Simona Stankeviciute, MD, MSc

Simona Stankeviciute, MD, MSc

Simona Stankeviciute, MD, MSc

Principal Consultant

Simona is a Principal Consultant at Parexel, helping out with drug development at various stages: from opening an IND or submitting a CTA to MAA or NDA/BLA submission, provides help with interactions with regulatory agencies, performs gap analyses

Work experience

Simona has over five years of experience as a clinical assessor in the EMA and complex experience in clinical and regulatory research and development (R&D). She was trained in health technology assessment for medicines and served as an assessor for Health technology assessment (HTA) submissions.

Prior to joining Parexel, Simona has been a clinical pharmacology and clinical assessor, working on European Medicines Agency (EMA) submissions and Marketing Applications (MAAs), line extensions, Type II variations, Scientific Advice, assessing clinical part of these applications. She has served as an alternate member of the CHMP. She has expertise in regulatory review and drug development experience in multiple indications, including Dermatology, Neurology (Multiple Sclerosis), Infectious Diseases, ATMPs, Nephrology, Haematology, Oncology, Cardiovascular medicines, for biologics and small molecules.

Education

Simona is a medical doctor, also trained in clinical pharmacology. She is an expert in preparation for and conduct of Scientific Advice meetings with EMA and his areas or expertise include clinical pharmacology, including advanced pharmacokinetics and pharmacodynamics, and basic modelling/simulation.

She has a Master of Biomedical Sciences and Medical Doctor degree at Lithuanian University of Health Sciences, Kaunas.

We are always available for a conversation.

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We are always available for a conversation.

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