Exam in Clinical Development – Efficacy of Medicines


This exam is offered in collaboration between University of Copenhagen and Medicademy as part of the Master of Medicines Regulatory Affairs. It is possible to follow the exam as a single course student.

Type of assessment
Written assignment, 4 hours
The examination is held on Digital Exam - the online platform for examination at the University of Copenhagen. The examination consist of:
- Descriptive questions
- Essay

The descriptive questions will be weighted 60%
The essay will be weighted 40%
All aids allowed



Marking scale
passed/not passed
Censorship form
No external censorship
Criteria for exam assessment

To achieve the grade passed, the student shall (in an adequate level) be able to:


  • Explain and discuss the required clinical documentation for a marketing authorisation application (MAA)
  • Explain and identify the principles of clinical development from phase I to IV for both small molecules and biopharmaceuticals
  • Explain and discuss how clinical risk assessment can be handled during development



  • Create, analyse and evaluate a regulatory strategy plan for the clinical development of a new medicinal product
  • Evaluate the possibilities and consequences of the clinical development plan on the desired product information



  • Contribute to plans and proposals with regard to clinical development and documentation

Part time Master and Diploma courses

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