During the year, the main operational focus was on implementing the new organizational structure of Merck Serono in R&D, which now comprises two major functions. The Global Research and Early Development function is responsible for projects in discovery and pre-clinical stages through to Proof of Confidence, when the available clinical data are judged sufficient to justify significant investment in large-scale clinical development. In this function teams are clustered around certain therapeutic areas as well as platform technologies. The Global Development and Medical function is responsible for the late-stage clinical development of products, managing their submissions to regulatory authorities and then overseeing the post-approval lifecycle management. The main disciplines included in this function are clinical development regulatory, safety, as well as medical and scientific affairs. It also includes the quality function which ensures compliance with state-of-the-art Good Practices (Laboratory, Clinical and Manufacturing).
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