SMRMIFS01U  Master's project

Volume 2017/2018
Education

Master of Medicines Regulatory Affairs

Content

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).

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.

Learning Outcome

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

Individually supervised project work.
Credit
12 ECTS
Type of assessment
Written assignment
Oral defence, 1 hour
Written report of 20-28 pages handed in according to the masters project agreement
Oral defence consiting of 20 minutes presentation and subsequent disussion.
Aid
All aids allowed
Marking scale
7-point grading scale
Censorship form
External censorship
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

  • Category
  • Hours
  • Project work
  • 304
  • Guidance
  • 15
  • Exam
  • 2
  • Exam Preparation
  • 15
  • Total
  • 336