7 November 2024

Drug Regulatory Science

Direct your company towards a more robust decision-making process based on scientific evidence as well as administrative and legal aspects of regulation.


Regulation of medicines should be based on reliable science. With Regulatory Science we study both intentional as well as unintentional effects of drug regulation, regulatory instruments and regulatory decision-making, on drug development and innovation and on public health. Per Sindahl, PhD fellow at Copenhagen Centre of Regulatory Science, has an interesting take on that:

 “As we demand that medicines are effective, this should also be the case for the system overseeing medicines. In other words, the regulation of medicines must contribute to the patients’ safety, and we should know to what extent it does.”









The scientific approach enables you to challenge current concepts of benefit/risk assessment. You will get skills to facilitate a sound and transparent regulatory decision-making and rethink your approval strategies based on clinical relevance and scientific legitimacy.

































Course details

Duration: 3 days on campus
Dates: Expected to be offered next time in autumn 2024
Frequency: Only available every second year
Place: University of Copenhagen, Copenhagen, Denmark
Course fee: EU/EEA citizens
Master student: 10,000 DKK
Single course participant: 12,000 DKK

Non-EU/EEA citizens
Master student: 11,500 DKK
Single course participant: 13,500 DKK

The fee includes lunch/coffee.
Payment conditions

Level and credit: Master course; 3 ECTS
Examination date: See the exam schedule
Application deadline: 8 weeks prior to course start
Admission: To be admitted, you must meet the admission criteria for Master of Medicines Regulatory Affairs

Course dates and application deadlines are announced via the programme newsletter.

Download course curriculum