Department of Audit of Clinical and Preclinical Studies and Pharmacovigilance Systems

Myroslava Ohloblina

Head of Division

202-17-00 / 5000 ogloblina@dec.gov.ua

Serhii Rasputniak

Deputy Head of the Division

202-17-00 / 1011 rasputnyak@dec.gov.ua

Department of Clinical Audit of Clinical and Preclinical Studies

Department for audit of the applicants' pharmacovigilance system

Alla Obrebska

Head of Department

202-17-00 / 7301 obrebska@dec.gov.ua

The main purpose of the structural unit's activities is

• Monitoring of clinical trials of medicinal products in Ukraine in accordance with regulatory requirements by conducting clinical audits (GCP inspections) of compliance with Good Clinical Practice (GCP);
• Monitoring preclinical studies in Ukraine for compliance with regulatory requirements by conducting audits of preclinical study;
• Monitoring of the applicant's pharmacovigilance in accordance with regulatory requirements by auditing the applicant's pharmacovigilance system;
• Development of regulatory documents in the field of clinical trials of medicinal products, implementation of international requirements for conducting clinical trials of medicinal products and preclinical studies of medicinal products;
• Development of methodological approaches to the organization, conduct, and analysis of clinical trials and preclinical studies of medicinal products, and oversight of studies;
• Educational activities – organizing seminars and conferences, publications, and providing advisory and methodological assistance.

The main tasks of the Division are

• Conducting clinical audits of clinical trials of medicinal products and audits of preclinical studies of medicinal products in accordance with regulatory requirements;
• Conducting audits of applicants' pharmacovigilance systems (scheduled, targeted) in accordance with regulatory requirements;
• Conducting scientific and organizational work on developing regulatory documents, technical requirements, guidelines and resolutions on the organization, conduct and control of clinical trials and preclinical studies of medicinal products, and audit of the applicant's pharmacovigilance system;
•  Participation in implementing the processes of harmonization of technical requirements, guidelines, resolutions and recommendations adopted in the EU regarding preclinical studies and clinical trials of medicinal products;
• Participation in organizing and conducting seminars, international symposia, conferences, etc. on issues within the competence of the Department;
• Publishes materials on the conduct of preclinical studies and clinical trials of medicinal products with the aim of implementing international standards (GLP and GCP);
• Performs other functions necessary for carrying out its activities.