Kursussøgning, efter- og videreuddannelse – Københavns Universitet

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Kursussøgning, efter- og videreuddannelse

Exam in Biopharmaceuticals – Quality Development and Documentation

Practical information
Study year 2016/2017
December 11, 2017

Prices vary according to type of enrolment and nationality. For details please visit: 

EU/EEA citizens

non-EU/EEA citizens

Programme level Part Time Master
Course responsible
  • Lene Jørgensen (14-6f687168316d72756a68717668714376787167316e7831676e)
Lene Jørgensen is Head of Studies

Exam responsible:
Louise Ploug Berth, RA CMC Specialist, RA Inflammation Projects, Novo Nordisk A/S, Denmark (chief responsibility)
Sandra P. Auguste-Bowler, Scientific Adviser (Pharmaceutical Expert), LEO Pharma A/S, Denmark
  • Department of Pharmacy
Course number: SMRMIF007E

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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.


Study Board for Part-time Master’s Programmes of Pharmaceutical Sciences

Course type

Part time Master and Diploma courses ---- SKEMA LINK ----




Category Hours
Exam Preparation 24
Exam 3
English 27

Exam (SMRMIF007E)

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

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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