Exam in Regulatory Affairs in the EU

Education

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.

ECTS
1 ECTS
Type of assessment
Written assignment, 3
3 hours written assignment with descriptive questions held on Digital Exam - The online platform for examination at the University of Copenhagen.
Aid
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:

Knowledge

  • Explain and discuss the different types of marketing authorization application procedures in the EU

  • Explain and discuss the needed content for a clinical trial application

  • Explain and discussways to interact with authorities to obtain scientific advice

  • Explain and discuss the orphan medicinal product designation

  • Explain and discuss content and timing of the paediatric investigation plans

  • Explain and discuss the content of risk management plans

Skills

  • Analyse and consider the requirements for a MAA

  • Identify, analyse and consider opportunities and consequences related to different types of products and submissions e.g. orphan medical products

  • Understand and apply the EU requirement for paediatric investigation plans and risk management plans

  • Analyse the overall strategic choices for the regulatory procedure used during development, application and maintenance of the medical product

Competencies

  • Make strategic plans for applying for an MAA and provide/obtain the needed documentation.

Part time Master and Diploma courses

  • Category
  • Hours
  • Exam
  • 3
  • Exam Preparation
  • 24
  • English
  • 27