Dr. Sergii Rasputniak
Head of Laboratory and Clinical Practices (GLP, GCP) Audit Office at the State Expert Center of the Ministry of Health, Ukraine
Dr. Sergii Rasputniak was born in Chernihiv, Ukraine. After graduation from National Medical University, Kyiv in 1997 Dr. Rasputniak started his career as an urologist-oncologist in Ukrainian National Institute of Urology, Kyiv. Since 1999 Dr. Rasputniak moved to Ukrainian Regulatory Authority - State Expert Center of the Ministry of Health of Ukraine. Dr. Rasputniak had different positions within RA and now he is the Head Laboratory and Clinical Practices (GLP, GCP) Audit Office of the State Expert Center of the Ministry of Health of Ukraine. Dr. Rasputniak contributed to development of the local legislation for clinical research and it’s adaptation to ICH-GCP, international standards and harmonization with EU requirements. In his current position Dr. Rasputniak is responsible and focused on conduction of inspections and clinical audits of national, multinational and global clinical trials (phases 1 – 4) as well as non-interventional clinical research in Ukraine. Dr. Rasputniak is author of 65 publications, personally performed more than 450 inspections (clinical audits) of different clinical trials and sites in Ukraine, continuously participates in FDA-, EMA- and PMDA-inspections.
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