GMP and FDA Compliance in Pharmaceutical Development and IMP Manufacturing 23-24 September 2010 Vienna, Austria 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,--)
Objectives During this Course, specialists from the pharmaceutical industry and a former FDA Compliance Officer will share their expert knowledge about all important GMP aspects in Pharmaceutical Development and IMP Manufacturing. You will be able to elaborate and discuss both EU and FDA requirements. Background Not only in the manufacturing of marketed products (c)GMP-Compliance is mandatory. Also in the manufacturing of IMP supplies, compliance with the applicable GMP-Guidelines is obligatory. But which GMP requirements are the applicable ones? And do the requirements differ from clinical phase 1 to phase 3? A lot of data gained in the development studies will later be documented in the CMC part of the submission and many development lots are produced on the same equipment where clinical trial batches are manufactured. Complex challenges have to be faced to guarantee high quality products. The safety of the drug and hence the patient should be in the focus. Terminated studies or studies without usable results will lead to extensive extra costs and delays in the whole development and approval process. This course has been designed by the ECA to broaden your knowledge and to consolidate the various GMP aspects which need to be considered in a successful development of a new pharmaceutical product.