Kolodyezna T. Substantiation of scientific and methodological approaches to improving the quality management of clinical trials of drugs

Українська версія

Thesis for the degree of Doctor of Philosophy (PhD)

State registration number

0821U101958

Thesis Registration Form

0821U101958.pdf

Applicant for

Specialization

  • 226 - Фармація, промислова фармація

24-06-2021

Specialized Academic Board

ДФ 64.605.020

National University of Pharmacy

Essay

The dissertation is devoted to the scientific substantiation of methodical approaches to quality management of clinical trials (CT) of drugs by studying the current state of implementation of quality management systems (QMS) in CT in Ukraine, introduction of practical methods of risk management for research using the CAPA-planning tool, development of a methodological basis for work on improving the procedure for obtaining informed consent (IC), identification of obstacles in the communication processes that accompany the organization and conducting of CT and development of tools to overcome them

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Files

autoreferat-anotacija_kolodiezna-tju.pdf

дисертація Колодєзна ТЮ_new.pdf

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