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
Understanding Global Pharmaceutical Regulations: Stakeholder Perspectives and Strategies
This course explores the rationale behind the detailed legislation and guidelines regulating medicines, examining their global diversity and the factors influencing them, such as regulatory complexity, safety versus efficacy, cultural values, and economic considerations. It also analyses the perspectives of key stakeholders, including patients, governments, and the pharmaceutical industry.
Participants will develop critical thinking skills to assess stakeholders' rationales and incorporate contextual considerations into regulatory strategies. The course combines self-study, lectures, and group discussions, emphasizing critical reflection on global pharmaceutical regulations and stakeholder requirements.
As part of the course, participants will write an essay on a topic of personal interest, such as a specific therapeutic area or regional focus, applying their insights to real-world regulatory challenges.
For more details about the course, please refer to the course curriculum.
Graduate testimonial video
Course directors on »Global Pharmaceutical Policy - Rationales and Stakeholders«
Course details for »Global Pharmaceutical Policy - Rationales and Stakeholders«
Dates and examination
Learning outcomes
On completion of the course, you will be able to:
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critically examine the global diversity of pharmaceutical regulations within cultural and economic contexts
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analyse and discuss the framework, necessity, and consequences of pharmaceutical legislation and guidelines across jurisdictions
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explore the perspectives and rationales of key stakeholders, such as patients, governments, and the pharmaceutical industry
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develop skills to reflect on legislation and guidelines, challenge assumptions, and effectively communicate and negotiate messages in diverse contexts.
Admission criteria
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 and coffee.
More information
All course information is available in the course curriculum:Faculty of Health and Medical Sciences
Department of Pharmacy and Department of Drug Design and Pharmacology
Universitetsparken 2
DK-2100 Copenhagen
