Drug Regulatory Science
Course content
The course will enable the students to impact discussions on strategic regulatory decisions, and to critically reflect and discuss previously obtained knowledge about guidelines and regulations for clinical development of medicine.
Regulatory science research will set the foundations for class discussion centred around research methodology and methods, identification of data sources, and interpretation of research results.
The course will centre around 3-4 regulatory science research topics such as, patient involvement in drug development, benefit-risk assessment or accelerated approval pathways. During the course, the students will also be introduced to both qualitative and as quantitative research methods in regulatory science.
This course is a compulsory course at Copenhagen University's Master of Medicines Regulatory Affairs (MRA).
See course calendar for course dates
This course is compulsory at the 2018-curriculum
The course is open to single course students and students from other master's programmes.
After this course, the student will be able to
Knowledge
-
Describe various research approaches applied in Drug Regulatory Science
-
Describe use of strategies and data sources for to be used in Drug Regulatory Science research
Skills
-
Identify and conceptualise relevant Drug Regulatory Science research question and hypothesis, through analysing the scientific literature in context of regulatory systems
-
Identify approaches and methods to address Drug Regulatory Science research questions
- Discuss the advantages and challenges with recent regulatory innovations for drug development
Competencies
- Reflect on implications of results within Drug Regulatory Science, with the perspective of the society, academia and industry
- Identify and conceptualise relevant Drug Regulatory Science research question and hypothesis, through analysing the scientific literature in context of regulatory systems
- Impact discussions on strategic regulatory decisions
Lectures, class discussions and group work
The syllabus comprises a selection of book chapters, scientific papers and review papers.
A complete list of reading material will be distributed electronically before the course.
Basic knowledge of drug regulation systems, 1. acquired in MRA courses such as ‘The US regulatory environment’ and ‘The EU regulatory environment’ or otherwise OR 2. acquired in the MIND course- Drug Regulatory Affairs in Drug Development, is an advantage in the course.
Applicants must meet the following criteria:
• A bachelor's degree or a master’s degree in health and
medical sciences, natural sciences, applied sciences or equivalent
• At least 2 years work experience in the pharmaceutical industry,
in a medicines agency or in another relevant organization or
company
• Proficiency in English
See course calendar for course dates
Application deadline is 8 weeks before the first day of instruction. If we have empty seats after the application deadline, it is possible to apply after deadline.
- ECTS
- 3 ECTS
- Type of assessment
-
Written assignment
- Type of assessment details
- The student will be assessed based on a written assignment.
- Marking scale
- 7-point grading scale
- Censorship form
- No external censorship
- Exam period
-
The exam schedule is available on mra.ku.dk
- Re-exam
-
Written response to critique of own report
The exam schedule is available on mra.ku.dk
Criteria for exam assessment
To achieve the maximum grade of 12, the student should be able to:
Knowledge
- Describe the research approaches applied in a Drug Regulatory Science
- Describe use of strategies and data sources in Drug Regulatory Science research
Skills
- Discuss choice of research approaches and data sources in Drug Regulatory Science
- Identify relevant results in Drug Regulatory Science in context of the regulatory systems
Competencies
- Reflect on implications of results within Drug Regulatory Science, with the perspective of the society, academia and industry
- Identify and conceptualise relevant Drug Regulatory Science research question and hypothesis, through analysing the scientific literature in context of regulatory systems
Part time Master and Diploma courses
- Category
- Hours
- Lectures
- 21
- Preparation
- 30
- Project work
- 18
- Exam Preparation
- 14
- English
- 83
Kursusinformation
- Language
- English
- Course number
- SMRM18006U
- ECTS
- 3 ECTS
- Programme level
- Part Time Master
- Duration
-
3 days
- Placement
- Spring And Autumn
- Price
-
Prices vary according to type of enrolment and nationality. For details please visit: MRA programme webpage
Fee includes course materials and lunch/coffee. Textbook must be purchased by the participants.
- Schedulegroup
-
3 days full time
- Capacity
- 30
- 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 Coordinators
- Christine Erikstrup Hallgreen (19-686d776e78796e736a336d6671716c776a6a7345787a736933707a336970)
- Mathias Møllebæk (18-7165786c6d6577327173697070696665696f4477797268326f7932686f)
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