SMRMIF000E  Exam in Regulatory Affairs in the EU

Volume 2017/2018
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.

Credit
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.
Exam registration requirements

Students must have passed the course SMRMIF000U Regulatory Affairs in the EU in order to participate in the examination

Aid
All aids allowed
Marking scale
passed/not passed
Censorship form
No external censorship
Exam period

Announced in the MRA exam schedule on http://mra.ku.dk/calender/exams/

Re-exam

Announced in the MRA exam schedule on http://mra.ku.dk/calender/exams/

Criteria for exam assesment

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.

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