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ICH Topic E 6 (R1) Guideline for Good Clinical Practice, Section 2.1

Clinical and Diagnostics Center


Clinical and Diagnostics Center was established in 2000 as a subdivision of National University of Pharmacy (NUPh). It functions according to Medical Practice License and is regulated by “The Statute of Clinical and Diagnostics Center of NUPh” which was approved by the Ministry of Health of Ukraine. Clinical and Diagnostics Center of NUPh was accredited as the medical and prophylactic establishment of the highest category by the Head of accreditation committee of the Ministry of Health of Ukraine. It was also approved by the Resolution of Cabinet of Ministers No 501 from 16 May 2011 in the list of the healthcare establishments and programs which provide the fulfillment of state functions.In Clinical and Diagnostics Center there was founded the local ethical committee which works in a strict accordance with the requirements of the Ukrainian legislation and international rules of ICH GCP. We have gained wide experience in carrying out Phase I−IV trials and bioequivalence studies of drugs. We collaborate both with national manufactures and foreign companies from the USA, Great Britain, Germany, France, Sweden, Switzerland, Spain, Latvia, Poland, Croatia, Russia.
"Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s)".

CERTIFICATES






Igor A. Zupanets

Under the leadership of Prof. Zupanets there were defended 5 doctoral theses and 20 PhD theses. As a result of scientific establishment research there were created more than 22 drugs which are now on different stages of marketing introduction. At the site there were conducted more than 50 trials of Phase I−IV and bioequivalence studies of drugs as well.

5

DOCTORAL THESES


20

PhD THESES


22

DRUGS WAS CREATED


ICH Topic E 6 (R1) Guideline for Good Clinical Practice, Section 2.1

Medical staff


Clinical and Diagnostics Center is equipped with the diagnostic facilities The investigational team of Clinical and Diagnostics Center includes 3 Doctors of Medical (Pharmacy) Sciences, 9 PhD, 4 MD Investigators and 6 trial nurses. All investigators and trial nurses were certified for the highest qualification category. The resuscitation specialists and clinical pharmacists are also included in the staff. Altogether there are 26 persons. The study coordinator provides the coherence of the trial, and quality-control specialist is responsible for the quality of procedures. All investigators have passed clinical trials training courses and have got GCP certifications. Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s).

Equipment


Clinical and Diagnostics Center is equipped with the diagnostic facilities which are necessary for the clinical trials. During clinical trial of drug formulations «Terumo» Japan infusion pumps with the programmed regimen of intravenous drug infusion are used. Samples of blood plasma are separated in the refrigerator centrifuges «MPW 350R» and placed in the prelabeled tubes. The frozen blood and urine samples are stored at −80 °C in the refrigerator «JOUAN» before their shipment to the pharmacokinetic laboratory. This facility is additionally equipped with the system of back-up power supply. There are also two additional refrigerators with the temperature range from −20 °C to −80 °C. The samples of biological duplicates are stored at least 1 year after the end of the study. Clinical and Diagnostics Center has its own certified clinical laboratory which is equipped with the modern laboratory facilities capable to determine the basic laboratory tests very quickly. All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification.
ICH Topic E 6 (R1) Guideline for Good Clinical Practice, Section 2.1