SMRMIF000E Exam in Regulatory Affairs in the EU
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.
- Category
- Hours
- Exam
- 3
- Exam Preparation
- 24
- Total
- 27
- Credit
- 1 ECTS
- Type of assessment
- Written assignment, 33 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.
Course information
- Language
- English
- Course code
- SMRMIF000E
- Credit
- 1 ECTS
- Level
- Part Time Master
- Placement
- Autumn
9 October 2017
- Continuing and further education
- Price
Prices vary according to type of enrolment and nationality. For details please visit:
- Study board
- Study Board for the Professionel Master´s Degree Programmes at The Faculty og Health and Medical Science
Contracting department
- Department of Pharmacy
Course Coordinators
- Eva Maiken Holck (16-6a7b663372666e706a73336d7471687045787a736933707a336970)
- Mette Due Theilade Thomsen (13-6f6776766730766a716f7567704275777066306d7730666d)
Mette Due Theilade Thomsen - Principal Scientist, RA Paediatric Investigation Plan (PIP), RA GLP-1 and Obesity, Novo Nordisk A/S, Denmark