Improve Ukraine’s position in the field of international clinical research

02/ 09/ 2019

The Clinical Trial Subcommittee promotes the dialogue of international pharmaceutical business with government agencies to further develop this field in Ukraine

One of the key priorities of the Clinical Trials Subcommittee of European Business Association is to create a platform for free exchange of views between representatives of government agencies and the clinical research business to facilitate an open dialogue. In particular, an example of such an interaction is the meeting of the management and experts of the clinical research department of the world-wide pharmaceutical company Bayer with the management of SE “State Expert Center of the Ministry of Health of Ukraine”, which was organized with the support of the EBA Clinical Trials Subcommittee. The discussion touched upon such important issues as the improvement of processes in clinical research sites, the prospects of introducing electronic records, the criticality of reducing the time of examination, approval and initiation of clinical trials. Improvement in these issues would significantly reinforce Ukraine’s position as an international clinical research venue.

See below more details about this meeting.

The visit of Joachim Luithle, PhD, Head of Clinical Development Operations of Bayer, and Klaus-Gustav Beinhauer, PhD, Head of Site Management European cluster, to Ukraine

In early July, Joachim Luithle, Head of Clinical Development Operations of Bayer, and Klaus-Gustav Beinhauer, Head of Site Management European cluster, visited Ukraine. It was the first visit of such level.

During the visit, Joachim Luithle visited one of the research centers of Kyiv, which is involved in clinical trials conducted by Bayer in Ukraine. During co-monitoring visit, he noticed that he saw directions for improving the internal processes of conducting the trial, maintaining documentation and the need for a deeper transition to electronic document circulation. Automation of processes and transition from paper to digital is one of Bayer’s priorities for clinical studies in the nearest future.

Representatives of Bayer also conducted a meeting with the managers of the State Enterprise “State Expert Center of the Ministry of Health of Ukraine” (hereinafter referred to as “the SEC”) and Irina Magdik an Executive Director of the Clinical Trials Subcommittee of European Business Association.

SEC is a regulatory authority and one of the key stakeholders in obtaining permission to conduct clinical trials in Ukraine. At this meeting, the managers of the SEC provided current information on conducting clinical trials in Ukraine, a procedure for monitoring the quality of trials, acquainted with changes in the structure and activities of the SEC, current achievements and future plans. They talked about the participation of the SEC representatives in international meetings and joint inspections with international agencies such as FDA and EMA (European Medicines Agency). Representatives of Bayer shared the mission and goals of the company facing the global manufacturer of innovative medicines. Anatolii Lisovskyi, Country Head of Site Management of Bayer in Ukraine, presented the structure of the company, its main therapeutic directions in the development of medicines. Joachim Luithle stressed the intention to involve Ukraine in the list of participating countries in clinical trials conducted by Bayer and told about future of clinical trials.

The reports of the speakers caused a discussion among the participants of the meeting, raised the important issue of how to make Ukraine more attractive to clinical research for world pharmaceutical companies. The emphasis placed on the fact that the terms of approval of clinical trials are one of the important criteria for choosing countries to participate. Liudmyla Kovtun, Deputy Director for Clinical Affairs, confirmed her intention to continue work on shortening the terms of examination of clinical trial materials, which was an important condition for increasing the competitiveness of Ukraine at the international level in the context of conducting clinical trials. She also invited Mr. Luithle to take part in the sixth scientific and practical conference with international participation “Clinical Trials of Medicines in Ukraine”, planned to be conducted by the SEC in 2020.

Joachim Luithle expressed his gratitude for the dialogue and confidence that such meetings would contribute to making positive decisions on Ukraine’s inclusion in the list of countries participating in the future clinical trials of Bayer and other international pharmaceutical companies.

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