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 framework for the medicines authorities as well as become able to account for the arguments for and against patenting and data protection.
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 on eg. patenting and data exclusivity
Discuss how scientific knowledge (e.g. regulatory science) can be used to develop legislation of medicines.
Skills
Analyze and discuss the background for different parts of the detailed 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 books, book chapters, scientific papers and review papers. For example:
Abbott FM, Dukes G. Global Pharmaceutical Policy: Ensuring Medicines for Tomorrow's World 1ed: Edward Elgar Publishing Inc; 2011.
Bonini S, Eichler HG, Wathion N, Rasi G. Transparency and the European Medicines Agency--sharing of clinical trial data. N Engl J Med. 2014 Dec 25;371(26):2452-5. PubMed PMID: 25539105. Epub 2014/12/30. eng.
Mello MM, Francer JK, Wilenzick M, Teden P, Bierer BE, Barnes M. Preparing for Responsible Sharing of Clinical Trial Data. New England Journal of Medicine. 2013;369(17):1651-8.
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
- Theory exercises/group work: 30 hours
- Lectures: 30 hours
- Exam: 4 hours
- Category
- Hours
- Exam
- 4
- Lectures
- 30
- Preparation
- 48
- Theory exercises
- 30
- Total
- 112
- Credit
- 4 ECTS
- Type of assessment
- Written assignment, 4 hours4 hours written examination with brief descriptive questions and essay held on Digital Exam - The online platform for examination at the University of Copenhagen. The essay is based on a group assignment which is handed in during the course.
- Aid
- All aids allowed
- Marking scale
- 7-point grading scale
- Censorship form
- No external censorship
Criteria for exam assesment
To achieve the grade passed the student shall (in an adequate level) be able to:
Knowledge
Explain and discuss the pharmaceutical law frames and the need for pharmaceutical legislation
Discuss rationales for and consequences of regulations on eg. patenting and data exclusivity
Discuss how scientific knowledge (e.g. regulatory science) can be used to develop legislation of medicines.
Skills
Analyze and discuss the background for different parts of the detailed regulation of medicines from a global perspective
Discuss the societal aspects of pharmaceutical legislation
Competencies
Critically reflect upon global medicines legislation and guidelines
Course information
- Language
- English
- Course code
- SMRMIF008U
- Credit
- 4 ECTS
- Level
- Part Time Master
- Duration
- 27-28 February + 6-7 March 2017
- 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 Professional Master’s Degree Programmes at The Faculty of Health and Medical Sciences
Contracting department
- Department of Pharmacy
Course responsibles
- Sofia Kälvemark Sporrong (14-7b776e7169367b78777a7a77766f487b7d766c36737d366c73)