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 can be used as elective courses for Master of Medicines Regulatory Affairs, but remember to apply for a credit transfer.
Compulsory courses (34 ECTS)
-
The EU Regulatory Environment - Procedures and Applications
-
Clinical Development and Documentation
-
Drug Regulatory Science
-
Labelling as a Driver for Regulatory Strategy
-
Discovery and Development of Medicines
-
Safety of Medicines - From Non-clinical Development to Pharmacovigilance
-
The US Regulatory Environment
-
Global Pharmaceutical Policy - Rationales and Stakeholders
-
Transparency and Trustworthiness in Drug Development
Fixed elective courses (4 ECTS)
Electives (10 ECTS)
Courses from Master of Industrial Drug Development
-
Pharmacoepidemiology and postauthorisation safety studies
-
Big data, artificial intelligence and machine learning in drug safety
-
Value Based Health Care - The Future for the Health Care Sector?
-
Quality by Design (QbD) in Pharmaceutical Development
-
Biopharmaceuticals Drug Development
-
Digital Health
-
Market Access for Pharmaceutical Products - Trends and Challenges
-
Pharmacovigilance: Signal detection and risk management
-
Drug Formulation and Delivery
-
Discovery and Development of Medicines
-
Pharmacology
-
Process Development and Production of Active Pharmaceutical Ingredients (API)
-
Clinical Pharmacology and Biostatistics
-
QA QC GXP for Pharmaceutical Production
-
Non-clinical Safety and Toxicology
-
Drug Discovery