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The dissertation examines scientific, regulatory and scientific-practical rules and norms that determine the place, role, participation and functions of masters of pharmacy in clinical trials of medicinal products in humans. The place of the pharmacist in the observance of the scientific requirements for quality in the planning, conducting, reporting and reporting of clinical trials, the production of research medicinal products, in accordance with the Good Manufacturing and Good Laboratory Practice, ethical norms and standards, the activities of the Commissions have been studied in great detail. on ethics, monitoring, preparation of the Researcher's Brochure, control, sanctions, etc., which makes the work modern and up-to-date.. The developed dissertation thesis outlines the conclusion that both in Bulgaria and worldwide, the role and participation of the pharmacist in clinical trials of medicinal products have not been studied, described and analyzed in sufficient detail. For the first time a comprehensive and exhaustive regulatory, scientific and practical analysis of the role and participation of the pharmacist in clinical trials of medicinal products in Bulgaria has been made. The conducted research allows the formulation of specific recommendations for the development of training of students for the educational qualification degree "Master" in the professional field "Pharmacy" and can help to specialize and develop new areas of realization.
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