Specialists of the State Expert Center of the Ministry of Health of Ukraine took part in the international fellowship program "Efficient and Transparent Medicinal Product Approval Processes", held in Copenhagen. The training took place at the University of Copenhagen with the support of the DANIDA Fellowship Center (DFC).
The program brought together representatives of regulatory authorities from various countries of the world and was dedicated to modern approaches in the field of medicinal product regulation, pharmaceutical policy and assessment of the quality of medicines.
During the training, the participants considered the issues of transparency of regulatory procedures, global clinical development, and access of medicinal products to the market. Particular attention was paid to methods of assessing the benefit-risk balance, mutual recognition procedures, the use of decentralized tools in clinical trials, as well as modern approaches to communication on medicinal product safety issues.
The program also focused on updates to international guidelines, in particular ICH M4Q (R2), which provides for improving the structure of the registration dossier and enhancing the management of data on the quality of medicinal products.
Particular attention was paid to the digitalisation of regulatory processes. Participants became acquainted with approaches to the use of cloud platforms and artificial intelligence in regulatory activity. In particular, 10 of the principles developed by the EMA and the FDA were presented regarding the use of artificial intelligence at all stages of the medicinal product lifecycle – from development to pharmacovigilance.
During a separate meeting, the Ukrainian delegation presented approaches to harmonising legislation with EU norms in the field of registration and clinical trials of medicinal products and presented the activities of the State Expert Center of the Ministry of Health of Ukraine.
As part of the programme, participants also became acquainted with the work of the Danish Medicines Agency, visited a local pharmacy and the production facilities of the company Novo Nordisk.
From the Center, specialists of the Department of Expert Evaluation of Registration Materials and the Department of Expert Evaluation of Materials of Preclinical and Clinical Trials took part in the training.
The knowledge and experience gained will contribute to the improvement of regulatory procedures and the further integration of Ukraine into the European regulatory space.
