Forum was organized by the Department of Quality Management of the NUPh. Conference participants worked in the sections “Organizational aspects of management in pharmacy” and “Standardization, control and quality assurance in pharmacy” on the following topics:
- trends and prospects of the development of quality management in pharmacy;
- approaches to quality assurance at the stages of life cycle of the medicines (from development and research – the production and sales);
- development and implementation of quality management systems and integrated management systems in pharmaceutical and biotechnology companies, as well as in the enterprises producing medical products;
- training of quality control staff for the pharmaceutical industry;
- organization of the departments o standardization, control, quality assurance and management in pharmaceutical companies;
- risk assessment, monitoring and analysis of the processes of pharmaceutical quality systems;
- audits and self-inspections in the pharmaceutical enterprises;
- approaches, methods and means of organizing and carrying out of qualification activities (of premises, equipment and systems) and validation (of technological processes, cleaning procedures, analytical methods);
- quality assurance of measurements in pharmaceutical laboratories;
- legislative and regulatory activities in the field of circulation of drugs in Ukraine and other countries;
- use of applied methods and tools of quality management in pharmacy.
The conference was held with the participation of pharmaceutical companies, government regulatory agencies, research and educational institutions, gathering about 50 participants. At the plenary session spoke: Director of SE “Ukrainian Scientific Pharmacopoeial Center for quality of drugs”, D.Sc. in Chemistry, Professor O.I. Grizodub with the report “150 years of the British Pharmacopoeia”; Head of the Laboratory for pharmaceutical technology development of “Farmak” company, C.Sc. in Pharmacy, G.I. Borshchevskyi with the report “Physico-chemical studies in standardization of “Lesfal”; Research Laboratory of parenteral and oral liquid medicines, D.Sc. in Pharmacy, Professor L.G. Almakaieva with the report “Development and standardization of domestic reagents for modern radiopharmaceuticals”; C.Sc in Pharmacy, Associate Professor T.V. Krutskikh with the report “Outsourcing activities within the quality system of the company for production of medicines”; C.Sc in Pharmacy, Associate Professor V.O. Lebedynets with the report “Analysis of the new version of ISO 9001 standard and determination of the prospects of changes in the quality management of pharmaceutical companies”; C.Sc in Pharmacy, Associate Professor V.S. Kazakova with the report “On the issue of implementation of quality management systems in local government bodies through the example of healthcare sector”; research scientist of the State scientific-research laboratory of the NUPh for medicinal substances quality control O.O. Zavada with the report “Organized solutions as an instrument in management of chemical process at the stage of pharmaceutical development of the medicinal product”; junior research scientist of the State scientific-research laboratory of the NUPh for medicinal substances quality control I.A. Proskurova with the report “Harmonization of the national requirements to standardization of centaury herb with the requirements of the European Pharmacopoeia.”
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