Master’s course: EU eRegulatory Affaris/ Regulatory Affairs Management

The pharmaceutical and medical device sectors are one of the most highly regulated in the world second only to the neuclear and aerospace industries. In order to keep abreast of current trends it is necessary for professionals working in those industires to be well aquainted with current and futrue trends and regulations. Regulatory Affairs is an emerging profession increasingly gaining in importance. This University course targets regulatory affairs professionals with about 3-5 years experience in regulatory affairs. Candidates with no prior experience but with a degree of higher education (min bachelor degree) can also benefit from this course. Participants will receive a thorough in depth training in all aspects of EU regulatory affairs covering both the pharmaceutical and medical device sectors. The course consists of 7 modules after which students can register for the EU RAC certification (Regulatory Affairs Certification) offered by the Regulatory Affairs Professionals Society (RAPS). The modules will be taught in an active manner involving classical lecturing aided by case studies, mock exams and lively discussions.