Within the framework of the Strategic Sector Cooperation between Ukraine and the Kingdom of Denmark, specialists of the State Expert Center of the Ministry of Health of Ukraine are participating in a seminar on clinical trials. The training takes place at the Danish Medicines Agency (DKMA).
The visit to Denmark is part of the Center's systematic work on developing expert capacity, studying modern European regulatory approaches and further harmonizing the national system of medicinal products regulation with the legislation of the European Union.
The seminar program covers a wide range of issues related to the organization and expert evaluation of clinical trials in EU countries.
During the first day, special attention was paid to the organization of the clinical trials system in Denmark and the interaction between the Danish Agency and the National Committee on Health Research Ethics. Together with colleagues, the practical application of the requirements of European legislation in the field of clinical trials, current EU initiatives and mechanisms of cooperation between regulators and ethics committees were discussed.
As part of the visit, the Ukrainian delegation presented the Center's practices in the expert evaluation of clinical trial materials. Particular attention was paid to the transformation of the medicinal products regulatory system in Ukraine, in particular in the context of future institutional changes, the establishment of a new state control body and the harmonisation of clinical trial procedures with European approaches.
The Center consistently continues to develop international partnership and to engage in professional initiatives that contribute to strengthening expert capacity and further bringing the national regulatory system closer to European standards.
Participation in such trainings allows the Center's specialists to deepen their professional knowledge and adopt the best European practices that can be adapted to the Ukrainian healthcare system.
Ahead are three more days of a packed programme, new practices and insights.
We thank our Danish partners for their support and cooperation.
