From the Belarus Ministry of Health Dear Colleagues! Every year, more and more drug clinical trials are done in the Republic of Belarus. The Ministry of Health in The Republic of Belarus empowered UE “Center for Examination and Tests in Health Services" to conduct government control (documentation review, clinical trials monitoring, inspection of clinical data system) of the process. The most essential issue of governmental regulation of clinical studies is to ensure high quality of their performance. It means a variety of regular and systematic activities, developed to ensure compliance of clinical study realization, data analysis, documentation and study results submission to trilateral ICH GCP Guidelines and Ministry of Health in Republic of Belarus Order # 254 of 13 August 1999. Today the Republic of Belarus can boast of a well developed system of quality assurance of drug clinical studies. Although, in this sphere there are still many issues, and their resolving claim international cooperation and demand exchange of experience, gained in different countries. In August 2008 MB-Quest/Pharm-Olam Group, one of the largest Clinical Research Organizations on Russian and Belorussian market, held a five-day Open Training-Seminar, devoted to monitoring, supervision and quality assurance of multicenter drug clinical trials in compliance with ICH GCP standards. Concerned specialists from Russia, Ukraine, Belarus and Kazakhstan took part in the Seminar. The meeting had an atmosphere of mutual interest and goodwill and let to the full extent to get familiarized with national peculiarities of drug clinical studies in the Russian Federation at the stages of planning, realization and quality control. During the meeting questions were highlighted such as Phase (I-IV) of drug clinical studies, study design peculiarities, and ethical issues. As well as, algorithm of monitoring visits planning, quality control and assurance of compliance with international and national clinical study requirements were discussed. As for our country, the issues discussed at the meeting are of great importance, as the number of clinical trials submissions for approval to Ministry of Health in the Republic of Belarus from leading foreign Pharmaceutical Companies and large Clinical Research Organizations with the request to permit to conduct multicenter drug clinical trials in the Republic of Belarus are increasing. This fact shows that our country has really good possibilities in the field of quality control and quality assurance of complicated and important trials as well as in pharmaceutical sphere. Participation in trainings of this kind allows harmonization of methodological procedures with other countries and strategically resolve urgent problems in this serious matter of governmental quality control of drug clinical studies. ALEXANDR STOLIAROV
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