Global Pharmaceutical Policy - Rationales and Stakeholders
Understand the global diversity of frames for pharmaceutical legislation and guidelines. Regulations of medicines will be reviewed in a context influenced by e.g. regulatory complexity, safety in relation to efficacy, cultures, values and economy.
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.
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 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.
Innovate and strengthen the regulatory process
The course is intended for regulatory affairs specialist employed in industry, regulatory agencies or consulting.
Participants must
- Hold a relevant bachelor degree or equivalent
- Have a minimum 2 years of relevant job experience
- Be proficient in English
Find detailed information about the admission criteria.
Ramune Jacobsen, Associate Professor, Department of Pharmacy, University of Copenhagen, Denmark
Janine Traulsen, External Lecturer, Department of Pharmacy, University of Copenhagen, Denmark
This course is offered as a compulsory part of Master of Medicines Regulatory Affairs.
Priority is given to students enrolled on Master of Medicines Regulatory Affairs. Once the enrolled students have been admitted to the course, the remaining seats are distributed on a first-come, first-served basis.
Course details
| Duration: | 4 days on campus |
| Dates: | 7-10 November 2023 |
| Frequency: | Only available every second year |
| Place: | University of Copenhagen, Copenhagen, Denmark |
| Course fee: | EU/EEA citizens Master student: 13,000 DKK Single course participants: 15,000 DKK Non-EU/EEA citizens The fee includes lunch/coffee. |
| Level and credit: | Master course; 4 ECTS |
| Examination date: | To be announced in the exam schedule |
| Application deadline: | 8 weeks prior to first day of lectures |
| Admission: | To be admitted, you must meet the admission criteria for Master of Medicines Regulatory Affairs |
Course dates and application deadlines are announced via the programme newsletter.
Download course curriculum