Global Medicines Legislation and Guidelines

Course content

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.

Education

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.

Learning outcome

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

- Preparation/​self-studies: 48 hours
- Theory exercises/group work: 30 hours
- Lectures: 30 hours
- Exam: 4 hours

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.

Applicants must meet the following criteria:
• A relevant bachelor degree or equivalent
• A minimum of 2 years of relevant job experience
• Proficiency in English

ECTS
4 ECTS
Type of assessment
Written assignment, 4 hours
4 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 assessment

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

Part time Master and Diploma courses

  • Category
  • Hours
  • Preparation
  • 48
  • Theory exercises
  • 30
  • Lectures
  • 30
  • Exam
  • 4
  • English
  • 112