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.

Type of assessment
Written assignment, 3 hours
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
Censorship form
No external censorship
Criteria for exam assessment

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


  • 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.


  • 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.


  • 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.

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