Last Thursday, December 14th, Vladimir Seredyuk, MD, represented GCT Quality Assurance Department in Skolkovo Innovation Center. Networking with QA experts in the region is not only about meeting new prospect, but about sharing the best practices in this constantly developing field.
In his speech, Dr. Seredyuk shared his personal experience of passing the inspections of the FDA, EMA, Roszdravnadzor and the State Expert Center of the Ministry of Health of Ukraine.
All the participants of the forum demonstrated a very high professional level during the presentations and discussions. The statistics on the results of the findings of the regulatory inspections by the FDA, EMA, MHRA and Roszdravnadzor for year 2016 were presented and considerable attention was paid to the Risk-based Approach in the light of the requirements of the new edition of ICH GCP E6 (R2), the introduction of Risk-based Approach into real practice in the local market of clinical research, conducting audits in a hybrid monitoring model, risk-based approach to validation of electronic data. One of the presentations was devoted to the protection of personal data in the Russian Federation and the EU. Another important topic of discussion was on the achievement of the continuity of business. The forum showed the urgency for creating a professional organization of QA workers in Russia. A discussion was initiated to find solutions and will be continued on the electronic quality assurance forum (eaquality.org).