Purpose of the meeting – clarification of the impact of the new ICH E6 (R3) guideline "Good Clinical Practice" of 23 January 2025 on the work of commissions during clinical trials.
The event will be conducted by specialists of the Department of Expert Evaluation of Preclinical and Clinical Trial Materials and the Audit Department of the Center.
During the webinar, the following issues will be considered:
- Background for the revision of the ICH GCP E6 (R2) guideline, features of ICH GCP E6(R3).
- Impact of ICH GCP E6(R3) on the work of ethics commissions.
- Assessment of safety information of the investigational medicinal product and ICH GCP E6(R3) reporting.
- Typical remarks regarding the activities of Ethics Commissions at healthcare institutions (LEC) during clinical audits.
Approximate duration of the meeting – 2 hours.
Participation is free upon prior registration.
To get access, fill out the Google form https://forms.gle/UcDSqTp7HhcDTX2o6 on the official website of the Center or scan the QR code
Dear members of ethics commissions!
We invite you to join the preparation of the meeting and to express your proposals on current issues in the work of ethics commissions.
Please send your proposals to the email address: shemetilo@dec.gov.ua (Yurii Shemetyllo – Head of the Department for Coordination of the Work of Local Ethics Commissions and Monitoring of Adverse Reactions of the State Expert Center of the Ministry of Health of Ukraine), or to the email address: amsw@dec.gov.ua (Agency for Methodological and Scientific-Practical Work of the State Expert Center of the Ministry of Health of Ukraine).
