Fabrice Romanet

Senior Vice President, Head of Program Leadership, Regulatory and Governmental Affairs
Fresenius Kabi Biopharma

Fabrice Romanet is biologist by training and has worked in R&D within the pharmaceutical industry for over 17 years.
Fabrice is now Senior Vice President responsible for heading up the global departments of Program Leadership, Regulatory Affairs and Healthcare Policy at Fresenius Kabi Biopharmaceuticals Business Unit with it’s global HQ based in Eysins, Switzerland. Fresenius Kabi is a division of Fresenius SE which is a large, 100 year old, global healthcare company with over 310,000 employees and over 65 production facilities worldwide. Fresenius Kabi now have biosimilars approved in both the autoimmune and oncology domain and have a broad and exciting pipeline of future biosimilars. As an end-to-end developer, Fabrice is especially interested in delivering high quality, affordable biologics to healthcare systems around the world and has extensive experience in liaising with leading health agencies such as EMA, FDA, Health Canada, TGA and MHRA. As an active member of the US associations AAM, Biosimilar Forum and Medicine For Europe, Fabrice has a keen interest in pursuing science-led evolution of regulatory development biosimilar guidelines. Fabrice believes that streamlining the root to approval for biosimilars is of paramount importance to futureproof biosimilars.

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