Master of Medicines Regulatory Affairs

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 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.

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.

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.