Drug Regulatory Affairs (MSc, 3 Semesters) – Distance Learning

The program is an international master’s program on the regulation of medicinal products, biological and biotechnological products as well as on the regulation of other health care products i.e medical devices and herbal medicinal products.

The programme targets individuals involved in the regulatory and legislative areas of the pharmaceutical industry, as well as employees in healthcare and biotech companies or in regulatory bodies. Candidates will gain a comprehensive and detailed knowledge of the procedures related to the application, registration and approval of drugs and biological and biotechnological products that will qualify them to specialize in the entire process of drug registration from the initial stages of discovery to final approval and to the post-marketing surveillance. Programme participants will thus be qualified to advise and involve professional groups in the development process surrounding the regulatory and statutory requirements governing drug registration, potentially shortening the length of time it takes for companies to obtain a marketing approval and managing the drug on the international market. Also, the programme offers the opportunity for continuing professional development of persons already employed in this field at the junior level.