SMRMIFS01U Master's project
The master's project typically comprises a literature study
on a selected topic, selection and description of relevant
regulations, guidelines literature and scientifically based
documentation, a discussion of the scientific based documentation
related to the relevant literature, regulations and guidelines and
a conclusion on the results of the project. The project topic can
be an investigation of a particular regulatory case, implementation
of a regulatory activity in a company, or a study of a particular
regulatory problem. In any event, the selected subject should be
put into the context of a broad regulatory perspective.
Project work should preferably be conducted at the student's
workplace. If that is not possible, the Study Board will help the
student with contacts to a relevant place of study. The written
report will be supervised by at least one teacher from The Faculty
of Health and Medical Sciences (Faculty supervisor) and preferably
also by an employee from the company or institution hosting the
master's project (external supervisor).
The company at which the project is conducted may require a
declaration of confidentiality by the student, supervisors and
potentially also the external examiner. In this event, the
master's project is confidential.
Master’s projects can be carried out in groups of no more than two
students. Any group work must be approved by the supervisor as a
part of the master's project agreement. If a Master’s project
is written by a group of students, the oral examination must be
individual and the student may only attend the examination of the
other students in the group if his or her examination has been
held.
Half-way through the project, the student is encouraged to make an
oral presentation (approx. 30 min.) on project status, a so-called
mid-term assessment, to the supervisors and other relevant persons.
The master's project must be written in English. The final oral
examination is usually conducted in English, but may be conducted
in Danish, if the examinee, examiner and external examiner agree.
All master’s projects must have an abstract in English (compulsary)
and may include an abstract in Danish (optional). The abstract
must be maximum one A4 page. The abstract must summarize the
research question, the methods used, important findings, a
discussion if relevant, and a conclusion. The abstract will be
included in the overall assessment of the master's project.
The cover page of the master’s project must include the title in
English, and subtitle if relevant, the student’s name, study
programme, the year, the name or names of supervisor/s, department
but not the student’s civil registration (CPR) number. The master’s
project is handed in via digital exam.
Under the supervision of a researcher the student must critically acquire knowledge about scientific method and apply such knowledge for the solution of a scientific problem of the student's own choice within the field of regulatory science.
A student who has concluded a Master’s project will be able to:
Knowledge
explain and justify relevant regulations, guidelines, theory and scientific documentations when conducting a regulatory research project and to justify the choices made
take a critical approach to the methodologies/theories applied within area of the project, based on international research relevant to the research question/hypotesis
Skills
apply, analyze and consider key scientific elements in regulatory legislation and regulatory guidelines
plan and carry out a practice-oriented research project that can help strengthening part of pharmaceutical regulatory affairs
Select and process a well-defined and clear regulatory science probleminto a written statement of purpose
formulate a regulatory research question/hypothesis
describe the results achieved and draw conclusions in a way that is clear and understandable
make an oral presentation and discussion of the completed project.
Competencies
critically discuss, assess, conclude and put into perspective own and others' research results at a high international scientific level while including relevant literature
analyse and discuss application of new methods, technologies and strategies to aid successful medicines development and regulatory review
Students must have completed all courses and passed all exams in the programme before the master project oral exam.
- Category
- Hours
- Project work
- 315
- Guidance
- 15
- Exam
- 2
- Total
- 332
You sign up for the master’s project course through the self-service. The registration deadline is June 1st for master project courses starting in the fall, and December 1st for master project courses starting in the spring.
After signing up for the master’s project course, you must submit a master’s project agreement by the specified deadline to register for the master’s project exam.
Master’s project agreement
You must have completed and approved the master’s project agreement
before you can start the master’s project. You can find the
master’s project agreement here. The master’s project agreement
must be approved by your supervisor.
- Credit
- 12 ECTS
- Type of assessment
- Written assignmentOral defence, 1 hour
- Type of assessment details
- Written report of 20-28 pages handed in according to the
masters project agreement
Oral defence (max 1 1/2 hour) consiting of 20 minutes presentation and subsequent discussion. - Aid
- All aids allowed
It is allowed to use ChatGPT and similar technologies (Large Language Models - LLM) as aids.
- Marking scale
- 7-point grading scale
- Censorship form
- External censorship
- Exam period
Exam Schedules for Medicines Regulatory Affairs – University of Copenhagen (ku.dk)
Criteria for exam assesment
To achieve the grade 12 the student should be able to:
Knowledge
explain and justify relevant regulations, guidelines, theory and scientific documentations when conducting a regulatory research project and to justify the choices made
take a critical approach to the methodologies/theories applied within area of the project, based on international research relevant to the research question/hypotesis
Skills
apply, analyze and consider key scientific elements in regulatory legislation and regulatory guidelines
plan and carry out a practice-oriented research project that can help strengthening part of pharmaceutical regulatory affairs
Select and process a well-defined and clear regulatory science probleminto a written statement of purpose
formulate a regulatory research question/hypothesis
describe the results achieved and draw conclusions in a way that is clear and understandable
make an oral presentation and discussion of the completed project.
Competencies
critically discuss, assess, conclude and put into perspective own and others' research results at a high international scientific level while including relevant literature
analyse and discuss application of new methods, technologies and strategies to aid successful medicines development and regulatory review
Course information
- Language
- English
- Course code
- SMRMIFS01U
- Credit
- 12 ECTS
- Level
- Part Time Master
- Placement
- Autumn, Spring And Summer
- Schedule
- Placement and Schedule is established in the master's project agreement
Price
Fees are published on the programme's homepage https://https://mra.ku.dk/fees/
The fee covers supervision, evaluation of the master's project, administration, use of library facilities, etc.
Study board
- Study Board for the Professionel Master´s Degree Programmes at The Faculty og Health and Medical Science
Contracting department
- Department of Pharmacy
Contracting faculty
- Faculty of Health and Medical Sciences
Course Coordinators
- Lene Jørgensen (lene.jorgensen@sund.ku.dk)