| The Course of Studies entitled "Drug Regulatory Affairs" at the Faculty of Mathematics and Natural Sciences of the Rhenisch Friedrich Wilhelm University in Bonn (see also the homepage of the University of Bonn) is a postgraduate course of studies as defined in Clause 90 of the Act on Tertiary Educational Institutions. It has been designed as an interdisciplinary course covering areas of pharmaceutical sciences, law and medicine. This selective, practical postgraduate course of studies is intended to impart knowledge about the chemical, pharmaceutical, pharmacological, toxicological and clinical content of regulatory documentation and its evaluation. The aim is also to provide information on IT, drug development, quality assurance and quality management, pharmaceutical law in Europe and important areas outside Europe, and on regulatory strategies.
The course of studies takes twelve months, including the practical work. This is equivalent to two semesters. The theoretical part of the course is taught in twelve modules of 20 to 30 hours each for a total attendance time of 345 hours. The modules are spread across two semesters. The classes will be taught in German or English, depending on their content. Students are also required to complete six-month period of practical training in the field of Drug Regulatory Affairs.
Candidates passing the examination will be awarded a Certificate of Master of Drug Regulatory Affairs by the Faculty of Mathematics and Natural Sciences.
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