A seminar on laws and regulations of clinical trials took place in TSMU

On September 8, 2017 specialists of the State Expert Center of the Ministry of Health of Ukraine gave in Ternopil State Medical University a seminar Good Clinical Practice (GCP), Laws and Regulations for Conducting Clinical Trials.

 

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Deputy Director of the Clinical Issues Department Liudmyla Kovtun  in her presentation examined in detail the issues of legal regulation for conducting of clinical trials, the introduction of Good Clinical Practice in Ukraine, reviewed types and phases of clinical trials, the duties of the researcher and the documents accompanying the clinical trial.

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Lesia Yankova, Director of the Department of Clinical Trials Materials Expertise, overviewed ethical aspects of clinical trials. She also focused on clinical trial audits, including ones offered by SEC.

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As a part of their visit to TSMU, representatives of the State Expert Center of the Ministry of Health of Ukraine met with its rector Professor Mykhaylo Korda. During the meeting, they discussed administration of clinical and preclinical studies at carried out by university-affiliated researchers.