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 e.g. the preapproved courses below.
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 Atrium (title subject to changes):
- Module 5: Global Regulatory Strategies
- Module 9: Product Life Cycle Activities
- Module 12: Drug/Device Combination products
Part two: Preparing a written report under supervision at the University of Copenhagen. The report must be between 10-max 15 standard pages.
Elective for Master of Medicines Regulatory Affairs
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 Independent Elective studies of a maximum of 5 ECTS.
Enrolment is done in collaboration between the student and the
project supervisor. The student is responsible for finding a
suitable supervisor at the desired department.
An agreement signed by both student and supervisor must be sent
to the Master’s Administration Office
master@sund.ku.dk. The
course fee must be paid before the student starts working on the
project.
- ECTS
- 2,5 ECTS
- Type of assessment
-
Other
- Type of assessment details
- 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
It is allowed to use ChatGPT and similar technologies (Large Language Models - LLM) as aids.
- Marking scale
- 7-point grading scale
- Censorship form
- No external censorship
Course Teacher(s) without external examiner
- Exam period
-
Exam Schedules for Medicines Regulatory Affairs – University of Copenhagen (ku.dk)
- Re-exam
-
The exam form for the reexam is the same as the ordinary exam. See dates in the exam schedule.
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
Kursusinformation
- Language
- English
- Course number
- SMRMIFI01U
- ECTS
- 2,5 ECTS
- Programme level
- Part Time Master
- Duration
-
The course duration varies, depending on the agreement with the supervisor.
- Placement
- Spring And Autumn
- Price
-
Prices vary according to type of enrolment and nationality. For details please visit: MRA programme webpage
- Schedulegroup
-
.
- Capacity
- 1
- Studyboard
- Study Board for the Professionel Master´s Degree Programmes at The Faculty og Health and Medical Science
Contracting department
- Department of Pharmacy
Contracting faculty
- Faculty of Health and Medical Sciences
Course Coordinator
- Lene Jørgensen (14-756e776e3773787b706e777c6e77497c7e776d37747e376d74)
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