Kursussøgning, efter- og videreuddannelse – Københavns Universitet

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Kursussøgning, efter- og videreuddannelse

Exam in Regulatory Affairs in the EU

Practical information
Study year 2016/2017
10 October 2016

Prices vary according to type of enrolment and nationality. For details please visit: 

EU/EEA citizens

non-EU/EEA citizens


Programme level Part Time Master
Course responsible
  • Lene Jørgensen (14-6f687168316d72756a68717668714376787167316e7831676e)
  • Department of Pharmacy
Course number: SMRMIF000E

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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.


Study Board for Part-time Master’s Programmes of Pharmaceutical Sciences

Course type

Part time Master and Diploma courses


Lene Jørgensen is Head of Studies

Exam responsible:
Eva Maiken Holck - Regulatory Affair Manager, LEO Pharma A/S, Denmark (chief responsibility)
Mette Due Theilade Thomsen - Principal Scientist, RA Paediatric Investigation Plan (PIP), RA GLP-1 and Obesity, Novo Nordisk A/S, Denmark ---- SKEMA LINK ----




Category Hours
Exam 3
Exam Preparation 24
English 27

Exam (SMRMIF000E)

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.


All aids allowed

Marking scale

passed/not passed

Criteria for exam assessment

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


  • 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


  • 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


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

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