SMRMIF008U Global Medicines Legislation and Guidelines
This course is a compulsory course at Copenhagen University's Master of Medicines Regulatory Affairs (MRA).
The course is open to single course students and students from other master's programmes.
The aim of the course is to illustrate and discuss the reasons for the highly detailed regulation that the development of medicines is subjected to, and how scientific knowledge can be used to develop this legislation. The student will obtain knowledge on the frameworks for the medicines authorities in different jurisdictions as well as data integrity.
After completion of the course the student will be able to reflect upon the societal aspects of legislation in a global perspective, discuss the background for the highly detailed regulation of medicines as well as suggest how scientific knowledge (e.g. regulatory science) can be used to comment, revise and influence legislation of medicines.
After completion of the course the student will be able to:
Knowledge
Explain and discuss the pharmaceutical law frames and the need for pharmaceutical legislation
Discuss rationales for and consequences of regulations in different jurisdictions around the world
Discuss how scientific knowledge (e.g. regulatory science) can be used to develop legislation of medicines.
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
The syllabus comprises relevant international guidelines (e.g. EMA, FDA), 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.
• A relevant bachelor degree or equivalent
• A minimum of 2 years of relevant job experience
• Proficiency in English
- Project work: 28 hours
- Lectures (incl. exercises): 28 hours
- Exam preparation: 20 hours
- Exam: 4 hours
- Category
- Hours
- Exam
- 4
- Exam Preparation
- 20
- Lectures
- 28
- Preparation
- 32
- Project work
- 28
- Total
- 112
Application deadline is 8 weeks before the first day of instruction.
- Credit
- 4 ECTS
- Type of assessment
- Written assignment, 4 hours4 hours written assignment with brief descriptive questions and essay held on Digital Exam - The online platform for examination at the University of Copenhagen. The essay is based topics discussed and material handed out during the course.
- Aid
- All aids allowed
- Marking scale
- 7-point grading scale
- Censorship form
- No external censorship
- Exam period
Exam schedule is published on http://mra.ku.dk/calender/exams/
- Re-exam
Exam schedule is published on http://mra.ku.dk/calender/exams/
Criteria for exam assesment
To achieve the maximum grade of 12, the student should be able to:
Knowledge
Explain and discuss the pharmaceutical law frames and the need for pharmaceutical legislation
Discuss rationales for and consequences of regulations in different jurisdictions around the world
Discuss how scientific knowledge (e.g. regulatory science) can be used to develop legislation of medicines.
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
- SMRMIF008U
- Credit
- 4 ECTS
- Level
- Part Time Master
- Duration
- 3-6 April 2018
- Placement
- Spring
- Schedule
- 2 + 2 days
- Continuing and further education
- Price
Prices vary according to type of enrolment and nationality. For details please visit:
- Study board
- Study Board for the Professionel Master´s Degree Programmes at The Faculty og Health and Medical Science
Contracting department
- Department of Pharmacy
Course Coordinators
- Sofia Kälvemark Sporrong
(14-7672696c6431767372757572716a4376787167316e7831676e)
course responsible