Courses and dates
The programme consists of 60 ECTS credits divided among compulsory courses, a fixed elective course, elective courses and a master’s project.
To complete the Master of Medicines Regulatory Affairs, you must choose 1 of the fixed elective courses. The other one may be used as an elective course.
Compulsory courses (34 ECTS)
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Global Pharmaceutical Policy - Rationales and Stakeholders
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Discovery and Development of Medicines
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Transparency and Trustworthiness in Drug Development
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The US Regulatory Environment
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Drug Regulatory Science
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The EU Regulatory Environment - Procedures and Applications
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Clinical Development and Documentation
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Safety of Medicines - From Non-clinical Development to Pharmacovigilance
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Labelling as a Driver for Regulatory Strategy
Fixed elective courses (4 ECTS)
Elective courses (10 ECTS)
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Digital Health
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Market Access for Pharmaceutical Products - Trends and Challenges
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Quality by Design (QbD) in Pharmaceutical Development
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Biopharmaceuticals Drug Development
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Value Based Health Care - The Future for the Health Care Sector?
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Clinical Pharmacology and Biostatistics
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QA QC GXP for Pharmaceutical Production
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Drug Discovery
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Non-clinical Safety and Toxicology
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Drug Regulatory Affairs in Drug Development
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Drug Formulation and Delivery
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Process Development and Production of Active Pharmaceutical Ingredients (API)
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Pharmacology