Pharmaceutical Regulatory Affairs

Biography

Biography: Vladimir Popov

Abstract

Over the last years a number of factors have an influence on the market of clinical trials and prompted changes. Drug developers tend to define intrinsic and extrinsic factors of interregional differences which can influence an outcome of international clinical trials. The increase in R&D costs should be taken into consideration because the activity of trials and developmental activity has been increasing over the last decade, but the number of new drugs’ approvals has officially decreased. Analysis of the results of inspections of FDA/EMA and Russian authorities over the last 5 years does not show an improvement in the quality of trials and clinical trials inspections by the IRB/IECs and Sponsor. The results of the FDA inspections related to the frequency of clinical investigator-related deficiencies based on post-inspection correspondence issued showed that the situation has not changed positively either; thus in 2011, out of 407 Domestic and Foreign inspections, 128 had findings (31%), and in 2014, out of 472 inspections - 171 (36%) had findings in the category “Protocol violations”. The above-mentioned factors influence the clinical trials' quality and require the compliance to quality standards from all parties who organize and conduct clinical trials. The risk-based management, that is, one of approaches to solving the problem, has been implemented on a wide-scale. On the part of the regulatory authorities (FDA/EMA), regulatory-procedures harmonization is being introduced. The number of risk-based inspections, co-inspections of FDA/EMA/Russian regulatory authorities, is increasing; the training of inspectors is being harmonized.