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

[3–0, 3 cr.]

The course provides foundational, knowledge of pharmaceutical, biotechnology and medical device industries and the position and duties of the office of Regulatory Affairs is an integral part of the organizational structure of the company. It liaises at the interphase of drug development, manufacturing, marketing and clinical research and is the key interface between the company and the national 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.