Programme structure – University of Copenhagen

Programme Structure

The Master of Medicines Regulatory Affairs programme is a part-time programme equivalent to 1 year of full-time study. The continuing professional development programme can be taken over a period of 2 to 6 years. It consists of 8 compulsory courses, 1 fixed elective course, a number of elective courses (10 ECTS) and a Master's project.

NOTE: It is possible to participate in a single course as a freelance student.

All courses are intensive three-day to two-week modules. This structure makes it possible for international participants to follow the programme. Participants are expected to prepare extensively for each course and an exam is held after each course.

Compulsory courses (34 ECTS) ECTS
Clinical Development and Documentation 4
Discovery and Development of Medicines 5
Transparency and Trustworthiness in Drug Development 3
Global Pharmaceutical Policy - Rationales and Stakeholders 4
Drug Regulatory Science 3
The EU Regulatory Environment - Procedures and Applications 4
The US Regulatory Environment 4
Safety of Medicines - from Non-clinical Development to Pharmacovigilance

4

Labelling as a Driver for Regulatory Strategy

3

Fixed Electives (4 ECTS) Choose one ECTS
Quality – Drug Substance and Drug Products 4
Biopharmaceuticals – Quality Development and Documentation 4
Electives (10 ECTS)
Master's project (12 ECTS) 

Compulsory courses

The 8 compulsory courses gives the student thorough insight into regulatory affairs and competences to create a smoother regulatory affairs process. 4 of these courses are offered in collaboration with Atrium, formerly known as Medicademy.

Fixed elective courses

During the fixed elective study unit, students must choose one course out of two possible courses. The student can choose between the courses Quality - active substance and medicinal product and Biopharmaceuticals - quality development and documentation.

If a student wish to follow both courses, it is possible to take the second course as an elective course.

Elective courses

Students identify relevant elective study courses of a total of 10 ECTS that support the participant's personal study profile. The Elective courses must be approved by the Board of Studies.

Master's project

The master's project completes the master's programme. It is a practice-oriented research project on an elective topic which allows students to apply the acquired skills and knowledge to a case from an organisation or company. The project is usually supervised by a university lecturer and a supervisor from the student's workplace.