Master of Drug Regulatory Affairs
The "Master of Drug Regulatory Affairs" (MDRA) course at the Faculty of Mathematics and Natural Sciences at the Rheinische Friedrich-Wilhelms-Universität Bonn is an advanced master’s course offered in cooperation with the German Society for Regulatory Affairs (DGRA).
It is interdisciplinary between the pharmaceutical sciences, law and medical sciences. Through targeted, practical postgraduate training, knowledge is to be imparted about chemical, pharmaceutical, pharmacological, toxicological and clinical content of approval documentation and its assessment as well as about information systems, drug development, quality assurance and management, pharmaceutical law in Europe and in important areas outside Europe as well about approval strategies.
The study period, including the internship, is 24 months, corresponding to 4 semesters. The theory of the course is taught in 12 modules, each lasting around 20 to 30 hours with a total attendance time of around 345 hours. The modules are spread over two semesters. The courses are held in German or English depending on the course content. An internship with a total duration of six months in the "Drug Regulatory Affairs" department must be completed during the course .
The scientific training concludes with a master's thesis (written examination paper). This has to be written in a processing time of a maximum of six months and usually in English.
After passing the exam, the Faculty of Mathematics and Natural Sciences issues a "Master of Drug Regulatory Affairs" certificate.
Web links
- Information from the University of Bonn on the course
- Chair of Drug Regulatory Affairs, University of Bonn
- Information from the German Society for Regulatory Affairs on the course
Individual evidence
- ^ Information from the German Society for Regulatory Affairs on the course
- ↑ University of Bonn ( Memento of the original from July 22, 2012 in the Internet Archive ) Info: The archive link was automatically inserted and not yet checked. Please check the original and archive link according to the instructions and then remove this notice.
- ↑ Examination regulations for the advanced master's program in Drug Regulatory Affairs of the Faculty of Mathematics and Natural Sciences at the Rheinische Friedrich-Wilhelms-Universität Bonn (PDF; 176 kB)
