Darnitsa plans to focus on improving and enhancing standards for document preparation, clinical trials, quality assurance and market authorization of drugs and monitoring of their use. This was stated by Dmytro Shymkiv, the chairman of the board of directors of the company.
The pharmaceutical company Darnitsa became a member of the Regulatory Affairs Professionals Society (RAPS), the world’s largest organization of professionals of regulation in the field of health care and related products (medicines, medical devices, biological preparations and food products). The RAPS is headquartered in the United States near Washington with offices and affiliates around the world. Founded in 1976, the RAPS is a non-profit organization that develops regulatory professional standards, conducts researches, promotes knowledge sharing and networking, and provides a regulatory affairs certification (RAC).
According to the top manager, within the framework of participation in the global network, the corporation plans to focus on improving and enhancing standards for document preparation, clinical trials, quality assurance and market authorization of drugs and monitoring of their use.
In an emergency situation in the global health care system caused by the COVID-19 pandemic, regulatory affairs professionals in all countries are facing new challenges. The RAPS has the necessary resources to overcome them. By joining this global network, Darnitsa has opened up new opportunities for improving professional competencies in this area. Due to the increased standards of work in the regulatory sphere, the Ukrainian pharmaceutical concern received additional tools to expand the availability of safe and effective medicines.
Despite the times of crisis, Darnitsa Group continues to actively invest in new research and development. Moreover, the pandemic gave impetus to the implementation of projects that were previously only discussed. Now the pharmaceutical company Darnitsa is systematically introducing the latest IT technologies into its production, working on increasing the number of in silico studies, which are based on computer modelling of biological experiments. All this will make it possible to predict the consequences of diseases and the outcome of therapy faster and more accurately, which means that the pharmaceutical industry will be able to produce new, much more effective medicines with fewer side effects.
