SMRMIFI01U  Independent Elective Study

Volume 2017/2018
Education

Elective for Master of Medicines Regulatory Affairs and Master of Pharmaceutical Regulatory Affairs students

Content

The objective is to give the student an opportunity to organize and carry out an independent study motivated by academic as well as personal interests, under the guidance of a faculty member from the School of Pharmaceutical Sciences. The study may be carried out in Denmark or abroad.

An independent research or review project of varying duration (2.5 or 5 ECTS credits). The responsible supervisor and the student select a specific topic together and agree on the objective, scope and size of the project. The student provides a written account (two to three pages) of the objective, scope, size and content of the project, as well as a supplementary description of specific academic objectives. The supervisor must approve this project description before the student starts working on the project. The student must work independently guided by the supervisor. The project may be:

  • based on experimental work in a laboratory or elsewhere
  • an academic review
  • based on calculations/modulations/simulations
  • based on a course taken elsewhere

 

Students may have to sign a special agreement English version/ Danish version (see appendix to the course description English version/ Danish version) if the student is carrying out the project in connection with a research project at PharmaSchool or if the student is collaborating with an external institution or company.

 

Learning Outcome

A student who has concluded the individual project will be able to:

Knowledge

  • explain and justify relevant scientific documentation 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

  • plan and carry out a practice-oriented research project that can help strengthening part of regulatory sciences

  • Select and process a well-defined and clear  science problem into a  statement of purpose

  • formulate a research question/hypothesis

  • describe the results achieved and draw conclusions in a way that is clear and understandable

 

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/or regulatory review

The independent elective study must be part of the study schedule for the elective part of the master’s programme that the student has agreed on with his or her master’s project supervisor.
Individually supervised project work.

The student is entitled to study guidance during the project amounting to a maximum of 4 hours per 2.5 ECTS credits.
The Independent Elective Study student can be either 2.5 ECTS credits (equals approx. 70 student working hours) or 5 ECTS credit points (equals approx. 140 student working hours).
Credit
2,5 ECTS
Type of assessment
Other
Written report, poster, paper, oral examination or similar as agreed upon in the agreement signed by student and supervisor.
Exam registration requirements

No requirements

Aid
All aids allowed
Marking scale
7-point grading scale
Censorship form
No external censorship
Course Teacher(s) without external examiner
Criteria for exam assesment

To achieve the grade 12 the student should be able to:

Knowledge

  • explain and justify relevant scientific documentation 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

  • plan and carry out a practice-oriented research project that can help strengthening part of regulatory sciences

  • Select and process a well-defined and clear  science problem into a  statement of purpose

  • formulate a research question/hypothesis

  • describe the results achieved and draw conclusions in a way that is clear and understandable

 

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/or regulatory review

  • Category
  • Hours
  • Project work
  • 70
  • Total
  • 70