The common standard for planning, organizing and conducting clinical trials, as well as the design and presentation of their results are GCP standards and local regulatory requirements. Confident knowledge and understanding of the standards and related processes are the key to efficient and responsible implementation of all clinical trials participants functions.
On the basis of National University of Pharmacy (Kharkov) with the participation of State Enterprise «State Expert Center of Ministry of Health of Ukraine» training seminars «Good Clinical Practice (GCP). Legislative, regulatory requirements and ethical aspects of conducting clinical trials» are conducted regularly. The following issues are considered in the framework of the seminar:
- regulatory regulation of clinical trials;
- organizational issues of clinical trials;
- documents accompanying the clinical trial;
- ethical aspects of clinical trials;
- rights and duties of research ethics committees;
- ensuring the rights and safety of volunteers;
- duties of the researcher;
- responsibilities of the sponsor;
- monitoring, audit of clinical trial;
- preparation for clinical audit.
This training workshop is for you, if you are:
- the Principal Investigator or co-investigator in clinical trials;
- clinical trials coordinator;
- the head of the clinical site on the basis of which clinical trials are conducted or planned;
- the head of clinical and diagnostics laboratory / radiology department in a medical institution, on the basis of which clinical trials are conducted or planned;
- clinical trials monitor;
- planning to become a participant of clinical trial at any of its stages;
- interested in development of innovative medicines.
Mailing address: 27 Pushkinskaya Str., Kharkov, 61057, Ukraine
Useful link:Study Protocol Development