SMRMIF006E Exam in Quality – Active Substance and Medicinal Product
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, 3 hours3 hours written assignment with descriptive questions and multiple choice held on Digital Exam - The online platform for examination at the University of Copenhagen.
- Exam registration requirements
Students must have passed the course SMRMIF006U Quality – Active Substance and Medicinal Product in order to participate in the examination
- Aid
- All aids allowed
- Marking scale
- passed/not passed
- Censorship form
- No external censorship
- Exam period
Exam schedule is published on http://mra.ku.dk/calender/exams/
- Re-exam
Exam schedule is published 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 regulatory quality documentation in regards to medicinal product development
Explain and identify the basic principles of regulatory quality documentation and how this work is regulated through guidelines and standards
Explain and discuss how quality build into daily activities may improve performance and may result in faster submissions and approvals
Skills
Apply and analyse development processes, reports, specifications, methods and data to ensure coherency and transparency of the quality dossier and compliance with required guidelines and quality standards
Analyse and discuss the CMC documentation in relation to the clinical phases
Competences
Prepare quality plans and describe decision steps with regard to pharmaceutical development and documentation
Course information
- Language
- English
- Course code
- SMRMIF006E
- Credit
- 1 ECTS
- Level
- Part Time Master
- Placement
- Autumn
14 December 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
- Poul Egon Bertelsen
(5-79777d6d7449756e783679716a7b766a376c7876)
External associate professor - Karen Wibe Enevoldsen (21-73697a6d76367f716a6d366d766d7e77746c7b6d76487b7d766c36737d366c73)
Poul E. Bertelsen - Associate Principal Scientist, Takeda, Switzerland (chief responsibility)
Karen Wibe Enevoldsen - Head of Section, Pharmaceutical Product Development, LEO Pharma A/S, Denmark