Workshop "Availability of innovative medicines for oncology patients (i) in off-label mode"
Innovative medicines in oncology, support for academic clinical studies and off-label indications from the point of view of a clinical oncologist - these were, among other things, the topics of this year's workshop, organized for the seventh time in a row by the Masaryk Cancer Institute in cooperation with PharmAround endowment fund within the 43rd Brno Oncology days and 33rd Conference for non-medical health professionals, which are traditionally held in the congress pavilion of the Brno Exhibition Center.
This year's program opened with the topic of academic clinical studies in the field of oncology. The issue of support and implementation of studies in the Czech Republic was approached by the head of the department of clinical trials of the Masaryk Oncology Institute, doc. MUDr. Regina Demlova, PhD. The possibilities of using innovative designs of clinical studies in oncology were presented by Mgr. Adam Svobodnik, PhD. from Aixial. Mgr. Renata Hejnová, the coordinator of clinical trials at the Masaryk Institute of Oncology, brought an interesting look at the management of an academic clinical study thanks to her experience from the coordinator's practice.
The second block of the workshop was focused on the topic of oncological drugs in the off-label mode. Mgr. Irena Storová, director of the State Institute for Drug Control, presented the principles of the entry of innovative drugs into clinical practice, from the perspective of the state authority and the regulator. The historical context of the introduction of drugs into the clinical treatment of cancer patients was presented by doc. MUDr. Jana Prausová, PhD., MBA, Head of the Oncology Clinic of the 2nd Faculty of Medicine, Charles University and the University Hospital in Motol. Deputy Minister of Health, Mgr. Filip Vrubel supplemented the legislative framework for the entry of new drugs in the field of oncology, specifically the issue of the often mentioned paragraph 16, and promised the legislature to return this point to its original purpose. In the end, prof. MUDr. Jan Žaloudík, CSc, director of the Masaryk Cancer Institute, thus closing the discussion with experts and staff in oncology and other areas, thus concluding a pleasant meeting full of valuable information.
Mgr. Šárka Podolská, coordinator of the PharmAround endowment fund, tel: +420 739 663 639
The PharmAround Endowment Fund was established in January 2015 and its activities follow on from the successful project of the Medical Faculty of Masaryk University in Brno. Its aim is to raise awareness of drug life cycle issues through educational activities, in particular in relation to clinical trials, pharmacovigilance or pharmacoeconomic aspects. The endowment fund supports independent access to information and organizes professional courses, workshops and conferences for physicians, educators, researchers, students and the general public.