Global Pharmaceutical Policy - Rationales and Stakeholders – University of Copenhagen

Master of Medicines Regulatory Affairs > Courses > Global Pharmaceutical ...

Global Pharmaceutical Policy - Rationales and Stakeholders

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.

Course dates

  • 3-6 April 2018

Exam date:

  • Submission of written assignment by 4 May 2018

Application deadline:

  •  28 February 2018

Course fee:

EU/EEA citizens Non EU/EEA citizens
Master student DKK 13.000 DKK 15.000
Single course student DKK 15.000 DKK 17.000