COURSE CURRICULUM

The MSc in Regulatory Affairs covers a comprehensive range of subjects designed to develop expertise in all aspects of pharmaceutical, biologics, and medical device regulation. Students will study Lifecycle Management, Vigilance, Surveillance and Risk Management, which focuses on ensuring the ongoing safety, efficacy, and compliance of products throughout their market life. The Pharmaceutical Technology Regulatory Affairs module equips learners with the knowledge and skills to navigate complex regulatory frameworks and implement effective strategies for product approval and maintenance. Non-Clinical and Clinical Evaluation of Pharmaceutical Technologies provides a detailed understanding of preclinical and clinical testing requirements, enabling students to critically assess data for regulatory submission and decision-making. Principles of Discovery of Medicines and Development Planning introduces learners to the full drug development pipeline, including discovery, design, testing, and regulatory planning. Research Methods and Technical Report Writing develop critical analytical and communication skills essential for producing high-quality regulatory documentation, including technical reports, submissions, and dossiers. Special Populations and Biologicals and Advanced Therapies focus on the regulatory requirements for vulnerable populations and advanced biologic therapies, ensuring that graduates are equipped to manage complex, emerging technologies in line with global standards. A key component of the program is the Dissertation, which allows learners to undertake an independent research project, often in collaboration with industry, to apply their knowledge in real-world contexts. Special features of this MSc include opportunities to expand professional responsibilities, gain access to leadership roles within regulatory affairs, and build a strong professional network. Students benefit from interaction with other regulatory professionals and industry experts, enhancing their practical understanding of the sector while fostering connections that support career development. The combination of theoretical learning, practical application, and industry engagement ensures that graduates are highly competent, strategically aware, and well-prepared to contribute to regulatory compliance, innovation, and leadership in the global pharmaceutical and medical device industries.