Purpose: The aim of this module is to give Regulatory Affair employees knowledge about the scientific background of biologics and biotechnological products and the regulatory requirements to fulfil, in order to obtain approval of these types of medicinal products.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.
Please note that applications will be considered in order of receipt.All lecturers have been carefully chosen and represent both the Competent Authorities and the Pharmaceutical Industry. dating sider for homoseksuelle Horsens Further, learning activities will be enhanced through interaction with other students and group work on case stories, illustrating the everyday dilemmas and decisions for regulatory professionals working with biopharmaceuticals.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.
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This stems from our historical heritage and our role in society as the leading technology and communications company in Denmark.Each year, TDC Group receives numerous requests and applications for sponsorships.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 participation will be considered on a case-by-case basis.
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