SMRMIF007E Exam in Biopharmaceuticals – Quality Development and Documentation
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 held on Digital Exam - The online platform for examination at the University of Copenhagen.
- Exam registration requirements
Students must have passed the course SMRMIF007U Biopharmaceuticals – Quality Development and Documentation 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
Understand the basic principles of manufacturing biopharmaceuticals - from the recombinant starting material to the final product, including product characterization and setting specifications as well as the specific quality issues of biopharmaceuticals.
Understand the critical parts of CMC/Quality sections of the submission file.
Understand the regulatory expectations to meet in CMC/Quality documentation throughout the different phases of clinical development for approval of these types of medicinal products and for demonstration comparability during life cycle management.
Skills
Evaluate and organise information provided by CMC/Quality stakeholders during product development and post-approval.
Prepare regulatory CMC/Quality strategies, consider both EU and FDA aspects throughout the clinical development.
Evaluate relevant regulations and guidelines for biopharmaceuticals.
Competencies
- Apply best practice in product characterisation and setting of release/stability specifications of a biopharmaceutical, including comparability issues related to manufacturing changes, when preparing a CMC/Quality meeting with Authorities, and when structuring the CMC/Quality sections for IND/CTA and BLA/MAA in the CTD format.
Course information
- Language
- English
- Course code
- SMRMIF007E
- Credit
- 1 ECTS
- Level
- Part Time Master
- Placement
- Autumn
December 11, 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
- Lene Jørgensen
(14-6f687168316d72756a68717668714376787167316e7831676e)
Head of studies
Louise Ploug Berth, RA CMC Specialist, RA Inflammation Projects, Novo Nordisk A/S, Denmark (chief responsibility)
Sandra Patricia Auguste-Bowler, Scientific Adviser (Pharmaceutical Expert), LEO Pharma A/S, Denmark