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.
The participation will be considered on a case-by-case basis.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. gratis danske dating sider Vallensbæk 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.Red Hat Forum in Copenhagen is Denmark's number one premier conference for open innovation technologies.The event brings together senior executives, IT decision makers, customers, partners, developers to discuss cloud innovation, devops and containers.
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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.Please read the descriptions below and check their websites in order to choose the right hotel for you! There are no hotels very close to the Medicademy facilities which is why we have chosen these two hotels, very centrally located, situated in the same block, right next to each other and close to Nørreport train- and Metro station, to where the airport train goes.During the course, students will meet very experienced lecturers and benefit from their individual competencies in different areas.
All lecturers have been carefully chosen and represent both the Competent Authorities and the Pharmaceutical Industry.We have fixed prices at these two hotels, which mean that you are guaranteed to get the prices below.However, if the prices at some days/periods are lowered – you will of course get the lower price!You can book as follows: Hotel Kong Arthur****Nørre Søgade 111370 København K 45 3395 7720Email: mailto:[email protected] the Copenhagen lakes, close to Nørreport Station, train and Metro. Hotel Kong Arthur is an optimum location for your business, leisure and meeting needs.Patio with service and 3 restaurants in connection with the hotel. We have put all our experience as well as heart and soul into creating a haven for those who are looking for high quality combined with real Danish hospitality.