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The digitalization of the pharmacovigilance of medicines will enable manufacturers to ensure the maximum safety of medicines, - expert

19 January 2021

Synchronizing Ukrainian legislation in the field of pharmacovigilance with the provisions of EU legislation will allow Ukrainian pharmaceutical companies to improve the quality and safety of medicines. Oleksandr Torhun, the head of the department for regulatory issues of "Darnitsa" pharmaceutical company, said this in an interview to the business portal Pharma.net.ua.

He reminded that a process to improve the legislation of Ukraine in the field of pharmacovigilance of medicines was launched at the end of December 2020. The participants included the authorized body of the State Enterprise "State Expert Center of the Ministry of Health of Ukraine" and business representatives - the European Business Association, the Association of Representatives of International Pharmaceutical Manufacturers of Ukraine, the American Chamber of Commerce in Ukraine, the Association "Ukrainian Medicines Producers", NGO "Association of Indian Pharmaceutical Manufacturers" ( IRMA), GS Association of Innovative Medicines Manufacturers.

This process, according to Torhun, is aimed at harmonizing Ukrainian legislation with the provisions of EU legislation. He also mentioned other issues that were being discussed - digitalization of the national pharmacovigilance system, data exchange, both at the state level and between the regulatory body and drug manufacturers. These are key aspects of drug safety control.

Darnitsa is aiming to establish a more flexible and modern business model with a focus on the patient. Moving in this direction we use advanced solutions to increase transparency of the monitoring process of the use of drugs and the safety of treatment in general. The main tasks of the IT product for pharmacovigilance are: the ability to digitize data on adverse reactions, have constant and uninterrupted access to the data and the ability to exchange it with the State Enterprise "State Expert Center of the Ministry of Health of Ukraine" in the electronic format accepted throughout the world. This feature is implemented in partnership with the OtiPharm Data Pro project. In addition, digitalization of pharmacovigilance processes helps to focus on two important components: patients affairs and patient care. That is, any appeal of a patient or a doctor will be worked out and a comprehensive assistance will be provided," Torhun said.

He also added that nowadays the world is actively discussing new opportunities for collecting data for pharmacovigilance and there are various projects already that in the near future may become a usual everyday occurrence in Ukraine.

"For example, the collection of data on adverse reactions and adverse events through social networks, Facebook and Twitter, in particular. Such approaches will greatly simplify the collection of information and filing of applications, increasing the role of a patient in pharmacovigilance. Since Darnitsa is patient-centered, we are constantly studying best practices and new ideas. The digital transformation of pharmacovigilance means we will continue to improve in order to ensure the maximum level of quality and safety of our medicines," explained Oleksandr Torhun.

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