Master's Course "Drug Regulatory Affairs"
Frequently Asked Questions about the Master's Course "Drug Regulatory Affairs"
Do all students receive the academic degree if they have paid the tuition fees?
No;according to the Examination Regulations all examinations must have been passed. However, with the exception of the Master’s thesis, two additional attempts may be made at all examinations. Only one more attempt is possible for the Master’s thesis. If a student drops out or does not pass the last possible examination, he/she will receive a confirmation of participation in the modules attended – with marks on request.
How high is the drop-out rate?
After the first 14 courses the drop-out rate is an average of 5%. We are proud of this low figure. Half of the drop-outs failed to complete “only” their Master’s thesis. Other reasons were illness, change in job, or similar.
I would like to distribute the modules over several years. What would be the best way to do this?
This depends on your individual situation. You can
a) take the modules which are the important to you in the first year according to your own interests and corporate requirements; or
b) attend the modules alternately (e.g. in the first year the uneven numbers and in the second year the even numbers). This would be the best solution for a good life/work balance because you are required to produce course work (=homework) after each module within three to four weeks of having attended a module; or
c) you decide under consideration of the examinations whether to attend the modules with additional examinations (written or oral examination, modules [2, 3, 5] and [ 8, 9, 10]) in the first or second year.
How old are the participants?
We have a relatively large age range amongst the participants. Some students are below 30 whilst a few are over 50. Most are in their mid 30s to early/mid 40s.
Do both men and women study this subject?
We tend to have more women than men in our experience, but gender has no influence on the awarding of a place or success in the course.
How many students spread the modules over several years?
In recent years between 25 and 50% of the students.
Why do students spread the modules over several years?
This can have several reasons. Some companies do not permit their employees to take 23 days and two Thursdays a year as holiday.
Some participants do not wish to burden their partners or family with the frequent periods spent away from home/learning periods within a year.
Some do not wish to cope with the work load alongside a full time job.
I haven’t had any experience in Regulatory Affairs so far. Can I attend the course nevertheless?
Yes, but please expect the preparation and home work to usually take more time than would be necessary for students working in marketing authorisation every day and who can put theory into working practice.
How quickly can I achieve the academic degree?
The standard period of study is 3 years. According to the Examination Regulations, the course must be completed within 4 years. However, for reasons of the Examination Regulations you will not be able to complete the course in less than in 1.5 years. You attend the modules from September to August and only then can you commence your Master’s these (4 months) or the placement (6 months).
For students with more than three years of pertinent professional full-time experience, the possibility exists to have this time credited as placement before the start of the course. This shortens the period of study accordingly.
Do I need to attend all 12 modules?
Yes, if you wish to obtain the academic degree M.D.R.A.
Can I also attend only individual modules?
Yes, the application documents are the same for everyone. You simply cross “individual module“ in the application form and enter the desired module(s).The criteria for admission also apply to these participants, but they do not need to demonstrate the requisite professional experience.
Will I automatically be given a place?
No; this will depend on whether you satisfy the criteria for admission AND how many applicants there are.
How many places are awarded annually?
The number of participants is approximately 60. Since a certain number of places are already taken by students from the previous year spreading the modules, we can only award around 45-50 places per year.
Is the course recognised?
The course has been accredited since 2011, i.e. credit points you acquire here can be credited in other courses and vice-versa.
Students and graduates also report that the mention of participation in the course opened the path to a job interview, not only in Germany but also in the neighbouring countries.
Assessment of foreign degree certificates
If you would like to know how your foreign degree certificate is assessed in Germany, the anabin database operated by the Secretariat of the Ständige Konferenz der Kultusminister der Länder in the Federal Republic of Germany will assist.
If you receive a positive assessment, then please enclose this with your application to our course.
Do events also take place online or in other cities?
We do not offer any courses online. However, the lecture documents are provided as PDF files in the intranet. Our part-time course is conducted in classes in Bonn. This gives you the opportunity to network with your fellow students and also to get to know the lecturers personally.
Which tuition fees can I expect during the course?
The tuition fee is € 8,000. This covers the cost for all lectures, exercises, examinations and catering during the modules. For those students spreading the modules, a semester fee of € 100 per semester is payable in addition starting from the 5th semester.
You should also expect a further € 6,000 - 8,000 for travel and accomodation in Bonn. Please check the figures yourself!
Do I have to attend all 12 modules in one year?
No; you can also distribute the 23 weekends over 2 or 3 years. However, you must state the distribution of the modules in your application for our administrative planning. This will have no influence on admission to the course.
Do I have to do the Master’s thesis or the placement after the modules?
This is your decision. If you have an idea for the Master’s thesis during the module phase, you can reserve the subject four months before application.
If you have onlya temporary job which we can recognise as placement and it is not certain that you will then obtain a job in marketing authorisation, you should start with the placement.
Do I have to do my placement in one place?
No; you can also divide the placement, e.g. also before and after the Master’s thesis. At least three months should be spent in the pharmaceutical industry.
Does it make sense to start a placement or a job in Regulatory Affairs although I have not yet completed the module phase, i.e. this time cannot be recognised as placement in accordance with the Examination Regulations?
Definitely YES. Daily practice provides a further insight into the subject.
What is the typical type of work in Regulatory Affairs?
You will find information on this in our information sheets "Anforderungsprofil für ein behördliches Praktikum" and "Anforderungsprofil für ein industrielles Praktikum":
What costs can I expect for the course?
The tuition fee is € 8,000. This covers the cost for all lectures, exercises, examinations and catering during the modules. For those students spreading the modules a semester fee of € 100 per semester is payable in addition starting from the 5th semester.
You should also expect a further € 6,000-8,000 for travel and accommodation in Bonn. Please check the figures yourself!
Where can I stay in Bonn?
We will send you a list of hotels when you are accepted for the course. An overview of all hotels can also be found here. However, you are responsible for the planning and reservation of arrival and accommodation.
What are the lecture and break times?
A list of the lecture and break times can be found here.
Are the students insured against accidents during the internship of the University of Bonn?
The University of Bonn does not provide accident insurance coverage during the compulsory internship. The reason is that in internships the University has no direct influence on the way of implementation and the running of the trainee. The students are involved into the companys operation procedure. The internship company is responsable for the accident insurance.