23 November, 2022
At the request of Professor Mayer, Head of the Internal Hematology and Oncology Clinic at the University Hospital Brno, the CZECRIN research infrastructure prepared a training on current topics related to clinical trials. The two-hour training for 18 clinic representatives took place on Tuesday, November 15, 2022, at the Institute of Pharmacology of the Faculty of Medicine of the Medical Faculty of Masaryk University.
The initial topic was “The Clinical Trials Regulation (EU Regulation 536/2014) and the CTIS system”. This regulation harmonizes the procedures for submitting, evaluating, and supervising clinical trials in the EU through the CTIS information portal. The second topic of the training then covered the requirements for conducting first-in-human (FIH) studies under the new legislation. The training was very interactive, with many questions and a rich discussion.