Global Pharmaceutical Policy – Rationales and Stakeholders

This course covers the rationales for the highly detailed legislation and guidelines regulating medicines, including their consequences. The global diversity when it comes to regulations of medicines will be reviewed in a context influenced by e.g. regulatory complexity, safety in relation to efficacy, cultures, values and economy. 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 regulatory 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.