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 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.

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 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

- Preparation/​self-studies: 32 hours
- Project work: 28 hours
- Lectures (incl. exercises): 28 hours
- Exam preparation: 20 hours
- Exam: 4 hours

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.

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 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
Criteria for exam assessment

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

Part time Master and Diploma courses

  • Category
  • Hours
  • Preparation
  • 32
  • Project work
  • 28
  • Lectures
  • 28
  • Exam Preparation
  • 20
  • Exam
  • 4
  • English
  • 112