Employees of the State Expert Center 01.04.22 held an online seminar for investigators and members of ethics committees: "Good Clinical Practice (GCP). Regulatory framework for conducting clinical trials in Ukraine".
Such seminars are held in fulfillment of the statutory tasks of the Center in order to explain the main provisions of international requirements for conducting clinical trials – ICH GCP ("Guideline. Medicinal Products. Good Clinical Practice ST-N MoH of Ukraine 42-7.0:2008", approved by MoH order No. 95 of 16.02.2009, as amended by MoH order of 26.09.2017 No. 1169) and the requirements of MoH order of 23.09.2009 No. 690 "On Approval of the Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Clinical Trial Materials and the Model Regulations on Ethics Committees", as amended.
47 attendees took part in the seminar. Staff of the Department for Expert Evaluation of Preclinical and Clinical Trial Materials and the Directorate for Audit of Laboratory and Clinical Practices (GLP, GCP) delivered 7 presentations, which also outlined the specifics of conducting clinical trials in Ukraine under present-day conditions (martial law, quarantine restrictions, etc.).
