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Attendees of the course 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 characterization 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.
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The discussions on CMC/Quality strategies will include both FDA and EU aspects, and the lectures will focus attention on both FDA and EU 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.
Tivoli Ballet School offers an exclusive seminar classes taught by Kevin Haigen and Anna Urban, Hamburg Ballet School, and Eva Draw, University of North Carolina School of the Arts, together with Heather Jürgensen, Ballet Kiel.
The repertoire classes will be based on experts from John Neumeier choreography. On arrival you will receive a welcome folder with necessary information about Tivoli, the locations, the city and of course the seminar.
This means that you will be enrolled at both Medicademy and the University of Copenhagen and that your data will be registered at both institutions.