Aleksandr Stiblo, Deputy Director BD, and Maria Voynova, Clinical Research Associate, attended local russian conference dedicated to issues of preclinical and clinical studies of drugs, biomedical cell products and clinical trials of medical devices. The event took place in St. Petersburg on 10th and 11th of June, gathering together regulatory authorities, biopharma companies, ethical committees, investigators and contract research organizations.
Among the topics discussed were current issues in conducting clinical studies of medical products, devices and biomedical cell products. For instance, there was a discussion about clinical trials with adaptive designs and combined phase designs in Russia. Russian Regulatory Authority (Roszdravnadzor) shared latest insights about Sponsor/CRO risk-based inspection model.