SMRMIF003E  Exam in Clinical Development – Efficacy of Medicines

Volume 2017/2018

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%
Exam registration requirements

Students must have passed the course SMRMIF003U Clinical Development – Efficacy of Medicines in order to participate in the examination

All aids allowed



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

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
  • Category
  • Hours
  • Exam Preparation
  • 25
  • Exam
  • 4
  • Total
  • 29