Biotechnology for Non-Biotechnologists 23 - 24 March 2010 Barcelona, Spain Please click here to view the program of this conference or course To book for this program, just click on the option: Book this option: Non-ECA Members (EUR 1690,--) Book this option: ECA Members (EUR 1521,--) Book this option: EU GMP Inspectorates (EUR 845,--) Book this option: APIC Members (does not include ECA Membership) (EUR 1605,--)
At this conference we offer a Conference Exhibition. Please click here in order to view the registration form (PDF) for exhibitors.
Objectives This course will provide Non-Biotechnologists with an overview and insight in pharmaceutical biotechnology. It will also present the opportunities of biotechnology in GMP manufacturing. Common aspects of production analytics will be discussed just as well as regulatory aspects of Biopharmaceuticals (bacteria and cell culture) and specific requirements on clinical studies and marketing authorisation. It will furthermore concentrate on topics like virus reduction, cell banking, media fills and dedicated rooms and personnel. The course will be completed by a presentation of the current comprehensive bodies of legislation. Background From a historical view, Biopharmaceuticals are no new business. Antibiotics and vaccines have been well known for more than 60 years. But with the marketing authorisation of the first pharmaceutical product, produced by gene technology in the 80s, a new era of biopharmaceutical and biotechnological development and manufacturing started. In 2007, 204521342f all new released pharmaceuticals were Biopharmaceuticals. Future pharmaceutical products based on Biotechnology and the Biosimilars (Biogenerics) will become more and more important and present a higher share of pharmaceutical products