PHA730 Regulatory Affairs (including Pharmaceutical, Biotechnology and Device Industries)

[3–0, 3 cr.]

This course provides foundational knowledge of pharmaceutical, biotechnological and medical device industries, cosmetics and food supplements, and the position and duties of the office of Regulatory Affairs an integral part of the organizational structure of these companies. This officeliaises at the interphase of drug development, manufacturing, marketing and clinical research and is the key interface between the company and the national, regional or international regulatory authorities. The course includes company organization and commercialization activities, e.g., drug discovery, chemical synthesis, product development, quality assurance, manufacturing, quality control and pharmacovigilance, clinical research, marketing and post-marketing surveillance.