Dr. Silvia Casagrande works as Clinical Evidence Manager in the Clinical Affairs department in Orthofix SRL. In her role Silvia defines and execute the clinical strategy for CE marking & FDA clearance/approval products in development, manages the preparation and update of CERs, PMCF plans and reports, and SSCPs. She is also involved in the preparation of operative techniques and Instructions For Use leaflets. Before she worked as Clinical Regulatory Lead in the Global Regulatory Compliance team in BSI where she was involved in the development of the processes for clinical evaluation and post-market requirements and in monitoring, maintaining and improving these processes. She also contributed to regulatory supervision of clinical oversight process and delivered internal training in these areas.
Silvia holds a MSc in Pharmaceutical Biotechnology from University of Padua, Italy and a PhD in Cancer Biology from ETH Zurich, Switzerland.