Biopharmaceuticals - Quality Development and Documentation – University of Copenhagen

Master of Medicines Regulatory Affairs > Courses > Biopharmaceuticals - Q...

25 May 2018

Biopharmaceuticals - Quality Development and Documentation

The aim of this course is to give attendees knowledge about the scientific background of
biotechnological products and the regulatory requirements to fulfil, in order to obtain approval of these types of medicinal products.

Attendees will get an understanding of the quality issues specific to biopharmaceuticals, for example; the generation of a recombinant microorganism, the expression of the product from the microorganisms and its purification, and the regulatory expectations for characterisation of a biopharmaceutical product and to release/stability specifications set for these types of products. As process changes are inevitable during development of a biological/biotechnological product this course will provide the implications of changes in the production process and elaborate the concept of comparability.

In addition to providing the students with a general understanding of specific quality issues for biopharmaceuticals, this course will focus on how to prepare regulatory CMC/Quality strategies and how to ensure compliance with regulatory requirements throughout the clinical development and post-approval processes. The discussions on CMC/Quality strategies will include both EU and FDA aspects, and the lectures will focus attention on both EU and FDA regulatory procedures for approval of biopharmaceuticals. Further, the course will guide the students through the structure of CMC/Quality sections for IND/CTA and BLA/MAA in the CTD format.

What do you gain?


  • 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 FDA and EU 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.

Course dates

  • 3-5 April 2019

Application deadline

  • 6 March 2019

Applications will be processed by receipt, and applicants are admitted on a "first come, first served" basis. Registration will close when the maximum number of seats are taken. Applicants will be notified of admission within 4 weeks of submitted application.
Please note that the course
can be cancel or rescheduled if the number of participants fails to meet the required minimum.

Exam dates

  • To be announced

Course fee

EU/EEA citizens Non EU/EEA citizens
Master student DKK 17.975 DKK 19.975
Single course student DKK 19.975 DKK 22.000