An introduction to drug mechanisms, pharmacokinetics and pharmacodynamics as they apply in clinical trial settings.

Covers end-to-end clinical trial management including study design, site selection, protocol adherence and regulatory compliance.

Equips students with skills to identify, evaluate and report adverse drug reactions in accordance with global regulatory requirements.

Covers data collection, validation, and management processes to ensure data integrity throughout the clinical trial lifecycle.

Develops the ability to produce clear, accurate regulatory and scientific documents including CSRs, protocols and patient-facing materials.

Provides a comprehensive understanding of global regulatory pathways for drug approval, including submissions to FDA, EMA and other health authorities.