SMRM18001U Global Pharmaceutical Policy – Rationales and Stakeholders
This course is a compulsory course for students at Copenhagen University's Master of Medicines Regulatory Affairs (MRA).
See homepage for course dates on the webpage for Master of Medicines Regulatory Affairs
This course is compulsory at both the 2016-curriculum and
the 2018-curriculum.
The course is open to single course students and students from other master's programmes.
This course covers the rationales for the highly detailed legislation and guidelines regulating medicines, including their consequences. The global diversity when it comes to regulations of medicines will be reviewed in a context influenced by e.g. regulatory complexity, safety in relation to efficacy, cultures, values and economy. Regulations and different rationales behind them are elucidated from the perspectives of different stakeholders, such as patients, governments and the pharmaceutical industry.
Participants will learn to be aware and critical of stakeholders and their rationales for different requirements. This contextual thinking provides students with the means to include contextual considerations into regulatory strategies.
Teaching includes self-study, lectures and group discussions. Participants are trained individually and in groups to critically reflect on global pharmaceutical legislation and guidelines, stakeholders and their rationales for different requirements, which are critical to consider from early on during the development of medicines. Participants will work individually on an essay motivated by personal interests. The essay can for example focus on a specific therapeutic area and/or relevant region.
After completion of the course the student will be able to:
Knowledge
- Explain and discuss the pharmaceutical legislation and guideline frames and the need for pharmaceutical legislation and guidelines
- Discuss rationales for and consequences of regulations in different jurisdictions around the world
- Discuss the perspectives and rationales of important stakeholders involved in pharmaceutical legislation and guidelines
Skills
- Analyze and discuss the background for and use of different parts of the regulation of medicines
- Discuss the societal aspects of pharmaceutical legislation from a global perspective
Competencies
- Critically reflect upon global medicines legislation and guidelines and initiate, apply, challenge and negotiate a message through in various contexts
Abbott FM, Dukes G. Global Pharmaceutical Policy. Edward Elgar Pubishing Ltd. 2011 or later
A selection of book chapters, scientific papers and review papers.
A complete list of reading material will be distributed electronically before the course. In total corresponding to approximately 400 pages of self-study.
- Category
- Hours
- Lectures
- 24
- Preparation
- 40
- Seminar
- 8
- Exam
- 40
- Total
- 112
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.
Apply directly on the programme's webpage
- Credit
- 4 ECTS
- Type of assessment
- Written assignment
- Type of assessment details
- Written assignment/essay
- Aid
- All aids allowed
The use AI chatbots, such as ChatGPT or any similar softwares, is not allowed during exams.
- Marking scale
- 7-point grading scale
- Censorship form
- No external censorship
- Exam period
Exam schedule is published on mra.ku.dk
- Re-exam
The exam form for the reexam is the same as the ordinary exam. See dates in the exam schedule on mra.ku.dk
Criteria for exam assesment
To achieve the maximum grade of 12, the student should be able to:
Knowledge
- Explain and discuss the pharmaceutical legislation and guideline frames and the need for pharmaceutical legislation and guidelines
- Discuss rationales for and consequences of regulations in different jurisdictions around the world
- Discuss the perspectives and rationales of important stakeholders involved in pharmaceutical legislation and guidelines
Skills
- Analyze and discuss the background for and use of different parts of the regulation of medicines
- Discuss the societal aspects of pharmaceutical legislation from a global perspective
Competencies
- Critically reflect upon global medicines legislation and guidelines
Course information
- Language
- English
- Course code
- SMRM18001U
- Credit
- 4 ECTS
- Level
- Part Time Master
- Duration
- 4 days
- Placement
- Spring And Autumn
- Schedule
- 4 days full time
- Course capacity
- 30
Study board
- 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
- Ramune Jacobsen (ramune.jacobsen@sund.ku.dk)