The Darnytsia closed joint-stock company (CJSC) is about to complete the work on creating a digital platform for collecting data on the drug side effects. Commenting on this news, the head of the Board of Directors of the Darnytsia Group, Dmytro Shymkiv, underlined that for Darnytsia, the patients’ safety is its priority number one. Therefore, the cloud version of the storage has the highest level of protection. The digital platform was being developed as part of the large-scale digitalization of the concern, including monitoring the medicine use.
Dmytro Shymkiv reported that data collection and exchange on this platform would be carried out jointly with the State Expert Center of the Ministry of Public Health in the international E2B format. Monitoring of the medicine safety use starts from development and research and continues at the stages of market sales and direct usage stages. It focuses on identifying and analyzing adverse reactions of the body when using drugs.
The monitoring process involves such entities as regulatory authorities, pharmaceutical companies, doctors, patients, and pharmacists. The manufacturer is responsible for implementing pharmaceutical supervision and informs the regulatory authorities of each occurrence of side effects.
According to Shymkiv’s speech, the digitalization of the pharmaceutical concern brings fulfillment of an idea to create a unified database of notifications related to the use of medicines. Analyzing this data will prevent the occurrence of unwanted adverse reactions. In addition, the digitalization of pharmaceutical supervision increases the transparency of monitoring and the efficiency of interaction with foreign regulatory authorities.
The top manager also explained that the Darnytsia pharmaceutical company needs to become a part of the global pharmaceutical supervision system in order to speed up the process of entering the markets of countries with strict regulatory policies.
Nowadays, the Darnytsia Group’s supervision system involves monitoring medicine use in organic markets and some EU countries. It is regarded as a competitive advantage, due to which there is an opportunity to enhance the export capacity of Darnytsia CJSC.
Dmytro Shymkiv also shared plans according to which the pharmaceutical concern intends to conduct training on working with the digital platform for patients, doctors, and medical representatives by mid-2021.