Simona Stankeviciute, M.D., M.Sc.

Principal Consultant, Regulatory Strategy

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Prior to joining Parexel, Simona served as a clinical and clinical pharmacology assessor for centralized procedures at the Lithuanian State Medicines Control Agency, and she served as an alternate member of EMA’s Committee for Medicinal Products for Human Use. She was also trained in health-technology assessment for medicines and has served as a head of HTA unit. She has regulatory and clinical expertise in multiple therapeutic areas—including dermatology, neurology, and infectious disease—and modalities, including advanced therapy medicinal products, biologics, and small molecules. She helps Parexel clients prepare for scientific advice meetings with the EMA; submit marketing-authorization applications, line extensions, and Type II variations; and perform advanced pharmacokinetics, pharmacodynamics, and basic modeling and simulations. In addition to experience with the EU regulators, Simona has had supported many sponsors with their clinical programs in the US, including interactions with US FDA.