Master of Medicines Regulatory Affairs


Programme Description

Learn how to facilitate sound and transparent regulatory decision-making

Master of Medicines Regulatory Affairs is a continuing education programme targeted at professionals in the pharmaceutical industry. Admission requires a minimum of two years of relevant work experience.

Experts within regulatory affairs are essential for companies facing an increasingly complex approval process for bringing new products to market. As a Master of Medicines Regulatory Affairs, you can help secure your company a safe, coherent and successful regulatory process.

The scientific approach of this master’s programme enables you to argue for clinical relevance and scientific legitimacy to ensure a strong, reliable and quality-based storyline.

Programme Structure

Part-time study for full-time employees

The 60 ECTS credits master’s programme (equivalent to 1 year of full-time study) is designed to be completed within 2 to 6 years of part-time study. Full-time study is not an option, as many courses are only available every second year.

All courses are designed with a minimum of classroom attendance, in order to fit the busy schedule of regulatory affairs specialist. All courses are lectured in Copenhagen, Denmark.

Programme layout

Sign up for individual courses or enrol in the full programme

The Master’s programme consists of compulsory courses (34 ECTS), fixed elective courses (4 ECTS), elective courses (10 ECTS) and a master's project (12 ECTS).

Compulsory courses 34 ECTS
Clinical Development and Documentation* 4 ECTS
Drug Regulatory Science 3 ECTS
Discovery and Development of Medicines 5 ECTS
Global Pharmaceutical Policy - Rationales and Stakeholders 4 ECTS
The EU Regulatory Environment - Procedures and Applications* 4 ECTS
The US Regulatory Environment* 4 ECTS
Transparency and Trustworthiness in Drug Development 3 ECTS
Safety of Medicines - From Non-clinical Development to Pharmacovigilance 4 ECTS
Labeling as a Driver for Regulatory Strategy 3 ECTS
Fixed elective courses (choose 1) 4 ECTS
Quality - Drug Substance and Drug Products* 4 ECTS
Biopharmaceuticals - Quality Development and Documentation* 4 ECTS
Elective courses (preapproved) 10 ECTS
Market Access for Pharmaceutical Products 3 ECTS
Quality by Design (QbD) in Pharmaceutical Development 3 ECTS
Biopharmaceuticals Drug Development 3 ECTS
Value-Based Health Care - the future for the health care sector? 3 ECTS
Master’s project 12 ECTS

*Offered in a collaboration with Atrium, a private course provider established by the Danish Association of the Pharmaceutical Industry.


Master of Medicines Regulatory Affairs is developed in collaboration with Atrium, which is a private course provider established by the Danish Association of the Pharmaceutical Industry. Atrium contributes with 5 practice-based courses.

Learning Outcome

The programme provides you with a mix of practice-based competencies, in-depth scientific knowledge, and effective negotiation skills.

A comprehensive understanding of the regulatory process enables you to take a more strategic and tactic approach. This way, you can ensure innovation progress, maintain product safety, and yet obtain a sound and speedy marketing authorization.

Enroll in the master’s programme and:

  • Achieve a thorough insight into the regulatory process at all stages during drug development;
  • Become competent in analyzing, predicting and advising on drug regulations and directives;
  • Learn to critically examine legislation in regulatory science;
  • Get an overview of the differences in regulatory demands globally;
  • Understand how to organise the regulatory work across the classic safety, clinical and quality disciplines to prevent delays in the innovation process.

Tuition fee

  • Enrolment fee: DKK 10,000
  • Course fees: From DKK 10,000 to 28,000
  • Full programme: From DKK 240,000

The cost for the full programme vary according to your enrolment status, choice of elective course and citizenship (see below).

The tuition fee is differentiated, but still fixed – negotiation is not an option

The Danish Government pays a Ministry subsidy for EU/EEA students, whereas all other students must pay the full course price.

  • Full course price: all non-EU/EEA citizens (actual costs)
  • Reduced course price: all EU/EEA citizens (costs partly covered through a Ministry subsidy)

All courses are provided at a lower cost for students enrolled in Master of Medicines Regulatory Affairs than for single course students, typically DKK 2,000 per course.

The University of Copenhagen does not offer tuition remission or scholarships

The University of Copenhagen does not offer any grants or scholarships. Nor can we answer inquiries regarding funding.

Admission and application

Admission criteria for individual courses or the full programme

The same admission criteria apply, whether you wish to follow individual courses or the full programme.

  • Relevant bachelor’s degree or equivalent
  • At least two years of relevant work experience within regulatory affairs or equivalent
  • Meet the language requirements stated at the programme website

Application process

Fill out the application form via the Master’s programme website,, and remember the required documentation.

If applying for individual courses, please use the link on the individual course pages. Application deadline for typically 8 weeks prior to the first day of lecture.

The programme has rolling admission, so applications are evaluated as they come in.

Residence permits and visas

Students from non-EU/EEA countries must obtain a visa before entering Denmark. Visa requirements to enter the country vary, so you must consult the Danish embassy or consulate in your area.

Admission to a part-time study programme does not warrant a residence permit as a student. For further information, please contact the Danish Immigration Service.

  • TYPE: Continuing Professional Development
  • PLACE: University of Copenhagen, Denmark
  • DURATION: 2-6 years part-time study
  • LANGUAGE: English
  • PARTICIPANTS: Regulatory affairs specialist employed in industry, regulatory agencies or consulting
  • ADMISSION: Continually admission for individual courses and the full programme

Duration and price

Start date: Open enrolment

Duration: 2 – 6 years part-time

Price: From DKK 10,000 to DKK 28,000 per course. From DKK 250,000 to DKK 290,000 for the full programme.

Deadline: The programme has a rolling admission and application are processed as they come in.

Last updated May 2019

About the School

Driven by intellectual creativity and critical thinking since 1479, researchers and students at the University of Copenhagen have expanded horizons and contributed to moving the world forward. With it ... Read More

Driven by intellectual creativity and critical thinking since 1479, researchers and students at the University of Copenhagen have expanded horizons and contributed to moving the world forward. With its 5,000 researchers and 39,000 students, the University boasts an international research and study environment and is highly ranked on the leading ranking lists of the world's best universities. Read Less