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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.
This course is a part of
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.”
Course content
This course introduces the concept of regulatory science as the foundation of both regulatory and legislative decisions.
At this course, you will be presented with fundamental scientific investigations that challenge your perception and incentive to use new tools and standards to evaluate the efficacy, safety, quality and performance of medical products.
You will be taught how to evaluate the performance of drug regulations and regulatory instruments, the gaps of the tools and how to choose tools and methods that support regulatory decision-making.
Teaching includes lectures, case-studies, oral presentations and group discussions. Participants are trained to critically reflect on pharmaceutical legislation and guidelines, which are critical to ensure a quality-based storyline.
Course director on Drug Regulatory Science
Course details for Drug Regulatory Science
Dates and examination
Course dates
Expected to be offered next time in Spring 2026.
The course is available every second year.
Examination
Please find the exam dates in the exam plan.
You can find further information about the course and the exam in the course curriculum.
See an overview of all courses on Master of Medicines Regulatory Affairs.
Learning outcomes
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.
Admission criteria
Regulatory affairs specialists striving to innovate and strengthen the regulatory process
The course is intended for regulatory affairs specialists employed in industry, regulatory agencies or consulting.
You must meet the following criteria to be admitted to this course:
- Hold a relevant bachelor degree or equivalent
- Have a minimum 2 years of relevant job experience
- Be proficient in English
Find detailed information in the admission criteria on Master of Medicines Regulatory Affairs.
You will receive a response to your application at the earliest on 1 May and no later than 2 weeks after the application deadline.
Priority is given to enrolled students
This course is offered as a compulsory course in the Master of Medicines Regulatory Affairs programme. Priority is given to students already enrolled. Once the enrolled students have been admitted to the course, the remaining seats are distributed on a first-come, first-served basis.
Place
University of Copenhagen
Department of Pharmacy/
Department of Drug Design and Pharmacology
Universitetsparken 2
2100 Copenhagen
Denmark
Contact
Annette Villumsen
Study Administration Officer
Tel.: +45 35 33 60 66