Purpose of the seminar – to deepen understanding of the updated principles and mandatory provisions of Good Clinical Practice (GCP) and the current regulatory framework for clinical trials in Ukraine. The training is devoted to the updated ICH Guideline for Good Clinical Practice E6 (R3).
Invited to participate are investigators and physicians, members of ethics committees, sponsors and applicants, representatives of pharmaceutical companies and medicinal product manufacturers, scientists, young researchers, and all specialists in the medical and pharmaceutical fields who seek to deepen their knowledge of modern approaches to the organization and conduct of clinical trials.
Organizers and speakers of the GCP seminar: the Agency for Methodological and Scientific-Practical Work in cooperation with specialists of the Department of Expert Evaluation of Preclinical and Clinical Trial Materials and the Audit Department.
In the GCP seminar program
- Regulatory framework for conducting clinical trials. Overview of Section II. Principles of Good Clinical Practice.
- Activities of ethics committees at healthcare institutions in which clinical trials of medicinal products are conducted. Overview of changes to section I. Expert council of a medical institution/independent ethics committee (Annex 1).
- Procedure for obtaining informed consent of the subject. Review of clause 2.8 of section 2. Investigator (Annex 1).
- Clinical trial sites and the research team – regulatory requirements. Overview of changes to Section II, Investigator (Annex 1).
- Clinical trial protocol and Investigator's Brochure. Amendments and clarifications. Appendix A, Appendix B.
- Documents accompanying a clinical trial. Overview of Appendix C. – Essential documents for conducting clinical trials.
- Investigational medicinal product. Review of item 3.15. of section 3, Annex 1.
- Evaluation of safety information on the investigational medicinal product and reporting.
- Computerized systems.
- Investigator's responsibilities (from R2 to R3).
- Sponsor responsibilities. Monitoring. Audit (from R2 to R3).
- Clinical audit of a clinical trial.
PROGRAM
Certificate: After participating in the seminar, each participant will receive a certificate confirming that their knowledge complies with the provisions of the procedure for conducting clinical trials in Ukraine.
Presentation materials of the GCP seminar will be available to attendees upon request.
Registration: to participate, you must fill out the Application and send it electronically in doc / docx format to the Agency for Methodological and Scientific-Practical Work: amsw@dec.gov.ua
Contact person
Svitlana Borodai
Leading Specialist of the Agency for Methodological and Scientific-Practical Work
tel.: +38 (044) 202-17-00 (2251)
e-mail: borodai@dec.gov.ua
Look for more Center seminars in the Plan of External Training Events of the Center for 2026 and book dates in advance.
The purpose of the events — raising professional awareness, developing competencies, and disseminating up-to-date knowledge and best practices among healthcare professionals, taking into account modern challenges and needs. The plan includes a series of training events in various formats: from practical seminars to specialized thematic webinars. The events will be held both online and offline to ensure maximum accessibility for participants.
We look forward to your participation!
