Literature: A list of recommended literature will be send to the participants approx. The list will be divided into mandatory and optional reading.The mandatory references is part of the examination syllabus.
By the end of this module, the student should be able to:- understand the basic principles of manufacturing biopharmaceuticals - from the recombinant starting material to the final product - including the critical parts of CMC/Quality sections of the filing dossier, and the regulatory expectations to meet in CMC/Quality documentation throughout the different phases of clinical development and for approval of these types of medicinal products- 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, and evaluate relevant regulations and guidelines for biopharmaceuticals- use 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 Content: 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.
Staged: “Pas de Quatre”, “Dying Swan”, Grand Pas from “Raymonda”, Pas de Deux from “Corsaire”, and full length of “La Bayadere” together with artistic director Nicolaj Hübbe.
Coached dancers in “Sleeping Beauty”, “Nutcracker”, “Swan Lake”, “Serenade”, “The Cage”, “Dances at the Gathering”, “Giselle”, “Lady of the Camellias”, and “A Midsummer Night’s Dream”.
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.
Please note that applications will be considered in order of receipt.