Independent Elective Study

Course content

An independent research or review project of varying duration (2.5 or 5 ECTS credits).

Students can design their elective study together with a supervisor from the Faculty of Health and Medical Sciences or choose one of the preapproved combinations.

 

Self designed course

The student select a specific topic together with an supervisor. The supervisor must approve 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 conference activities
  • based on a course taken elsewhere

 

Preapproved course

The Study Board has pre-approved the following combinations, which are weighted at 5 ECTS credits and have two parts:

Part one: Participation in one of the pre-approved courses at Medicademy:

  • Module 4: The Regulatory Affairs Environment in Japan
  • Module 5: Regulatory Strategic Considerations during Global Drug Development
  • Module 9: Product Life Cycle Activities
  • Module 11: Roles and Responsibilities of a Regulatory Affairs Professional - based on Good Regulatory Practice
  • Module 12: Medical Devices - Drug/Device Combinations
  • Module 13: The Regulatory Environment in Major Markets Outside the ICH – How to optimize your Regulatory Strategy dealing with the BRIC Countries
  • Module 14: Veterinary Regulatory Affairs in the EU
  • Module 15: The Regulatory Affairs Environment for Generic Products in the EU

Part two: Preparing a written report under supervision at the University of Copenhagen. The report must be between 10-max 15 standard pages.

Education

Elective for Master of Medicines Regulatory Affairs

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

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 must be part of the study schedule for the elective part of the master’s programme.

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). Student enrolled in the Master of Medicines Regulatory Affairs can participate in Indpendent Elective studies of a maximum of 5 ECTS.

Individual
Continuous feedback during the course of the semester
Feedback by final exam (In addition to the grade)
ECTS
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.
Aid
All aids allowed
Marking scale
passed/not passed
Censorship form
No external censorship
Course Teacher(s) without external examiner
Criteria for exam assessment

To pass 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

Part time Master and Diploma courses

  • Category
  • Hours
  • Project work
  • 70
  • English
  • 70