SMPMA0014E 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 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).
Before commencing the master's project, the student
should sign a
master's project agreement. The master's project
agreement should be send by email to
master@sund.ku.dk.
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 to the Faculty supervisor in four
copies.
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.
- Category
- Hours
- Exam
- 1
- Guidance
- 15
- Project work
- 330
- Total
- 346
Before commencing the master's project, the student should contact a relevant Faculty supervisor to make a master's project agreement. The student must send a copy of the master's project agreement to master@sund.ku.dk.
- Credit
- 12 ECTS
- Type of assessment
- Written assignment, Approximately 6 monthsOral defence, Approximately 1 1/2 hourWritten report (25-40 pages). The oral defence (approximately 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.
- Aid
- All aids allowed
- Marking scale
- 7-point grading scale
- Censorship form
- External censorship
Criteria for exam assesment
Grade 12 is given for an excellent project showing high-level command of all aspects of the project topic, with no or only a few minor weaknesses.
Grade 7 is given for a good project displaying good command of the project topic, with some weaknesses.
Grade 02 is given for a project meeting only the minimum requirements for acceptance
Course information
- Language
- English
- Course code
- SMPMA0014E
- Credit
- 12 ECTS
- Level
- Part Time Master
- Duration
- Placement
- Autumn, Spring And Summer
- Schedule
- Placement and Schedule is established in the master's project agreement
- Continuing and further education
- Price
DKK 30,000 The fee covers supervision, evaluation of the master's project, administration, use of library facilities, etc.
- Study board
- Study Board for Part-time Master’s Programmes of Pharmaceutical Sciences
Contracting department
- Department of Pharmacy
Course responsibles
- Lene Jørgensen (lene.jorgensen@sund.ku.dk)
Lecturers
The project supervisor is also course administrator and is responsible for ensuring the academic content of the project.