Taisa Herasymchuk
Director of the Department
The main purpose of the structural unit's activities is
- Expert evaluation of clinical trial materials (protocols, substantial amendments);
- Analysis of adverse reactions during clinical trials of medicinal products;
- Oversight of the conduct of clinical trials of medicinal products in Ukraine in accordance with regulatory requirements;
- Expert evaluation of preclinical study materials;
- Development of regulatory documents in the field of clinical trials, implementation of international requirements for conducting clinical trials and preclinical studies of medicinal products;
The main tasks of the Department are
- Receipt of clinical trial materials for expert evaluation in order to prepare summary conclusions on the conduct of clinical trials/substantial amendments;
- Organization of the expert evaluation of clinical trial materials;
- Conducting expert evaluation of preclinical study materials and audit of preclinical studies of medicinal products in accordance with current regulatory requirements;
- Organization of work on the collection, registration and analysis of reports of adverse reactions during clinical trials of medicinal products;
- Scientific and organizational work on developing regulatory documents, technical requirements, guidelines, and resolutions on the organization, conduct, and analysis of clinical trials and preclinical studies of medicinal products, and on oversight of studies. Participation in developing drafts of regulatory and legislative acts and instructions, and their revisions;
- Performing other functions necessary to achieve the goals of the Department's activities.
The Department includes
Department for Specialized Evaluation of Preclinical and Clinical Trial Materials
Olha Smoliar
Head of Department
Department for Preliminary Evaluation of Preclinical and Clinical Trial Materials
Tetiana Fedorchuk
Head of Department
Department for Expert Evaluation of the Quality of Materials for Clinical Trials
Liliia Komar
Acting Head of Department
Department for Coordination of Local Ethics Committees and Monitoring of Adverse Reactions
Yurii Shemetylo
Head of Department
Organizational sector
Mykola Kondratiuk
Head of sector
Sector for expert evaluation of preclinical study materials
