COURSE CURRICULUM

In Year 1, students acquire comprehensive knowledge of the scientific, regulatory, and managerial foundations of pharmaceutical research and development. Core subjects include Basic Principles of Industrial Pharmaceutical Manufacturing and Drug Development Theory, which introduce the structure and stages of medicinal product development. Quality Assurance and Quality Management Skills (GxP) focus on internationally recognized standards governing pharmaceutical activities. Principles of Pharmacology, Toxicology, and Biopharmacy provide essential scientific background, while Theory and Principles of Pharmacovigilance address drug safety monitoring. Students also study Pharmaceutical Management, Sales and Marketing, and Basic Health Economics to understand market access and commercialization. Database Management, Biostatistics, and Pharmacometrics develop analytical competencies, complemented by General Legal Education and Health Law. Further subjects include Bioethics and Research Ethics, Preclinical Studies, Clinical Studies, Clinical Trial Authorization from legal and ethical perspectives, Drug Registration, Pharmacovigilance, and Project Management.In Year 2, the curriculum advances toward specialized and applied competencies. Modules such as Preclinical Studies II, Clinical Studies II and III, and Drug Registration II deepen professional expertise. Students explore Clinical Studies and Registration of Medical Devices, as well as Food and Cosmetics Regulatory Knowledge. Pharmacovigilance II and Project Management II and III strengthen operational and leadership skills. Additional subjects include Data Management, Closure and Archiving of Clinical Trials, Communication in Healthcare, Leadership Styles and Skills, Presentation and Publication Skills, and Business Communication, preparing graduates for managerial roles in an international pharmaceutical environment.