Global Pharmaceutical Policy - Rationales and Stakeholders

This course covers the rationales for the highly detailed regulations of medicines, including their consequences. 

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

WHAT YOU WILL LEARN

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.

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.

COURSE CONTENT

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.

PARTICIPANTS

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

COURSE DETAILS

Course dates

4 days, 5-8 November 2019

Course fee

EU/EEA citizens Master student DKK 13,000

Non EU/EEA citizens Master student DKK 15,000

EU/EEA citizens Single course student DKK 15,000

Non EU/EEA citizens Single course student DKK 17,000

Application deadline

10 September 2019

Lecturers

• Sofia Kälvemark Sporrong
• Janine Traulsen
• Merete Schmiegelow

EXAMINATION

An written assignment in the form of an essay.

Credit

4 ECTS

Examination date

To be announced