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Оксана Колосовська

Dmytro Shymkiv: Darnitsa creates a digital platform for collecting data on adverse drug reactions

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ZAO Darnitsa is concluding the creation of a digital platform for collecting data on adverse drug reactions.

Commenting on this news, the chairman of the Darnitsa Group board of directors Dmytro Shymkiv emphasized that safety of patients is paramount for "Darnitsa". Therefore, the cloud version of the storage has the highest level of protection. The digital platform was developed as part of the large-scale digitalization of the concern, which also includes monitoring of the use of medicines. 

Dmytro Shymkiv said that on this platform collecting and exchanging data will be carried out jointly with the State Expert Center of the Ministry of Health in the international E2B format. Monitoring the safety of drug use begins from the moment of its development and research and continues at the stages of sale on the market and direct use. It is aimed at identifying and analyzing adverse reactions of the body when using drugs. The monitoring process  involves regulators, pharmaceutical companies, doctors, patients and pharmacists. The manufacturer is responsible for the implementation of pharmaceutical surveillance and is expected to inform the regulatory authorities of each occurrence of adverse reactions.

According to Shymkiv, the digitalization of the pharmaceutical concern brings closer the creation of a unified database of notifications related to the use of medicines. Analysis of this data will prevent occurence of unwanted side effects.  In addition, digitalization of pharmaceutical surveillance increases the transparency of the monitoring process as well as the efficiency of interaction with foreign regulators. The top manager also explained that the pharmaceutical company Darnitsa needs to become a part of the global pharmaceutical surveillance system in order to accelerate penetration to the markets of countries with tough regulatory policies. The Darnitsa Group's surveillance system now includes monitoring of the use of drugs in limited markets. This is a competitive advantage that can strengthen the export potential of ZAO Darnitsa.

Dmytro Shymkiv envisions that by mid-2021 they are due to have accomplished a training for patients, doctors and medical representatives to enable them to work with the digital platform.

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Monitoring of the use of medicines.

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