I First-in-Human Learning Path

The Preclinical & Laboratory Foundations Learning Path focuses on the nonclinical and laboratory quality environment — covering GLP, laboratory management systems, instrument qualification, cleaning validation, and foundational GMP. It is designed for laboratory scientists, quality assurance personnel, and validation specialists operating upstream of clinical trials.

In comparison, the Phase I First-in-Human Learning Path focuses on the regulatory, ethical, and operational requirements for conducting first-in-human clinical trials — including GCP, informed consent, dose escalation design, and site-level trial management. This learning path is the essential precursor for professionals who want to understand the scientific and quality infrastructure that supports the transition from discovery to clinical development.