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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.
Medicademy accept up to 10 - 20 % of the seats at a module to be occupied by applicants who have none or limited experience within the regulatory affairs area.
These participants must have experience within the pharmaceutical/biological area that qualify them to benefit from the training and to participate actively during the module.
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.
During the course, students will meet very experienced lecturers and benefit from their individual competencies in different areas.
The participants must have a educational background at bachelor level within a relevant area and at least two years’ experience within Regulatory Affairs or equivalent qualifications.