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Global Pharmaceutical Policy - Rationales and Stakeholders
This course covers the rationales for the highly detailed regulations of medicines, including their consequences.
This course is a part of
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.
Although EU and USA remain first priority regions for many pharmaceutical companies, authorization and launching of products in other regions are of increasing importance.
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.
Course Directors on Global Pharmaceutical Policy - Rationales and Stakeholders
Course details about Global Pharmaceutical Policy - Rationales and Stakeholders
Dates and examination
Course dates
Expected to be offered in autumn 2025.
Examination
Please find the exam dates in the exam plan.
You can find further information about the course and the exam in the course curriculum.
See an overview of all courses on Master of Medicines Regulatory Affairs.
Learning outcomes
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.
Admission criteria
Regulatory affairs specialists striving to innovate and strengthen the regulatory process
The course is intended for regulatory affairs specialists employed in industry, regulatory agencies or consulting.
You must meet the following criteria to be admitted to this course:
- Hold a relevant bachelor degree or equivalent
- Have a minimum 2 years of relevant job experience
- Be proficient in English
Find detailed information in the admission criteria on Master of Medicines Regulatory Affairs.
Priority is given to enrolled students
This course is offered as a compulsory course in the Master of Medicines Regulatory Affairs programme. Priority is given to students already enrolled. Once the enrolled students have been admitted to the course, the remaining seats are distributed on a first-come, first-served basis.
Tuition fees
EU/EEA citizens
Master student: 14,350 DKK
Single course participant: 15,350 DKK
Non-EU/EEA citizens
Master student: 16,750 DKK
Single course participant: 17,750 DKK
The fee includes lunch/coffee.
Place
University of Copenhagen
Department of Pharmacy/
Department of Drug Design and Pharmacology
Universitetsparken 2
2100 Copenhagen
Denmark
Contact
Annette Villumsen
Study Administration Officer
Tel.: +45 35 33 60 66