Global Pharmaceutical Policy – Rationales and Stakeholders

Course content

Although EU and USA remain first priority regions for many pharmaceutical companies, authorization and launching of products in other regions are of increasing importance.

This course covers the rationales for the highly detailed regulations of medicines, including their consequences. The global diversity when it comes to regulations of medicines will be reviewed in a cultural and economic context. 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 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. 

Education

This course is a compulsory course for students at Copenhagen University's Master of Medicines Regulatory Affairs (MRA).

 

See course calender for course dates


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.

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 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

Teaching includes self-study, lectures and group discussions.

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.

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

Oral
Collective
ECTS
4 ECTS
Type of assessment
Written assignment
Written assignment/essay
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 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

 

Part time Master and Diploma courses

  • Category
  • Hours
  • Preparation
  • 40
  • Lectures
  • 24
  • Exam
  • 40
  • Seminar
  • 8
  • English
  • 112