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

[3–0, 3 cr.]

This course provides students 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. The office of regulatory affairs liaises at the interphase of drug development, manufacturing, marketing, medical, market access and clinical research and is the key interface between the company and the national, regional or international regulatory authorities. The course includes an extended review on regulatory expertise on international, regional and local levels, including practical cases in quality assurance, manufacturing, quality control, pharmacovigilance, clinical research, marketing and post-marketing surveillance.