Drug Regulatory Affairs

The pharmaceutical industry is subject to strict supervision by both national and international authorities that regulate the development, production, approval and distribution of drugs and medicinal products on the basis of laws, guidelines and recommendations. The complexity and diversity of “regulatory affairs“ has steadily increased in the daily operations of pharmaceutical companies due to their need to adapt to EU-wide laws, advancing globalization and the development of new markets, among others.

The master's degree program for continuing education in Drug Regulatory Affairs is offered by the University of Bonn in conjunction with the German Society for Drug Regulatory Affairs (Deutsche Gesellschaft für Drug Regulatory Affairs e.V., DGRA). This degree program is interdisciplinary, spanning the fields of pharmacy, law and medicine. It is aimed at university graduates with at least two years of relevant work experience who seek to gain additional, academically well-grounded qualifications to fill a demanding position in a regulatory affairs department or related area.

Possible lines of work:

Pharmaceutical industry, national and international pharmaceutical oversight authorities involved in approval processes, German federal authorities under the Federal Ministry of Health, centers for clinical studies, contract research institutions, consulting firms, law firms, ethics commissions, trade associations, specialized companies, academia (teaching/research at universities, research institutions, etc.)

Tuition: €8,000 total

Master’s degree programs for continuing education are subject to tuition. The amount of tuition depends on the range of courses offered in the particular degree program and is based the program’s scale of charges.