25 November 2024

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.

Biopharmaceuticals - Quality Development and Documentation

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.

















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.































Sandra P. Auguste-Bowler, External Lecturer, Principal Regulatory Specialist, Novo Nordisk A/S
Heidi Smed Christensen, External Lecturer, Senior Director, RA CMC at Genmab



























Course details

Duration: 3 days
Dates: 25-27 November 2024
Frequency: Once per year
Place: Atrium, Greater Copenhagen, Denmark
Course fee:

EU/EEA citizens
Master student: 20,273 DKK
Single course participant: 22,273 DKK

Non-EU/EEA citizens
Master student: 22,673 DKK
Single course participant: 24,673 DKK

The fee includes lunch/coffee.
Payment conditions

Level and credit: Master course; 4 ECTS
Examination date: See the exam schedule
Application deadline: 14 October 2024
Admission: To be admitted, you must meet the admission criteria for Master of Medicines Regulatory Affairs

Course dates and application deadlines are announced via the programme newsletter.
Download course curriculum