Master of Medicines Regulatory Affairs
Innovate and strengthen the regulatory process
Who is it for?
The Master of Medicines Regulatory Affairs is continuing professional development for professionals in the pharmaceutical industry.
The Master’s programme targets working professionals from the regulatory and legislative fields as well as employees in healthcare and biotech companies or in regulatory bodies.
Key benefits
This programme provides you with a comprehensive understanding of the regulatory process at all stages during drug development:
- Analyse, use, and advise on drug regulations and directives
- Understand and develop collaboration across various specialist fields
- Organise the regulatory work to optimise the processes towards authorisation
In addition, you will build a strong network with fellow students and lecturers from the life science industry.
Overview
One of the reasons I chose the programme is that it allows me to continue my regular work during my studies, and I can take it at my own pace.
Structure
Part-time study for working professionals
The Master of Medicines Regulatory Affairs is designed to fit into the busy schedule of working professionals. All courses are organised as short, intensive in-person courses and we announce all course dates well in advance.
You can enroll in one course, multiple courses, or the entire programme, depending on your needs and availability. If you opt to take a single course, you are welcome to return and pursue additional courses or the entire programme later.
The master's programme can be completed with part-time study in 2-6 years.
Flexible study
The programme is flexible and allows you to organise the courses in the order and pace that suits you best. It comprises a total of 60 ECTS credits. Each ECTS credit is equivalent to 27.5 hours of study, which includes preparation, course activity and exam.
| Compulsory courses | 34 ECTS |
|---|---|
| Discovery and Development of Medicines | 5 ECTS |
| Clinical Development and Documentation | 4 ECTS |
| Drug Regulatory Science | 3 ECTS |
| Global Pharmaceutical Policy – Rationales and Stakeholders | 2.5 ECTS |
| Labelling as a Driver for Regulatory Strategy | 3 ECTS |
| Safety of Medicines - from Non-clinical Development to Pharmacovigilance | 5 ECTS |
| The EU Regulatory Environment – Procedures and Applications | 2.5 ECTS |
| The US Regulatory Environment | 2.5 ECTS |
| Transparency and Trustworthiness in Drug Development | 2.5 ECTS |
| Fixed elective courses - choose one course | 4 ECTS |
| Quality - Drug Substance and Drug Product | 4 ECTS |
| Biopharmaceuticals - Quality Development and Documentation (4 ECTS) | 4 ECTS |
| Elective courses | 10 ECTS |
| Choose from a selection of courses. | 12-20 ECTS |
| Master's project | 12-20 ECTS |
| Complete the programme with Master's project. | 12-20 ECTS |
Bridging the gap between practice-based knowledge and the latest research
We prioritise bridging the gap between practice-based knowledge and experiences, and the latest research in interdisciplinary regulatory science by joining leading experts from the Life Science industry and university researchers.
By attending the Master of Medicines Regulatory Affairs you will have the opportunity to build networks with both lecturers and fellow students. This is an important advantage that can support your career development opportunities in the Life Science industry.
Examination schedules
View exam and re-exam details by clicking the link below.
Courses
Compulsory courses
To apply and view the full description and details, please click on the course.
Elective Courses
Click on the link below to view the elective courses.
Teaching staff
The teaching staff comprises leading researchers from the university and world-class experts from the life science industry. This collaboration enables an outstanding combination of research-based and close-to-practice teaching, fostering an easier transfer of knowledge and skills into work situations.
You can find more information about the teaching staff under each course description.
Head of studies
Partners
Atrium
The Master of Medicines Regulatory Affairs is a co-creation between the University of Copenhagen and Atrium.
Atrium is an international educational academy established in 1972. As an independent part of the Danish Association of the Pharmaceutical Industries, Atrium has a close connection to the experts in the pharmaceutical industry and medicines agencies. Atrium is one of Europe’s leading private course providers of practice-based courses in regulatory affairs.
Through a close collaboration with leading experts in the pharmaceutical industry, Atrium ensures high quality research, academic level, and world class professors.
A total of 5 courses at the Master of Medicines Regulatory Affairs are offered in collaboration with Atrium – 3 compulsory courses and the 2 fixed elective courses.
Copenhagen Centre for Regulatory Science
CORS aims at being one of Europe’s leading centres for research and education in Regulatory Science. Their objective is to participate in building the regulatory framework that will make innovative medicinal products available to patients.
CORS was established to meet the University of Copenhagen’s strategic commitment to become internationally influential in the field of research and education in regulatory science.
This strategic centre contributes to the Master of Medicines Regulatory Affairs through interdisciplinary research in regulatory science.
The mission of CORS is to improve the drug regulatory system and improve the health of the society and sustainable drug innovation.
I can think of many occasions during my daily regulatory affairs work where I have applied the broad knowledge from the MRA courses for problem solving.
Tuition Fees
Master's programme:
EU, EEA or Swiss citizens: From 235.341 DKK.
Non-EU, non-EEA, or non-Swiss citizens: From 271.891 DKK.
The total programme tuition fee varies based on your selected elective courses. The fees for individual courses are listed in the course presentation.
Citizens from the EU, EEA, and Switzerland are eligible for reduced tuition fees according to EU legislation, which explains the disparity in the tuition fees.
Tuition fees are charged per course. You can plan the sequence and the pace of your courses to suit you, and we will invoice you accordingly.
Funding
The University of Copenhagen does not offer grants or scholarships for the Master of Medicines Regulatory Affairs.
Gross Salary Scheme/Bruttolønsordning
You might consider financing parts of your tuition fees through the Gross Salary Scheme. A gross salary scheme is a tax advantage that allows you to include the tuition fee expense as part of your gross salary. In essence, the tuition fee will be deducted from your salary before taxes are applied.
If you are working in Denmark, you can learn more about the gross salary scheme (Bruttolønsordning) at the Danish Tax Agency:
Application period - Master's programme:
1 June 2024 - 1 november 2024.
The admission is closed for the full programme.
Submit your application from 1 June 2024.
Admission
The Master admits full programme students every year. You can apply for admission from 1 June to 1 November and studies begins in February.
Admission criteria
Qualifying degree
Applicants must hold a Bachelor's degree or, a professional Bachelor’s degree, a diploma degree, a Master’s degree in Health and Medical Sciences, Natural Sciences, Applied Sciences or equivalent.
Work experience
After completing the qualifying degree, you are required to have a minimum of two years of relevant work experience in the pharmaceutical industry, in a medicines agency or in another relevant organisation or company.
English proficiency
You must have a standard of English equivalent to level B in Danish secondary education.
Admission criteria exemption
The admissions committee may consider applicants who do not possess one of the specified qualifying degrees if the applicant is deemed to possess comparable educational qualifications. Please note that the requirement of having two years of relevant work experience will not be exempted.
Collect documentation for your application
An official certified diploma and transcript of academic records, with stamp and signature from your home university.
In case the original documents are not available in one of the following languages: Danish, Swedish, Norwegian, English, German or French, you are required to upload a certified translation with the copy of the original document.
A CV with your relevant work experiences which clearly states workplaces, specific work periods and job responsibilities.
You can document your English language proficiency in one of the following ways:
Native English language
Native English speakers from the USA, Canada, Australia, New Zealand, UK or Ireland may submit a copy of the page of their passport that has their photograph as proof.
Diploma from a Nordic university
Nordic applicants can demonstrate their English proficiency by submitting a certified copy of a high school diploma proving that they have passed English level B or by submitting a certified copy of a bachelor's or master’s diploma from a Nordic university.
Degree from an English speaking country
Applicants who have earned a bachelor’s or master’s degree from the USA, Canada, Australia, New Zealand, UK or Ireland can demonstrate their English proficiency by submitting a certified copy of their degree certificate if their degree was taught in English. A semester or year spent on a student exchange programme is not sufficient.
English working language
Applicants working in companies with English as the official working language can demonstrate their English proficiency by submitting a letter from their employer, on official headed paper, stating that their working language is English.
English language proficiency test
Applicants can demonstrate their English proficiency if they have passed a recognised English language proficiency test with an adequate score. We accept the following tests:
|
Name of test |
Minimum score |
Information required for online check of test |
|
IETLS (academic) IELTS Home Edition |
6.5 (overall test score) 6.5 (overall test score) Only overall score will be considered. |
TRF Number (Test Report Form Number) |
|
TOEFL
(MyBest Scores are not accepted) |
83 83 560 |
Registration number |
|
Cambridge Advanced (CAE) |
Passed at level C1 or C2 |
ID-number and Secret Number |
|
Cambridge Proficiency |
Passed at level C1 or C2 |
ID-number and Secret Number |
ELTS and TOEFL tests older than 2 years will not be accepted (counted from the programme application deadline). The Cambridge Assessment English may have been gained at any time.
A copy of your passport (photo page) is required for non-Danish citizens. If you are a non-EU/EEA citizen with a permanent Danish residence permit, a copy of this permit must be uploaded.
Please check whether you require a visa to enter Denmark by consulting the list from the Danish Immigration Service:
If you are admitted to the programme and require a visa, we will assist you in the application process. Please note that the visa application can only begin upon receipt of the initial tuition fee installment.
Also note, that acceptance into a part-time study programme does not entitle you to a residence permit in Denmark. For additional details, please contact the Danish Immigration Service:
Guidance and admission
Annette Villumsen
Study Administration Officer
Tel.: +45 35 33 60 66
Master of Medicines Regulatory Affairs
Continuing Professional Development
Faculty of Health and Medical Sciences
University of Copenhagen
Blegdamsvej 3B
2200 Copenhagen N - DK
Lene Jørgensen
Associate Professor and Head of Studies
Department of Pharmacy - University of Copenhagen
Lene Jørgensen is heading the study programmes of Master of Industrial Drug Development (MIND) and Master of Medicines Regulatory Affairs (MRA). She has a keen interest in pharmaceutical, development, design and production as well as regulatory aspects.
Lene has been teaching pharmacists for over 20 years. Since 2012, she has been heading the MRA programme, and since 2019, she has also been leading the MIND programme. Her aim is to integrate the best from research with practical applications in the development and registration of medicinal products. Additionally, she strives to ensure that courses and educational activities are valuable for both participants, lecturers, and course responsibles.
Elisabeth Hildebrandt-Eriksen
PhD in Neurobiology from Denmark
Elisabeth Hildebrandt-Eriksen has an M.Sc. in human biology and a PhD in neurobiology from UCPH and is employed at ALK A/S within the field of regulatory affairs mainly with responsibility for nonclinical activities, a position she has held since 2015.
What would you like to specialize in with MRA?
"With my new knowledge from MRA I can see many occasions during my daily regulatory affairs work when the broad knowledge I have acquired from the MRA courses is applied. Not every bit equally much, but all courses have a function as part of the curriculum, and I am making use of them and applying the knowledge I have gained when I need it. Some courses’ themes have a natural overlap with topics learned during previous education(s). That may be nice as a repetition or a bit in excess. I guess it can never be avoided altogether in a curriculum which fathoms many different job backgrounds."
What made you choose a Master in the first place? And how did you learn about the programme?
“To me, learning new skills is fun - especially in a structured and well-planned way and not only ‘ad hoc’ problem solving because a sudden situation at work requires you to know something about xyz ‘by yesterday’.
Also, the satisfaction of pulling something through as intended and getting the acknowledgement with a degree. That is nice – especially since I hopefully will get there after the summer holiday, when I have written and defended my thesis.”
How did you learn about the programme?
“As I started at ALK in 2015, I just surfed for continued education courses in regulatory affairs, I guess. At that time, MRA was only in the process of being planned by UCPH, and the curriculum had yet to be approved by the Ministry. I could start in 2016.
I considered Medicademy (now Atrium) for their regulatory affairs diploma line and UCPH. I liked the UCPH curriculum better because of the opportunity to write a master. There are a lot of similarities and an extensive collaboration between the two organisations, but the master thesis is absent from the diploma and so is access to the University library, a flash-back from days as a student. So, I guess UCPH is a bit ‘nerdier’, but that suits me well. I like finding information, digging into a subject and exploring solutions. For this the UCPH library is an added bonus.”
How did the study fit in with the rest of your everyday life - i.e. in relation to work and spare time?
“Sometimes well and sometimes less well. From previous courses, I had received some credit transfer – dispensation to take a couple of MRA courses. The courses otherwise exceed the ordinary annual allowance for continued education for employees at ALK. Consequently, I had in part to finance them myself to accomplish the necessary ECTS.
At some point, I asked the study board for an extension of the study period while working part-time, which was granted on the grounds that I demonstrated study activity all the time (i.e. every year). That was a big relief to me, because showing progression is one thing – I agree to that – but taking a course twice a year is sometimes not achievable - it depends on the current workload on your job, and that is not predictable.”
How do you use your new skills from the education in your work?
“I can think of many occasions during my daily regulatory affairs work where I have applied the broad knowledge from the MRA courses for problem solving. Of course I haven’t used all aspects equally, but all the courses have been useful, and I have applied the knowledge gained when I needed it.”
How would you evaluate the teachers' professionalism and communication skills?
“Most of them were very professional and concise and the courses have been very useful. The collaboration with Atrium seems essential because of the experience the teachers from the industry share. However, teaching quality, like in any institution, varies at times. The courses that were held in collaboration with Atrium have the quality of teachers originating from the industry, while UCPH is contributing with the academic angle (which often will be different from the industry’s) widening the horizon and demanding answers to other questions otherwise not posed in daily regulatory affairs work. The MRA hence offers you a view from both sides.”
Are there one or more courses you attended that you would single out? And why?
”The course CMC of biologics was an eye-opener for me in relation to the complexity of ‘building’ large molecules and the strategic implications for product development. I would also highlight the shorter courses on transparency and regulatory policy, where the knowledge gained at these courses is transformed into an essay at their end. I also heard very good things about the ‘labelling as a driver for regulatory strategy’ course, but I took the Atrium equivalent, so I cannot tell myself.”
Would you recommend the Master to others and why?
”Yes! Learning new skills is fun, especially in a structured way and not because a sudden situation in your work requires you to learn some.
I think that the Master would suit those who are eager to learn the ‘what is behind this or that’, get more information on regulatory affairs matters and its frame as a whole. Comparing with the diploma, some ‘basics’ (the course with MIND) and some ‘extras’ (ethics, regulatory policy) and of course the specialisation in the thesis, stand out. If this appeals to you and you are willing to use some of your spare time on the education, you will also have fun.”
Interview from 2024.
Moses Kasigazi
Pharmacist from Rwanda
First Graduate of Regulatory Affairs Programme to help African Governments
The first Master of Medicines Regulatory Affairs student, Moses Kasigazi, has just graduated. He intends to use his experience from the programme to advise the government and regulatory bodies in Rwanda to help improve the African medical and pharmaceutical markets.
Moses Kasigazi is a pharmacist with a Master’s degree in Global Health and Infectious Diseases. He has just this month been awarded the Master of Medicines Regulatory Affairs at the Faculty of Health and Medical Sciences because he wants to contribute to the growth of regulatory affairs and regulation of medicines in his home country, Rwanda.
“I noticed there was a general move towards strengthening regulatory affairs back home, but the country was restrained by limited resources and capacity. I chose this Master’s programme because I want to be able to help advise government and regulatory bodies in Rwanda on how to optimize regulatory affairs without compromising the outcome on access to medicines. For that, I needed a specialized education, and I found that at University of Copenhagen,” he says.
Now that he has finished the programme, he is the first Master of Regulatory Affairs from the University of Copenhagen.
Experience from different nationalities
In most of Africa, the medical market is quite different from the one we know in Denmark and Europe.
“There are just less options in Africa. Most of the markets there are price-best markets, meaning the big decisions are made based on the potential for money. But this programme teaches us that quality and outcome is also a very important part of the market access pathways. It gives me ideas on new methods and options I could suggest to my government to improve the regulatory terrain,” he says.
Being a hub for students of many different nationalities and different fields of the pharmaceutical sector, the international teaching environment at University of Copenhagen gives the students the opportunity to compare their experiences from within the field across companies and borders of their home countries.
“We get a thorough insight into what difficulties are present in different countries without having to travel there. In that way, we are presented to the issues through a lens of actual experience. We learn a lot from each other,” Moses says.
A partnership is crucial
In order to overcome some of the obstacles that are present in the African market access area, it is helpful to draw on the experiences of the lecturers, most of whom are professionals with vast experience in the areas they lecture on.
“Studying at University of Copenhagen, we are given the chance to see some of these issues from the perspective of the companies. That enables me to give better advice on market access and other regulatory affairs to the regulatory bodies back home. It gives me the tools to better advocate for quality and outcome rather than price, but keeping in mind access and affordability for patients. I am now aware, more than ever, that the whole process has to be a partnership with other stakeholders. Otherwise, it can’t be done,” Moses says.
Interview from January 2020.
Ewa Törnqvist
Regulatory Consultant from Sweden
With a background in biomedicine, Ewa Törnqvist has worked in the pharmaceutical industry for the last 16 years.
“To get a broader perspective of the industry, I took single courses in statistics, biomedical ethics and drug development, but I always wanted to get a master’s degree. I couldn’t find any programme that seemed relevant until I discovered Master of Medicines Regulatory Affairs at University of Copenhagen,” Ewa says.
Work and study at the same time with immediate benefits
Ewa is running her own consultancy firm within regulatory affairs, and wanted a program that mix well with her ambitions and workload.
“One of the reasons I chose the programme is because it allows me to continue my regular work during my studies, and I can take it in my own pace.”
Now halfway through the program, Ewa thinks she has found the perfect master’s degree.
“In daily work, I mainly focus on what is relevant at the moment. However, as a master student, I need to do extensive reads about a specific subject. It does not only give me a better understanding of the current tasks, but it also gives me a deeper knowledge” says Ewa.
A great match for learning
The programme structure of the Master of Medicines Regulatory Affairs turned out to be exactly what Ewa needed to continue to develop her skills. “The mix between the industrial perspective and the scientific view from the university is a great match, and I have gotten a broader perspective of the regulatory affairs area,” she says.
“From the industry point of view, you meet people from different areas and functions, and from the university, you meet people from all over the world. It is interesting to see how everyone has completely different perspectives and you learn so much by discussing with others. Sometimes we discuss issues that I have never even thought about and it is great to be challenged and reminded that there are different ways of viewing things.”
The combination of experienced teachers and guest lecturers, a programme of high quality, and motivated co-students leaves Ewa with a certain recommendation:
“I definitely recommend the Master of Medicines Regulatory Affairs to others. The lecturers have a high standard and broad knowledge, and the other students are very experienced. This combination creates a wide perspective, interesting discussions and a great network. It has been a really positive experience so far,” concludes Ewa.
Interview from april 2020.