SMPMA0014E Master's project
Master of Pharmaceutical Regulatory Affairs
The master's project typically comprises a literature study
on a selected topic, selection and description of relevant
regulations, guidelines literature and scientific 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.
The written master’s report on the work conducted plus the subsequent oral examination must document that the student is able:
- To plan and carry out a practice-oriented research project that can help strengthens part of pharmaceutical regulatory affairs
- To formulate a regulatory research question/hypothesis
- To write a statement of purpose
- To use relevant regulations, guidelines, theory and scientific documentations when conducting a regulatory research project and to justify the choices made
- To describe the regulatory research work conducted as well as the results achieved and conclusions in a way that is clear and understandable
- To make a critical analysis with a balanced discussion of the described regulatory research and results
- To make an oral presentation and discussion of the completed project.
- 12 ECTS
- Type of assessment
- Written assignment, Approximately 6 monthsOral defence, Approximately 1 1/2 hourWritten report (20-28 pages). The oral defence (max 1 1/2 hours) consists of an oral presentation of approximately 20-30 minutes and subsequent discussion.
- Exam registration requirements
The master’s project should complete the programme.
- All aids allowed
- Marking scale
- 7-point grading scale
- Censorship form
- External censorship
Criteria for exam assesment
Assesment will be based on the student's spelling and writing skill as well as the scientific content of the thesis. The scientific content will carry the most weight.
- Project work