Clinical Trials of Pharmaceutical Products in Ukraine
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FOCUS ON EASTERN EUROPE AND CENTRAL ASIA: MEETING REPORT
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Clinical Trials of Pharmaceutical Products in Ukraine Meeting Report from the First National Scientific and Practical Conference; 2–3 November 2006; Kiev, Ukraine Yurii I. Kundiiev,1 Peter N. Vitte2 and Francis P. Crawley3 1 2 3
National Bioethics Committee of Ukraine, Kiev, Ukraine Information Centre on Bioethics, Kiev, Ukraine Good Clinical Practice Alliance – Europe, Brussels, Belgium
The First Scientific and Practical Conference on Clinical Trials of Pharmaceutical Products in Ukraine was held in Kiev on 2–3 November, 2006 and has played an essential role in the establishment of and interaction between ethics committees of different levels and profiles within Ukraine. The conference was attended by approximately 600 participants from 10 countries, and was a unique chance for experts and physicians to share their knowledge and experiences. The event included 13 sessions, six roundtable discussions, two master-classes and three training workshops/seminars. At the opening ceremony, Professor Yurii Kundiiev, the Head of the National Bioethics Committee and Vice-President of the Academy of the Medical Sciences of Ukraine, opened the conference by stressing the importance of protecting human rights and dignity within the scope of clinical trials. The World Health Organization (WHO) representative, Dr Nina Sautenkova, then turned the attention of participants towards establishing Ukraine as a leader in national pharmaceutical policy. The Head of the International Commission on the Standardization and Quality Assurance of Pharmaceutical Products of the Commonwealth of Independent States (CIS)1, Professor Victor Dmitriev, reported that the number of clinical trials being undertaken within the CIS has rapidly increased over the last few years. This has resulted in many significant benefits for all the parties concerned, including patients, physicians, hospitals and countries.
The main opening report of the conference was given by the Director of the State Pharmacological Center of the Ministry of Health of Ukraine, Professor Victor Chumak. The title of his lecture was the Circulation of Pharmaceutical Products in Ukraine: Problems and Perspectives. He discussed the legislative pyramid of laws, regulations and orders that are relevant to the clinical trials mechanism. He reminded attendees of the seventh article of the National Law About Approval of Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Materials Pertinent to Clinical Trials and Model Regulations of the Ethics Committee and the Order of the Cabinet of Ministers of Ukraine No. 375 from 2005, which introduced this law into clinical practice. He then went on to report that there are already 20 000 registered trademarked medications available in Ukraine. The State Pharmacological Center within the Ministry of Health of Ukraine has given a great deal of attention to the rules of Good Laboratory Practice (GLP), Goo
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