SMRMIF003E Exam in Clinical Development – Efficacy of Medicines
Volume 2016/2017
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.
Workload
- Category
- Hours
- Exam
- 4
- Exam Preparation
- 25
- Total
- 29
Exam (SMRMIF003E)
- Credit
- 1 ECTS
- Type of assessment
- Written assignment, 4 hoursThe 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
- Aid
- All aids allowed
- Marking scale
- passed/not passed
- Censorship form
- No external censorship
- Exam period
Published in the exam plan on the homepage of the MRA programme
- Re-exam
Published in the exam plan on the homepage of the MRA programme
Criteria for exam assesment
To achieve the grade passed, the student shall (in an adequate level) be able to:
Knowledge
- 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
Skills
- 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
Competencies
- Contribute to plans and proposals with regard to clinical development and documentation
Course information
- Language
- English
- Course code
- SMRMIF003E
- Credit
- 1 ECTS
- Level
- Part Time Master
- Placement
- Spring
7 April 2017
- Continuing and further education
- Price
Prices vary according to type of enrolment and nationality. For details please visit:
- Study board
- Study Board for Part-time Master’s Programmes of Pharmaceutical Sciences
Contracting department
- Department of Pharmacy
Course responsibles
- Lourdes Cantarero Arevalo
(13-6e7177306563707663746774714275777066306d7730666d)
Head of studies
Lene Jørgensen is Head of Studies.
Exam Responsible:
Ann Christine Korsgaard, External associate professor ack@biotrack.dk
Dorte Bjørn-Larsen, Novo Nordisk A/S dbl@novonordisk.com
Exam Responsible:
Ann Christine Korsgaard, External associate professor ack@biotrack.dk
Dorte Bjørn-Larsen, Novo Nordisk A/S dbl@novonordisk.com
Saved on the
22-03-2017