External Lecturer, Department of Pharmacy, University of Copenhagen and Principal Regulatory Specialist, Novo Nordisk A/S
Biopharmaceuticals - Quality Development and Documentation
Learn about the quality issues specific to biopharmaceuticals, which also covers the regulatory characterisation of a biopharmaceutical product and the stability specifications needed for approval of these medicinal products.
This course gives you knowledge about the scientific background of biotechnological products and the regulatory requirements to fulfill, in order to obtain approval of these types of medicinal products.
You 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.
Course content
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.
For more details about the course, please refer to the course curriculum.
Course directors on »Biopharmaceuticals - Quality Development and Documentation«
Sandra P. Auguste-Bowler
Heidi Smed Christensen
External Lecturer, Department of Pharmacy, University of Copenhagen and Senior Director, Regulatory Affairs, Genmab A/S
Course details for »Biopharmaceuticals - Quality Development and Documentation«
Dates and examination
Course dates
1-3 December 2025
The course is available every year.
Examination
Please find the exam dates in the exam plan.
Learning outcomes
This course will provide you with an understanding of the basic principles of manufacturing biopharmaceuticals – from the recombinant starting material to the final product. This include product characterization and setting specifications as well as the specific quality issues of biopharmaceuticals. You will also be able to evaluate relevant regulations and guidelines for biopharmaceuticals.
You will learn about the critical parts of CMC/Quality sections of the submission file, evaluate information provided by CMC/Quality stakeholders and prepare regulatory CMC/Quality strategies consider both FDA and EU aspects throughout the clinical development.
You will be able to 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.
Admission criteria
You must meet the following criteria to be admitted to this course:
- Hold a relevant bachelor degree or equivalent.
- Have a minimum 2 years of relevant job experience.
- Be proficient in English.
Find detailed information in the admission criteria on Master of Medicines Regulatory Affairs.
You will receive a response to your application at the earliest on 1 May and no later than 2 weeks after the application deadline.
Priority is given to enrolled students
This course is offered as a fixed elective course in the Master of Medicines Regulatory Affairs programme. Priority is given to students already enrolled. Once the enrolled students have been admitted to the course, the remaining seats are distributed on a first-come, first-served basis.
Partnership with Atrium
Atrium is a partner of Master of Medicines Regulatory Affairs. This course is one of 5 courses at the Master's programme, which are offered in collaboration with Atrium.
Atrium is one of Europe’s leading private course providers of practice-based courses in Regulatory Affairs. Their courses are based on collaboration with academia, industry experts and representatives from healthcare authorities.
International educational academy
Atrium is an international educational academy established by The Danish Association of the Pharmaceutical Industry (Lif). As a part of the Danish Association of the Pharmaceutical Industries, Atrium has a close connection to the experts in the Pharmaceutical Industry.
Tuition fees
EU/EEA citizens
Master student: 20,830 DKK
Single course: 22,830 DKK
Non-EU/EEA citizens
Master student: 23,230 DKK
Single course: 25,230 DKK
The fee includes lunch and coffee.
More information
All course information is available in the course curriculum:Place
Atrium
Lersø Parkallé 101
2100 Copenhagen
Denmark
Contact
Annette Villumsen
Study Administration Officer
master@sund.ku.dk
Tel: +45 35 33 60 66