Courses and dates
The programme consists of 60 ECTS credits divided among compulsory courses, one fixed elective course, elective courses and a master’s project.
Elective courses
Courses from Master of Industrial Drug Development may be used as elective courses on Master of Medicines Regulatory Affairs, but remember to apply for a credit transfer.
Compulsory courses (34 ECTS)
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Discovery and Development of Medicines
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Safety of Medicines - From Non-clinical Development to Pharmacovigilance
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The US Regulatory Environment
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The EU Regulatory Environment - Procedures and Applications
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Clinical Development and Documentation
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Global Pharmaceutical Policy - Rationales and Stakeholders
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Transparency and Trustworthiness in Drug Development
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Drug Regulatory Science
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Labelling as a Driver for Regulatory Strategy
Fixed elective courses (4 ECTS)
Electives (10 ECTS)
Master's project (12 ECTS)
Courses from Master of Industrial Drug Development
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Pharmacology
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Big Data, Artificial Intelligence and Machine Learning in Drug Safety
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Process Development and Production of Active Pharmaceutical Ingredients (API)
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Biopharmaceuticals Drug Development
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Digital Health
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Quality by Design (QbD) in Pharmaceutical Development
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Market Access for Pharmaceutical Products - Trends and Challenges
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Clinical Pharmacology and Biostatistics
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Pharmacovigilance: Signal detection and risk management
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QA QC GXP for Pharmaceutical Production
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Value Based Health Care - The Future for the Health Care Sector?
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Non-clinical Safety and Toxicology
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Drug Discovery
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Pharmacoepidemiology and postauthorisation safety studies
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Drug Formulation and Delivery